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27500.0 | 2014-04-17 00:00:00 UTC | Glaxo Looking into Misconduct Charges - Analyst Blog | ABBV | https://www.nasdaq.com/articles/glaxo-looking-into-misconduct-charges-analyst-blog-2014-04-17 | nan | nan | GlaxoSmithKline ( GSK ) recently responded to investigations and charges of misconduct in Jordan and Lebanon. Glaxo clarified that it is taking a number of steps to address the issue. The company disclosed that it is looking into allegations brought against some of its employees in these countries. For this, the company is using both internal and external teams. However, the investigations are not over yet.
We note that this is not a one-off misconduct charge surfacing at Glaxo. In 2013, there were a number of breaches in Glaxo's sales and marketing policies (161 violations), most of which resulted in written warnings (113) and even some dismissals (48).
Glaxo is also facing investigations and charges of fraudulent behavior and ethical misconduct leveled by Chinese government authorities. The investigation is still ongoing; it is likely that a number of employees working at Glaxo were engaged in fraudulent practices.
Our Take
We note that the Emerging Markets and Asia Pacific (EMAP) market - of which China and the Middle East/Africa are a part - contributed more than 25% to Glaxo's revenues in 2013.
We remind investors that Pharmaceuticals and Vaccines sales were adversely affected (by 4%) in 2013 due to the ongoing investigation in China. Revenues generated in China were down 18% in 2013. We are thus concerned about a potential decline in Glaxo's revenues in the Middle East/Africa region. Pharmaceuticals sales in the region were up 5% in 2013 to £1,018 million. We believe that any strict action enforced against Glaxo will impact the company's top line in the long term.
Glaxo currently holds a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include AbbVie Inc. ( ABBV ), Allergan Inc. ( AGN ) and Johnson & Johnson ( JNJ ). All three sport a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Some better-ranked stocks in the healthcare sector include AbbVie Inc. ( ABBV ), Allergan Inc. ( AGN ) and Johnson & Johnson ( JNJ ). ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. In 2013, there were a number of breaches in Glaxo's sales and marketing policies (161 violations), most of which resulted in written warnings (113) and even some dismissals (48). | Some better-ranked stocks in the healthcare sector include AbbVie Inc. ( ABBV ), Allergan Inc. ( AGN ) and Johnson & Johnson ( JNJ ). ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. Some better-ranked stocks in the healthcare sector include AbbVie Inc. ( ABBV ), Allergan Inc. ( AGN ) and Johnson & Johnson ( JNJ ). Glaxo is also facing investigations and charges of fraudulent behavior and ethical misconduct leveled by Chinese government authorities. | Some better-ranked stocks in the healthcare sector include AbbVie Inc. ( ABBV ), Allergan Inc. ( AGN ) and Johnson & Johnson ( JNJ ). ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. The investigation is still ongoing; it is likely that a number of employees working at Glaxo were engaged in fraudulent practices. |
27501.0 | 2014-04-17 00:00:00 UTC | Has A Streamlined FDA Raised The Value Of Drug Stocks? | ABBV | https://www.nasdaq.com/articles/has-streamlined-fda-raised-value-drug-stocks-2014-04-17 | nan | nan | Last month, three Democrats from the U.S. Congress sent a now-famous letter toGilead Sciences ( GILD ) questioning the $84,000 price of its new blockbuster hepatitis C medicine, Sovaldi. Among the reasons raising suspicions that the price didn't need to be that high: the speed with which Sovaldi was approved by the Food and Drug Administration.
"Gilead filed for and received a Priority Review and Breakthrough Therapy designation, which reduces the FDA review goal date from ten to six months," they wrote. Among the questions the lawmakers wanted Gilead to answer: What was "the value to the company of the expedited review"?
Wall Street has pondered that very question as drugmakers soared to the head of the market in a multiyear rally. Gilead wasn't alone in getting fast-tracked approval for its drugs.
According to data collected by wealth-management firm Robert W. Baird, in 2006 the average time it took for a drug to go through the approval process was 17.5 months. Last year, it was 13.2 months.
The rate of regulatory approvals on a new drug's first attempt has also increased sharply, from 56% to 89%. Many argue that the effect of turning new drugs into breadwinners more quickly and shortening an R&D cycle typically estimated at costing above $1 billion has also driven up the value of many drugmakers.
And it has added another talking point in the great debate between bulls and bears about the true value of drug stocks. This point pertains especially to biotechs which, even after the recent sell-off, are still collectively worth triple their value at this time in 2011. The issue is: Has a streamlined approval process permanently increased the pipeline productivity of drugmakers?
"I wouldn't use the word 'permanent,'" said Baird biotech analyst Christopher Raymond. "But is it fundamentally changed? Absolutely."
Legislate, Then Collaborate
Raymond says that the streamlining began with the Prescription Drug User Fee Act, or PDUFA, first passed in 1992, under which drugmakers pay a substantial fee to the FDA every time they submit a new drug application. In exchange, the FDA agreed to stick to certain performance benchmarks.
The rule change resulted from complaints made by AIDS activists about how long it was taking to get new medicines approved. But it took years for the process to bear fruit, as the bureaucracy restructured, using funds provided by the PDUFA.
"Not only did they reinvest (the funds) in review staff, but they reinvested into doing their own research and having better infrastructure to be able to collaborate with companies," Raymond said.
The most important collaboration for most companies is in clinical-trial design. This is especially important for the most innovative drugs out there, which can potentially be the biggest sellers.
"There are unique challenges to approving biologics," said Amitabh Chandra, director of health-policy research at the Harvard Kennedy School of Government. "In principle because they're so new, there's going to be a lot of procedural uncertainty on the part of approval panels in terms of what to ask for."
However, industry insiders say that the ground has shifted noticeably in the past decade. Jay Luly, CEO ofEnanta Pharmaceuticals ( ENTA ), testified to this shift when IBD interviewed him in December about the company's biologic drug, called a protease inhibitor, that is part ofAbbVie 's ( ABBV ) three-drug cocktail to treat hepatitis C. He said that when his company started investigating hepatitis C in the early 2000s, he wouldn't have imagined clinical trials like those that AbbVie conducted on the cocktail.
"The assumption was that you would get a protease approved as a single agent, and then you would do combinations with it once it was approved," Luly said.
A decade ago, Luly said, few in the industry envisioned the FDA as a constructive partner in exploring such combinations in the early stages of drug trials and testing.
"The way it's played out is probably much better than any of us had ever imagined," he said.
Assessing Survival Vs. Cure
Another important task for drugmakers and the FDA is coming up with meaningful clinical endpoints for the trials. In the case of hepatitis C, the endpoint has been "cure," but a lot of serious, chronic diseases can be improved by treatment even if they fall short of a cure. And in some cases, waiting to see if the patient can really be cured would take a long time.
Industry watchers say that this problem has led to more use of the progression-free-survival ( PFS ) metric in cancer-drug trials. The most obvious metric to use is overall survival. The metric gauges how much longer patients on the drug live compared to those who aren't on it. But cancer cases can linger for years, making the data costly in terms of time and funding.
Drugmakers continue to track overall, long-term survival in their trial subjects. But when patients on the drug survive significantly longer without their disease getting worse, it can make a valid substitute for FDA purposes.
"People are realizing that just using overall survival is way too risk-averse," said Chandra. "Patients die the longer and longer you wait. And there's value to just living longer with cancer while waiting for the next therapy."
It's still not totally clear how much weight the FDA affords to PFS, though. For instance, this month the biotech community has debated whetherPfizer ( PFE ) can file for approval based on phase-two data it reported April 6 on its breast-cancer drug palbociclib.
The drug showed an excellent PFS benefit of 10.2 months when compared with the control group. However, it did not show an overall-survival trend, which defenders pointed out would have been nearly impossible with a small patient group at this stage of the game.
Some analysts have been claiming that phase-two data is enough to file on. Others have stated that the FDA will probably need at least interim phase-three data. Pfizer has not yet decided whether to file.
Hazards Of Fast Tracking
Nonetheless, observers generally agree that the trend has been toward earlier approvals of drugs, especially potentially life-saving ones. In fact, a study published in the Journal of the American Medical Association in January found that 37% of the FDA's approvals between 2005 and 2012 -- of both new drugs and new uses for older drugs -- came after only one large, "pivotal" clinical trial, which typically means phase two.
That shortening of the process traces to programs created in the 1990s such as 1992's Accelerated Approval Program and 1998's Fast Track designation .
But along with its benefits, fast-tracking also carries hazards. For instance, in 2006 the FDA approvedRoche 's (RHHBY) blockbuster drug Avastin for breast cancer, based on a single trial. However, as results rolled out from subsequent trials, there was no apparent survival benefit, resulting in the FDA removing breast cancer from Avastin's label in 2011. (It's still sold for other uses.)
Analysts say that other scandals that erupted in the late 1990s and the early 2000s, around such drugs asGlaxoSmithKline 's (GSK) Avandia andMerck 's (MRK) Vioxx, led to at least a temporary backtrack in the trend toward faster approvals.
"By and large, immediately following Vioxx, and to a lesser degree Avandia, you saw the FDA pull its horns in a little," said Les Funtleyder, author of "Healthcare Investing." "The danger, which we kind of saw in the late '90s and the early 2000s, is (the expectation that) the FDA just rubber-stamps everything."
Raymond agrees that there was a "road bump," particularly after Mark McClellan, who was commissioner of the FDA from 2002 to 2004, was perceived by many as being too lenient.
"It's possible that if we were to see a similar situation of a bigger magnitude, the FDA would pull back," he said. "But I think the science behind what FDA has done is so much more rigorous now, it's hard to see what that could be."
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Jay Luly, CEO ofEnanta Pharmaceuticals ( ENTA ), testified to this shift when IBD interviewed him in December about the company's biologic drug, called a protease inhibitor, that is part ofAbbVie 's ( ABBV ) three-drug cocktail to treat hepatitis C. He said that when his company started investigating hepatitis C in the early 2000s, he wouldn't have imagined clinical trials like those that AbbVie conducted on the cocktail. A decade ago, Luly said, few in the industry envisioned the FDA as a constructive partner in exploring such combinations in the early stages of drug trials and testing. For instance, this month the biotech community has debated whetherPfizer ( PFE ) can file for approval based on phase-two data it reported April 6 on its breast-cancer drug palbociclib. | Jay Luly, CEO ofEnanta Pharmaceuticals ( ENTA ), testified to this shift when IBD interviewed him in December about the company's biologic drug, called a protease inhibitor, that is part ofAbbVie 's ( ABBV ) three-drug cocktail to treat hepatitis C. He said that when his company started investigating hepatitis C in the early 2000s, he wouldn't have imagined clinical trials like those that AbbVie conducted on the cocktail. But cancer cases can linger for years, making the data costly in terms of time and funding. For instance, this month the biotech community has debated whetherPfizer ( PFE ) can file for approval based on phase-two data it reported April 6 on its breast-cancer drug palbociclib. | Jay Luly, CEO ofEnanta Pharmaceuticals ( ENTA ), testified to this shift when IBD interviewed him in December about the company's biologic drug, called a protease inhibitor, that is part ofAbbVie 's ( ABBV ) three-drug cocktail to treat hepatitis C. He said that when his company started investigating hepatitis C in the early 2000s, he wouldn't have imagined clinical trials like those that AbbVie conducted on the cocktail. Legislate, Then Collaborate Raymond says that the streamlining began with the Prescription Drug User Fee Act, or PDUFA, first passed in 1992, under which drugmakers pay a substantial fee to the FDA every time they submit a new drug application. In fact, a study published in the Journal of the American Medical Association in January found that 37% of the FDA's approvals between 2005 and 2012 -- of both new drugs and new uses for older drugs -- came after only one large, "pivotal" clinical trial, which typically means phase two. | Jay Luly, CEO ofEnanta Pharmaceuticals ( ENTA ), testified to this shift when IBD interviewed him in December about the company's biologic drug, called a protease inhibitor, that is part ofAbbVie 's ( ABBV ) three-drug cocktail to treat hepatitis C. He said that when his company started investigating hepatitis C in the early 2000s, he wouldn't have imagined clinical trials like those that AbbVie conducted on the cocktail. Cure Another important task for drugmakers and the FDA is coming up with meaningful clinical endpoints for the trials. But cancer cases can linger for years, making the data costly in terms of time and funding. |
27502.0 | 2014-04-17 00:00:00 UTC | Roche Meets Sales Estimates in Q1 - Analyst Blog | ABBV | https://www.nasdaq.com/articles/roche-meets-sales-estimates-in-q1-analyst-blog-2014-04-17 | nan | nan | Roche's ( RHHBY ) sales for the first quarter of 2014 came in at CHF 11.5 billion, up 5% from a year ago. In terms of dollars, sales of $13.0 billion were in line with the Zacks Consensus Estimate.
All growth rates mentioned below are on a year-over-year basis and at constant exchange rates.
Quarter in Detail
Sales in the first quarter were driven by solid demand for its recently launched drugs, Perjeta and Kadcyla, for HER2-positive breast cancer and rheumatoid arthritis drug Actemra/RoActemra.
Roche reports business in two divisions: Pharmaceuticals and Diagnostics.
Sales of the Pharmaceuticals division increased 4% to CHF 9.0 billion, driven by strong sales of oncology drugs.
Sales of the HER2 breast cancer franchise, which consists of Herceptin, Perjeta and Kadcyla, increased 17%. The franchise was boosted by key approvals in 2013 - Kadcyla in the U.S. and EU and Perjeta in the EU. The sharp rise in Avastin sales (+9%) was due to its strong demand for the treatment of advanced ovarian cancer in Europe, and colorectal cancer in the U.S. and Europe. Demand for blood cancer and rheumatoid arthritis drug MabThera/Rituxan (+3%) was also strong.
Roche's immunology and ophthalmology franchise continue to gain traction. Sales of Actemra/RoActemra were up 23%. Lucentis, indicated for wet age-related macular degeneration (AMD), was up 8%.
However, sales of chemotherapy drug Xeloda were lower due to the generic competition in the U.S. and Europe.
Revenues from the Diagnostics division went up 7% to CHF 2.4 billion driven by solid performance of the Professional diagnostics (+9%) unit and Molecular diagnostics (+4%). Diabetes Care sales increased 5% despite a continued challenging and volatile market environment while Tissue Diagnostics grew 4%. The recent acquisition of IQuum will further strengthen Roche's molecular diagnostics market portfolio.
2014 Outlook
Roche expects sales in 2014 to increase in the low to mid-single digits. The company expects core earnings per share to grow at a higher rate than sales in 2014. Roche intends to further increase its dividend in 2014. We note that the Board of Directors approved a 6% dividend increase to CHF 7.80 per share in Mar 2014.
Pipeline Update
During the first quarter of 2014, the subcutaneous formulation of MabThera was approved in Europe.
The U.S. Food and Drug Administration (FDA) approved Xolair for an additional indication. Xolair is now approved in the U.S. for the treatment of chronic idiopathic urticaria (CIU), in adults and adolescents (12 years and above) with inadequate response to H1-antihistamine treatment. We note that Novartis ( NVS ) licensed Xolair from Roche. Roche markets Xolair in the U.S.
However, Roche suffered a few setbacks also in the quarter. Roche's three phase III studies on schizophrenia candidate bitopertin did not meet their primary endpoints and hence were discontinued. Consequently, Roche conducted futility analyses on the three remaining phase III studies on bitopertin and decided to discontinue two of those studies and continue with just one study (NightLyte).
Moreover, a phase III study on lung cancer candidate onartuzumab was also stopped in the quarter due to a lack of clinically meaningful efficacy. Nevertheless, Roche's investigational immunotherapy candidate for lung cancer, anti-PDL1 (RG7446), moved into phase III.
Our Take
We are encouraged by Roche's first quarter performance. The oncology portfolio looks solid as ever and we expect further traction in 2014. We are also impressed by the company's efforts to grow its portfolio beyond oncology to immunology and ophthalmology.
However, Roche expects to face generic competition for key drugs - Valcyte and Xeloda - in 2014. The loss from the entry of generics for the overall portfolio in 2014 is estimated at CHF1 billion.
Roche currently carries a Zacks Rank #3 (Hold). Investors may consider other large cap pharmas like Allergan ( AGN ) and AbbVie ( ABBV ). Both carry a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Investors may consider other large cap pharmas like Allergan ( AGN ) and AbbVie ( ABBV ). ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report To read this article on Zacks.com click here. Diabetes Care sales increased 5% despite a continued challenging and volatile market environment while Tissue Diagnostics grew 4%. | ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report To read this article on Zacks.com click here. Investors may consider other large cap pharmas like Allergan ( AGN ) and AbbVie ( ABBV ). Quarter in Detail Sales in the first quarter were driven by solid demand for its recently launched drugs, Perjeta and Kadcyla, for HER2-positive breast cancer and rheumatoid arthritis drug Actemra/RoActemra. | ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report To read this article on Zacks.com click here. Investors may consider other large cap pharmas like Allergan ( AGN ) and AbbVie ( ABBV ). Quarter in Detail Sales in the first quarter were driven by solid demand for its recently launched drugs, Perjeta and Kadcyla, for HER2-positive breast cancer and rheumatoid arthritis drug Actemra/RoActemra. | Investors may consider other large cap pharmas like Allergan ( AGN ) and AbbVie ( ABBV ). ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report To read this article on Zacks.com click here. Quarter in Detail Sales in the first quarter were driven by solid demand for its recently launched drugs, Perjeta and Kadcyla, for HER2-positive breast cancer and rheumatoid arthritis drug Actemra/RoActemra. |
27503.0 | 2014-04-16 00:00:00 UTC | ITOT, QCOM, MCD, ABBV: Large Outflows Detected at ETF | ABBV | https://www.nasdaq.com/articles/itot-qcom-mcd-abbv-large-outflows-detected-etf-2014-04-16 | nan | nan | Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the iShares Core S&P Total U.S. Stock Market ETF (Symbol: ITOT) where we have detected an approximate $33.7 million dollar outflow -- that's a 2.9% decrease week over week (from 13,850,000 to 13,450,000). Among the largest underlying components of ITOT, in trading today Qualcomm, Inc. (Symbol: QCOM) is up about 0.3%, McDonald's Corp (Symbol: MCD) is down about 0.1%, and AbbVie Inc. (Symbol: ABBV) is up by about 0.1%. The chart below shows the one year price performance of ITOT, versus its 200 day moving average:
Looking at the chart above, ITOT's low point in its 52 week range is $69.94 per share, with $87.00 as the 52 week high point - that compares with a last trade of $84.74. Comparing the most recent share price to the 200 day moving average can also be a useful technical analysis technique -- learn more about the 200 day moving average » .
Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). Creation of new units will mean the underlying holdings of the ETF need to be purchased, while destruction of units involves selling underlying holdings, so large flows can also impact the individual components held within ETFs.
Click here to find out which 9 other ETFs experienced notable outflows »
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Among the largest underlying components of ITOT, in trading today Qualcomm, Inc. (Symbol: QCOM) is up about 0.3%, McDonald's Corp (Symbol: MCD) is down about 0.1%, and AbbVie Inc. (Symbol: ABBV) is up by about 0.1%. The chart below shows the one year price performance of ITOT, versus its 200 day moving average: Looking at the chart above, ITOT's low point in its 52 week range is $69.94 per share, with $87.00 as the 52 week high point - that compares with a last trade of $84.74. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. | Among the largest underlying components of ITOT, in trading today Qualcomm, Inc. (Symbol: QCOM) is up about 0.3%, McDonald's Corp (Symbol: MCD) is down about 0.1%, and AbbVie Inc. (Symbol: ABBV) is up by about 0.1%. The chart below shows the one year price performance of ITOT, versus its 200 day moving average: Looking at the chart above, ITOT's low point in its 52 week range is $69.94 per share, with $87.00 as the 52 week high point - that compares with a last trade of $84.74. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). | Among the largest underlying components of ITOT, in trading today Qualcomm, Inc. (Symbol: QCOM) is up about 0.3%, McDonald's Corp (Symbol: MCD) is down about 0.1%, and AbbVie Inc. (Symbol: ABBV) is up by about 0.1%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the iShares Core S&P Total U.S. Stock Market ETF (Symbol: ITOT) where we have detected an approximate $33.7 million dollar outflow -- that's a 2.9% decrease week over week (from 13,850,000 to 13,450,000). The chart below shows the one year price performance of ITOT, versus its 200 day moving average: Looking at the chart above, ITOT's low point in its 52 week range is $69.94 per share, with $87.00 as the 52 week high point - that compares with a last trade of $84.74. | Among the largest underlying components of ITOT, in trading today Qualcomm, Inc. (Symbol: QCOM) is up about 0.3%, McDonald's Corp (Symbol: MCD) is down about 0.1%, and AbbVie Inc. (Symbol: ABBV) is up by about 0.1%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the iShares Core S&P Total U.S. Stock Market ETF (Symbol: ITOT) where we have detected an approximate $33.7 million dollar outflow -- that's a 2.9% decrease week over week (from 13,850,000 to 13,450,000). The chart below shows the one year price performance of ITOT, versus its 200 day moving average: Looking at the chart above, ITOT's low point in its 52 week range is $69.94 per share, with $87.00 as the 52 week high point - that compares with a last trade of $84.74. |
27504.0 | 2014-04-16 00:00:00 UTC | Glaxo's Tanzeum Approved in the U.S. - Analyst Blog | ABBV | https://www.nasdaq.com/articles/glaxos-tanzeum-approved-in-the-u.s.-analyst-blog-2014-04-16 | nan | nan | GlaxoSmithKline 's ( GSK ) diabetes drug, (EU trade name: Eperzan), gained approval in the U.S. as an adjunct to diet and exercise in adults suffering from type II diabetes.
The U.S. Food and Drug Administration (FDA) approved Tanzeum, a glucagon-like peptide-1 receptor agonist (GLP-1), on the basis of encouraging data from eight phase III trials. Glaxo expects to launch the once-weekly drug in the U.S. in the third quarter of this year.
We remind investors that last month Tanzeum was also approved by the European Medicines Agency. Glaxo expects to launch the drug in the third and fourth quarters of this year in several countries in Europe. Launches are expected to continue thereafter in other European countries.
However, Tanzeum's label will include a boxed warning regarding potential risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). Use of GLP-1 receptor agonists have been found (at clinically relevant exposures) to be associated with thyroid C-cell tumors in rodent studies.
The FDA has requested Glaxo to conduct additional post-marketing studies on Tanzeum evaluating the risk of MTC. The FDA has also asked for a study evaluating the use of the drug in pediatric patients and a cardiovascular outcomes trial.
Meanwhile, Tanzeum has been approved with a Risk Evaluation and Mitigation Strategy with communication plan regarding serious risks associated with Tanzeum.
Our Take
Type II diabetes affects approximately 24 million people in the U.S., thus representing a lucrative market. Tanzeum's once-weekly treatment regimen for type II diabetes provides patients with a more convenient treatment option over the daily dosing regime of GLP-1 products including Novo Nordisk 's ( NVO ) Victoza among others.
However, we are concerned about the potential MTC related risks associated with Tanzeum. We believe this can limit the drug's sales significantly.
Additionally, we note that AstraZeneca ( AZN ) already markets Bydureon, a GLP-1 receptor agonist with once weekly dosing. Apart from that, several big pharma companies have GLP-1 candidates (semaglutide) with once weekly dosing in late-stage development.
Glaxo carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector includes AbbVie Inc. ( ABBV ), carrying a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | A better-ranked stock in the healthcare sector includes AbbVie Inc. ( ABBV ), carrying a Zacks Rank #2 (Buy). ABBVIE INC (ABBV): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report To read this article on Zacks.com click here. The U.S. Food and Drug Administration (FDA) approved Tanzeum, a glucagon-like peptide-1 receptor agonist (GLP-1), on the basis of encouraging data from eight phase III trials. | A better-ranked stock in the healthcare sector includes AbbVie Inc. ( ABBV ), carrying a Zacks Rank #2 (Buy). ABBVIE INC (ABBV): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report To read this article on Zacks.com click here. However, Tanzeum's label will include a boxed warning regarding potential risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). | ABBVIE INC (ABBV): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report To read this article on Zacks.com click here. A better-ranked stock in the healthcare sector includes AbbVie Inc. ( ABBV ), carrying a Zacks Rank #2 (Buy). Meanwhile, Tanzeum has been approved with a Risk Evaluation and Mitigation Strategy with communication plan regarding serious risks associated with Tanzeum. | A better-ranked stock in the healthcare sector includes AbbVie Inc. ( ABBV ), carrying a Zacks Rank #2 (Buy). ABBVIE INC (ABBV): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report To read this article on Zacks.com click here. Glaxo expects to launch the once-weekly drug in the U.S. in the third quarter of this year. |
27505.0 | 2014-04-15 00:00:00 UTC | Will Abbott Labs (ABT) Disappoint This Quarter? - Analyst Blog | ABBV | https://www.nasdaq.com/articles/will-abbott-labs-abt-disappoint-this-quarter-analyst-blog-2014-04-15 | nan | nan | Abbott Laboratories ( ABT ) is scheduled to report first quarter 2014 results before the opening bell on Apr 16, 2014.
Last quarter, Abbott Labs reported break-even earnings. On an average, Abbott Labs has posted a 6.20% positive surprise in the last four quarters. Let's see how things are shaping up for the first quarter.
Factors to Influence 1Q Results
Abbott Labs is an extremely diversified company with its presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013.
However, the business environment continues to be challenging due to austerity measures in developed markets and weak economic conditions in the developing markets.
Moreover, we were disappointed by the disruption in international nutrition sales in the third quarter of 2013. The disruption is likely to stretch into the first half of 2014. The nutrition division is the company's fastest growing business and hence a disruption in business will impact growth rates going forward.
Nevertheless, the Medical Devices and Diagnostics business look promising.
Earnings Whispers?
Our proven model does not conclusively show that Abbott Labs will beat earnings this quarter. That is because a stock needs to have both a positive Earnings ESP and a Zacks Rank #1, #2 or #3 to be able to beat consensus estimates. That is not the case here as you will see below.
Zacks ESP : The ESP, which represents the difference between the Most Accurate estimate and the Zacks Consensus Estimate, is -2.86%. This is because both the Most Accurate Estimate currently stands at 34 cents while the Zacks Consensus Estimate currently stands at 35 cents.
Zacks Rank #3 (Hold): Abbott Labs' Zacks Rank #3 (Hold) lowers the predictive power of ESP because the Zacks Rank #3 when combined with a negative ESP makes surprise prediction difficult.
We caution against stocks with Zacks Ranks #4 and #5 (Sell-rated stocks) going into the earnings announcement, especially when the company is seeing negative estimate revisions.
Stocks to Consider
Here are some other stocks in the broader healthcare sector that you may want to consider as our model shows that these have the right combination of elements to post an earnings beat this season:
Biogen Idec Inc. ( BIIB ) has an Earnings ESP of +8.14% and holds a Zacks Rank #3 (Hold). Biogen will be reporting first quarter results on Apr 23.
Shire ( SHPG ) has an Earnings ESP of +1.79% and holds a Zacks Rank #2 (Buy). Shire will report first quarter results on May 1.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Factors to Influence 1Q Results Abbott Labs is an extremely diversified company with its presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Laboratories ( ABT ) is scheduled to report first quarter 2014 results before the opening bell on Apr 16, 2014. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. Factors to Influence 1Q Results Abbott Labs is an extremely diversified company with its presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013. Zacks Rank #3 (Hold): Abbott Labs' Zacks Rank #3 (Hold) lowers the predictive power of ESP because the Zacks Rank #3 when combined with a negative ESP makes surprise prediction difficult. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. Factors to Influence 1Q Results Abbott Labs is an extremely diversified company with its presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013. Zacks Rank #3 (Hold): Abbott Labs' Zacks Rank #3 (Hold) lowers the predictive power of ESP because the Zacks Rank #3 when combined with a negative ESP makes surprise prediction difficult. | Factors to Influence 1Q Results Abbott Labs is an extremely diversified company with its presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. Last quarter, Abbott Labs reported break-even earnings. |
27506.0 | 2014-04-15 00:00:00 UTC | Bristol-Myers Seeks Approval for HIV Combo Drug - Analyst Blog | ABBV | https://www.nasdaq.com/articles/bristol-myers-seeks-approval-for-hiv-combo-drug-analyst-blog-2014-04-15 | nan | nan | Bristol-Myers Squibb Company ( BMY ) announced that it has filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) earlier in the month (Apr 4, 2014) seeking approval for a fixed-dose combination of its established HIV treatment Reyataz (atazanavir sulfate) and Gilead Sciences ' ( GILD ) cobicistat for treating the virus. While Reyataz is a protease inhibitor, Cobicistat is a boosting agent -- the addition of which increases the efficacy of certain HIV-1 therapies by elevating their levels in the blood.
Bristol-Myers is looking to get the once-daily, single tablet fixed-dose combination approved in conjunction with other antiretroviral agents for the treatment of HIV-1 infection. Approval of the cocktail treatment would simplify matters for HIV-1 patients by eliminating the need to take a boosting agent in a separate tablet.
Bristol-Myers stated in its press release that Reyataz is the only protease inhibitor to be studied in combination with cobicistat in a randomized, phase III study (Gilead's study 114). The double-blind study compared the efficacy and safety of cobicistat-boosted Reyataz with Reyataz boosted by AbbVie 's ( ABBV ) HIV therapy Norvir (ritonavir) over 48 weeks in treatment naïve HIV infected adults. We believe investors will certainly look forward to further updates on the fixed-dose combination therapy.
We remind investors that Bristol-Myers and Gilead teamed up in 2011 developing and commercializing the once-daily, single tablet fixed-dose combination. According to the deal, Bristol-Myers is responsible for the formulation, manufacturing, registration, distribution and commercialization of the cocktail therapy across the globe. Gilead is exclusively responsible for the manufacture, development and commercialization of cobicistat as a stand-alone therapy and for use in combination with other agents.
Bristol-Myers, a biopharmaceutical company, carries a Zacks Rank #2 (Buy). A better-ranked stock in the biopharma space is Regeneron Pharmaceuticals ( REGN ), carrying a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | The double-blind study compared the efficacy and safety of cobicistat-boosted Reyataz with Reyataz boosted by AbbVie 's ( ABBV ) HIV therapy Norvir (ritonavir) over 48 weeks in treatment naïve HIV infected adults. ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report To read this article on Zacks.com click here. Bristol-Myers Squibb Company ( BMY ) announced that it has filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) earlier in the month (Apr 4, 2014) seeking approval for a fixed-dose combination of its established HIV treatment Reyataz (atazanavir sulfate) and Gilead Sciences ' ( GILD ) cobicistat for treating the virus. | ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report To read this article on Zacks.com click here. The double-blind study compared the efficacy and safety of cobicistat-boosted Reyataz with Reyataz boosted by AbbVie 's ( ABBV ) HIV therapy Norvir (ritonavir) over 48 weeks in treatment naïve HIV infected adults. Bristol-Myers is looking to get the once-daily, single tablet fixed-dose combination approved in conjunction with other antiretroviral agents for the treatment of HIV-1 infection. | ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report To read this article on Zacks.com click here. The double-blind study compared the efficacy and safety of cobicistat-boosted Reyataz with Reyataz boosted by AbbVie 's ( ABBV ) HIV therapy Norvir (ritonavir) over 48 weeks in treatment naïve HIV infected adults. Bristol-Myers Squibb Company ( BMY ) announced that it has filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) earlier in the month (Apr 4, 2014) seeking approval for a fixed-dose combination of its established HIV treatment Reyataz (atazanavir sulfate) and Gilead Sciences ' ( GILD ) cobicistat for treating the virus. | The double-blind study compared the efficacy and safety of cobicistat-boosted Reyataz with Reyataz boosted by AbbVie 's ( ABBV ) HIV therapy Norvir (ritonavir) over 48 weeks in treatment naïve HIV infected adults. ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report To read this article on Zacks.com click here. Bristol-Myers is looking to get the once-daily, single tablet fixed-dose combination approved in conjunction with other antiretroviral agents for the treatment of HIV-1 infection. |
27507.0 | 2014-04-15 00:00:00 UTC | Repros Completes Enrollment for Androxal Study - Analyst Blog | ABBV | https://www.nasdaq.com/articles/repros-completes-enrollment-for-androxal-study-analyst-blog-2014-04-15 | nan | nan | Repros Therapeutics Inc. ( RPRX ) announced it has completed enrollment for one of the two head-to-head studies on its secondary hypogonadism candidate, Androxal.
The two identical, 17-week, double-blind studies will compare the safety and efficacy of Androxal with a testosterone replacement therapy (topical gel) and placebo in restoring and maintaining testicular function. The primary endpoint of the study is to find if Androxal is superior to both placebo and the topical gel based on normal testosterone levels and normal sperm concentrations achieved by patients.
While the first study (ZA-305) enrolled 120 men, the second study (ZA-304) will also enroll the same number of patients. The enrollment process for ZA-304 is expected to be completed in the next few weeks.
Top-line data from the studies are expected by Oct 2014. Repros plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2014.
We note that earlier this year, Repros had announced the outcome of its meeting with the FDA. The meeting was held to discuss phase III data requirements to file an NDA for Androxal. Following the meeting, the company came to the conclusion that no additional safety studies would be required to support the NDA submission of Androxal. The safety of Androxal will stand on its own merit during NDA review.
Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel.
Repros currently carries a Zacks Rank #4 (Sell). We expect investor focus to remain on Androxal updates. Some better-ranked biopharma stocks include Regeneron Pharmaceuticals, Inc. ( REGN ) and Amgen Inc. ( AMGN ), both carrying a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Repros Therapeutics Inc. ( RPRX ) announced it has completed enrollment for one of the two head-to-head studies on its secondary hypogonadism candidate, Androxal. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Some better-ranked biopharma stocks include Regeneron Pharmaceuticals, Inc. ( REGN ) and Amgen Inc. ( AMGN ), both carrying a Zacks Rank #1 (Strong Buy). | ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. Repros Therapeutics Inc. ( RPRX ) announced it has completed enrollment for one of the two head-to-head studies on its secondary hypogonadism candidate, Androxal. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Repros Therapeutics Inc. ( RPRX ) announced it has completed enrollment for one of the two head-to-head studies on its secondary hypogonadism candidate, Androxal. |
27508.0 | 2014-04-14 00:00:00 UTC | Will Johnson & Johnson (JNJ) Miss This Earnings Season? - Analyst Blog | ABBV | https://www.nasdaq.com/articles/will-johnson-johnson-jnj-miss-this-earnings-season-analyst-blog-2014-04-14 | nan | nan | Johnson & Johnson ( JNJ ) is scheduled to report first quarter 2014 results before the opening bell on Apr 15. Last quarter, Johnson & Johnson had posted an earnings surprise of +3.33%. Let's see how things are shaping up for this announcement.
Factors at Play
Johnson & Johnson has delivered positive earnings surprises in the last four quarters with an average beat of 3.75%.
Although revenues will continue to be impacted by genericization, the strong performance of the pharmaceuticals segment especially products like Remicade, Zytiga, Prezista, Invokana, Stelara, Intelence, Xarelto, Simponi, Velcade and Invega Sustenna should partially offset the negative impact of genericization.
Meanwhile, pricing pressure, manufacturing issues and the U.S. healthcare reform measures will affect the bottom line.
Earnings Whispers?
Our proven model does not conclusively show that Johnson & Johnson is likely to beat earnings this quarter. That is because a stock needs to have both a positive Earnings ESP (Expected Surprise Prediction) and a Zacks Rank of #1, 2 or 3 for this to happen. That is not the case here as you will see below.
Zacks ESP: The Earnings ESP for Johnson & Johnson is 0.00% since the Most Accurate Estimate stands at $1.48, in line with the Zacks Consensus Estimate.
Zacks Rank #2 (Buy): Johnson & Johnson's Zacks Rank #2 has little effect on the predictive power of ESP because the Zacks Rank #2 when combined with a 0.00% ESP makes surprise prediction difficult.
Other Stocks to Consider
Here are some other companies you may want to consider as our model shows that they have the right combination of elements, that is, a positive Zacks Earnings ESP and a Zacks Rank #1, 2 or 3.
Biogen Idec Inc. ( BIIB ) has an Earnings ESP of +8.14% and holds a Zacks Rank #3 (Hold). Biogen will be reporting first quarter results on Apr 23.
AbbVie Inc. ( ABBV ) has an Earnings ESP of +1.47% and holds a Zacks Rank #3. AbbVie will report first quarter results on Apr 25.
Cubist Pharmaceuticals Inc. ( CBST ) has an Earnings ESP of +5.56% and holds a Zacks Rank #3. Cubist will be reporting first quarter results on Apr 22.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc. ( ABBV ) has an Earnings ESP of +1.47% and holds a Zacks Rank #3. AbbVie will report first quarter results on Apr 25. ABBVIE INC (ABBV): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. | ABBVIE INC (ABBV): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) has an Earnings ESP of +1.47% and holds a Zacks Rank #3. AbbVie will report first quarter results on Apr 25. | ABBVIE INC (ABBV): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) has an Earnings ESP of +1.47% and holds a Zacks Rank #3. AbbVie will report first quarter results on Apr 25. | ABBVIE INC (ABBV): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) has an Earnings ESP of +1.47% and holds a Zacks Rank #3. AbbVie will report first quarter results on Apr 25. |
27509.0 | 2014-04-14 00:00:00 UTC | Hard-to-Cure Patients May Benefit from Merck's HCV Drug - Analyst Blog | ABBV | https://www.nasdaq.com/articles/hard-to-cure-patients-may-benefit-from-mercks-hcv-drug-analyst-blog-2014-04-14 | nan | nan | Merck ( MRK ) presented interim data from an ongoing phase II study on its once-daily, all-oral hepatitis C virus (HCV) combination regimen - MK-5172 (a NS3/4A protease inhibitor) and MK-8742 (a NS5A replication complex inhibitor). The additional data was presented at the annual meeting of the European Association for the Study of the Liver (EASL).
The randomized, dose-responsive, parallel-group, multiple-site, double-blind, phase II C-WORTHy study is evaluating the efficacy and safety of MK-5172/MK-8742 in patients with chronic HCV genotype 1 infection (GT1). Interim analysis revealed that impressive sustained virologic response rates (SVR) were observed for 12 or 18 weeks after 4 to 8 weeks of completion of therapy in hard-to-cure patients. Hard-to-cure patients include first-line patients with liver cirrhosis, prior-null responder patients with and without cirrhosis and patients with HIV/HCV co-infection.
The study assessed MK-5172 plus MK-8742 in different patient populations for different treatment durations with or without ribavirin (RBV). SVR rates for 12 and 18 weeks in treatment-naïve cirrhotic patients were 97% (both) in the MK-5172/MK-8742 arm as compared to 90% and 97%, respectively, in patients who received MK-5172/MK-8742 plus RBV.
SVR rates for 12 and 18 weeks in prior-null responder patients were higher in MK-5172/MK-8742 plus RBV arm (94% and 100%, respectively) as compared to the MK-5172/MK-8742 arm (91% and 97%, respectively). 12-weeks SVR rate in treatment-naïve, non-cirrhotic patients with HCV/HIV co-infection treated with MK-5172/MK-8742 was 90% and MK-5172/MK-8742 plus RBV was 97%.
Based on encouraging data from phase II studies, Merck has initiated a phase III program, C-EDGE, which will evaluate the safety and efficacy of MK-5172/MK-8742 with and without RBV in several genotypes and a range of patient populations with chronic HCV.
Our Take
We are pleased with the string of positive data presented by Merck on its investigational HCV therapy. We believe that it has a good chance of gaining approval based on high response rates. A new successful HCV treatment would provide a boost to Merck's sales. We note that Merck's HCV drug, Victrelis, recorded revenues of $428 million (down 15%) in 2013.
Several companies are working on getting their all-oral treatment regimens for HCV patients with GT1 in the market. Gilead Sciences Inc. ( GILD ) is looking to get its once-daily fixed-dose HCV cocktail treatment, ledipasvir plus Sovaldi, approved in the U.S. The company has already submitted a marketing application to the FDA. Meanwhile, Bristol-Myers Squibb Company ( BMY ) is not far behind. A few days back, the company submitted a marketing application for its all-oral combination of daclatasvir and asunaprevir. The FDA has granted Breakthrough Therapy designation to the combination. AbbVie Inc. ( ABBV ) is also developing an oral investigational fixed-dose combination regimen (phase III) targeting this lucrative market. We believe that apart from efficacy and safety, dosing and pricing will play crucial roles in determining the winner.
Merck currently carries a Zacks Rank #3 (Hold). Bristol-Myers is a better-ranked stock with a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc. ( ABBV ) is also developing an oral investigational fixed-dose combination regimen (phase III) targeting this lucrative market. ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. The randomized, dose-responsive, parallel-group, multiple-site, double-blind, phase II C-WORTHy study is evaluating the efficacy and safety of MK-5172/MK-8742 in patients with chronic HCV genotype 1 infection (GT1). | ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) is also developing an oral investigational fixed-dose combination regimen (phase III) targeting this lucrative market. Merck ( MRK ) presented interim data from an ongoing phase II study on its once-daily, all-oral hepatitis C virus (HCV) combination regimen - MK-5172 (a NS3/4A protease inhibitor) and MK-8742 (a NS5A replication complex inhibitor). | ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) is also developing an oral investigational fixed-dose combination regimen (phase III) targeting this lucrative market. Hard-to-cure patients include first-line patients with liver cirrhosis, prior-null responder patients with and without cirrhosis and patients with HIV/HCV co-infection. | AbbVie Inc. ( ABBV ) is also developing an oral investigational fixed-dose combination regimen (phase III) targeting this lucrative market. ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. Merck ( MRK ) presented interim data from an ongoing phase II study on its once-daily, all-oral hepatitis C virus (HCV) combination regimen - MK-5172 (a NS3/4A protease inhibitor) and MK-8742 (a NS5A replication complex inhibitor). |
27510.0 | 2014-04-11 00:00:00 UTC | Encouraging Data from Bristol-Myers - Analyst Blog | ABBV | https://www.nasdaq.com/articles/encouraging-data-from-bristol-myers-analyst-blog-2014-04-11 | nan | nan | Bristol-Myers Squibb Company ( BMY ) announced encouraging data from a phase III study (Hallmark-Dual: n>700) which evaluated the combination of daclatasvir (DCV: a NS5A inhibitor) and asunaprevir (ASV: a NS3 inhibitor) over 24 weeks in patients infected with genotype 1b version of hepatitis C virus (HCV). The combination is an all-oral, interferon and ribavirin-free regimen.
The percentage of patients who achieved sustained virologic response at 12 weeks after the completion of the treatment (SVR12) by the combination constituted the primary end point of the multinational study. Data from the study revealed that 90% treatment naïve patients achieved SVR12. The primary objective was met by 82% patients who failed to respond to peginterferon/ribavirin therapy. Similarly, 82% patients, who could not tolerate peginterferon/ribavirin therapy, achieved SVR12. Moreover, SVR12 rates were found to be roughly similar in cirrhotic (84%) and non-cirrhotic (85%) patients.
Bristol-Myers said that data from the Hallmark-Dual study formed part of the package on the basis of which the company sought U.S. approval for the combination earlier in the week. We note that Bristol-Myers is looking to get DCV approved in the EU as well in combination with other agents for treating adults suffering from HCV with compensated liver disease, inclusive of genotypes 1, 2, 3, and 4. The application is under accelerated review in the EU.
Bristol-Myers is also looking to get the combination of DCV and ASV approved in Japan for treating adults suffering from genotype 1b version of HCV. The patients were either ineligible for or intolerant to interferon therapy or non-responders to the same. Data from the Hallmark-Dual study was comparable to the phase III study results on the cocktail therapy, which formed the basis of the submission of the marketing application in that country.
Bristol-Myers stated in its press release that HCV affects approximately 170 million patients worldwide with a significant number being affected by the disease in the EU alone. The prevalence of genotype 1b HCV patients is high in the EU.
Apart from Bristol-Myers, companies such as Gilead Sciences ( GILD ) and AbbVie ( ABBV ) are also developing all-oral, interferon and ribavirin-free HCV therapies.
Bristol-Myers currently carries a Zacks Rank #2 (Buy). Amgen ( AMGN ) is a better-ranked stock with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Apart from Bristol-Myers, companies such as Gilead Sciences ( GILD ) and AbbVie ( ABBV ) are also developing all-oral, interferon and ribavirin-free HCV therapies. ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. The percentage of patients who achieved sustained virologic response at 12 weeks after the completion of the treatment (SVR12) by the combination constituted the primary end point of the multinational study. | Apart from Bristol-Myers, companies such as Gilead Sciences ( GILD ) and AbbVie ( ABBV ) are also developing all-oral, interferon and ribavirin-free HCV therapies. ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Bristol-Myers is also looking to get the combination of DCV and ASV approved in Japan for treating adults suffering from genotype 1b version of HCV. | ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Apart from Bristol-Myers, companies such as Gilead Sciences ( GILD ) and AbbVie ( ABBV ) are also developing all-oral, interferon and ribavirin-free HCV therapies. Bristol-Myers Squibb Company ( BMY ) announced encouraging data from a phase III study (Hallmark-Dual: n>700) which evaluated the combination of daclatasvir (DCV: a NS5A inhibitor) and asunaprevir (ASV: a NS3 inhibitor) over 24 weeks in patients infected with genotype 1b version of hepatitis C virus (HCV). | Apart from Bristol-Myers, companies such as Gilead Sciences ( GILD ) and AbbVie ( ABBV ) are also developing all-oral, interferon and ribavirin-free HCV therapies. ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Similarly, 82% patients, who could not tolerate peginterferon/ribavirin therapy, achieved SVR12. |
27511.0 | 2014-04-11 00:00:00 UTC | Abbott Labs Progresses with Absorb - Analyst Blog | ABBV | https://www.nasdaq.com/articles/abbott-labs-progresses-with-absorb-analyst-blog-2014-04-11 | nan | nan | Abbott Laboratories ( ABT ) announced that it has completed enrollment of three clinical trials on Absorb, a drug-eluting coronary bioresorbable vascular scaffold (BVS) device.
The ABSORB III trial (n=2000) will evaluate the potential benefits of Absorb in people with coronary artery disease in the U.S. The trials are being conducted to support approvals of Absorb in the U.S, Japan and China.
The primary endpoint of ABSORB III trial is target lesion failure (TLF), a combined measure of the safety and effectiveness of Absorb versus Xience family of drug eluting stents at the end of first year. The trials in Japan and China also have the same primary endpoint.
The vascular portfolio of Abbott Labs has drug eluting stents such as the Xience series and Absorb. We note that Absorb already has a marketing approval in Europe and is available in more than 60 countries around the world.
We are encouraged by the recent positive updates on Abbott Labs' vascular portfolio. In Mar 2014, the U.S. Food and Drug Administration (FDA) approved Abbott Labs' Supera peripheral stent system for the treatment of people with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD). Abbott Labs' acquired Supera stent through the acquisition of IDEV Technologies in Aug 2013.
Abbott Labs is continuously working to boost its vascular products portfolio and expects to launch several products in the next few years. The vascular business is an important part of Abbott Labs' product portfolio and generated sales of $3.0 billion in 2013, down 1.5% from 2012.
The continued rollout of Absorb and Xience Xpedition along with new products such as Supera stents will strengthen Abbott Labs' vascular portfolio in 2014. We note that China, Japan and the U.S. together account for more than 50% of the world's heart stent market.
We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ( ABBV ), in Jan 2013.
The business environment was challenging in 2013 due to austerity measures undertaken by developed markets and weak economic conditions elsewhere. We believe Abbott Labs' diversification in varied business lines will enable the company to counter the challenging business environment and maintain top-line growth.
Abbott Labs currently carries a Zacks Rank #3 (Hold). Right now, large-cap pharma companies that look attractive include Allergan ( AGN ) and Johnson & Johnson ( JNJ ). Both carry a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ( ABBV ), in Jan 2013. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ( ABBV ), in Jan 2013. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. |
27512.0 | 2014-04-10 00:00:00 UTC | AbbVie Inc. (ABBV) Ex-Dividend Date Scheduled for April 11, 2014 | ABBV | https://www.nasdaq.com/articles/abbvie-inc-abbv-ex-dividend-date-scheduled-april-11-2014-2014-04-10 | nan | nan | AbbVie Inc. ( ABBV ) will begin trading ex-dividend on April 11, 2014. A cash dividend payment of $0.42 per share is scheduled to be paid on May 15, 2014. Shareholders who purchased ABBV stock prior to the ex-dividend date are eligible for the cash dividend payment. This represents an 5% increase over the prior quarter. At the current stock price of $50.63, the dividend yield is 3.32%.
The previous trading day's last sale of ABBV was $50.63, representing a -7.58% decrease from the 52 week high of $54.78 and a 26.26% increase over the 52 week low of $40.10.
ABBV is a part of the Health Care sector, which includes companies such as Johnson & Johnson ( JNJ ) and Novartis AG ( NVS ). ABBV's current earnings per share, an indicator of a company's profitability, is $2.56. Zacks Investment Research reports ABBV's forecasted earnings growth in 2014 as -.81%, compared to an industry average of -.7%.
For more information on the declaration, record and payment dates, visit the ABBV Dividend History page. Our Dividend Calendar has the full list of stocks that have an ex-dividend today.
Interested in gaining exposure to ABBV through an Exchange Traded Fund [ETF]?
The following ETF(s) have ABBV as a top-10 holding:
First Trust IPOX-100 Index Fund ( FPX )
Merrill Lynch Pharmaceutical HOLDRS ( PPH )
Guggenheim Spin-Off ETF ( CSD )
Select Sector SPDR Fund - Health Care ( XLV )
SPDR S&P Pharmaceuticals ETF ( XPH ).
The top-performing ETF of this group is PPH with an increase of 12.5% over the last 100 days. FPX has the highest percent weighting of ABBV at 8.99%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Shareholders who purchased ABBV stock prior to the ex-dividend date are eligible for the cash dividend payment. Zacks Investment Research reports ABBV's forecasted earnings growth in 2014 as -.81%, compared to an industry average of -.7%. For more information on the declaration, record and payment dates, visit the ABBV Dividend History page. | The following ETF(s) have ABBV as a top-10 holding: First Trust IPOX-100 Index Fund ( FPX ) Merrill Lynch Pharmaceutical HOLDRS ( PPH ) Guggenheim Spin-Off ETF ( CSD ) Select Sector SPDR Fund - Health Care ( XLV ) SPDR S&P Pharmaceuticals ETF ( XPH ). The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. AbbVie Inc. ( ABBV ) will begin trading ex-dividend on April 11, 2014. | Shareholders who purchased ABBV stock prior to the ex-dividend date are eligible for the cash dividend payment. The previous trading day's last sale of ABBV was $50.63, representing a -7.58% decrease from the 52 week high of $54.78 and a 26.26% increase over the 52 week low of $40.10. The following ETF(s) have ABBV as a top-10 holding: First Trust IPOX-100 Index Fund ( FPX ) Merrill Lynch Pharmaceutical HOLDRS ( PPH ) Guggenheim Spin-Off ETF ( CSD ) Select Sector SPDR Fund - Health Care ( XLV ) SPDR S&P Pharmaceuticals ETF ( XPH ). | Shareholders who purchased ABBV stock prior to the ex-dividend date are eligible for the cash dividend payment. ABBV's current earnings per share, an indicator of a company's profitability, is $2.56. The following ETF(s) have ABBV as a top-10 holding: First Trust IPOX-100 Index Fund ( FPX ) Merrill Lynch Pharmaceutical HOLDRS ( PPH ) Guggenheim Spin-Off ETF ( CSD ) Select Sector SPDR Fund - Health Care ( XLV ) SPDR S&P Pharmaceuticals ETF ( XPH ). |
27513.0 | 2014-04-10 00:00:00 UTC | Merck Up on Encouraging HCV Data - Analyst Blog | ABBV | https://www.nasdaq.com/articles/merck-up-on-encouraging-hcv-data-analyst-blog-2014-04-10 | nan | nan | Merck ( MRK ) presented additional data from an ongoing phase II study on its once-daily, all-oral hepatitis C virus (HCV) combination regimen - MK-5172 (100 mg, a NS3/4A protease inhibitor) and MK-8742 (50 mg, a NS5A replication complex inhibitor). The additional data was presented at the annual meeting of the European Association for the Study of the Liver (EASL). Investors reacted positively to the news with the stock moving up 3.74%.
The two-part, parallel-group, randomized (within group) phase II C-WORTHy study is evaluating the efficacy and safety of MK-5172/MK-8742 in patients with chronic HCV genotype 1 infection (GT1). The study assessed MK-5172 plus MK-8742 for different treatment durations with or without ribavirin (RBV).
As per interim data from the study, sustained virologic response (SVR) rate after 12 weeks of treatment was 98% in the MK-5172/MK-8742 arm as compared to 94% in patients who received MK-5172/MK-8742 plus RBV. The MK-5172/MK-8742 and RBV combination showed an SVR rate of 83% at 8 weeks of treatment.
Based on encouraging data from the phase II studies, Merck has initiated a phase III program, C-EDGE, which will evaluate the safety and efficacy of MK-5172/MK-8742 with and without RBV in several genotypes and a range of patient populations with chronic HCV.
Meanwhile, Merck also announced new data from the dose-ranging phase II PN038 study evaluating MK-5172 (25 mg, 50 mg, and 100 mg) with peginterferon alfa-2b and RBV in treatment-naïve, non-cirrhotic patients with GT1 infection. At 12 weeks of treatment, SVR rates of 83.3%, 75% and 48.3% were observed in patients receiving 100 mg, 50 mg and 25 mg of MK-5172, respectively.
Our Take
We believe that Merck's investigational therapy has a good chance of gaining approval based on high response rates. A new successful HCV treatment would provide a boost to Merck's sales. We note that Merck's HCV drug, Victrelis, recorded revenues of $428 million (down 15%) in 2013.
Several companies are working on getting their all-oral treatment regimens for HCV patients with GT1 in the market. Gilead Sciences Inc. ( GILD ) is looking to get its once-daily fixed-dose HCV cocktail treatment, ledipasvir plus Sovaldi, approved in the U.S. The company has already submitted the marketing application to the FDA. Meanwhile, Bristol-Myers Squibb Company ( BMY ) is not far behind. A few days back, the company submitted the marketing application for its all-oral combination of daclatasvir and asunaprevir. The FDA has granted Breakthrough Therapy designation to the combination. AbbVie Inc. ( ABBV ) is also developing an oral investigational fixed-dose combination regimen (phase III) targeting this lucrative market. We believe that apart from efficacy and safety, dosing and pricing will play crucial roles in determining the winner.
Merck currently carries a Zacks Rank #3 (Hold). Bristol-Myers is a better-ranked stock with a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc. ( ABBV ) is also developing an oral investigational fixed-dose combination regimen (phase III) targeting this lucrative market. ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. The two-part, parallel-group, randomized (within group) phase II C-WORTHy study is evaluating the efficacy and safety of MK-5172/MK-8742 in patients with chronic HCV genotype 1 infection (GT1). | ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) is also developing an oral investigational fixed-dose combination regimen (phase III) targeting this lucrative market. Merck ( MRK ) presented additional data from an ongoing phase II study on its once-daily, all-oral hepatitis C virus (HCV) combination regimen - MK-5172 (100 mg, a NS3/4A protease inhibitor) and MK-8742 (50 mg, a NS5A replication complex inhibitor). | ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) is also developing an oral investigational fixed-dose combination regimen (phase III) targeting this lucrative market. Merck ( MRK ) presented additional data from an ongoing phase II study on its once-daily, all-oral hepatitis C virus (HCV) combination regimen - MK-5172 (100 mg, a NS3/4A protease inhibitor) and MK-8742 (50 mg, a NS5A replication complex inhibitor). | AbbVie Inc. ( ABBV ) is also developing an oral investigational fixed-dose combination regimen (phase III) targeting this lucrative market. ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. As per interim data from the study, sustained virologic response (SVR) rate after 12 weeks of treatment was 98% in the MK-5172/MK-8742 arm as compared to 94% in patients who received MK-5172/MK-8742 plus RBV. |
27514.0 | 2014-04-08 00:00:00 UTC | Bristol-Myers Seeks FDA Approval for HCV Candidates - Analyst Blog | ABBV | https://www.nasdaq.com/articles/bristol-myers-seeks-fda-approval-for-hcv-candidates-analyst-blog-2014-04-08 | nan | nan | Bristol-Myers Squibb Company ( BMY ) announced that it has filed new drug applications (NDAs) with the U.S. Food and Drug Administration (FDA) for hepatitis C virus (HCV) candidates, daclatasvir (DCV) and asunaprevir (ASV). While daclatasvir belongs to a new class of drugs- NS5A inhibitors- asunaprevir is a NS3 protease inhibitor.
Bristol-Myers is looking to get the combination of DCV and ASV (an all-oral, interferon and ribavirin-free regimen) approved in the U.S. for treating patients with genotype 1b HCV on the basis of data submitted in the applications. Furthermore, the biopharma major is looking to get DCV approved combined with other agents for multiple genotypes of the virus on the basis of data submitted in the DCV NDA.
The combination of DCV and ASV was granted a breakthrough therapy designation by the FDA earlier in the year for the genotype 1b HCV indication. The designation will help expedite the development and review process of the regimen. In 2013, the all-oral combination of daclatasvir, asunaprevir and BMS-791325 received a similar designation. U.S. approval for the combination will be sought in the first quarter of 2015.
Bristol-Myers stated in its press release that HCV affects approximately 170 million patients worldwide with a significant number being afflicted by the disease in the U.S. alone.
We note that Bristol-Myers is looking to get DCV approved in the EU as well in combination with other agents for treating adults suffering from HCV with compensated liver disease, inclusive of genotypes 1, 2, 3, and 4. The application is under accelerated review in the EU. Bristol-Myers is also looking to get the combination of DCV and ASV approved in Japan for treating adults suffering from genotype 1b version of HCV. The patients were either ineligible for or intolerant to interferon therapy or non-responders to the same.
Bristol-Myers is highly optimistic of the potential of the combination therapy. Companies like AbbVie ( ABBV ) are also developing therapies targeting the highly lucrative HCV market.
Bristol-Myers carries a Zacks Rank # 2 (Buy). Better-ranked stocks in the biopharma space include Alkermes ( ALKS ) and Alexion Pharmaceuticals ( ALXN ). Both stocks carry a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Companies like AbbVie ( ABBV ) are also developing therapies targeting the highly lucrative HCV market. ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report To read this article on Zacks.com click here. Bristol-Myers is looking to get the combination of DCV and ASV (an all-oral, interferon and ribavirin-free regimen) approved in the U.S. for treating patients with genotype 1b HCV on the basis of data submitted in the applications. | ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report To read this article on Zacks.com click here. Companies like AbbVie ( ABBV ) are also developing therapies targeting the highly lucrative HCV market. Bristol-Myers is looking to get the combination of DCV and ASV (an all-oral, interferon and ribavirin-free regimen) approved in the U.S. for treating patients with genotype 1b HCV on the basis of data submitted in the applications. | ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report To read this article on Zacks.com click here. Companies like AbbVie ( ABBV ) are also developing therapies targeting the highly lucrative HCV market. Bristol-Myers is looking to get the combination of DCV and ASV (an all-oral, interferon and ribavirin-free regimen) approved in the U.S. for treating patients with genotype 1b HCV on the basis of data submitted in the applications. | Companies like AbbVie ( ABBV ) are also developing therapies targeting the highly lucrative HCV market. ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report To read this article on Zacks.com click here. Bristol-Myers is looking to get the combination of DCV and ASV (an all-oral, interferon and ribavirin-free regimen) approved in the U.S. for treating patients with genotype 1b HCV on the basis of data submitted in the applications. |
27515.0 | 2014-04-08 00:00:00 UTC | FDA Target Date for Gilead's HCV Candidate - Analyst Blog | ABBV | https://www.nasdaq.com/articles/fda-target-date-for-gileads-hcv-candidate-analyst-blog-2014-04-08 | nan | nan | Following the strong initial sales of its potential blockbuster hepatitis C virus (HCV) treatment, Sovaldi (nucleotide analog polymerase inhibitor), Gilead Sciences ( GILD ) is looking to bring another HCV treatment - a fixed-dose combination Sovaldi and ledipasvir (NS5A inhibitor) into the market.
With a view to achieve the above objective, Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market the cocktail therapy for treating adults with chronic hepatitis C virus (HCV) genotype 1 infection in Feb 2014. Gilead filed the marketing application on the basis of encouraging data from three phase III studies (ION-1, ION-2 and ION-3).
The studies evaluated the combination with or without ribavirin in almost 2000 genotype 1 chronic hepatitis C patients. The approval of the combination would not only reduce the treatment duration of chronic hepatitis C genotype 1 infection substantially but also eliminate the need for interferon injections or ribavirin which have significant side effects. Gilead stated that 75% of the HCV affected population in the U.S. suffer from the genotype 1 version.
The FDA announced that it will review the application on a priority basis. The FDA reviews applications for priority review designated drugs within eight months of submission as against the usual 12 months. Consequently, a decision from the FDA is expected by Oct 10, 2014 (target date). We note that the U.S. regulatory authority generally reviews those drugs, which offer major advances in treating diseases over existing therapies, on a priority basis.
The fixed dose regimen is also under review in the EU for the same indication. The European Medicines Agency (EMA) validated the biopharmaceutical company's marketing application for the candidate last month and at the same time accepted Gilead's request for an accelerated assessment of the application. Acceptance of the request has reduced the EMA's review period of the application by two months.
We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV.
Gilead carries a Zacks Rank # 3 (Hold). Better-ranked stocks in the biopharma space include Alkermes ( ALKS ) and Alexion Pharmaceuticals ( ALXN ). Both stocks carry a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. The approval of the combination would not only reduce the treatment duration of chronic hepatitis C genotype 1 infection substantially but also eliminate the need for interferon injections or ribavirin which have significant side effects. | ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. Following the strong initial sales of its potential blockbuster hepatitis C virus (HCV) treatment, Sovaldi (nucleotide analog polymerase inhibitor), Gilead Sciences ( GILD ) is looking to bring another HCV treatment - a fixed-dose combination Sovaldi and ledipasvir (NS5A inhibitor) into the market. | ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. Following the strong initial sales of its potential blockbuster hepatitis C virus (HCV) treatment, Sovaldi (nucleotide analog polymerase inhibitor), Gilead Sciences ( GILD ) is looking to bring another HCV treatment - a fixed-dose combination Sovaldi and ledipasvir (NS5A inhibitor) into the market. | We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. With a view to achieve the above objective, Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market the cocktail therapy for treating adults with chronic hepatitis C virus (HCV) genotype 1 infection in Feb 2014. |
27516.0 | 2014-04-03 00:00:00 UTC | Encouraging Results on Gilead's Sovaldi - Analyst Blog | ABBV | https://www.nasdaq.com/articles/encouraging-results-on-gileads-sovaldi-analyst-blog-2014-04-03 | nan | nan | Gilead Sciences, Inc. ( GILD ) announced encouraging top-line results from a phase III study (GS-US-334-0118: n=156) in Japan on its potential blockbuster chronic hepatitis C virus (HCV) infection treatment Sovaldi (sofosbuvir: nucleotide analog polymerase inhibitor).
The study is evaluating the all-oral combination of Sovaldi and ribavirin in patients suffering from the genotype 2 version of chronic HCV. Gilead said that the phase III study met its primary efficacy endpoint of superiority compared to a predefined historical control sustained virologic response (SVR) rate. Data from the study revealed that 97% of the evaluated genotype 2 HCV patients on being treated with the cocktail therapy achieved a SVR 12 weeks after completion of the therapy.
Sovaldi was approved in the U.S. in Dec 2013 and launched immediately thereafter. The drug performed impressively in the fourth quarter of 2013 recording U.S. sales of $136.4 million. European approval of the drug came in Jan 2014.
The incidence of chronic HCV is on the rise in Japan with a significant proportion of patients being affected by the genotype 2 version of the virus. Consequently approval in Japan would further boost the drug's sales potential. Approval would bring down the duration of therapy significantly. Currently, HCV therapy includes up to 48 weeks of treatment with a regimen inclusive of injectable peg-IFN.
Moreover, the current standard of care comes with several side effects which make it difficult for patients to remain on treatment. Encouraged by the positive results, Gilead intends to seek Japanese approval for the drug by mid-2014.
Gilead is also seeking approval to market a fixed-dose combination of ledipasvir (NS5A inhibitor) and Sovaldi (with or without ribavirin) for treating adults with chronic HCV genotype 1 infection in the U.S., EU and Canada. Gilead is evaluating the efficacy and safety of the combination in a phase III study in Japan for treating patients with genotype 1 chronic HCV infection, the most common HCV strain in the country.
Sustained virologic response data 12 weeks after completion of therapy are expected in the latter half of 2014. We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV.
Though pleased with the update on Sovaldi regarding the Japanese phase III study, we believe that investor focus will remain on Gilead's response to the letter issued by the Congress' Committee on Energy and Commerce last week expressing concerns about the exorbitant price tag ($84,000 for a 12-week treatment period) attached to the drug. Since HCV is more prevalent in the low-income strata of the society, Gilead's pricing policy has attracted severe criticism.
Gilead carries a Zacks Rank #1 (Strong Buy). Alexion Pharmaceuticals, Inc. ( ALXN ) and Alkermes ( ALKS ) are examples of biopharma stock carrying same rank as Gilead.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Gilead Sciences, Inc. ( GILD ) announced encouraging top-line results from a phase III study (GS-US-334-0118: n=156) in Japan on its potential blockbuster chronic hepatitis C virus (HCV) infection treatment Sovaldi (sofosbuvir: nucleotide analog polymerase inhibitor). | ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. Gilead Sciences, Inc. ( GILD ) announced encouraging top-line results from a phase III study (GS-US-334-0118: n=156) in Japan on its potential blockbuster chronic hepatitis C virus (HCV) infection treatment Sovaldi (sofosbuvir: nucleotide analog polymerase inhibitor). | ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. Gilead Sciences, Inc. ( GILD ) announced encouraging top-line results from a phase III study (GS-US-334-0118: n=156) in Japan on its potential blockbuster chronic hepatitis C virus (HCV) infection treatment Sovaldi (sofosbuvir: nucleotide analog polymerase inhibitor). | We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Gilead Sciences, Inc. ( GILD ) announced encouraging top-line results from a phase III study (GS-US-334-0118: n=156) in Japan on its potential blockbuster chronic hepatitis C virus (HCV) infection treatment Sovaldi (sofosbuvir: nucleotide analog polymerase inhibitor). |
27517.0 | 2014-03-31 00:00:00 UTC | Abbott's Supera Stent Approved in the U.S. - Analyst Blog | ABBV | https://www.nasdaq.com/articles/abbotts-supera-stent-approved-in-the-u.s.-analyst-blog-2014-03-31 | nan | nan | Abbott Laboratories ( ABT ) received a boost for its vascular portfolio when it announced that the U.S. Food and Drug Administration (FDA) approved its Supera peripheral stent system for the treatment of people with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD).
The FDA approval was supported by encouraging data from the SUPERB trial which showed that the Supera stent was highly effective in opening up blocked blood vessels in the upper leg, even in difficult cases.
Moreover, it was observed that there were no stent fractures during the first year following the treatment with the Supera stent and at two years there was a very low stent fracture rate of 0.5%.
We note that Abbott Labs acquired Supera stent through the acquisition of IDEV Technologies in Aug 2013. The Supera stent already carries a CE mark in Europe for treating blocked blood vessels caused by PAD.
Hence, an approval in the U.S. will further boost vascular sales. The vascular business is an important part of Abbott Labs' product portfolio and generated sales of $3.0 billion in 2013, down 1.5% from 2012. The vascular portfolio of Abbott Labs already boasts of drug eluting stents such as Xience series and Absorb.
Abbott Labs is continuously working to boost its vascular products portfolio and expects to launch several products in the next few years. The continued rollout of Absorb and Xience Xpedition along with new products such as Supera stents will further strengthen Abbott Labs' vascular portfolio in 2014.
We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013.
The business environment was challenging in 2013 due to austerity measures undertaken by developed markets and weak economic conditions elsewhere. We believe Abbott Labs' diversification in varied business lines will enable the company to counter the challenging business environment and maintain top-line growth.
Abbott Labs currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Shire ( SHPG ) and Lannett Company, Inc. ( LCI ). Both carry a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report LANNETT INC (LCI): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. The FDA approval was supported by encouraging data from the SUPERB trial which showed that the Supera stent was highly effective in opening up blocked blood vessels in the upper leg, even in difficult cases. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report LANNETT INC (LCI): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. Abbott Laboratories ( ABT ) received a boost for its vascular portfolio when it announced that the U.S. Food and Drug Administration (FDA) approved its Supera peripheral stent system for the treatment of people with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD). | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report LANNETT INC (LCI): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. Abbott Laboratories ( ABT ) received a boost for its vascular portfolio when it announced that the U.S. Food and Drug Administration (FDA) approved its Supera peripheral stent system for the treatment of people with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD). | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report LANNETT INC (LCI): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. The vascular business is an important part of Abbott Labs' product portfolio and generated sales of $3.0 billion in 2013, down 1.5% from 2012. |
27518.0 | 2014-03-28 00:00:00 UTC | Gilead's HCV Candidate Under Review in the EU - Analyst Blog | ABBV | https://www.nasdaq.com/articles/gileads-hcv-candidate-under-review-in-the-eu-analyst-blog-2014-03-28 | nan | nan | Gilead Sciences, Inc. ( GILD ), which has been in the eye of the storm with lawmakers in the U.S. questioning the pricing of its recently approved potential blockbuster hepatitis C virus (HCV) treatment, Sovaldi, received encouraging news from the EU. Gilead's efforts to get its once-daily fixed-dose HCV combination therapy - ledipasvir (NS5A inhibitor) plus Sovaldi (nucleotide analog polymerase inhibitor) - approved in the EU appears to be on track with the European Medicines Agency (EMA) validating the biopharmaceutical company's marketing application for the candidate.
The EMA accepted the company's request for an accelerated assessment of the application, which seeks marketing approval of the all-oral cocktail therapy for treating adults suffering from the genotype 1 version of chronic HCV. Acceptance of the request has reduced the EMA's review period of the application by two months.
Gilead filed the marketing application on the basis of encouraging data from three phase III studies (ION-1, ION-2 and ION-3). The studies evaluated the combination with or without ribavirin in almost 2000 genotype 1 chronic hepatitis C patients. Approval of the combination would not only reduce the treatment duration of chronic hepatitis C genotype 1 infection significantly but also eliminate the need for interferon injections or ribavirin, which have significant side effects. Furthermore, the combination would become the first oral treatment for HCV patients with genotype 1 infection to be available in the EU following approval. Gilead stated that majority of the HCV affected population in the EU suffers from the genotype 1 version.
Approval for the combination has also been sought in the U.S. and Canada. We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV.
Though pleased with the regulatory update on the combination of ledipasvir and Sovaldi, we believe that investor focus will remain on Gilead's response to the letter issued by the Congress' Committee on Energy and Commerce last week expressing concerns about the exorbitant price tag ($84,000 for a 12-week treatment period) attached to the drug. Since HCV is more prevalent in the low-income strata of the society, Gilead's pricing policy has attracted severe criticism. Gilead will have to submit a response by Apr 3.
Gilead carries a Zacks Rank #1 (Strong Buy). Alexion Pharmaceuticals, Inc. ( ALXN ) and Alkermes ( ALKS ) are examples of biopharma stock carrying same rank as Gilead.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Gilead Sciences, Inc. ( GILD ), which has been in the eye of the storm with lawmakers in the U.S. questioning the pricing of its recently approved potential blockbuster hepatitis C virus (HCV) treatment, Sovaldi, received encouraging news from the EU. | ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. Gilead's efforts to get its once-daily fixed-dose HCV combination therapy - ledipasvir (NS5A inhibitor) plus Sovaldi (nucleotide analog polymerase inhibitor) - approved in the EU appears to be on track with the European Medicines Agency (EMA) validating the biopharmaceutical company's marketing application for the candidate. | ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. Gilead's efforts to get its once-daily fixed-dose HCV combination therapy - ledipasvir (NS5A inhibitor) plus Sovaldi (nucleotide analog polymerase inhibitor) - approved in the EU appears to be on track with the European Medicines Agency (EMA) validating the biopharmaceutical company's marketing application for the candidate. | We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. The EMA accepted the company's request for an accelerated assessment of the application, which seeks marketing approval of the all-oral cocktail therapy for treating adults suffering from the genotype 1 version of chronic HCV. |
27519.0 | 2014-03-27 00:00:00 UTC | Myriad Genetics Inks HRD Alliance with Tesaro - Analyst Blog | ABBV | https://www.nasdaq.com/articles/myriad-genetics-inks-hrd-alliance-with-tesaro-analyst-blog-2014-03-27 | nan | nan | Recently molecular diagnostic company Myriad Genetics Inc. ( MYGN ) entered into a companion diagnostics research collaboration with pharmaceutical major Tesaro, Inc. ( TSRO ). After the announcement on Mar 24, Myriad Genetics' shares went up 2.3% to close the trading session at $34.41. However, this bullish sentiment did not last, thanks to the biotech selloff at the end of last week. This was followed by additional speculation about a possible biotech bubble. Accordingly, the share price of Myriad Genetics, similar to many other players in this niche, dropped more than 4.8% yesterday.
This alliance marks Myriad Genetics' fifth such collaboration with a major pharmaceutical company based on its homologous recombination deficiency (HRD) test. Per the agreement, Tesaro will use this HRD test to evaluate and identify tumor types that may react to a PARP (poly-ADP ribose polymerase) inhibitor like niraparib, currenty in phase III for the treatment of ovarian and breast cancer. The financial terms of the deal were not disclosed.
With an estimated market opportunity of $3 billion for the HRD test, management at Myriad Genetics is confident that the collaboration with Tesaro will seamlessly strengthen its foothold in the companion diagnostics market. While only a subset of patients respond to PARP inhibitors, the HRD test has established itself successfully as the most comprehensive test to identify these patients who are likely to respond to treatment.
According to Myriad Genetics, high HRD scores are predominant in all breast cancer subtypes and in most of the major cancer types. An earlier published data had revealed that the HRD test predicted drug response to platinum therapy in triple-negative breast cancer type.
Myriad Genetics is emerging as a strong player in the companion diagnostic market as evident from its strategic deals with several pharmaceutical majors.The company has PARP collaborations with majors like AstraZeneca plc ( AZN ) and AbbVie Inc. ( ABBV ) among others. We believe that these developments should augur well for the long-term development of the company. The stock currently carries a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Myriad Genetics is emerging as a strong player in the companion diagnostic market as evident from its strategic deals with several pharmaceutical majors.The company has PARP collaborations with majors like AstraZeneca plc ( AZN ) and AbbVie Inc. ( ABBV ) among others. ABBVIE INC (ABBV): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report MYRIAD GENETICS (MYGN): Free Stock Analysis Report TESARO INC (TSRO): Free Stock Analysis Report To read this article on Zacks.com click here. Per the agreement, Tesaro will use this HRD test to evaluate and identify tumor types that may react to a PARP (poly-ADP ribose polymerase) inhibitor like niraparib, currenty in phase III for the treatment of ovarian and breast cancer. | Myriad Genetics is emerging as a strong player in the companion diagnostic market as evident from its strategic deals with several pharmaceutical majors.The company has PARP collaborations with majors like AstraZeneca plc ( AZN ) and AbbVie Inc. ( ABBV ) among others. ABBVIE INC (ABBV): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report MYRIAD GENETICS (MYGN): Free Stock Analysis Report TESARO INC (TSRO): Free Stock Analysis Report To read this article on Zacks.com click here. Recently molecular diagnostic company Myriad Genetics Inc. ( MYGN ) entered into a companion diagnostics research collaboration with pharmaceutical major Tesaro, Inc. ( TSRO ). | Myriad Genetics is emerging as a strong player in the companion diagnostic market as evident from its strategic deals with several pharmaceutical majors.The company has PARP collaborations with majors like AstraZeneca plc ( AZN ) and AbbVie Inc. ( ABBV ) among others. ABBVIE INC (ABBV): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report MYRIAD GENETICS (MYGN): Free Stock Analysis Report TESARO INC (TSRO): Free Stock Analysis Report To read this article on Zacks.com click here. Recently molecular diagnostic company Myriad Genetics Inc. ( MYGN ) entered into a companion diagnostics research collaboration with pharmaceutical major Tesaro, Inc. ( TSRO ). | Myriad Genetics is emerging as a strong player in the companion diagnostic market as evident from its strategic deals with several pharmaceutical majors.The company has PARP collaborations with majors like AstraZeneca plc ( AZN ) and AbbVie Inc. ( ABBV ) among others. ABBVIE INC (ABBV): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report MYRIAD GENETICS (MYGN): Free Stock Analysis Report TESARO INC (TSRO): Free Stock Analysis Report To read this article on Zacks.com click here. Recently molecular diagnostic company Myriad Genetics Inc. ( MYGN ) entered into a companion diagnostics research collaboration with pharmaceutical major Tesaro, Inc. ( TSRO ). |
27520.0 | 2014-03-26 00:00:00 UTC | Pharma & Biotech Stock Outlook - March 2014 - Zacks Analyst Interviews | ABBV | https://www.nasdaq.com/articles/pharma-biotech-stock-outlook-march-2014-zacks-analyst-interviews-2014-03-26 | nan | nan | The pharmaceutical sector has been slowly but steadily recovering from the impact of the patent cliff being faced by several companies over the past few years. The worst of the patent cliff is over and the NYSE ARCA Pharmaceutical Index (^DRG) is up 21.4% over the last year. So far in 2014, the index is up 6.9%.
Several companies which had been struggling to post growth in the face of genericization over the past few years are now on the recovery path. New products should start contributing significantly to results, and increased pipeline visibility and appropriate utilization of cash should increase confidence in the sector.
Products that lost exclusivity recently include Eli Lilly's ( LLY ) Cymbalta and Evista. AstraZeneca's ( AZN ) Nexium could also start facing generics from May 2014 in the U.S. where sales were $2.1 billion in 2013.
Collaborations, Acquisitions and Restructuring
The pharma sector witnessed major merger and acquisitions (M&A) activity over the last couple of years. Going forward, we expect small bolt-on acquisitions to continue. In-licensing activities and collaborations for the development of pipeline candidates have also increased significantly. Several pharma companies are focusing on in-licensing mid-to-late stage pipeline candidates that look promising, instead of developing a product from scratch, which involves a lot of funds and time.
Small biotech companies are open to in-licensing activities and collaborations. Most of these companies find it challenging to raise cash, thereby making it difficult for them to survive and continue with the development of promising pipeline candidates. Therefore, it makes sense for them to seek deals with pharma companies that are sitting on huge piles of cash.
We recommend biotech stocks that have attractive pipeline candidates or technology that can be used for the development of novel therapeutics. Therapeutic areas which could see a lot of in-licensing activity include immuno-oncology, oncology, central nervous system disorders, diabetes and immunology/inflammation. The hepatitis C virus (HCV) market is also attracting a lot of attention.
Some recent acquisitions/deals include Shire's ( SHPG ) acquisition of ViroPharma, Salix's ( SLXP ) acquisition of Santarus as well as the acquisition of Optimer Pharmaceuticals and Trius Therapeutics by Cubist Pharmaceuticals ( CBST ) and that of Elan by Perrigo Company ( PRGO ). A major acquisition agreement was announced recently -- that of Forest Labs ( FRX ) by Actavis ( ACT ). This deal shows the intention of generic companies to establish a strong position in the branded market. Another significant deal was the one signed between Celgene ( CELG ) and OncoMed Pharmaceuticals ( OMED ) for the joint development and commercialization of up to six anti-cancer stem cell candidates from OncoMed's biologics pipeline.
Another trend that we are seeing in recent months is the divestment of non-core business segments. Pfizer ( PFE ) sold its Capsugel unit and its Nutrition business in Aug 2011 and Nov 2012, respectively. Pfizer then spun off its animal health business into a new company, Zoetis ( ZTS ).
Meanwhile, GlaxoSmithKline ( GSK ) divested certain non-core brands from its Consumer Healthcare segment. In Aug 2011, AstraZeneca sold its Astra Tech business to DENTSPLY ( XRAY ). The monetization of non-core assets will allow the pharma/biotech companies to focus on their areas of expertise. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Johnson & Johnson ( JNJ ) is also looking to divest its ortho-clinical diagnostics business. Vertex ( VRTX ) monetized its Incivo-related royalties; the company can use the cash generated from this deal for its cystic fibrosis program.
Restructuring activities are also gaining momentum as large pharma companies are looking to cut costs and streamline their operations. Most of these companies are re-evaluating their pipelines and discontinuing programs which do not have a favorable risk-benefit profile. Some of the companies that announced restructuring plans include Merck ( MRK ), Novartis ( NVS ), Eli Lilly, Shire and Sanofi ( SNY ).
Destination Ireland
Of late, several companies have been looking towards Ireland for acquisitions. The latest company to join the Irish club is Horizon Pharma ( HZNP ) which is doing a reverse merger with Dublin-based Vidara. Tax benefits are a major attraction for such deals. Other such recent acquisitions include that of Warner Chilcott by Actavis and Elan by Perrigo.
Emerging Markets and Biosimilars
Another trend seen in the pharmaceutical sector is a focus on emerging markets. Companies like Mylan ( MYL ), Pfizer, Merck, Eli Lilly, Glaxo and Sanofi are all looking to expand their presence in India, China, Brazil and other emerging markets.
Until recently, most of the commercialization efforts were focused on the U.S. -- the largest pharmaceutical market -- along with Europe and Japan. Emerging markets are slowly and steadily gaining more importance, and several companies are now shifting their focus to these areas.
However, while higher demand for medicines, government initiatives for healthcare, new patient population and increasing use of generics should help drive demand, we point out that emerging markets are also not immune to genericization. Moreover, investigations into bribery charges in China could put a lid on near-term growth.
Meanwhile, growth in Europe will continue to be pressurized by austerity and cost-containment measures.
We are also seeing several companies entering into deals for the development of biosimilars, generic versions of biologics. Companies like Merck, Amgen, Biogen ( BIIB ) and Actavis are all targeting the highly lucrative biosimilars market.
4Q Earnings
All companies falling under the Medical sector have reported fourth quarter and full year 2013 results. While earnings-beat and revenue-beat ratios (percentage of companies coming out with positive surprises) were pretty impressive, growth ratios were modest. Fourth quarter results were characterized by currency headwinds as well as the impact of generics.
Fourth quarter 2013 earnings "beat ratio" was 74.0% while the revenue "beat ratio" was 76.0%. Total earnings for this sector were up 1.1%, compared to 0.2% recorded in the third quarter of 2013. Total revenues moved up 5.3% in the quarter versus 5.8% growth in the third quarter of 2013.
Looking at the consensus earnings expectations for the first quarter, earnings are expected to decline 3.3%. Tough challenges for some companies, negative currency movement and a few patent expirees will affect first quarter growth. However, growth should pick up from the second quarter for which 1.6% earnings growth is expected.
Overall, 2014 earnings are expected to grow 6.5%. For a detailed look at the earnings outlook for the Medical and other sectors, please check our Zacks Earnings Trends report.
Focus on New Products
2013 saw the FDA approving 27 novel medicines, about one-third (33%) of which were identified by the FDA as "First-in-Class," meaning they use a new and unique mechanism of action for treating a medical condition. These include drugs like Invokana (type II diabetes), Kadcyla (HER2-positive late-stage breast cancer), Sovaldi (an interferon-free oral treatment for some patients with chronic hepatitis C) and Mekinist (metastatic melanoma).
Yet another one-third of the approved drugs fall under the rare or "orphan" disease category that affects 200,000 or fewer Americans. These include Imbruvica (mantle cell lymphoma), Gazyva (chronic lymphocytic leukemia), Kynamro (homozygous familial hypercholesterolemia) and Adempas and Opsumit (both for pulmonary arterial hypertension). Three of the approved drugs - Gazyva, Imbruvica and Sovaldi - had breakthrough therapy designation. Breakthrough status, a new designation that became effective after Jul 9, 2012, is designed to cut short the development time of promising new treatments.
Some important products approved in 2013 include:
Drugs like Tecfidera, Sovaldi and Imbruvica represent strong commercial potential.
So far in 2014, drugs that have gained approval include AstraZeneca's Myalept (complications of leptin deficiency) and Farxiga (type II diabetes), Chelsea Therapeutics' ( CHTP ) Northera (to treat neurogenic orthostatic hypotension), BioMarin's ( BMRN ) Vimizim (Morquio A syndrome) and Vanda Pharma's ( VNDA ) Hetlioz (non-24- hour sleep-wake disorder).
Upcoming events include FDA advisory panel review of the regulatory application for MannKind's ( MNKD ) experimental diabetes treatment, Afrezza. April should be an active month with the agency expected to deliver a response on the approvability of several experimental drugs including Afrezza, Glaxo's Eperzan (type II diabetes) and Arzerra (CLL).
Zacks Industry Rank
Within the Zacks Industry classification, pharma and biotech are broadly grouped into the Medical sector (one of 16 Zacks sectors) and further sub-divided into four industries at the expanded level: large-cap pharma, med-biomed/gene, med-drugs and med-generic drugs.
We rank all the 260-plus industries in the 16 Zacks sectors based on the earnings outlook and fundamental strength of the constituent companies in each industry. To learn more, visit: About Zacks Industry Rank .
As a point of reference, the outlook for industries with Zacks Industry Rank #88 and lower is 'Positive,' between #89 and #176 is 'Neutral' and #177 and higher is 'Negative.'
The Zacks Industry Rank for large-cap pharma is #225, med-biomed/gene is #69, med-drugs is #84, while the med-generic drugs is #8. Analyzing the Zacks Industry Rank for different medical segments, it is obvious that the outlook is Positive for med-drugs, med-biomed/gene and med-generic drugs and Negative for large-cap pharma stocks.
OPPORTUNITIES
While several companies will continue to face challenges like EU austerity measures and genericization, the pharma industry is out of the worst of its genericization phase. Many companies which had faced generic headwinds in the last couple of years should continue to see a sustained improvement in results this year. Cost-cutting, downsizing, streamlining of the pipeline, growth in emerging markets and new product launches should support growth.
Among pharma stocks, Shire, a Zacks Rank #1 (Strong Buy) stock, looks well-positioned for growth with the company expanding its product portfolio and pipeline through the acquisition of ViroPharma. Horizon Pharma, a Zacks Rank #2 (Buy) stock, also seems on the right path with the company announcing its plans to acquire Ireland-based Vidara.
In the biotech space, we are positive on Biogen. Tecfidera, the company's recently launched oral multiple sclerosis drug, is off to a strong start with the product delivering sales of $876 million (as of Dec 31, 2013) since its launch in early April 2013. While Tecfidera has gained the top spot in the oral multiple sclerosis market in the U.S., Avonex and Tysabri should continue contributing significantly to sales. Tecfidera gained EU approval recently. Biogen is also progressing with its hemophilia pipeline.
We are also positive on Amgen ( AMGN ). Amgen should be able to deliver on its long-term strategy based on expansion in key markets, launch of new manufacturing technologies, and pipeline development. Enbrel should continue performing well. Amgen's late-stage pipeline is also moving along. While Amgen is a Zacks Rank #2 stock, Biogen is a Zacks Rank #3 (Hold) stock.
Gilead, a Zacks Rank #1 stock, continues to do well in the HIV segment and has a potential blockbuster in its portfolio in the form of HCV treatment, Sovaldi.
Among generic companies, Actavis looks well-positioned. Actavis is slowly and steadily building its position in the branded market through acquisitions (Actavis Group, Warner Chilcott and the upcoming acquisition of Forest). With fewer major patent expiries slated to occur in the next few years, we are encouraged by Actavis' focus on building its branded and biosimilars pipeline. The company carries a Zacks Rank #2.
WEAKNESSES
We recommend avoiding names that offer little growth or opportunity for a take-out. These include companies which are developing drugs that are likely to face regulatory hurdles.
Among large-cap pharma companies, Eli Lilly is gearing up for another round of patent expiries -- Cymbalta in Dec 2013 and Evista this year. We prefer waiting on the sidelines until the company is able to emerge from the impact of genericization.
Companies that currently carry a Zacks Rank #4 (Sell) include Bayer ( BAYRY ), Sanofi and Glaxo among others. Sanofi, which is facing currency headwinds, was in the news recently related to the development of its PCSK9 inhibitor, alirocumab. The FDA has asked Sanofi and partner Regeneron ( REGN ) to evaluate potential neurocognitive adverse events across the global development program for alirocumab, especially in long-term studies. While results on PCSK9 inhibitors in development have been encouraging so far, this is the first time that serious safety concerns have been raised.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOMARIN PHARMA (BMRN): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report CELGENE CORP (CELG): Free Stock Analysis Report CHELSEA THERAP (CHTP): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MANNKIND CORP (MNKD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ONCOMED PHARMA (OMED): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO CO PLC (PRGO): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report SALIX PHARM-LTD (SLXP): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. These include drugs like Invokana (type II diabetes), Kadcyla (HER2-positive late-stage breast cancer), Sovaldi (an interferon-free oral treatment for some patients with chronic hepatitis C) and Mekinist (metastatic melanoma). | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOMARIN PHARMA (BMRN): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report CELGENE CORP (CELG): Free Stock Analysis Report CHELSEA THERAP (CHTP): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MANNKIND CORP (MNKD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ONCOMED PHARMA (OMED): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO CO PLC (PRGO): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report SALIX PHARM-LTD (SLXP): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Some of the companies that announced restructuring plans include Merck ( MRK ), Novartis ( NVS ), Eli Lilly, Shire and Sanofi ( SNY ). | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOMARIN PHARMA (BMRN): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report CELGENE CORP (CELG): Free Stock Analysis Report CHELSEA THERAP (CHTP): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MANNKIND CORP (MNKD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ONCOMED PHARMA (OMED): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO CO PLC (PRGO): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report SALIX PHARM-LTD (SLXP): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Zacks Industry Rank Within the Zacks Industry classification, pharma and biotech are broadly grouped into the Medical sector (one of 16 Zacks sectors) and further sub-divided into four industries at the expanded level: large-cap pharma, med-biomed/gene, med-drugs and med-generic drugs. | Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOMARIN PHARMA (BMRN): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report CELGENE CORP (CELG): Free Stock Analysis Report CHELSEA THERAP (CHTP): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MANNKIND CORP (MNKD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ONCOMED PHARMA (OMED): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO CO PLC (PRGO): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report SALIX PHARM-LTD (SLXP): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Collaborations, Acquisitions and Restructuring The pharma sector witnessed major merger and acquisitions (M&A) activity over the last couple of years. |
27521.0 | 2014-03-26 00:00:00 UTC | Pharma & Biotech Stock Outlook - March 2014 - Industry Outlook | ABBV | https://www.nasdaq.com/articles/pharma-biotech-stock-outlook-march-2014-industry-outlook-2014-03-26 | nan | nan | The pharmaceutical sector has been slowly but steadily recovering from the impact of the patent cliff being faced by several companies over the past few years. The worst of the patent cliff is over and the NYSE ARCA Pharmaceutical Index (^DRG) is up 21.4% over the last year. So far in 2014, the index is up 6.9%.
Several companies which had been struggling to post growth in the face of genericization over the past few years are now on the recovery path. New products should start contributing significantly to results, and increased pipeline visibility and appropriate utilization of cash should increase confidence in the sector.
Products that lost exclusivity recently include Eli Lilly's ( LLY ) Cymbalta and Evista. AstraZeneca's ( AZN ) Nexium could also start facing generics from May 2014 in the U.S. where sales were $2.1 billion in 2013.
Collaborations, Acquisitions and Restructuring
The pharma sector witnessed major merger and acquisitions (M&A) activity over the last couple of years. Going forward, we expect small bolt-on acquisitions to continue. In-licensing activities and collaborations for the development of pipeline candidates have also increased significantly. Several pharma companies are focusing on in-licensing mid-to-late stage pipeline candidates that look promising, instead of developing a product from scratch, which involves a lot of funds and time.
Small biotech companies are open to in-licensing activities and collaborations. Most of these companies find it challenging to raise cash, thereby making it difficult for them to survive and continue with the development of promising pipeline candidates. Therefore, it makes sense for them to seek deals with pharma companies that are sitting on huge piles of cash.
We recommend biotech stocks that have attractive pipeline candidates or technology that can be used for the development of novel therapeutics. Therapeutic areas which could see a lot of in-licensing activity include immuno-oncology, oncology, central nervous system disorders, diabetes and immunology/inflammation. The hepatitis C virus (HCV) market is also attracting a lot of attention.
Some recent acquisitions/deals include Shire's ( SHPG ) acquisition of ViroPharma, Salix's ( SLXP ) acquisition of Santarus as well as the acquisition of Optimer Pharmaceuticals and Trius Therapeutics by Cubist Pharmaceuticals ( CBST ) and that of Elan by Perrigo Company ( PRGO ). A major acquisition agreement was announced recently -- that of Forest Labs ( FRX ) by Actavis ( ACT ). This deal shows the intention of generic companies to establish a strong position in the branded market. Another significant deal was the one signed between Celgene ( CELG ) and OncoMed Pharmaceuticals ( OMED ) for the joint development and commercialization of up to six anti-cancer stem cell candidates from OncoMed's biologics pipeline.
Another trend that we are seeing in recent months is the divestment of non-core business segments. Pfizer ( PFE ) sold its Capsugel unit and its Nutrition business in Aug 2011 and Nov 2012, respectively. Pfizer then spun off its animal health business into a new company, Zoetis ( ZTS ).
Meanwhile, GlaxoSmithKline ( GSK ) divested certain non-core brands from its Consumer Healthcare segment. In Aug 2011, AstraZeneca sold its Astra Tech business to DENTSPLY ( XRAY ). The monetization of non-core assets will allow the pharma/biotech companies to focus on their areas of expertise. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Johnson & Johnson ( JNJ ) is also looking to divest its ortho-clinical diagnostics business. Vertex ( VRTX ) monetized its Incivo-related royalties; the company can use the cash generated from this deal for its cystic fibrosis program.
Restructuring activities are also gaining momentum as large pharma companies are looking to cut costs and streamline their operations. Most of these companies are re-evaluating their pipelines and discontinuing programs which do not have a favorable risk-benefit profile. Some of the companies that announced restructuring plans include Merck ( MRK ), Novartis ( NVS ), Eli Lilly, Shire and Sanofi ( SNY ).
Destination Ireland
Of late, several companies have been looking towards Ireland for acquisitions. The latest company to join the Irish club is Horizon Pharma ( HZNP ) which is doing a reverse merger with Dublin-based Vidara. Tax benefits are a major attraction for such deals. Other such recent acquisitions include that of Warner Chilcott by Actavis and Elan by Perrigo.
Emerging Markets and Biosimilars
Another trend seen in the pharmaceutical sector is a focus on emerging markets. Companies like Mylan ( MYL ), Pfizer, Merck, Eli Lilly, Glaxo and Sanofi are all looking to expand their presence in India, China, Brazil and other emerging markets.
Until recently, most of the commercialization efforts were focused on the U.S. -- the largest pharmaceutical market -- along with Europe and Japan. Emerging markets are slowly and steadily gaining more importance, and several companies are now shifting their focus to these areas.
However, while higher demand for medicines, government initiatives for healthcare, new patient population and increasing use of generics should help drive demand, we point out that emerging markets are also not immune to genericization. Moreover, investigations into bribery charges in China could put a lid on near-term growth.
Meanwhile, growth in Europe will continue to be pressurized by austerity and cost-containment measures.
We are also seeing several companies entering into deals for the development of biosimilars, generic versions of biologics. Companies like Merck, Amgen, Biogen ( BIIB ) and Actavis are all targeting the highly lucrative biosimilars market.
4Q Earnings
All companies falling under the Medical sector have reported fourth quarter and full year 2013 results. While earnings-beat and revenue-beat ratios (percentage of companies coming out with positive surprises) were pretty impressive, growth ratios were modest. Fourth quarter results were characterized by currency headwinds as well as the impact of generics.
Fourth quarter 2013 earnings "beat ratio" was 74.0% while the revenue "beat ratio" was 76.0%. Total earnings for this sector were up 1.1%, compared to 0.2% recorded in the third quarter of 2013. Total revenues moved up 5.3% in the quarter versus 5.8% growth in the third quarter of 2013.
Looking at the consensus earnings expectations for the first quarter, earnings are expected to decline 3.3%. Tough challenges for some companies, negative currency movement and a few patent expirees will affect first quarter growth. However, growth should pick up from the second quarter for which 1.6% earnings growth is expected.
Overall, 2014 earnings are expected to grow 6.5%. For a detailed look at the earnings outlook for the Medical and other sectors, please check our Zacks Earnings Trends report.
Focus on New Products
2013 saw the FDA approving 27 novel medicines, about one-third (33%) of which were identified by the FDA as "First-in-Class," meaning they use a new and unique mechanism of action for treating a medical condition. These include drugs like Invokana (type II diabetes), Kadcyla (HER2-positive late-stage breast cancer), Sovaldi (an interferon-free oral treatment for some patients with chronic hepatitis C) and Mekinist (metastatic melanoma).
Yet another one-third of the approved drugs fall under the rare or "orphan" disease category that affects 200,000 or fewer Americans. These include Imbruvica (mantle cell lymphoma), Gazyva (chronic lymphocytic leukemia), Kynamro (homozygous familial hypercholesterolemia) and Adempas and Opsumit (both for pulmonary arterial hypertension). Three of the approved drugs - Gazyva, Imbruvica and Sovaldi - had breakthrough therapy designation. Breakthrough status, a new designation that became effective after Jul 9, 2012, is designed to cut short the development time of promising new treatments.
Some important products approved in 2013 include:
Drugs like Tecfidera, Sovaldi and Imbruvica represent strong commercial potential.
So far in 2014, drugs that have gained approval include AstraZeneca's Myalept (complications of leptin deficiency) and Farxiga (type II diabetes), Chelsea Therapeutics' ( CHTP ) Northera (to treat neurogenic orthostatic hypotension), BioMarin's ( BMRN ) Vimizim (Morquio A syndrome) and Vanda Pharma's ( VNDA ) Hetlioz (non-24- hour sleep-wake disorder).
Upcoming events include FDA advisory panel review of the regulatory application for MannKind's ( MNKD ) experimental diabetes treatment, Afrezza. April should be an active month with the agency expected to deliver a response on the approvability of several experimental drugs including Afrezza, Glaxo's Eperzan (type II diabetes) and Arzerra (CLL).
Zacks Industry Rank
Within the Zacks Industry classification, pharma and biotech are broadly grouped into the Medical sector (one of 16 Zacks sectors) and further sub-divided into four industries at the expanded level: large-cap pharma, med-biomed/gene, med-drugs and med-generic drugs.
We rank all the 260-plus industries in the 16 Zacks sectors based on the earnings outlook and fundamental strength of the constituent companies in each industry. To learn more, visit: About Zacks Industry Rank .
As a point of reference, the outlook for industries with Zacks Industry Rank #88 and lower is 'Positive,' between #89 and #176 is 'Neutral' and #177 and higher is 'Negative.'
The Zacks Industry Rank for large-cap pharma is #225, med-biomed/gene is #69, med-drugs is #84, while the med-generic drugs is #8. Analyzing the Zacks Industry Rank for different medical segments, it is obvious that the outlook is Positive for med-drugs, med-biomed/gene and med-generic drugs and Negative for large-cap pharma stocks.
OPPORTUNITIES
While several companies will continue to face challenges like EU austerity measures and genericization, the pharma industry is out of the worst of its genericization phase. Many companies which had faced generic headwinds in the last couple of years should continue to see a sustained improvement in results this year. Cost-cutting, downsizing, streamlining of the pipeline, growth in emerging markets and new product launches should support growth.
Among pharma stocks, Shire, a Zacks Rank #1 (Strong Buy) stock, looks well-positioned for growth with the company expanding its product portfolio and pipeline through the acquisition of ViroPharma. Horizon Pharma, a Zacks Rank #2 (Buy) stock, also seems on the right path with the company announcing its plans to acquire Ireland-based Vidara.
In the biotech space, we are positive on Biogen. Tecfidera, the company's recently launched oral multiple sclerosis drug, is off to a strong start with the product delivering sales of $876 million (as of Dec 31, 2013) since its launch in early April 2013. While Tecfidera has gained the top spot in the oral multiple sclerosis market in the U.S., Avonex and Tysabri should continue contributing significantly to sales. Tecfidera gained EU approval recently. Biogen is also progressing with its hemophilia pipeline.
We are also positive on Amgen ( AMGN ). Amgen should be able to deliver on its long-term strategy based on expansion in key markets, launch of new manufacturing technologies, and pipeline development. Enbrel should continue performing well. Amgen's late-stage pipeline is also moving along. While Amgen is a Zacks Rank #2 stock, Biogen is a Zacks Rank #3 (Hold) stock.
Gilead, a Zacks Rank #1 stock, continues to do well in the HIV segment and has a potential blockbuster in its portfolio in the form of HCV treatment, Sovaldi.
Among generic companies, Actavis looks well-positioned. Actavis is slowly and steadily building its position in the branded market through acquisitions (Actavis Group, Warner Chilcott and the upcoming acquisition of Forest). With fewer major patent expiries slated to occur in the next few years, we are encouraged by Actavis' focus on building its branded and biosimilars pipeline. The company carries a Zacks Rank #2.
WEAKNESSES
We recommend avoiding names that offer little growth or opportunity for a take-out. These include companies which are developing drugs that are likely to face regulatory hurdles.
Among large-cap pharma companies, Eli Lilly is gearing up for another round of patent expiries -- Cymbalta in Dec 2013 and Evista this year. We prefer waiting on the sidelines until the company is able to emerge from the impact of genericization.
Companies that currently carry a Zacks Rank #4 (Sell) include Bayer ( BAYRY ), Sanofi and Glaxo among others. Sanofi, which is facing currency headwinds, was in the news recently related to the development of its PCSK9 inhibitor, alirocumab. The FDA has asked Sanofi and partner Regeneron ( REGN ) to evaluate potential neurocognitive adverse events across the global development program for alirocumab, especially in long-term studies. While results on PCSK9 inhibitors in development have been encouraging so far, this is the first time that serious safety concerns have been raised.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOMARIN PHARMA (BMRN): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report CELGENE CORP (CELG): Free Stock Analysis Report CHELSEA THERAP (CHTP): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MANNKIND CORP (MNKD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ONCOMED PHARMA (OMED): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO CO PLC (PRGO): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report SALIX PHARM-LTD (SLXP): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. These include drugs like Invokana (type II diabetes), Kadcyla (HER2-positive late-stage breast cancer), Sovaldi (an interferon-free oral treatment for some patients with chronic hepatitis C) and Mekinist (metastatic melanoma). | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOMARIN PHARMA (BMRN): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report CELGENE CORP (CELG): Free Stock Analysis Report CHELSEA THERAP (CHTP): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MANNKIND CORP (MNKD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ONCOMED PHARMA (OMED): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO CO PLC (PRGO): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report SALIX PHARM-LTD (SLXP): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Some of the companies that announced restructuring plans include Merck ( MRK ), Novartis ( NVS ), Eli Lilly, Shire and Sanofi ( SNY ). | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOMARIN PHARMA (BMRN): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report CELGENE CORP (CELG): Free Stock Analysis Report CHELSEA THERAP (CHTP): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MANNKIND CORP (MNKD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ONCOMED PHARMA (OMED): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO CO PLC (PRGO): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report SALIX PHARM-LTD (SLXP): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Zacks Industry Rank Within the Zacks Industry classification, pharma and biotech are broadly grouped into the Medical sector (one of 16 Zacks sectors) and further sub-divided into four industries at the expanded level: large-cap pharma, med-biomed/gene, med-drugs and med-generic drugs. | Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOMARIN PHARMA (BMRN): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report CELGENE CORP (CELG): Free Stock Analysis Report CHELSEA THERAP (CHTP): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report HORIZON PHARMA (HZNP): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MANNKIND CORP (MNKD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ONCOMED PHARMA (OMED): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO CO PLC (PRGO): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report SALIX PHARM-LTD (SLXP): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Collaborations, Acquisitions and Restructuring The pharma sector witnessed major merger and acquisitions (M&A) activity over the last couple of years. |
27522.0 | 2014-03-24 00:00:00 UTC | ConocoPhillips Now #46 Largest Company, Surpassing AbbVie | ABBV | https://www.nasdaq.com/articles/conocophillips-now-46-largest-company-surpassing-abbvie-2014-03-24 | nan | nan | In the latest look at the underlying components of the S&P 500 ordered by largest market capitalization, ConocoPhillips (Symbol: COP) has taken over the #46 spot from AbbVie Inc. (Symbol: ABBV), according to The Online Investor .
Market capitalization is an important data point for investors to keep an eye on, for various reasons. The most basic reason is that it gives a true comparison of the value attributed by the stock market to a given company's stock. Many beginning investors look at one stock trading at $10 and another trading at $20 and mistakenly think the latter company is worth twice as much - that of course is a completely meaningless comparison without knowing how many shares of each company exist. But comparing market capitalization (factoring in those share counts) creates a true "apples-to-apples" comparison of the value of two stocks. In the case of ConocoPhillips (Symbol: COP), the market cap is now $82.84 billion, versus AbbVie Inc. (Symbol: ABBV) at $81.59 billion.
Below is a chart of ConocoPhillips versus AbbVie Inc. plotting their respective size rank within the S&P 500 over time (COP plotted in blue; ABBV plotted in green):
Below is a three month price history chart comparing the stock performance of COP vs. ABBV:
Another reason market capitalization is important is where it places a company in terms of its size tier in relation to peers - much like the way a mid-size sedan is typically compared to other mid-size sedans (and not SUV's). This can have a direct impact on which mutual funds and ETFs are willing to own the stock. For instance, a mutual fund that is focused solely on Large Cap stocks may for example only be interested in those companies sized $10 billion or larger. Another illustrative example is the S&P MidCap index which essentially takes the S&P 500 index and "tosses out" the biggest 100 companies so as to focus solely on the 400 smaller "up-and-comers" (which in the right environment can outperform their larger rivals). So a company's market cap, especially in relation to other companies, carries great importance, and for this reason we at The Online Investor find value to putting together these rankings daily.
According to the ETF Finder at ETF Channel, COP and ABBV collectively make up 3.86% of the First Trust Mega Cap AlphaDEX Fund ETF ( FMK ) which is lower by about 0.8% on the day Monday.
At the closing bell, COP is up about 0.1%, while ABBV is off about 3.9% on the day Monday.
The 20 Largest U.S. Companies By Market Capitalization »
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Below is a chart of ConocoPhillips versus AbbVie Inc. plotting their respective size rank within the S&P 500 over time (COP plotted in blue; ABBV plotted in green): Below is a three month price history chart comparing the stock performance of COP vs. ABBV: Another reason market capitalization is important is where it places a company in terms of its size tier in relation to peers - much like the way a mid-size sedan is typically compared to other mid-size sedans (and not SUV's). In the latest look at the underlying components of the S&P 500 ordered by largest market capitalization, ConocoPhillips (Symbol: COP) has taken over the #46 spot from AbbVie Inc. (Symbol: ABBV), according to The Online Investor . In the case of ConocoPhillips (Symbol: COP), the market cap is now $82.84 billion, versus AbbVie Inc. (Symbol: ABBV) at $81.59 billion. | In the latest look at the underlying components of the S&P 500 ordered by largest market capitalization, ConocoPhillips (Symbol: COP) has taken over the #46 spot from AbbVie Inc. (Symbol: ABBV), according to The Online Investor . In the case of ConocoPhillips (Symbol: COP), the market cap is now $82.84 billion, versus AbbVie Inc. (Symbol: ABBV) at $81.59 billion. Below is a chart of ConocoPhillips versus AbbVie Inc. plotting their respective size rank within the S&P 500 over time (COP plotted in blue; ABBV plotted in green): Below is a three month price history chart comparing the stock performance of COP vs. ABBV: Another reason market capitalization is important is where it places a company in terms of its size tier in relation to peers - much like the way a mid-size sedan is typically compared to other mid-size sedans (and not SUV's). | Below is a chart of ConocoPhillips versus AbbVie Inc. plotting their respective size rank within the S&P 500 over time (COP plotted in blue; ABBV plotted in green): Below is a three month price history chart comparing the stock performance of COP vs. ABBV: Another reason market capitalization is important is where it places a company in terms of its size tier in relation to peers - much like the way a mid-size sedan is typically compared to other mid-size sedans (and not SUV's). In the latest look at the underlying components of the S&P 500 ordered by largest market capitalization, ConocoPhillips (Symbol: COP) has taken over the #46 spot from AbbVie Inc. (Symbol: ABBV), according to The Online Investor . In the case of ConocoPhillips (Symbol: COP), the market cap is now $82.84 billion, versus AbbVie Inc. (Symbol: ABBV) at $81.59 billion. | In the case of ConocoPhillips (Symbol: COP), the market cap is now $82.84 billion, versus AbbVie Inc. (Symbol: ABBV) at $81.59 billion. In the latest look at the underlying components of the S&P 500 ordered by largest market capitalization, ConocoPhillips (Symbol: COP) has taken over the #46 spot from AbbVie Inc. (Symbol: ABBV), according to The Online Investor . Below is a chart of ConocoPhillips versus AbbVie Inc. plotting their respective size rank within the S&P 500 over time (COP plotted in blue; ABBV plotted in green): Below is a three month price history chart comparing the stock performance of COP vs. ABBV: Another reason market capitalization is important is where it places a company in terms of its size tier in relation to peers - much like the way a mid-size sedan is typically compared to other mid-size sedans (and not SUV's). |
27523.0 | 2014-03-20 00:00:00 UTC | Health Care Select Sector SPDR Fund Experiences Big Inflow | ABBV | https://www.nasdaq.com/articles/health-care-select-sector-spdr-fund-experiences-big-inflow-2014-03-20 | nan | nan | Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Health Care Select Sector SPDR Fund (Symbol: XLV) where we have detected an approximate $178.4 million dollar inflow -- that's a 1.8% increase week over week in outstanding units (from 170,415,324 to 173,415,324). Among the largest underlying components of XLV, in trading today Gilead Sciences, Inc. (Symbol: GILD) is down about 1.6%, AbbVie Inc. (Symbol: ABBV) is off about 0.6%, and Express Scripts Holding Co (Symbol: ESRX) is up by about 0.5%. The chart below shows the one year price performance of XLV, versus its 200 day moving average:
Looking at the chart above, XLV's low point in its 52 week range is $44.22 per share, with $60.50 as the 52 week high point - that compares with a last trade of $59.40. Comparing the most recent share price to the 200 day moving average can also be a useful technical analysis technique -- learn more about the 200 day moving average » .
Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). Creation of new units will mean the underlying holdings of the ETF need to be purchased, while destruction of units involves selling underlying holdings, so large flows can also impact the individual components held within ETFs.
Click here to find out which 9 other ETFs had notable inflows »
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Among the largest underlying components of XLV, in trading today Gilead Sciences, Inc. (Symbol: GILD) is down about 1.6%, AbbVie Inc. (Symbol: ABBV) is off about 0.6%, and Express Scripts Holding Co (Symbol: ESRX) is up by about 0.5%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Health Care Select Sector SPDR Fund (Symbol: XLV) where we have detected an approximate $178.4 million dollar inflow -- that's a 1.8% increase week over week in outstanding units (from 170,415,324 to 173,415,324). The chart below shows the one year price performance of XLV, versus its 200 day moving average: Looking at the chart above, XLV's low point in its 52 week range is $44.22 per share, with $60.50 as the 52 week high point - that compares with a last trade of $59.40. | Among the largest underlying components of XLV, in trading today Gilead Sciences, Inc. (Symbol: GILD) is down about 1.6%, AbbVie Inc. (Symbol: ABBV) is off about 0.6%, and Express Scripts Holding Co (Symbol: ESRX) is up by about 0.5%. The chart below shows the one year price performance of XLV, versus its 200 day moving average: Looking at the chart above, XLV's low point in its 52 week range is $44.22 per share, with $60.50 as the 52 week high point - that compares with a last trade of $59.40. Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. | Among the largest underlying components of XLV, in trading today Gilead Sciences, Inc. (Symbol: GILD) is down about 1.6%, AbbVie Inc. (Symbol: ABBV) is off about 0.6%, and Express Scripts Holding Co (Symbol: ESRX) is up by about 0.5%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Health Care Select Sector SPDR Fund (Symbol: XLV) where we have detected an approximate $178.4 million dollar inflow -- that's a 1.8% increase week over week in outstanding units (from 170,415,324 to 173,415,324). The chart below shows the one year price performance of XLV, versus its 200 day moving average: Looking at the chart above, XLV's low point in its 52 week range is $44.22 per share, with $60.50 as the 52 week high point - that compares with a last trade of $59.40. | Among the largest underlying components of XLV, in trading today Gilead Sciences, Inc. (Symbol: GILD) is down about 1.6%, AbbVie Inc. (Symbol: ABBV) is off about 0.6%, and Express Scripts Holding Co (Symbol: ESRX) is up by about 0.5%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Health Care Select Sector SPDR Fund (Symbol: XLV) where we have detected an approximate $178.4 million dollar inflow -- that's a 1.8% increase week over week in outstanding units (from 170,415,324 to 173,415,324). The chart below shows the one year price performance of XLV, versus its 200 day moving average: Looking at the chart above, XLV's low point in its 52 week range is $44.22 per share, with $60.50 as the 52 week high point - that compares with a last trade of $59.40. |
27524.0 | 2014-03-14 00:00:00 UTC | Revenues Decline at Discovery Labs in Q4, Shares Down - Analyst Blog | ABBV | https://www.nasdaq.com/articles/revenues-decline-at-discovery-labs-in-q4-shares-down-analyst-blog-2014-03-14 | nan | nan | Discovery Laboratories, Inc. ( DSCO ) reported fourth quarter 2013 loss (excluding change in fair value of common stock warrant liability) of 15 cents per share, narrower than the Zacks Estimate of a loss of 16 cents per share. The loss (excluding change in fair value of common stock warrant liability) in the year-ago quarter was approximately 29 cents.
The company reported revenues of $74,000 in the final quarter of 2013, down 62%. Discovery Labs stated that revenues worth $140,000 from its approved drug Surfaxin were deferred in accordance with the revenue recognition policy followed by the company. Surfaxin, an intratracheal suspension, has been cleared by the U.S. Food and Drug Administration (FDA) for the prevention of respiratory distress syndrome (RDS) in premature infants who are at high risk of being affected by the disease.
Surfaxin is the first FDA-approved synthetic, peptide-containing surfactant available for the prevention of RDS in premature infants. Before Surfaxin, only animal-derived surfactants like AbbVie Inc .'s ( ABBV ) Survanta were available in the market.
Discovery Labs reported research & development (R&D) costs of $5.8 million in the final quarter of 2013 as against $6.1 million in the year-ago quarter. Selling, general & administrative (SG&A) costs declined 37% to $4.1 million in the final quarter of 2013.
For full year 2013, revenues jumped 99% to $388,000. The Zacks Consensus Estimate was $1 million. Loss for 2013 (excluding change in fair value of common stock warrant liability) narrowed to 83 cents per share from 96 cents incurred in 2012. The Zacks Consensus Estimate hinted at a loss of 84 cents per share.
Apart from releasing financial results, Discovery Labs provided an update on RDS candidate, Aerosurf. The company is evaluating the candidate in a phase IIa open label, single-dose study. Discovery Labs expects to report results from the study in the third quarter of this year.
Shares Down on Withdrawal of Surfaxin 2014 Sales Outlook
Shares of Discovery Labs tumbled in excess of 11% primarily due to the company's decision to withdraw the previously announced guidance of $8 million-$10 million for Surfaxin sales. The company said that it is of the opinion that the time needed to have the drug reviewed by hospital committees, accepted on hospital formulary, purchased by the hospital pharmacy and used in the neonatal intensive care unit is longer than what it had assumed while issuing the previous short-term revenue guidance for the drug. The company believes that it needs more actual experience pertaining to Surfaxin product cycle time to effectively project short-term sales of the drug,.
Discovery Labs carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the sector include Alexion Pharmaceuticals, Inc. ( ALXN ) and Alkermes ( ALKS ). Both stocks carry a Zacks Rank #1 (Strong Buy).
ABBVIE INC (ABBV): Free Stock Analysis Report
ALKERMES INC (ALKS): Free Stock Analysis Report
ALEXION PHARMA (ALXN): Free Stock Analysis Report
DISCOVERY LABS (DSCO): Free Stock Analysis Report
To read this article on Zacks.com click here.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Before Surfaxin, only animal-derived surfactants like AbbVie Inc . 's ( ABBV ) Survanta were available in the market. ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report DISCOVERY LABS (DSCO): Free Stock Analysis Report To read this article on Zacks.com click here. | ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report DISCOVERY LABS (DSCO): Free Stock Analysis Report To read this article on Zacks.com click here. Before Surfaxin, only animal-derived surfactants like AbbVie Inc . 's ( ABBV ) Survanta were available in the market. | ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report DISCOVERY LABS (DSCO): Free Stock Analysis Report To read this article on Zacks.com click here. Before Surfaxin, only animal-derived surfactants like AbbVie Inc . 's ( ABBV ) Survanta were available in the market. | Before Surfaxin, only animal-derived surfactants like AbbVie Inc . 's ( ABBV ) Survanta were available in the market. ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report DISCOVERY LABS (DSCO): Free Stock Analysis Report To read this article on Zacks.com click here. |
27525.0 | 2014-03-14 00:00:00 UTC | Horizon Pharma Banks On Two-For-One Arthritis Drugs | ABBV | https://www.nasdaq.com/articles/horizon-pharma-banks-two-one-arthritis-drugs-2014-03-14 | nan | nan | Specialty drug companyHorizon Pharma ( HZNP ) is on a roll with two arthritis drugs, Duexis and Vimovo.
Both treat arthritis pain and protect against ulcers, a two-for-one bang that most other drugs treating arthritis don't provide.
Like most arthritis drugs, the two use nonsteroidal anti-inflammatory drugs (NSAIDs). But there's an add-on: each roll in a layer of ulcer-protecting compounds.
In Duexis' case, it uses ibuprofen for pain and famotidine for ulcer protection. Vimovo is a combination of naproxen and an acid-reducing proton pump inhibitor.
One of the biggest problems with NSAIDs is that, with repeated use, they can cause bleeding and ulcers in the upper digestive tract.
Patients taking NSAIDs often take separate drugs for preventing bleeding and ulcers, meaning they may take 10 to 20 pills a day.
Duexis is dosed three times daily. Vimovo, an extended-release drug, is taken twice daily.
"Having the GI (gastrointestinal tract) protection in the same formulation is a big advantage," said analyst Edward Nash of Cowen & Co.
With an aggressive sales effort, co-pay assistance program and price hikes, Duexis net sales jumped 473% in 2013 to $59 million as prescriptions for it rose 128% to 214,690.
Vimovo didn't show up much in Horizon's 2013 results. Horizon acquired the U.S. rights fromAstraZeneca ( AZN ) on Nov. 18, and started logging sales in January. It also raised prices on it.
Drug Sales Mount
In early February, the full weight of an expanded sales force for both drugs kicked in. New prescriptions for Vimovo grew 10% in January and 18% in February, Horizon said in its March 13 report on fourth-quarter results, citing figures from IMS Health.
A third drug, Rayos, is not nearly as material to Horizon. The low-dose prednisone steroid drug took in $5.8 million in net revenue in 2013, the first full year of its launch. Its European counterpart, Lodotra, netted $8.2 million.
In the company's fourth-quarter report, CEO Timothy Walbert called 2013 a "transformational year" because of Duexis' growth, the launch of Rayos and the acquisition of Vimovo.
He said Horizon should post its first profit this year. And with positive cash flow, the company could step up growth through an acquisition or in-licensing of more products or companies, he said.
"The platform is scalable. They could apply the same business model to different drug products," said analyst Difei Yang of R.F. Lafferty & Co.
But Horizon's revenue in the fourth quarter missed analyst views, sending shares down more than 4% that day. It recovered some of that loss the next day.
Net sales in the quarter still jumped 370% to $30.1 million but below the $32 million analysts had expected. Duexis accounted for nearly 77% of the total.
Analysts had revised their forecasts after Horizon said in a preliminary announcement on Jan. 29 that revenue in the fourth quarter would total $31.9 million-$32.4 million.
But the firm said in its Q4 report that it subsequently determined service fees to wholesalers should be recorded as a reduction in revenue rather than an increase in cost of goods sold, effectively cutting net revenue. The change had no impact on gross profit, net income, per-share earnings or cash flow.
And Horizon beat views on the bottom line with a 4-cents-per-share loss in the quarter. Analysts had expected an 8-cent loss. It posted a 40-cent loss in the same quarter a year earlier. Management maintained 2014 revenue guidance of $190 million-$205 million.
Despite the top-line miss, Yang said, "It was a good quarter." She called the change in the way cost of goods was recorded "immaterial."
With $74 million in net revenue in 2013, up from $18.8 million in 2012, fast-growing Horizon Pharma is still one of the smaller players in the drug industry.
But with Duexis and now Vimovo, specialty pharma firm Horizon is building momentum in the massive arthritis pain market, where some of the biggest firms in the drug industry compete.
Major players in the arthritis market includePfizer ( PFE ), with the blockbuster Celebrex, andAbbVie ( ABBV ) with Humira. Plus there's a host of generic-drug firms, includingTeva Pharmaceuticals ( TEVA ),Actavis (ACT) andMylan (MYL).
"How could a small company like this compete with big pharmas," Nash said he first asked when he looked at Horizon Pharma in 2011 when it was preparing to go public.
He soon saw that CEO Walbert would likely push hard to make Duexis compete aggressively in the market.
But Horizon's strategy isn't to compete with Celebrex or other branded drugs as much as it is to get patients to convert from generic ibuprofen or naproxen.
Besides having drugs that work well, Nash says, Walbert's talent is "marketing them properly to begin with." If something is not working, "he makes changes right away."
Take Horizon's co-promotion partnership with Mallinckrodt, a subsidiary ofCovidien (COV), which began for Duexis in mid-2012.
Nash says Walbert broke off the collaboration when it wasn't meeting his expectations. He hired 50 sales reps "to take over where Mallinckrodt left off."
Horizon now has a sales force of nearly 300.
Subhead Here
Walbert had previously led biopharm firm IDM Pharma, which was acquired by Takeda America Holdings in 2009. He earlier held executive posts with other drug firms, including NeoPharma and what is now AbbVie.
Under AstraZeneca, Vimovo hadn't been actively promoted, analysts say. But weekly prescriptions were still higher than those for Duexis, which hadn't been on the market as long. Duexis launched in December 2011.
Vimovo will likely continue to log higher prescriptions than Duexis, at least in the near-term, analysts say. In the week ending Feb. 28, Duexis prescriptions tallied 4,567 to Vimovo's 5,719, according to IMS Health.
But Vimovo's sales have lagged those of Duexis. In 2013, Vimovo netted $21 million in sales, Horizon's chief commercial officer Todd Smith said at a Roth conference March 10.
Analysts expect Horizon's 2014 revenue to rise 194% vs. 2013 to $218 million and go up another 40% in 2015. They predict a 22-cent profit this year and an upwardly revised 91 cents next year.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Major players in the arthritis market includePfizer ( PFE ), with the blockbuster Celebrex, andAbbVie ( ABBV ) with Humira. He earlier held executive posts with other drug firms, including NeoPharma and what is now AbbVie. New prescriptions for Vimovo grew 10% in January and 18% in February, Horizon said in its March 13 report on fourth-quarter results, citing figures from IMS Health. | Major players in the arthritis market includePfizer ( PFE ), with the blockbuster Celebrex, andAbbVie ( ABBV ) with Humira. He earlier held executive posts with other drug firms, including NeoPharma and what is now AbbVie. New prescriptions for Vimovo grew 10% in January and 18% in February, Horizon said in its March 13 report on fourth-quarter results, citing figures from IMS Health. | Major players in the arthritis market includePfizer ( PFE ), with the blockbuster Celebrex, andAbbVie ( ABBV ) with Humira. He earlier held executive posts with other drug firms, including NeoPharma and what is now AbbVie. Specialty drug companyHorizon Pharma ( HZNP ) is on a roll with two arthritis drugs, Duexis and Vimovo. | Major players in the arthritis market includePfizer ( PFE ), with the blockbuster Celebrex, andAbbVie ( ABBV ) with Humira. He earlier held executive posts with other drug firms, including NeoPharma and what is now AbbVie. Net sales in the quarter still jumped 370% to $30.1 million but below the $32 million analysts had expected. |
27526.0 | 2014-03-12 00:00:00 UTC | Notable ETF Inflow Detected - XLV, ABBV, ESRX, LLY | ABBV | https://www.nasdaq.com/articles/notable-etf-inflow-detected-xlv-abbv-esrx-lly-2014-03-12 | nan | nan | Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Health Care Select Sector SPDR Fund (Symbol: XLV) where we have detected an approximate $166.8 million dollar inflow -- that's a 1.7% increase week over week in outstanding units (from 167,615,324 to 170,415,324). Among the largest underlying components of XLV, in trading today AbbVie Inc. (Symbol: ABBV) is down about 0.6%, Express Scripts Holding Co (Symbol: ESRX) is trading flat, and Eli Lilly & Co. (Symbol: LLY) is higher by about 0.7%. The chart below shows the one year price performance of XLV, versus its 200 day moving average:
Looking at the chart above, XLV's low point in its 52 week range is $44.22 per share, with $60.50 as the 52 week high point - that compares with a last trade of $59.55. Comparing the most recent share price to the 200 day moving average can also be a useful technical analysis technique -- learn more about the 200 day moving average » .
Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). Creation of new units will mean the underlying holdings of the ETF need to be purchased, while destruction of units involves selling underlying holdings, so large flows can also impact the individual components held within ETFs.
Click here to find out which 9 other ETFs had notable inflows »
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Among the largest underlying components of XLV, in trading today AbbVie Inc. (Symbol: ABBV) is down about 0.6%, Express Scripts Holding Co (Symbol: ESRX) is trading flat, and Eli Lilly & Co. (Symbol: LLY) is higher by about 0.7%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Health Care Select Sector SPDR Fund (Symbol: XLV) where we have detected an approximate $166.8 million dollar inflow -- that's a 1.7% increase week over week in outstanding units (from 167,615,324 to 170,415,324). The chart below shows the one year price performance of XLV, versus its 200 day moving average: Looking at the chart above, XLV's low point in its 52 week range is $44.22 per share, with $60.50 as the 52 week high point - that compares with a last trade of $59.55. | Among the largest underlying components of XLV, in trading today AbbVie Inc. (Symbol: ABBV) is down about 0.6%, Express Scripts Holding Co (Symbol: ESRX) is trading flat, and Eli Lilly & Co. (Symbol: LLY) is higher by about 0.7%. The chart below shows the one year price performance of XLV, versus its 200 day moving average: Looking at the chart above, XLV's low point in its 52 week range is $44.22 per share, with $60.50 as the 52 week high point - that compares with a last trade of $59.55. Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. | Among the largest underlying components of XLV, in trading today AbbVie Inc. (Symbol: ABBV) is down about 0.6%, Express Scripts Holding Co (Symbol: ESRX) is trading flat, and Eli Lilly & Co. (Symbol: LLY) is higher by about 0.7%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Health Care Select Sector SPDR Fund (Symbol: XLV) where we have detected an approximate $166.8 million dollar inflow -- that's a 1.7% increase week over week in outstanding units (from 167,615,324 to 170,415,324). The chart below shows the one year price performance of XLV, versus its 200 day moving average: Looking at the chart above, XLV's low point in its 52 week range is $44.22 per share, with $60.50 as the 52 week high point - that compares with a last trade of $59.55. | Among the largest underlying components of XLV, in trading today AbbVie Inc. (Symbol: ABBV) is down about 0.6%, Express Scripts Holding Co (Symbol: ESRX) is trading flat, and Eli Lilly & Co. (Symbol: LLY) is higher by about 0.7%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Health Care Select Sector SPDR Fund (Symbol: XLV) where we have detected an approximate $166.8 million dollar inflow -- that's a 1.7% increase week over week in outstanding units (from 167,615,324 to 170,415,324). The chart below shows the one year price performance of XLV, versus its 200 day moving average: Looking at the chart above, XLV's low point in its 52 week range is $44.22 per share, with $60.50 as the 52 week high point - that compares with a last trade of $59.55. |
27527.0 | 2014-03-10 00:00:00 UTC | Update on Endo's Product Portfolio - Analyst Blog | ABBV | https://www.nasdaq.com/articles/update-on-endos-product-portfolio-analyst-blog-2014-03-10 | nan | nan | Endo Health Solutions ' ( ENDP ) top line has been under pressure over the past few quarters due to declining sales of its key drugs. Sales have been hurt by generic competition. Endo recorded sales of $584.9 million in the fourth quarter of 2013, down 22%. Soft sales of painkillers, Lidoderm and Opana ER hurt the top line.
To combat the generic threat, Endo has been signing deals/making acquisitions and also looking to introduce new products. The recent approval of Endo's Aveed (a long-acting testosterone undecanoate injection) by the U.S. Food and Drug Administration (FDA) is a positive for the company. Aveed has been approved for treating adults suffering from hypogonadism (deficiency/absence of the male hormone testosterone).
The FDA approval was gained on the basis of encouraging phase III data on men suffering from hypogonadism in the U.S. The 84-week study evaluated men with an average age of 54 years and a serum total testosterone level below 300 ng/dL. Taking into account the risks associated with the use of Aveed, the drug will be distributed through a strict Risk Evaluation and Mitigation Strategy (REMS) program.
The path leading to the approval of Aveed in the U.S. has been anything but smooth. The FDA issued a complete response letter (CRL) to Endo on Aveed in the second quarter of 2013 due to safety concerns. Endo subsequently resubmitted the new drug application (NDA) addressing the concerns. The FDA accepted the resubmitted NDA and gave a favorable decision after reviewing the application.
With the U.S. approval in hand, focus has shifted to Aveed's commercialization. Aveed will compete with drugs like Auxilium Pharmaceuticals ' ( AUXL ) Testim and AbbVie 's ( ABBV ) AndroGel in the market.
Endo carries a Zacks Rank #3 (Hold). An example of a better-ranked stock in the medical sector is Shire ( SHPG ) with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Aveed will compete with drugs like Auxilium Pharmaceuticals ' ( AUXL ) Testim and AbbVie 's ( ABBV ) AndroGel in the market. ABBVIE INC (ABBV): Free Stock Analysis Report AUXILIUM PHARMA (AUXL): Free Stock Analysis Report ENDO INTL PLC (ENDP): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. Endo Health Solutions ' ( ENDP ) top line has been under pressure over the past few quarters due to declining sales of its key drugs. | ABBVIE INC (ABBV): Free Stock Analysis Report AUXILIUM PHARMA (AUXL): Free Stock Analysis Report ENDO INTL PLC (ENDP): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. Aveed will compete with drugs like Auxilium Pharmaceuticals ' ( AUXL ) Testim and AbbVie 's ( ABBV ) AndroGel in the market. Zacks Investment Research The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | ABBVIE INC (ABBV): Free Stock Analysis Report AUXILIUM PHARMA (AUXL): Free Stock Analysis Report ENDO INTL PLC (ENDP): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. Aveed will compete with drugs like Auxilium Pharmaceuticals ' ( AUXL ) Testim and AbbVie 's ( ABBV ) AndroGel in the market. Endo Health Solutions ' ( ENDP ) top line has been under pressure over the past few quarters due to declining sales of its key drugs. | Aveed will compete with drugs like Auxilium Pharmaceuticals ' ( AUXL ) Testim and AbbVie 's ( ABBV ) AndroGel in the market. ABBVIE INC (ABBV): Free Stock Analysis Report AUXILIUM PHARMA (AUXL): Free Stock Analysis Report ENDO INTL PLC (ENDP): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. Sales have been hurt by generic competition. |
27528.0 | 2014-03-06 00:00:00 UTC | Pipeline Progress at Bristol-Myers - Analyst Blog | ABBV | https://www.nasdaq.com/articles/pipeline-progress-at-bristol-myers-analyst-blog-2014-03-06 | nan | nan | Bristol-Myers Squibb Company ( BMY ) presented encouraging data on its HIV candidate BMS-663068 (an attachment inhibitor) at the 21st conference on retroviruses and opportunistic Infections. The phase IIb study (n=254) evaluated the candidate in treatment experienced HIV-1 infected adults across four doses - (400 mg (twice daily); 800 mg (twice daily); 600 mg (once daily); 1200 mg (once a day)).
Data from the 24 week study revealed that BMS-663068 was as effective as the biopharma major's established HIV treatment Reyataz (boosted with AbbVie Inc. 's ( ABBV ) Norvir) in controlling the dreaded virus. Bristol-Myers said that treatment with BMS-663068 reduced the level of the virus to undetectable levels in 69%-80% patients, while Norvir boosted Reyataz therapy achieved similar results in 75% patients. Moreover, the candidate was found to be well tolerated in the study. No patient opted out of the study due to adverse events.
The positive results from the study are highly encouraging as successful development and subsequent commercialization of the candidate would enlarge the treatment options for HIV patients who have failed other therapies. In the event of the candidate entering the market, Bristol-Myers' top line would be boosted as the HIV market is lucrative. Bristol-Myers is also developing Reyataz and Gilead Sciences ' ( GILD ) cobicistat as a fixed dose combination to treat HIV patients.
According to the company, HIV affects 34 million people across the globe. Apart from Bristol-Myers, many other companies such as Merck & Co. ( MRK ) are developing candidates to treat HIV.
Bristol-Myers carries a Zacks Rank #3 (Hold). A better-ranked stock in the biopharma space is Gilead Sciences which carries a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Data from the 24 week study revealed that BMS-663068 was as effective as the biopharma major's established HIV treatment Reyataz (boosted with AbbVie Inc. 's ( ABBV ) Norvir) in controlling the dreaded virus. ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. Bristol-Myers Squibb Company ( BMY ) presented encouraging data on its HIV candidate BMS-663068 (an attachment inhibitor) at the 21st conference on retroviruses and opportunistic Infections. | Data from the 24 week study revealed that BMS-663068 was as effective as the biopharma major's established HIV treatment Reyataz (boosted with AbbVie Inc. 's ( ABBV ) Norvir) in controlling the dreaded virus. ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. The phase IIb study (n=254) evaluated the candidate in treatment experienced HIV-1 infected adults across four doses - (400 mg (twice daily); 800 mg (twice daily); 600 mg (once daily); 1200 mg (once a day)). | ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. Data from the 24 week study revealed that BMS-663068 was as effective as the biopharma major's established HIV treatment Reyataz (boosted with AbbVie Inc. 's ( ABBV ) Norvir) in controlling the dreaded virus. The phase IIb study (n=254) evaluated the candidate in treatment experienced HIV-1 infected adults across four doses - (400 mg (twice daily); 800 mg (twice daily); 600 mg (once daily); 1200 mg (once a day)). | Data from the 24 week study revealed that BMS-663068 was as effective as the biopharma major's established HIV treatment Reyataz (boosted with AbbVie Inc. 's ( ABBV ) Norvir) in controlling the dreaded virus. ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. Bristol-Myers said that treatment with BMS-663068 reduced the level of the virus to undetectable levels in 69%-80% patients, while Norvir boosted Reyataz therapy achieved similar results in 75% patients. |
27529.0 | 2014-03-04 00:00:00 UTC | Notable ETF Inflow Detected - XLV, ABBV, ESRX, LLY | ABBV | https://www.nasdaq.com/articles/notable-etf-inflow-detected-xlv-abbv-esrx-lly-2014-03-04 | nan | nan | Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Health Care Select Sector SPDR Fund (Symbol: XLV) where we have detected an approximate $171.1 million dollar inflow -- that's a 1.8% increase week over week in outstanding units (from 164,715,324 to 167,615,324). Among the largest underlying components of XLV, in trading today AbbVie Inc. (Symbol: ABBV) is up about 1.9%, Express Scripts Holding Co (Symbol: ESRX) is up about 1%, and Eli Lilly & Co. (Symbol: LLY) is higher by about 1.1%. The chart below shows the one year price performance of XLV, versus its 200 day moving average:
Looking at the chart above, XLV's low point in its 52 week range is $43.23 per share, with $60.01 as the 52 week high point - that compares with a last trade of $59.86. Comparing the most recent share price to the 200 day moving average can also be a useful technical analysis technique -- learn more about the 200 day moving average » .
Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). Creation of new units will mean the underlying holdings of the ETF need to be purchased, while destruction of units involves selling underlying holdings, so large flows can also impact the individual components held within ETFs.
Click here to find out which 9 other ETFs had notable inflows »
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Among the largest underlying components of XLV, in trading today AbbVie Inc. (Symbol: ABBV) is up about 1.9%, Express Scripts Holding Co (Symbol: ESRX) is up about 1%, and Eli Lilly & Co. (Symbol: LLY) is higher by about 1.1%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Health Care Select Sector SPDR Fund (Symbol: XLV) where we have detected an approximate $171.1 million dollar inflow -- that's a 1.8% increase week over week in outstanding units (from 164,715,324 to 167,615,324). The chart below shows the one year price performance of XLV, versus its 200 day moving average: Looking at the chart above, XLV's low point in its 52 week range is $43.23 per share, with $60.01 as the 52 week high point - that compares with a last trade of $59.86. | Among the largest underlying components of XLV, in trading today AbbVie Inc. (Symbol: ABBV) is up about 1.9%, Express Scripts Holding Co (Symbol: ESRX) is up about 1%, and Eli Lilly & Co. (Symbol: LLY) is higher by about 1.1%. The chart below shows the one year price performance of XLV, versus its 200 day moving average: Looking at the chart above, XLV's low point in its 52 week range is $43.23 per share, with $60.01 as the 52 week high point - that compares with a last trade of $59.86. Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. | Among the largest underlying components of XLV, in trading today AbbVie Inc. (Symbol: ABBV) is up about 1.9%, Express Scripts Holding Co (Symbol: ESRX) is up about 1%, and Eli Lilly & Co. (Symbol: LLY) is higher by about 1.1%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Health Care Select Sector SPDR Fund (Symbol: XLV) where we have detected an approximate $171.1 million dollar inflow -- that's a 1.8% increase week over week in outstanding units (from 164,715,324 to 167,615,324). The chart below shows the one year price performance of XLV, versus its 200 day moving average: Looking at the chart above, XLV's low point in its 52 week range is $43.23 per share, with $60.01 as the 52 week high point - that compares with a last trade of $59.86. | Among the largest underlying components of XLV, in trading today AbbVie Inc. (Symbol: ABBV) is up about 1.9%, Express Scripts Holding Co (Symbol: ESRX) is up about 1%, and Eli Lilly & Co. (Symbol: LLY) is higher by about 1.1%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Health Care Select Sector SPDR Fund (Symbol: XLV) where we have detected an approximate $171.1 million dollar inflow -- that's a 1.8% increase week over week in outstanding units (from 164,715,324 to 167,615,324). The chart below shows the one year price performance of XLV, versus its 200 day moving average: Looking at the chart above, XLV's low point in its 52 week range is $43.23 per share, with $60.01 as the 52 week high point - that compares with a last trade of $59.86. |
27530.0 | 2014-03-04 00:00:00 UTC | AbbVie HCV Combination Therapy Data Looks Good - Analyst Blog | ABBV | https://www.nasdaq.com/articles/abbvie-hcv-combination-therapy-data-looks-good-analyst-blog-2014-03-04 | nan | nan | AbbVie Inc. ( ABBV ) presented the first detailed results from the PEARL-III pivotal phase III study on its investigational hepatitis C virus (HCV) infection therapy at the Retroviruses and Opportunistic Infections (CROI) press conference. AbbVie's oral investigational regimen comprises a fixed-dose combination of ABT-450 co-formulated with ABT-267 (once daily) and ABT-333 with or without ribavirin (RBV), administered twice daily.
The global, multi-center, randomized, double-blind, placebo-controlled PEARL-III study (n = 419) evaluated the efficacy and safety of AbbVie's cocktail therapy in treatment-naïve non-cirrhotic chronic genotype 1b HCV infection patients for 12 weeks.
The study met its primary endpoints. Sustained virologic response rates after 12 weeks of treatment (SVR12) were 99.5% and 99% with and without RBV, respectively. Additionally, there were no discontinuations due to adverse events associated with the combination therapy.
AbbVie remains on track to file for its HCV treatment early in the second quarter of 2014. We note that the U.S. Food and Drug administration (FDA) has granted Breakthrough Therapy designation to AbbVie's HCV regimen with and without RBV. The designation should help expedite the review process for the candidate. The company believes that its HCV combination therapy can clinch an approval from the regulatory body this year itself.
AbbVie has partnered with Enanta Pharmaceuticals, Inc. ( ENTA ). Enanta shares have risen 19.1% since AbbVie initially presented data from four studies including PEARL-III in January.
Our Take
We believe that AbbVie's investigational therapy has a good chance of gaining approval based on high rates of response and backed by low discontinuation rates.
However, we note that several companies are in the race to launch their first all-oral treatment regime (without interferon injection) for HCV patients with genotype 1 infection in the U.S. Gilead Sciences Inc. ( GILD ) is looking to get its once-daily fixed-dose HCV cocktail treatment, ledipasvir plus Sovaldi, approved in the U.S. The company has already submitted the marketing application to the FDA. Meanwhile, Bristol-Myers Squibb Company ( BMY ) is not far behind with the FDA granting Breakthrough Therapy designation to its all-oral combination of daclatasvir and asunaprevir. We believe that apart from efficacy and safety, dosing and pricing will play crucial roles in determining the winner.
AbbVie currently carries a Zacks Rank #3 (Hold). Gilead is a better-ranked stock with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | The global, multi-center, randomized, double-blind, placebo-controlled PEARL-III study (n = 419) evaluated the efficacy and safety of AbbVie's cocktail therapy in treatment-naïve non-cirrhotic chronic genotype 1b HCV infection patients for 12 weeks. We note that the U.S. Food and Drug administration (FDA) has granted Breakthrough Therapy designation to AbbVie's HCV regimen with and without RBV. AbbVie Inc. ( ABBV ) presented the first detailed results from the PEARL-III pivotal phase III study on its investigational hepatitis C virus (HCV) infection therapy at the Retroviruses and Opportunistic Infections (CROI) press conference. | We note that the U.S. Food and Drug administration (FDA) has granted Breakthrough Therapy designation to AbbVie's HCV regimen with and without RBV. ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report ENANTA PHARMA (ENTA): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) presented the first detailed results from the PEARL-III pivotal phase III study on its investigational hepatitis C virus (HCV) infection therapy at the Retroviruses and Opportunistic Infections (CROI) press conference. | AbbVie Inc. ( ABBV ) presented the first detailed results from the PEARL-III pivotal phase III study on its investigational hepatitis C virus (HCV) infection therapy at the Retroviruses and Opportunistic Infections (CROI) press conference. The global, multi-center, randomized, double-blind, placebo-controlled PEARL-III study (n = 419) evaluated the efficacy and safety of AbbVie's cocktail therapy in treatment-naïve non-cirrhotic chronic genotype 1b HCV infection patients for 12 weeks. ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report ENANTA PHARMA (ENTA): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. | AbbVie Inc. ( ABBV ) presented the first detailed results from the PEARL-III pivotal phase III study on its investigational hepatitis C virus (HCV) infection therapy at the Retroviruses and Opportunistic Infections (CROI) press conference. AbbVie's oral investigational regimen comprises a fixed-dose combination of ABT-450 co-formulated with ABT-267 (once daily) and ABT-333 with or without ribavirin (RBV), administered twice daily. The global, multi-center, randomized, double-blind, placebo-controlled PEARL-III study (n = 419) evaluated the efficacy and safety of AbbVie's cocktail therapy in treatment-naïve non-cirrhotic chronic genotype 1b HCV infection patients for 12 weeks. |
27531.0 | 2014-02-24 00:00:00 UTC | FPX, ABBV, GM, KMI: Large Inflows Detected at ETF | ABBV | https://www.nasdaq.com/articles/fpx-abbv-gm-kmi-large-inflows-detected-etf-2014-02-24 | nan | nan | Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the First Trust US IPO Index Fund (Symbol: FPX) where we have detected an approximate $42.3 million dollar inflow -- that's a 10.0% increase week over week in outstanding units (from 9,000,002 to 9,900,002). Among the largest underlying components of FPX, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.7%, General Motors Co. (Symbol: GM) is down about 0.5%, and Kinder Morgan Inc. (Symbol: KMI) is lower by about 2.7%. The chart below shows the one year price performance of FPX, versus its 200 day moving average:
Looking at the chart above, FPX's low point in its 52 week range is $32.55 per share, with $47.56 as the 52 week high point - that compares with a last trade of $47.55. Comparing the most recent share price to the 200 day moving average can also be a useful technical analysis technique -- learn more about the 200 day moving average » .
Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). Creation of new units will mean the underlying holdings of the ETF need to be purchased, while destruction of units involves selling underlying holdings, so large flows can also impact the individual components held within ETFs.
Click here to find out which 9 other ETFs had notable inflows »
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Among the largest underlying components of FPX, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.7%, General Motors Co. (Symbol: GM) is down about 0.5%, and Kinder Morgan Inc. (Symbol: KMI) is lower by about 2.7%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the First Trust US IPO Index Fund (Symbol: FPX) where we have detected an approximate $42.3 million dollar inflow -- that's a 10.0% increase week over week in outstanding units (from 9,000,002 to 9,900,002). The chart below shows the one year price performance of FPX, versus its 200 day moving average: Looking at the chart above, FPX's low point in its 52 week range is $32.55 per share, with $47.56 as the 52 week high point - that compares with a last trade of $47.55. | Among the largest underlying components of FPX, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.7%, General Motors Co. (Symbol: GM) is down about 0.5%, and Kinder Morgan Inc. (Symbol: KMI) is lower by about 2.7%. The chart below shows the one year price performance of FPX, versus its 200 day moving average: Looking at the chart above, FPX's low point in its 52 week range is $32.55 per share, with $47.56 as the 52 week high point - that compares with a last trade of $47.55. Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. | Among the largest underlying components of FPX, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.7%, General Motors Co. (Symbol: GM) is down about 0.5%, and Kinder Morgan Inc. (Symbol: KMI) is lower by about 2.7%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the First Trust US IPO Index Fund (Symbol: FPX) where we have detected an approximate $42.3 million dollar inflow -- that's a 10.0% increase week over week in outstanding units (from 9,000,002 to 9,900,002). The chart below shows the one year price performance of FPX, versus its 200 day moving average: Looking at the chart above, FPX's low point in its 52 week range is $32.55 per share, with $47.56 as the 52 week high point - that compares with a last trade of $47.55. | Among the largest underlying components of FPX, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.7%, General Motors Co. (Symbol: GM) is down about 0.5%, and Kinder Morgan Inc. (Symbol: KMI) is lower by about 2.7%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the First Trust US IPO Index Fund (Symbol: FPX) where we have detected an approximate $42.3 million dollar inflow -- that's a 10.0% increase week over week in outstanding units (from 9,000,002 to 9,900,002). The chart below shows the one year price performance of FPX, versus its 200 day moving average: Looking at the chart above, FPX's low point in its 52 week range is $32.55 per share, with $47.56 as the 52 week high point - that compares with a last trade of $47.55. |
27532.0 | 2014-02-21 00:00:00 UTC | Dividend Increases: XL, ABBV, RUTH, LO, ITT | ABBV | https://www.nasdaq.com/articles/dividend-increases-xl-abbv-ruth-lo-itt-2014-02-21 | nan | nan | This morning, XL Group ( XL ) declared its quarterly dividend of 16 cents per share, an increase of about 14% over its prior dividend. Based on the current stock price, investors can expect a yield of about 2.2% going forward. Shares of XL Group were modestly higher today, climbing 0.5% so far.
Among dividend increases, AbbVie ( ABBV ) announced its quarterly dividend of 42 cents per share, an increase of about 5% over its prior dividend. Ruth's Hospitality Group ( RUTH ) announced its quarterly dividend of 5 cents per share, an increase of 25% over its prior dividend. Lorillard ( LO ) announced its quarterly dividend of 61.5 cents per share, an increase of about 12% over its prior dividend. And ITT Corporation ( ITT ) announced its quarterly dividend of 11 cents per share, an increase of 10%.
VIDEO: Dividend Increases: XL, ABBV, RUTH, LO, ITT
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | VIDEO: Dividend Increases: XL, ABBV, RUTH, LO, ITT The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Among dividend increases, AbbVie ( ABBV ) announced its quarterly dividend of 42 cents per share, an increase of about 5% over its prior dividend. Based on the current stock price, investors can expect a yield of about 2.2% going forward. | Among dividend increases, AbbVie ( ABBV ) announced its quarterly dividend of 42 cents per share, an increase of about 5% over its prior dividend. VIDEO: Dividend Increases: XL, ABBV, RUTH, LO, ITT The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Ruth's Hospitality Group ( RUTH ) announced its quarterly dividend of 5 cents per share, an increase of 25% over its prior dividend. | Among dividend increases, AbbVie ( ABBV ) announced its quarterly dividend of 42 cents per share, an increase of about 5% over its prior dividend. VIDEO: Dividend Increases: XL, ABBV, RUTH, LO, ITT The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. This morning, XL Group ( XL ) declared its quarterly dividend of 16 cents per share, an increase of about 14% over its prior dividend. | Among dividend increases, AbbVie ( ABBV ) announced its quarterly dividend of 42 cents per share, an increase of about 5% over its prior dividend. VIDEO: Dividend Increases: XL, ABBV, RUTH, LO, ITT The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. This morning, XL Group ( XL ) declared its quarterly dividend of 16 cents per share, an increase of about 14% over its prior dividend. |
27533.0 | 2014-02-20 00:00:00 UTC | Healthcare Stocks Higher in Late Trade - AbbVie Gains After Boosting Quarterly Dividend By 5% | ABBV | https://www.nasdaq.com/articles/healthcare-stocks-higher-late-trade-abbvie-gains-after-boosting-quarterly-dividend-5-2014 | nan | nan | Top Healthcare Stocks
HJNJ +0.97%
PFE +0.35%
ABT +0.59%
MRK +1.44%
AMGN +0.11%
Healthcare stocks were mostly higher Thursday, with the NYSE Healthcare Sector Index advancing 1.1% and shares of healthcare companies in the S&P 500 also rising 1.1% as a group.
In company news, shares of AbbVie ( ABBV ) were up 1.6% heading into Thursday's close after the drug-maker increased quarterly dividend by 5% to $0.42 per share, payable May 15 to shareholders of record on April 15.
With the $0.02 per share increase, ABBV has raised its dividend yearly for more than 25 years.
In other sector news,
(+) ACT, Climbs to a new 52-week high after reporting Q4 earnings of $3.17 per share, ex items, topping analyst forecasts by $0.13 per share. Revenue rose 58.8% year over year to $2.78 billion, also beating the Capital IQ consensus by around $120 million.
(-) ONTX, Said its rigosertib intravenous cancer treatment combined with best supportive care did not show a a statistically significant improvement in median survival rates when compared to best supportive care in patients with higher-risk myelodysplastic syndromes.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
Copyright (C) 2016 MTNewswires.com. All rights reserved. Unauthorized reproduction is strictly prohibited.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | In company news, shares of AbbVie ( ABBV ) were up 1.6% heading into Thursday's close after the drug-maker increased quarterly dividend by 5% to $0.42 per share, payable May 15 to shareholders of record on April 15. With the $0.02 per share increase, ABBV has raised its dividend yearly for more than 25 years. In other sector news, (+) ACT, Climbs to a new 52-week high after reporting Q4 earnings of $3.17 per share, ex items, topping analyst forecasts by $0.13 per share. | The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. In company news, shares of AbbVie ( ABBV ) were up 1.6% heading into Thursday's close after the drug-maker increased quarterly dividend by 5% to $0.42 per share, payable May 15 to shareholders of record on April 15. With the $0.02 per share increase, ABBV has raised its dividend yearly for more than 25 years. | In company news, shares of AbbVie ( ABBV ) were up 1.6% heading into Thursday's close after the drug-maker increased quarterly dividend by 5% to $0.42 per share, payable May 15 to shareholders of record on April 15. With the $0.02 per share increase, ABBV has raised its dividend yearly for more than 25 years. Healthcare stocks were mostly higher Thursday, with the NYSE Healthcare Sector Index advancing 1.1% and shares of healthcare companies in the S&P 500 also rising 1.1% as a group. | In company news, shares of AbbVie ( ABBV ) were up 1.6% heading into Thursday's close after the drug-maker increased quarterly dividend by 5% to $0.42 per share, payable May 15 to shareholders of record on April 15. With the $0.02 per share increase, ABBV has raised its dividend yearly for more than 25 years. Top Healthcare Stocks |
27534.0 | 2014-02-20 00:00:00 UTC | Sector Update: Healthcare | ABBV | https://www.nasdaq.com/articles/sector-update-healthcare-2014-02-20 | nan | nan | Healthcare stocks were mostly higher Thursday, with the NYSE Healthcare Sector Index advancing 1.1% and shares of healthcare companies in the S&P 500 also rising 1.1% as a group.
In company news, shares of AbbVie ( ABBV ) were up 1.6% heading into Thursday's close after the drug-maker increased quarterly dividend by 5% to $0.42 per share, payable May 15 to shareholders of record on April 15.
With the $0.02 per share increase, ABBV has raised its dividend yearly for more than 25 years.
In other sector news,
(+) ACT, Climbs to a new 52-week high after reporting Q4 earnings of $3.17 per share, ex items, topping analyst forecasts by $0.13 per share. Revenue rose 58.8% year over year to $2.78 billion, also beating the Capital IQ consensus by around $120 million.
(-) ONTX, Said its rigosertib intravenous cancer treatment combined with best supportive care did not show a a statistically significant improvement in median survival rates when compared to best supportive care in patients with higher-risk myelodysplastic syndromes.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
Copyright (C) 2016 MTNewswires.com. All rights reserved. Unauthorized reproduction is strictly prohibited.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | In company news, shares of AbbVie ( ABBV ) were up 1.6% heading into Thursday's close after the drug-maker increased quarterly dividend by 5% to $0.42 per share, payable May 15 to shareholders of record on April 15. With the $0.02 per share increase, ABBV has raised its dividend yearly for more than 25 years. In other sector news, (+) ACT, Climbs to a new 52-week high after reporting Q4 earnings of $3.17 per share, ex items, topping analyst forecasts by $0.13 per share. | With the $0.02 per share increase, ABBV has raised its dividend yearly for more than 25 years. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. In company news, shares of AbbVie ( ABBV ) were up 1.6% heading into Thursday's close after the drug-maker increased quarterly dividend by 5% to $0.42 per share, payable May 15 to shareholders of record on April 15. | In company news, shares of AbbVie ( ABBV ) were up 1.6% heading into Thursday's close after the drug-maker increased quarterly dividend by 5% to $0.42 per share, payable May 15 to shareholders of record on April 15. With the $0.02 per share increase, ABBV has raised its dividend yearly for more than 25 years. Healthcare stocks were mostly higher Thursday, with the NYSE Healthcare Sector Index advancing 1.1% and shares of healthcare companies in the S&P 500 also rising 1.1% as a group. | In company news, shares of AbbVie ( ABBV ) were up 1.6% heading into Thursday's close after the drug-maker increased quarterly dividend by 5% to $0.42 per share, payable May 15 to shareholders of record on April 15. With the $0.02 per share increase, ABBV has raised its dividend yearly for more than 25 years. (-) ONTX, Said its rigosertib intravenous cancer treatment combined with best supportive care did not show a a statistically significant improvement in median survival rates when compared to best supportive care in patients with higher-risk myelodysplastic syndromes. |
27535.0 | 2014-02-19 00:00:00 UTC | Biotech Stock Roundup: Regeneron's Eylea Impresses, Gilead Files for Next HCV Drug - Analyst Blog | ABBV | https://www.nasdaq.com/articles/biotech-stock-roundup-regenerons-eylea-impresses-gilead-files-next-hcv-drug-analyst-blog | nan | nan | Last week's biotech highlights include strong results from Regeneron ( REGN ) and Gilead's ( GILD ) marketing application for its next hepatitis C virus (HCV) treatment. The Medicines Co. ( MDCO ) was also in the news with the FDA's advisory panel refusing to back the company's antiplatelet agent, Cangrelor.
Regeneron on a Roll: There is no stopping Regeneron which continues to impress with its performance. The company's fourth quarter results were strong and guidance encouraging. Eye drug, Eylea, remains poised for growth. An FDA decision regarding the diabetic macular edema indication should be out in August.
Regeneron expects to file for a fourth indication, macular edema following branch retinal vein occlusion, shortly. The company will also be moving to a tax-efficient operating model -- the benefits should materialize from 2017. There is definitely a lot to like about Regeneron.
GILD Already Planning for Next HCV Drug: Gilead is looking to get its once-daily fixed-dose HCV cocktail treatment -- ledipasvir (NS5A inhibitor) plus Sovaldi (nucleotide analog polymerase inhibitor) -- approved in the U.S. Approval would make this combination the first oral treatment for HCV patients with genotype 1 infection to be available in the U.S. The important thing is that patients would not need to take interferon or ribavirin (RBV), which are usually associated with greater side effects.
But competition is not far behind. AbbVie ( ABBV ) recently provided data from four additional studies that evaluated its all-oral, interferon-free therapy with/without RBV in the same patient population.
AbbVie remains on track to file for its HCV treatment early in the second quarter of 2014 and expects to gain approval this year.
Both treatments look effective with high cure rates. But Gilead's treatment is once daily while AbbVie's will require more frequent dosing. However, eventually pricing will play a role as well in share uptake.
Cadence ( CADX ) to Be Acquired: Mallinckrodt plc will be acquiring Cadence for $14.00 per share in cash or about $1.3 billion. The offer price represents a 32% premium to the trailing 30-trading-day volume weighted average price of $10.62 per share for Cadence. The acquisition is slated to go through in mid-to-late March. Cadence shares were up 26.5% on the news.
MDCO's Cangrelor Fails to Get Panel Support: The Medicines Co.'s antiplatelet agent, Cangrelor, failed to get the support of the FDA's advisory panel. Primary concerns included the design of the study conducted with the candidate and higher bleeding rates compared to Plavix. Currently, chances of gaining FDA approval look pretty low - a final response should be out by Apr 30. Shares were down 11.5%.
Other Developments:
FDA Says Yes to BioMarin's ( BMRN ) Vimizim: BioMarin's enzyme replacement therapy, Vimizim, gained FDA approval for the treatment of Morquio A syndrome that is estimated to affect 3,000 people in the developed world. Vimizim, which is the first and only drug therapy approved for Morquio A syndrome, got approved with a broad label. About 350 patients are expected to be on the drug by year end. BioMarine's Vimizim sales guidance of $60 million - $70 million should be easily achievable - annual cost of treatment for a typical patient on Vimizim is expected to be about $380,000.
AVEO - Astellas Call It Quits: After facing several setbacks related to the development of oncology candidate, tivozanib, AVEO ( AVEO ) and partner Astellas ( ALPMY ) have decided to terminate their agreement for the development and commercialization of tivozanib. The worldwide collaboration and license agreement, which dates back to 2011, will come to an end on Aug 11, 2014, with full rights going back to AVEO.
The big question now is will AVEO continue on its own with the development of tivozanib. Considering the tivozanib-related setbacks, we do not think a partnership deal for the candidate will materialize any time soon.
Second Indication for Pharmacyclics' Imbruvica: The FDA approved Pharmacyclics' ( PCYC ) and Johnson & Johnson's ( JNJ ) Imbruvica for chronic lymphocytic leukemia (CLL) in patients who have undergone treatment with at least one therapy. CLL is the most common type of leukemia. This is the second indication for Imbruvica which gained approval last year for mantle cell lymphoma. Imbruvica has blockbuster potential.
Coming Up:
The CHMP's opinion on Vimizim's approval in the EU should be out on Friday. With the U.S. accounting for only 15% of the 1,500 patients identified by BioMarin, EU approval remains key.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie ( ABBV ) recently provided data from four additional studies that evaluated its all-oral, interferon-free therapy with/without RBV in the same patient population. AbbVie remains on track to file for its HCV treatment early in the second quarter of 2014 and expects to gain approval this year. But Gilead's treatment is once daily while AbbVie's will require more frequent dosing. | Click to get this free report >> ABBVIE INC (ABBV): Free Stock Analysis Report ASTELLAS PHARMA (ALPMY): Get Free Report AVEO PHARMACEUT (AVEO): Free Stock Analysis Report BIOMARIN PHARMA (BMRN): Free Stock Analysis Report CADENCE PHARMA (CADX): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report MEDICINES CO (MDCO): Free Stock Analysis Report PHARMACYCLICS (PCYC): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie ( ABBV ) recently provided data from four additional studies that evaluated its all-oral, interferon-free therapy with/without RBV in the same patient population. AbbVie remains on track to file for its HCV treatment early in the second quarter of 2014 and expects to gain approval this year. | Click to get this free report >> ABBVIE INC (ABBV): Free Stock Analysis Report ASTELLAS PHARMA (ALPMY): Get Free Report AVEO PHARMACEUT (AVEO): Free Stock Analysis Report BIOMARIN PHARMA (BMRN): Free Stock Analysis Report CADENCE PHARMA (CADX): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report MEDICINES CO (MDCO): Free Stock Analysis Report PHARMACYCLICS (PCYC): Free Stock Analysis Report REGENERON PHARM (REGN): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie ( ABBV ) recently provided data from four additional studies that evaluated its all-oral, interferon-free therapy with/without RBV in the same patient population. AbbVie remains on track to file for its HCV treatment early in the second quarter of 2014 and expects to gain approval this year. | AbbVie remains on track to file for its HCV treatment early in the second quarter of 2014 and expects to gain approval this year. AbbVie ( ABBV ) recently provided data from four additional studies that evaluated its all-oral, interferon-free therapy with/without RBV in the same patient population. But Gilead's treatment is once daily while AbbVie's will require more frequent dosing. |
27536.0 | 2014-02-14 00:00:00 UTC | SSO, ABBV, ACN, ACE: Large Outflows Detected at ETF | ABBV | https://www.nasdaq.com/articles/sso-abbv-acn-ace-large-outflows-detected-etf-2014-02-14 | nan | nan | Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Proshares Ultra S&P500 (Symbol: SSO) where we have detected an approximate $602.2 million dollar outflow -- that's a 26.8% decrease week over week (from 22,350,000 to 16,350,000). Among the largest underlying components of SSO, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.3%, Accenture plc (Symbol: ACN) is up about 0.5%, and ACE, Ltd. (Symbol: ACE) is higher by about 0.3%. The chart below shows the one year price performance of SSO, versus its 200 day moving average:
Looking at the chart above, SSO's low point in its 52 week range is $65.48 per share, with $102.71 as the 52 week high point - that compares with a last trade of $100.85. Comparing the most recent share price to the 200 day moving average can also be a useful technical analysis technique -- learn more about the 200 day moving average » .
Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). Creation of new units will mean the underlying holdings of the ETF need to be purchased, while destruction of units involves selling underlying holdings, so large flows can also impact the individual components held within ETFs.
Click here to find out which 9 other ETFs experienced notable outflows »
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Among the largest underlying components of SSO, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.3%, Accenture plc (Symbol: ACN) is up about 0.5%, and ACE, Ltd. (Symbol: ACE) is higher by about 0.3%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Proshares Ultra S&P500 (Symbol: SSO) where we have detected an approximate $602.2 million dollar outflow -- that's a 26.8% decrease week over week (from 22,350,000 to 16,350,000). The chart below shows the one year price performance of SSO, versus its 200 day moving average: Looking at the chart above, SSO's low point in its 52 week range is $65.48 per share, with $102.71 as the 52 week high point - that compares with a last trade of $100.85. | Among the largest underlying components of SSO, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.3%, Accenture plc (Symbol: ACN) is up about 0.5%, and ACE, Ltd. (Symbol: ACE) is higher by about 0.3%. The chart below shows the one year price performance of SSO, versus its 200 day moving average: Looking at the chart above, SSO's low point in its 52 week range is $65.48 per share, with $102.71 as the 52 week high point - that compares with a last trade of $100.85. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). | Among the largest underlying components of SSO, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.3%, Accenture plc (Symbol: ACN) is up about 0.5%, and ACE, Ltd. (Symbol: ACE) is higher by about 0.3%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Proshares Ultra S&P500 (Symbol: SSO) where we have detected an approximate $602.2 million dollar outflow -- that's a 26.8% decrease week over week (from 22,350,000 to 16,350,000). The chart below shows the one year price performance of SSO, versus its 200 day moving average: Looking at the chart above, SSO's low point in its 52 week range is $65.48 per share, with $102.71 as the 52 week high point - that compares with a last trade of $100.85. | Among the largest underlying components of SSO, in trading today AbbVie Inc. (Symbol: ABBV) is up about 0.3%, Accenture plc (Symbol: ACN) is up about 0.5%, and ACE, Ltd. (Symbol: ACE) is higher by about 0.3%. Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel , one standout is the Proshares Ultra S&P500 (Symbol: SSO) where we have detected an approximate $602.2 million dollar outflow -- that's a 26.8% decrease week over week (from 22,350,000 to 16,350,000). Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. |
27537.0 | 2014-02-11 00:00:00 UTC | Gilead Seeks U.S. Approval - Analyst Blog | ABBV | https://www.nasdaq.com/articles/gilead-seeks-u.s.-approval-analyst-blog-2014-02-11 | nan | nan | In a bid to strengthen its product portfolio further, Gilead Sciences, Inc. ( GILD ) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market the fixed-dose combination of ledipasvir ( a NS5A inhibitor: 90 mg) and sofosbuvir: 400 mg for treating adults with chronic hepatitis C virus (HCV) genotype 1 infection. Gilead filed the marketing application on the basis of encouraging data from three phase III studies (ION-1, ION-2 and ION-3).
The studies evaluated the combination with or without ribavirin in almost 2000 genotype 1 chronic hepatitis C patients. The approval of the combination would not only reduce the treatment duration of chronic hepatitis C genotype 1 infection to as low as eight weeks but also eliminate the need for interferon injections or ribavirin which have significant side effects. Gilead stated that 75% of the HCV affected population in the U.S. suffers from the genotype 1 version.
We note that the combination has been granted breakthrough therapy designation by FDA. The designation, which was enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act, should help fasten the development and review process for the candidate.
Gilead also intends to get the candidate approved in other territories across the globe. Gilead has already filed an application to the European Medicines Agency (EMA) for accelerated assessment of the combination. Acceptance of the request could reduce the EMA's review period of the application by two months.
We note that one of the components of the combination - sofosbuvir- is already approved in the U.S. (Dec 2013) and the EU (Jan 2014) under the trade name Sovaldi. Sovaldi is off to a strong start and recorded U.S. sales of $136.4 million in the fourth quarter of 2013. Sovaldi, with its high cure rates, a short treatment period and reduction/elimination of the need for interferon injections, has the potential to change the treatment paradigm in the HCV space.
Approval of the all oral ledipasvir/ sofosbuvir combination would further strengthen Gilead's product portfolio. We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV.
Gilead, a biopharmaceutical company, carries a Zacks Rank #2 (Buy). Better-ranked biopharma stocks include Actelion Ltd. ( ALIOF ) and Alexion Pharmaceuticals, Inc. ( ALXN ). Both companies carry a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. In a bid to strengthen its product portfolio further, Gilead Sciences, Inc. ( GILD ) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market the fixed-dose combination of ledipasvir ( a NS5A inhibitor: 90 mg) and sofosbuvir: 400 mg for treating adults with chronic hepatitis C virus (HCV) genotype 1 infection. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. In a bid to strengthen its product portfolio further, Gilead Sciences, Inc. ( GILD ) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market the fixed-dose combination of ledipasvir ( a NS5A inhibitor: 90 mg) and sofosbuvir: 400 mg for treating adults with chronic hepatitis C virus (HCV) genotype 1 infection. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. In a bid to strengthen its product portfolio further, Gilead Sciences, Inc. ( GILD ) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market the fixed-dose combination of ledipasvir ( a NS5A inhibitor: 90 mg) and sofosbuvir: 400 mg for treating adults with chronic hepatitis C virus (HCV) genotype 1 infection. | We note that AbbVie ( ABBV ) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report ALEXION PHARMA (ALXN): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. In a bid to strengthen its product portfolio further, Gilead Sciences, Inc. ( GILD ) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market the fixed-dose combination of ledipasvir ( a NS5A inhibitor: 90 mg) and sofosbuvir: 400 mg for treating adults with chronic hepatitis C virus (HCV) genotype 1 infection. |
27538.0 | 2014-01-31 00:00:00 UTC | AbbVie Misses on Earnings & Revs, Focus on HCV Data - Analyst Blog | ABBV | https://www.nasdaq.com/articles/abbvie-misses-on-earnings-revs-focus-on-hcv-data-analyst-blog-2014-01-31 | nan | nan | AbbVie Inc. ( ABBV ) reported fourth quarter 2013 earnings of 82 cents per share, a penny short of the Zacks Consensus Estimate. Revenues slipped 1.8% to $5.111 billion in the fourth quarter of 2013, missing the Zacks Consensus Estimate of $5.126 billion. Currency movement negatively impacted revenues by 0.7%. Revenues were also impacted by the loss of exclusivity on TriCor/TriLipix as well as the performance of products like AndroGel, Kaletra and Zemplar.
Including one-time items, fourth quarter 2013 earnings came in at 70 cents per share, down 28.6%.
Full year earnings were $3.14 per share, a penny below the Zacks Consensus Estimate. Revenues grew 2.2% to $18.790 billion, just short of the Zacks Consensus Estimate of $18.798 billion.
The Quarter in Detail
Key drug, Humira, recorded growth of 13.4% with revenues coming in at $3.04 billion. U.S. sales increased 18.1% ($1.667 billion). Ex- U.S. sales increased 8.2% to $1.372 billion. Other products that performed well included Synthroid (up 12.8% to $189 million), Creon (up 9.3% to $115 million) and Duodopa (up 20.1% to $49 million).
TriCor/TriLipix revenues fell 85.4% to $29 million. Niaspan sales declined 88.9% to $31 million.
AbbVie said that adjusted SG&A was 26.5% of sales in the fourth quarter - this reflects the company's investment in its growth brands.
Adjusted R&D was 15.6% of fourth quarter 2013 sales, reflecting the company's investment in its mid- and late-stage pipeline as well as its efforts to expand Humira's label.
AbbVie's pipeline represents significant potential - the company's late-stage pipeline includes several compounds or indications in phase III development targeting therapeutic areas like hepatitis C virus (HCV), immunology, and endometriosis.
Guidance Lags Expectations
AbbVie expects 2014 earnings in the range of $3.00 to $3.10 per share on revenues of about $19 billion. The Zacks Consensus Estimate of $3.17 is well above the guidance range. Meanwhile, the Zacks Consensus Estimate for revenues is slightly above the company's guidance at $19.2 billion.
HCV Data Overshadows Results
Along with reporting fourth quarter results, AbbVie announced that it has completed its phase III HCV studies. The company provided data from four additional studies that evaluated its all-oral, interferon-free therapy with/without ribavirin (RBV) in patients with chronic genotype 1 (GT1) HCV infection. The results confirmed previously presented data and showed high sustained virologic response rates 12 weeks post treatment (SVR12) and tolerability.
The high rates of response and tolerability coupled with low discontinuation rates are encouraging - AbbVie remains on track to file for its HCV treatment early in the second quarter of 2014.
The company believes it could gain approval for its HCV combination therapy this year itself.
Our Take
AbbVie is going through a transition period with its lipid franchise (TriCor, TriLipix and Niaspan) facing generic competition. We expect 2014 to remain challenging as the company absorbs the impact of the loss of exclusivity on the lipid franchise. However, this year should be catalyst rich for AbbVie as it continues to invest in its pipeline.
Even though AbbVie missed expectations in the fourth quarter, we expect investor focus to remain on the HCV data presented by the company.
AbbVie currently carries a Zacks Rank #3 (Hold). While we are positive on AbbVie's strong late-stage pipeline, dividend yield and growth strategy, we remain concerned about its dependence on Humira. We believe AbbVie will continue pursuing in-licensing deals and collaborations to boost its pipeline.
Some better-ranked stocks in the health care sector include H. Lundbeck A/S ( HLUKF ), Medivation ( MDVN ) and Allergan ( AGN ). While H. Lundbeck A/S and Medivation are Zacks Rank #1 (Strong Buy) stocks, Allergan is a Zacks Rank #2 (Buy) stock.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc. ( ABBV ) reported fourth quarter 2013 earnings of 82 cents per share, a penny short of the Zacks Consensus Estimate. AbbVie said that adjusted SG&A was 26.5% of sales in the fourth quarter - this reflects the company's investment in its growth brands. AbbVie's pipeline represents significant potential - the company's late-stage pipeline includes several compounds or indications in phase III development targeting therapeutic areas like hepatitis C virus (HCV), immunology, and endometriosis. | AbbVie Inc. ( ABBV ) reported fourth quarter 2013 earnings of 82 cents per share, a penny short of the Zacks Consensus Estimate. ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie said that adjusted SG&A was 26.5% of sales in the fourth quarter - this reflects the company's investment in its growth brands. | AbbVie Inc. ( ABBV ) reported fourth quarter 2013 earnings of 82 cents per share, a penny short of the Zacks Consensus Estimate. Even though AbbVie missed expectations in the fourth quarter, we expect investor focus to remain on the HCV data presented by the company. AbbVie said that adjusted SG&A was 26.5% of sales in the fourth quarter - this reflects the company's investment in its growth brands. | AbbVie said that adjusted SG&A was 26.5% of sales in the fourth quarter - this reflects the company's investment in its growth brands. AbbVie Inc. ( ABBV ) reported fourth quarter 2013 earnings of 82 cents per share, a penny short of the Zacks Consensus Estimate. AbbVie's pipeline represents significant potential - the company's late-stage pipeline includes several compounds or indications in phase III development targeting therapeutic areas like hepatitis C virus (HCV), immunology, and endometriosis. |
27539.0 | 2014-01-30 00:00:00 UTC | Novartis Earnings Miss Estimates in Q4 - Analyst Blog | ABBV | https://www.nasdaq.com/articles/novartis-earnings-miss-estimates-in-q4-analyst-blog-2014-01-30 | nan | nan | Novartis ( NVS ) reported fourth quarter 2013 earnings per share of 83 cents, up 1% from the year-ago period. Core earnings per share came in at $1.20, down 3% from the year-ago period and below the Zacks Consensus Estimate of $1.22.
All growth rates mentioned below are on a year-on-year basis and at constant exchange rates (CER).
Fourth quarter revenues increased 4% year over year to $15.1 billion but missed the Zacks Consensus Estimate of $15.4 billion.
Quarter in Detail
Novartis operates in five divisions: Pharmaceuticals, Alcon, Generics (Sandoz), Vaccines & Diagnostics and Consumer Health.
The Pharmaceuticals division recorded sales of $8.3 billion in the reported quarter, up 4% driven by strong volume growth. The division continues to benefit from the delayed entry of generic competition for Diovan monotherapy in the U.S. Diovan is indicated for hypertension.
Key drugs at Novartis such as Gilenya, Afinitor, Tasigna, Galvus, Xolair, Arcapta Neohaler/Onbrez Breezhaler, Seebri Breezhaler and Jakavi contributed 40% to total sales in the fourth quarter of 2013.
The Alcon Division recorded revenues of $2.7 billion in the fourth quarter, up 6% driven by growth in the Surgical Franchise. The growth in the Surgical Franchise was driven by demand for laser technology. Additionally, vision care business increased driven by strong sales in contact lenses. Sales in Ophthalmic Pharmaceuticals were driven by market share gains across fixed dose combination glaucoma and infection/inflammation products.
Sales from the Sandoz division increased 1% to $2.4 billion primarily due to higher sales of generic valsartan HCT in the U.S. and four months of Fougera sales.
Sales at the Vaccines and Diagnostics division were up 3% to $655 million. The growth in this division was driven by seasonal influenza, pre-pandemic sales including H7N9 in the U.S. and Menveo sales.
Consumer Health sales at Novartis were up 10% to $1.0 billion driven by strong growth in key brands along with re-launches of several products that were adversely impacted by supply issues in 2012.
Full year Results
Sales in 2013 came in at $57.9 billion, up 4% from 2012 but missing the Zacks Consensus Estimate of $58.1 billion. The entry of generics (Diovan and Zometa/Aclasta) impacted sales by $2.2 billion. Core earnings per share of $5.09 were up 4% from a year ago and beat the Zacks Consensus Estimate of $5.07 per share.
2014 Outlook
Novartis expects sales to increase in low to mid single digits in 2014. Assuming the generic Diovan Mono is launched in the U.S in the second quarter of 2014, generics are projected to impact sales by $3.0 billion in 2014 as compared to $2.2 billion in 2013.
Pipeline Update
Novartis received 18 product approvals in 2013. Key among them includes - Ultibro Breezhaler for chronic obstructive pulmonary disease (COPD) in Europe, Bexsero for MenB infections, approval for AirFluSal Forspiro for asthma and COPD in the EU. Novartis also filed AIN457 for approval in the U.S. and EU for moderate-to-severe plaque psoriasis.
The company's breast cancer candidate LEE011 has advanced into a phase III trial. Meanwhile, Sandoz also advanced its biosimilars pipeline by initiating a clinical trial on Abbvie's ( ABBV ) Humira (adalimumab).
We remind investors that Novartis sold its blood transfusion diagnostics business to Grifols in 2013 for $1.7 billion.
Our Take
Fourth quarter results were disappointing as Novartis missed our estimates. Sales of Lucnetis and Gilenya were also disappointing. We expect the entry of generic Diovan Meno to impact sales in the second half of 2014. We remind investors that Diovan was one of the key drugs of Novartis, generating over $3.5 billion in sales.
Novartis currently carries a Zacks Rank #3 (Hold). Right now, companies like Allergan ( AGN ) and Forest Laboratories ( FRX ) look well positioned. Both carry a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Meanwhile, Sandoz also advanced its biosimilars pipeline by initiating a clinical trial on Abbvie's ( ABBV ) Humira (adalimumab). ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report To read this article on Zacks.com click here. Quarter in Detail Novartis operates in five divisions: Pharmaceuticals, Alcon, Generics (Sandoz), Vaccines & Diagnostics and Consumer Health. | ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report To read this article on Zacks.com click here. Meanwhile, Sandoz also advanced its biosimilars pipeline by initiating a clinical trial on Abbvie's ( ABBV ) Humira (adalimumab). Fourth quarter revenues increased 4% year over year to $15.1 billion but missed the Zacks Consensus Estimate of $15.4 billion. | ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report To read this article on Zacks.com click here. Meanwhile, Sandoz also advanced its biosimilars pipeline by initiating a clinical trial on Abbvie's ( ABBV ) Humira (adalimumab). Sales from the Sandoz division increased 1% to $2.4 billion primarily due to higher sales of generic valsartan HCT in the U.S. and four months of Fougera sales. | Meanwhile, Sandoz also advanced its biosimilars pipeline by initiating a clinical trial on Abbvie's ( ABBV ) Humira (adalimumab). ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report To read this article on Zacks.com click here. The Pharmaceuticals division recorded sales of $8.3 billion in the reported quarter, up 4% driven by strong volume growth. |
27540.0 | 2014-01-30 00:00:00 UTC | Is AbbVie (ABBV) Poised to Beat Earnings Estimates? - Analyst Blog | ABBV | https://www.nasdaq.com/articles/is-abbvie-abbv-poised-to-beat-earnings-estimates-analyst-blog-2014-01-30 | nan | nan | AbbVie Inc. ( ABBV ) is scheduled to report fourth quarter 2013 results before the opening bell on Jan 31.
Last quarter, AbbVie had posted an earnings surprise of +5.13%. We expect the company to beat expectations in the fourth quarter as well.
Why a Likely Positive Surprise?
Our proven model shows that AbbVie is likely to beat earnings because it has the right combination of two key ingredients.
Positive Zacks ESP: The Earnings ESP (Expected Surprise Prediction), which represents the difference between the Most Accurate estimate and the Zacks Consensus Estimate, is +2.41%. This is a very meaningful and leading indicator of a likely positive earnings surprise.
Zacks #3 Rank (Hold): Note that stocks with Zacks Rank #1, #2 and #3 have a significantly higher chance of beating earnings estimates. We caution against stocks with Zacks Ranks #4 and #5 (Sell-rated stocks) going into the earnings announcement, especially when the company is seeing negative estimate revision momentum.
The combination of AbbVie's Zacks Rank #3 (Hold) and an earnings ESP of +2.41% makes us confident of an earnings beat on Jan 31.
What's Driving the Better-than-Expected Earnings?
AbbVie has delivered positive earnings surprises in the last three quarters with an average beat of 3.99%.
Although revenues will be impacted by the loss of exclusivity for Tricor, Trilipix and Niaspan, the strong performance of other products should offset the negative impact of genericization. Key growth driver, Humira, will continue to boost revenues. Other products that should continue performing well include Synthroid, Creon, Zemplar and Duodopa.
Other Stocks to Consider
AbbVie is not the only company looking up this earnings season. We also see likely earnings beats coming from these companies in the health care sector:
Sanofi ( SNY ) has earnings ESP of +2.27% and holds a Zacks Rank #3. Sanofi will report fourth quarter earnings on Feb 6.
Actavis plc ( ACT ) has an Earnings ESP of +0.33% and holds a Zacks Rank #1 (Strong Buy). Actavis will be reporting fourth quarter earnings on Feb 20.
Allergan Inc. ( AGN ) has an Earnings ESP of +0.75% and holds a Zacks Rank #2 (Buy). Allergan will be reporting fourth quarter earnings on Feb 5.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc. ( ABBV ) is scheduled to report fourth quarter 2013 results before the opening bell on Jan 31. Our proven model shows that AbbVie is likely to beat earnings because it has the right combination of two key ingredients. Last quarter, AbbVie had posted an earnings surprise of +5.13%. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) is scheduled to report fourth quarter 2013 results before the opening bell on Jan 31. Last quarter, AbbVie had posted an earnings surprise of +5.13%. | The combination of AbbVie's Zacks Rank #3 (Hold) and an earnings ESP of +2.41% makes us confident of an earnings beat on Jan 31. ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) is scheduled to report fourth quarter 2013 results before the opening bell on Jan 31. | Last quarter, AbbVie had posted an earnings surprise of +5.13%. AbbVie Inc. ( ABBV ) is scheduled to report fourth quarter 2013 results before the opening bell on Jan 31. Our proven model shows that AbbVie is likely to beat earnings because it has the right combination of two key ingredients. |
27541.0 | 2014-01-29 00:00:00 UTC | Is McKesson (MCK) Poised to Beat This Quarter? - Analyst Blog | ABBV | https://www.nasdaq.com/articles/is-mckesson-mck-poised-to-beat-this-quarter-analyst-blog-2014-01-29 | nan | nan | McKesson Corporation ( MCK ), a leading healthcare services provider, is scheduled to report fiscal third quarter 2014 results (ended Dec 31, 2013) on Jan 30, 2014.
Earnings beat the Zacks Consensus Estimate by 24 cents in the second quarter. On an average, the company has delivered a positive earnings surprise of 4.22% in the last four quarters. Let's see how things are shaping up for the same.
Why a Likely Positive Surprise?
Our proven model shows that McKesson is likely to beat earnings because it has the right combination of two key ingredients.
Positive Zacks ESP: The Expected Surprise Prediction or ESP ( Earnings ESP ), which represents the difference between the Most Accurate estimate and the Zacks Consensus Estimate, is 0.54%. This is meaningful and a leading indicator of a likely positive earnings surprise for the shares.
Zacks Rank #3 (Hold): Note that stocks with a Zacks Rank#1, #2 and #3 have a significantly higher chance of beating earnings estimates. We caution against stocks with Zacks Ranks #4 and #5 (Sell rated stocks) going into an earnings announcement, especially when the company is seeing negative estimate revision momentum.
The combination of McKesson's Zacks Rank #3 (Hold) and a positive ESP of 0.54% make us confident of an earnings beat on Jan 30.
Factors at Play
McKesson is a major player in the pharmaceutical and medical supplies distribution market. The company's Distribution Solutions segment continues to perform well. We are impressed by the company's efforts to realign its portfolio and focus on core profitable businesses.
We note that McKesson upped its earnings expectations to $8.40-$8.70 per share on the back of solid results in the first half of fiscal 2014, compared to the earlier estimate of $8.05-$8.35 per share. McKesson's performance in the fiscal first half was driven by consistent growth in the pharmaceutical business in the U.S. which is expected to grow significantly in the next several years driven by increased generic utilization.
McKesson has been actively pursuing deals and acquisitions to drive growth. The company acquired PSS World Medical in Feb 2013, which is now a part of McKesson's Medical Surgical Distribution business. The acquisition has bolstered McKesson's Medical Surgical Distribution business. McKesson is on the lookout for more such prudent deals, which will drive growth further.
Other Stocks to Consider
Here are some other companies you may want to consider as our model shows that they have the right combination of elements to post an earnings beat this quarter:
Sanofi ( SNY ) has an Earnings ESP of +2.27% and holds a Zacks Rank #3 (Hold). Sanofi will be reporting its fourth quarter earnings on Feb 6.
AbbVie Inc . ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. AbbVie will be reporting its fourth quarter earnings on Jan 31.
Actavis ( ACT ) has an Earnings ESP of +0.33% and holds a Zacks Rank #1 (Strong Buy). Actavis will be reporting its fourth quarter earnings on Feb 20.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc . ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. AbbVie will be reporting its fourth quarter earnings on Jan 31. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report MCKESSON CORP (MCK): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc . ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report MCKESSON CORP (MCK): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc . ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. | AbbVie Inc . ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. AbbVie will be reporting its fourth quarter earnings on Jan 31. |
27542.0 | 2014-01-29 00:00:00 UTC | Will Eli Lilly (LLY) Miss This Earnings Season? - Analyst Blog | ABBV | https://www.nasdaq.com/articles/will-eli-lilly-lly-miss-this-earnings-season-analyst-blog-2014-01-29 | nan | nan | Eli Lilly and Company ( LLY ) is scheduled to report fourth quarter 2013 results before the opening bell on Jan 30. Last quarter, Eli Lilly had posted an earnings surprise of +5.71%. Let's see how things are shaping up for this announcement.
Factors at Play
Eli Lilly has delivered positive earnings surprises in the last four quarters with an average beat of 9.25%.
Although revenues will be impacted by the loss of U.S. exclusivity for Cymbalta and Zyprexa, strong performance by Humulin, Alimta, Cialis, Trajenta, Humalog and Strattera will partially offset the negative impact of genericization. The animal health division should also continue to perform well.
Meanwhile, cost cutting efforts and share repurchases should boost the bottom line.
Earnings Whispers?
Our proven model does not conclusively show that Eli Lilly is likely to beat earnings this quarter. That is because a stock needs to have both a positive Earnings ESP (Expected Surprise Prediction) and a Zacks Rank of #1, 2 or 3 for this to happen. That is not the case here as you will see below.
Zacks ESP: The Earnings ESP for Eli Lilly is 0.00% since the Most Accurate Estimate is 73 cents, in line with the Zacks Consensus Estimate.
Zacks #3 Rank (Hold): Eli Lilly's Zacks Rank #3 (Hold) has little effect on the predictive power of ESP because the Zacks Rank #3 when combined with a 0.00% ESP makes surprise prediction difficult.
Other Stocks to Consider
Here are some other companies you may want to consider as our model shows that they have the right combination of elements, i.e., a positive Zacks Earnings ESP and a Zacks Rank #1, #2 or #3.
AbbVie Inc. ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. AbbVie will be reporting fourth quarter earnings on Jan 31.
Actavis plc ( ACT ) has an Earnings ESP of +0.33% and holds a Zacks Rank #1 (Strong Buy). Actavis will be reporting fourth quarter earnings on Feb 20.
Sanofi ( SNY ) has earnings ESP of +2.27% and holds a Zacks Rank #3. Sanofi will report fourth quarter earnings on Feb 6.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc. ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. AbbVie will be reporting fourth quarter earnings on Jan 31. ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. AbbVie will be reporting fourth quarter earnings on Jan 31. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. AbbVie will be reporting fourth quarter earnings on Jan 31. | AbbVie Inc. ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. AbbVie will be reporting fourth quarter earnings on Jan 31. ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. |
27543.0 | 2014-01-28 00:00:00 UTC | Investors Can't Miss These 3 Pharma Stocks - Earnings ESP | ABBV | https://www.nasdaq.com/articles/investors-cant-miss-these-3-pharma-stocks-earnings-esp-2014-01-28 | nan | nan | Investors Can't Miss These 3 Pharma Stocks
Things are definitely looking good for pharmaceutical companies this year on the back of product launches, restructuring activities and in-licensing deals. Several pharma companies have seen the worst of the patent cliff while for others there is a bright light at the end of the tunnel.
Companies like Forest Laboratories (FRX) and Eli Lilly (LLY) are bracing themselves for patent losses of key products in the forthcoming quarters. While Forest Labs' Namenda IR is likely to start facing generic competition early next year, Eli Lilly's Evista is slated to lose patent protection in a couple of months.
A common trend seen among big pharma companies struggling to come to terms with genericization is to acquire smaller players in the space. This trend is expected to continue among the companies yet to emerge from the patent cliff and those looking to strengthen their late-stage pipeline. Moreover, quite a few pharma giants have been selling their non-core assets in the last few years and will continue to do so in the coming years as well. For example, Bristol-Myers (BMY) is selling off its global diabetes business to long-time collaborator, AstraZeneca (AZN), to focus extensively on its existing portfolios comprising oncology, neurosciences, immunology, cardiovascular and virology.
The pharma companies are thus taking proactive measures to beat the generic wave and forge ahead. In fact, it is a good idea to zero in on a handful of pharma stocks that are poised to beat earnings estimates this quarter. An earnings beat should help these stocks gain investor confidence and show price improvement.
The Way to Pick Right Stocks
Given the huge number of industry participants, pinpointing stocks that have the potential to beat estimates could appear to be a daunting task, but our proprietary methodology makes it fairly simple. One way to narrow down the list of choices this earnings season is by looking at stocks that have the combination of a favorable Zacks Rank - Zacks Rank #1 (Strong Buy), #2 (Buy) or #3 (Hold) - and a positive Zacks Earnings ESP (Expected Surprise Prediction).
Earnings ESP is our proprietary methodology for identifying stocks that have high chances of surprising in their next earnings announcement. It shows the percentage difference between the Most Accurate estimate and the Zacks Consensus Estimate.
Our research shows that for stocks with this combination, the chance of a positive earnings surprise is as high as 70%.
Below are three pharma stocks we believe are best positioned to stand out this earnings season.
Sanofi ( SNY ), based in Paris, is engaged in developing and manufacturing pharmaceutical products, primarily for sale in the prescription drug market. The stock carries a Zacks Rank #3, with an Earnings ESP of +2.27%. The Zacks Consensus Estimate for the fourth quarter is 88 cents.
Although Sanofi could not deliver positive earnings surprises in the last three quarters, it looks poised to beat expectations in the fourth quarter. The company's diabetes franchise, like the last few quarters, is expected to deliver strong sales. However, genericization of several key drugs will keep affecting Sanofi's top line.
Sanofi will be reporting fourth quarter 2013 earnings on Feb 6.
AbbVie Inc. ( ABBV ) is a Zacks Rank #3 (Hold) stock with an Earnings ESP of +2.41%. The Zacks Consensus Estimate for the fourth quarter is 83 cents. In the past 7 days, estimates (on an average) have inched up a penny.
AbbVie, based in North Chicago, Ill., is engaged in the discovery, development, manufacturing and sale of proprietary pharmaceutical products. The company has delivered positive earnings surprises in the last three quarters and is expected to beat expectations in the fourth quarter as well.
Key growth driver Humira should continue with its strong performance in the fourth quarter. Other products like Synthroid, Creon and Duodopa are expected to do well.
AbbVie will be reporting fourth quarter 2013 earnings on Jan 31.
Allergan Inc. ( AGN ), based in Irvine, Calif., is a Zacks Rank #2 (Buy) stock with an Earnings ESP of +0.75%. The Zacks Consensus Estimate for the fourth quarter is $1.34.
Allergan is a global multi-specialty pharmaceutical company engaged in the development and commercialization of innovative products for eye care, neurological, medical aesthetics, medical dermatology, breast aesthetics, urological and other specialty markets. The company has delivered positive earnings surprises in three of the last four quarters with an average beat of 3.07%.
The company's specialty pharmaceuticals and eye-care pharmaceuticals segments are expected to do well in the fourth quarter. Allergan will be reporting fourth quarter 2013 earnings on Feb 5.
Bottom Line
While a number of pharma companies are seeing improvements in their financial results, there are others still facing tough challenges; the companies are nevertheless looking for better strategies to emerge as winners. A sneak peek at the space for some outperformers, backed by a solid Zacks Rank and a positive Zacks Earnings ESP, could be a great idea for investors to gain from this earnings season.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc. ( ABBV ) is a Zacks Rank #3 (Hold) stock with an Earnings ESP of +2.41%. AbbVie, based in North Chicago, Ill., is engaged in the discovery, development, manufacturing and sale of proprietary pharmaceutical products. AbbVie will be reporting fourth quarter 2013 earnings on Jan 31. | ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) is a Zacks Rank #3 (Hold) stock with an Earnings ESP of +2.41%. AbbVie, based in North Chicago, Ill., is engaged in the discovery, development, manufacturing and sale of proprietary pharmaceutical products. | AbbVie Inc. ( ABBV ) is a Zacks Rank #3 (Hold) stock with an Earnings ESP of +2.41%. AbbVie, based in North Chicago, Ill., is engaged in the discovery, development, manufacturing and sale of proprietary pharmaceutical products. AbbVie will be reporting fourth quarter 2013 earnings on Jan 31. | AbbVie Inc. ( ABBV ) is a Zacks Rank #3 (Hold) stock with an Earnings ESP of +2.41%. AbbVie, based in North Chicago, Ill., is engaged in the discovery, development, manufacturing and sale of proprietary pharmaceutical products. AbbVie will be reporting fourth quarter 2013 earnings on Jan 31. |
27544.0 | 2014-01-28 00:00:00 UTC | Is Biogen (BIIB) Poised to Beat Earnings Estimates? - Analyst Blog | ABBV | https://www.nasdaq.com/articles/is-biogen-biib-poised-to-beat-earnings-estimates-analyst-blog-2014-01-28 | nan | nan | Biogen Idec Inc. ( BIIB ) is scheduled to report fourth quarter 2013 results before the opening bell on Jan 29.
Last quarter, Biogen had posted an earnings surprise of +9.35%. We expect the company to beat expectations in the fourth quarter as well.
Why a Likely Positive Surprise?
Our proven model shows that Biogen is likely to beat earnings because it has the right combination of two key ingredients.
Positive Zacks ESP: The Earnings ESP (Expected Surprise Prediction), which represents the difference between the Most Accurate estimate and the Zacks Consensus Estimate, is +9.01%. This is a very meaningful and leading indicator of a likely positive earnings surprise.
Zacks #2 Rank (Buy): Note that stocks with Zacks Rank #1, #2 and #3 have a significantly higher chance of beating earnings estimates. We caution against stocks with Zacks Ranks #4 and #5 (Sell-rated stocks) going into the earnings announcement, especially when the company is seeing negative estimate revision momentum.
The combination of Biogen's Zacks Rank #2 (Buy) and an earnings ESP of +9.01% makes us confident of an earnings beat on Jan 29.
What is Driving the Better-than-Expected Earnings?
Biogen has delivered positive earnings surprises in the last three quarters with an average beat of 19.2%.
Biogen's new multiple sclerosis product, Tecfidera, which is off to a strong start should continue performing well and drive revenues. Meanwhile, Avonex and Tysabri should continue contributing significantly to revenues despite the presence of new entrants in the multiple sclerosis market.
Upside could result from a revenue benefit of about $95 million related to the pending settlement with the Italian National Medicines Agency. However, the timing of the final approval remains uncertain and could move into early 2014.
Other Stocks to Consider
Biogen is not the only company looking up this earnings season. We also see likely earnings beats coming from these companies in the medical sector:
Sanofi ( SNY ) has an Earnings ESP of +2.27% and holds a Zacks Rank #3 (Hold). Sanofi will be reporting fourth quarter earnings on Feb 6.
AbbVie Inc. ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. AbbVie will be reporting fourth quarter earnings on Jan 31.
Actavis plc ( ACT ) has an Earnings ESP of +0.33% and holds a Zacks Rank #1 (Strong Buy). Actavis will be reporting fourth quarter earnings on Feb 20.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc. ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. AbbVie will be reporting fourth quarter earnings on Jan 31. ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. AbbVie will be reporting fourth quarter earnings on Jan 31. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie Inc. ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. AbbVie will be reporting fourth quarter earnings on Jan 31. | AbbVie Inc. ( ABBV ) has an Earnings ESP of +2.41% and holds a Zacks Rank #3. AbbVie will be reporting fourth quarter earnings on Jan 31. ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. |
27545.0 | 2014-01-21 00:00:00 UTC | Earnings Preview: Will Abbott Labs (ABT) Disappoint This Quarter? - Analyst Blog | ABBV | https://www.nasdaq.com/articles/earnings-preview%3A-will-abbott-labs-abt-disappoint-this-quarter-analyst-blog-2014-01-21 | nan | nan | Abbott Laboratories ( ABT ) is scheduled to report fourth quarter 2013 results before the opening bell on Jan 22, 2014.
Last quarter, Abbott Labs posted a 7.84% positive surprise. On an average, Abbott Labs has posted a 4.57% positive surprise in the last four quarters. Let's see how things are shaping up for the fourth quarter.
Factors to Influence 4Q Results
Abbott Labs is an extremely diversified company with its presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013.
However, the business environment was challenging in 2013 due to austerity measures in developed markets and weak economic conditions in developing markets. We believe the pricing pressure in the EU and health care reforms in the U.S. will have a negative impact on sales.
Moreover, we were disappointed by the disruption in international nutrition sales in the third quarter of 2013. The disruption is likely to stretch into the first half of 2014. The nutrition division is the company's fastest growing business and hence a disruption in business will impact growth rates going forward. China is a key emerging market for Abbott Labs and the disruption is expected to negatively impact the bottom line by approximately 5 cents.
Earnings Whispers?
However, our proven model does not conclusively show that Abbott Labs will beat earnings this quarter. That is because a stock needs to have both a positive Earnings ESP and a Zacks Rank #1, #2 or #3 to be able to beat consensus estimates. That is not the case here as you will see below.
Zacks ESP: The ESP, which represents the difference between the Most Accurate estimate and the Zacks Consensus Estimate, is 0.00%. This is because both the Most Accurate Estimate and Zacks Consensus Estimate currently stand at 58 cents.
Zacks Rank #3(Hold): Abbott Labs' Zacks Rank #3 (Hold) when combined with a 0.00% ESP makes surprise prediction difficult.
We caution against stocks with Zacks Ranks #4 and #5 (Sell-rated stocks) going into the earnings announcement, especially when the company is seeing negative estimate revisions.
Stocks to Consider
Here are some large cap pharma stocks you may want to consider as our model shows that these have the right combination of elements to post an earnings beat this season:
Eli Lilly and Company ( LLY ) has Earnings ESP of +1.37% and holds a Zacks Rank #3. Eli Lilly will be reporting fourth quarter 2013 earnings on Jan 30, 2014.
Sanofi ( SNY ) has earnings ESP of +2.27% and holds a Zacks Rank #3. Sanofi will report fourth quarter 2013 results on Feb 6, 2014.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Factors to Influence 4Q Results Abbott Labs is an extremely diversified company with its presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Laboratories ( ABT ) is scheduled to report fourth quarter 2013 results before the opening bell on Jan 22, 2014. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. Factors to Influence 4Q Results Abbott Labs is an extremely diversified company with its presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013. Zacks Rank #3(Hold): Abbott Labs' Zacks Rank #3 (Hold) when combined with a 0.00% ESP makes surprise prediction difficult. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. Factors to Influence 4Q Results Abbott Labs is an extremely diversified company with its presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013. Zacks Rank #3(Hold): Abbott Labs' Zacks Rank #3 (Hold) when combined with a 0.00% ESP makes surprise prediction difficult. | Factors to Influence 4Q Results Abbott Labs is an extremely diversified company with its presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report To read this article on Zacks.com click here. Moreover, we were disappointed by the disruption in international nutrition sales in the third quarter of 2013. |
27546.0 | 2014-01-16 00:00:00 UTC | AbbVie Advances with Cancer Candidate - Analyst Blog | ABBV | https://www.nasdaq.com/articles/abbvie-advances-with-cancer-candidate-analyst-blog-2014-01-16 | nan | nan | AbbVie ( ABBV ) has commenced a phase III randomized, placebo-controlled, double-blind study on its cancer candidate, veliparib. The study will evaluate the efficacy and safety of veliparib plus carboplatin in patients suffering from early-stage, triple-negative breast cancer.
The study, consisting of three arms, will compare veliparib plus carboplatin or placebo plus carboplatin to standard neoadjuvant chemotherapy.
The key endpoint is pathological complete response which means there should not be any evidence of residual, invasive cancer in the breast tissue and lymph node tissue after treatment. The secondary endpoint is the rate of eligibility for breast conservation after treatment.
Other outcome measures that will be evaluated include event-free survival, overall survival, and complete response rate.
We are encouraged by AbbVie's efforts to develop the oncology pipeline which consists of several mid and late-stage candidates. Apart from veliparib, ABT-199 is another important late-stage oncology candidate in AbbVie's pipeline.
We expect 2014 to be a transitional year for the company as it absorbs the remaining impact of the genericization of its lipid franchise.
AbbVie has several pipeline-related events lined up this year including data on multiple sclerosis candidate, daclizumab from the DECIDE study in mid-14 and data on Elagolix from one of the two pivotal studies in endometriosis in the second half of 2014. Positive data on daclizumab would also allow the company to file for approval this year.
AbbVie also has some hepatitis C virus related milestones this year including regulatory submissions in the second quarter of 2014.
AbbVie is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the broader sector include Actelion Ltd. ( ALIOF ), Medivation, Inc. ( MDVN ) and Allergan ( AGN ). While Actelion and Medivation carry a Zacks Rank #1 (Strong Buy), Allergan is a Zacks Rank #2 (Buy) stock.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie ( ABBV ) has commenced a phase III randomized, placebo-controlled, double-blind study on its cancer candidate, veliparib. We are encouraged by AbbVie's efforts to develop the oncology pipeline which consists of several mid and late-stage candidates. Apart from veliparib, ABT-199 is another important late-stage oncology candidate in AbbVie's pipeline. | ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report MEDIVATION INC (MDVN): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie ( ABBV ) has commenced a phase III randomized, placebo-controlled, double-blind study on its cancer candidate, veliparib. We are encouraged by AbbVie's efforts to develop the oncology pipeline which consists of several mid and late-stage candidates. | AbbVie ( ABBV ) has commenced a phase III randomized, placebo-controlled, double-blind study on its cancer candidate, veliparib. AbbVie has several pipeline-related events lined up this year including data on multiple sclerosis candidate, daclizumab from the DECIDE study in mid-14 and data on Elagolix from one of the two pivotal studies in endometriosis in the second half of 2014. ABBVIE INC (ABBV): Free Stock Analysis Report ALLERGAN INC (AGN): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report MEDIVATION INC (MDVN): Free Stock Analysis Report To read this article on Zacks.com click here. | AbbVie ( ABBV ) has commenced a phase III randomized, placebo-controlled, double-blind study on its cancer candidate, veliparib. We are encouraged by AbbVie's efforts to develop the oncology pipeline which consists of several mid and late-stage candidates. Apart from veliparib, ABT-199 is another important late-stage oncology candidate in AbbVie's pipeline. |
27547.0 | 2014-01-13 00:00:00 UTC | Repros Continues to Gain on Androxal News - Analyst Blog | ABBV | https://www.nasdaq.com/articles/repros-continues-to-gain-on-androxal-news-analyst-blog-2014-01-13 | nan | nan | Repros Therapeutics Inc. 's ( RPRX ) share price increased 1.2% last week on the announcement that the company has initiated two studies on its secondary hypogonadism candidate, Androxal. Since then, the company has gained approximately 5.4%.
The two identical, 17-week, double-blinded, placebo controlled studies will compare the safety and efficacy of Androxal with a testosterone replacement therapy (topical gel) in restoring and maintaining testicular function. Both studies will enroll 120 men each. Top-line data from the studies are expected by Oct 2014. Repros plans to submit the new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2014.
Repros has already obtained the Investigational Review Board approval for several of the study sites. Meanwhile, several sites have started pre-screening patients with the drug shipment for the trial expected shortly.
We remind investors that the company had received guidance from the FDA related to the Androxal development program in Oct 2013. In view of the guidance, Repros delayed the regulatory submission from the previously expected timeline of mid-2014.
Last year, the company had announced encouraging top-line data from the first pivotal phase III study (ZA-301) and the second pivotal efficacy study (ZA-302), which evaluated Androxal for secondary hypogonadism. Both ZA-301 and ZA-302 - conducted under the FDA's Special Protocol Assessment (SPA) program - had met their respective primary endpoints.
We believe that Repros stands to benefit from the additional trials as data, if positive, can be added to the label. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel.
Repros currently carries a Zacks Rank #3 (Hold). We expect investor focus to remain on Androxal updates. Some better-ranked stocks in the biopharma space include Actelion Ltd. ( ALIOF ) and Jazz Pharmaceuticals ( JAZZ ). Both carry a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Repros Therapeutics Inc. 's ( RPRX ) share price increased 1.2% last week on the announcement that the company has initiated two studies on its secondary hypogonadism candidate, Androxal. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Last year, the company had announced encouraging top-line data from the first pivotal phase III study (ZA-301) and the second pivotal efficacy study (ZA-302), which evaluated Androxal for secondary hypogonadism. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. Repros Therapeutics Inc. 's ( RPRX ) share price increased 1.2% last week on the announcement that the company has initiated two studies on its secondary hypogonadism candidate, Androxal. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Top-line data from the studies are expected by Oct 2014. |
27548.0 | 2014-01-09 00:00:00 UTC | Seattle Gentics-AbbVie Deal Expanded - Analyst Blog | ABBV | https://www.nasdaq.com/articles/seattle-gentics-abbvie-deal-expanded-analyst-blog-2014-01-09 | nan | nan | Seattle Genetics, Inc. ( SGEN ) further expanded its antibody-drug conjugate (ADC) collaboration with AbbVieInc. ( ABBV ).
AbbVie will pay an upfront fee of $25 million for additional rights of using Seattle Genetics' ADC technology with AbbVie antibodies against oncology targets. Seattle Genetics could receive up to $255 million from AbbVie in the form of potential license fees, royalties on worldwide net sales of any resulting products and future milestone payments on achieving predetermined development and commercial objectives.
We note that in Mar 2011, Abbott Laboratories ( ABT ) (prior to its spin-off of AbbVie) had entered into a collaboration agreement with Seattle Genetics under which Abbott paid an upfront fee of $8 million for rights to utilize Seattle Genetics' ADC technology with its antibodies to a single oncology target. In Oct 2012, the deal was expanded and Abbott paid an additional $25 million. Seattle Genetics were to receive up to $220 million under that deal.
As per the agreement, AbbVie is responsible for research, product development, manufacturing and commercialization of ADC products. Seattle Genetics will also receive annual maintenance fees and research support payments for assistance provided to AbbVie in developing ADCs.
ADCs have lately been attracting a lot of interest with major companies entering into collaborations. 18 out of 30 ADC candidates in clinical development use Seattle Genetics' proprietary ADC technology. Seattle Genetics has alliances with many companies for the development of ADCs.
Seattle Genetics and AbbVie carry a Zacks Rank #3 (Hold). Investors may consider WuXiPharmaTech (Cayman) Inc. ( WX ), which carries a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Seattle Genetics could receive up to $255 million from AbbVie in the form of potential license fees, royalties on worldwide net sales of any resulting products and future milestone payments on achieving predetermined development and commercial objectives. We note that in Mar 2011, Abbott Laboratories ( ABT ) (prior to its spin-off of AbbVie) had entered into a collaboration agreement with Seattle Genetics under which Abbott paid an upfront fee of $8 million for rights to utilize Seattle Genetics' ADC technology with its antibodies to a single oncology target. Seattle Genetics will also receive annual maintenance fees and research support payments for assistance provided to AbbVie in developing ADCs. | AbbVie will pay an upfront fee of $25 million for additional rights of using Seattle Genetics' ADC technology with AbbVie antibodies against oncology targets. We note that in Mar 2011, Abbott Laboratories ( ABT ) (prior to its spin-off of AbbVie) had entered into a collaboration agreement with Seattle Genetics under which Abbott paid an upfront fee of $8 million for rights to utilize Seattle Genetics' ADC technology with its antibodies to a single oncology target. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report SEATTLE GENETIC (SGEN): Free Stock Analysis Report WUXI PHARMATECH (WX): Free Stock Analysis Report To read this article on Zacks.com click here. | AbbVie will pay an upfront fee of $25 million for additional rights of using Seattle Genetics' ADC technology with AbbVie antibodies against oncology targets. We note that in Mar 2011, Abbott Laboratories ( ABT ) (prior to its spin-off of AbbVie) had entered into a collaboration agreement with Seattle Genetics under which Abbott paid an upfront fee of $8 million for rights to utilize Seattle Genetics' ADC technology with its antibodies to a single oncology target. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report SEATTLE GENETIC (SGEN): Free Stock Analysis Report WUXI PHARMATECH (WX): Free Stock Analysis Report To read this article on Zacks.com click here. | AbbVie will pay an upfront fee of $25 million for additional rights of using Seattle Genetics' ADC technology with AbbVie antibodies against oncology targets. Seattle Genetics will also receive annual maintenance fees and research support payments for assistance provided to AbbVie in developing ADCs. Seattle Genetics, Inc. ( SGEN ) further expanded its antibody-drug conjugate (ADC) collaboration with AbbVieInc. |
27549.0 | 2014-01-07 00:00:00 UTC | Abbott Had A Transformational 2013, Here's What To Expect in 2014 | ABBV | https://www.nasdaq.com/articles/abbott-had-transformational-2013-heres-what-expect-2014-2014-01-07 | nan | nan | Abbott Labs ( ABT ) started 2013 by spinning off its proprietary pharmaceutical business as Abbvie ( ABBV ) on January 1, 2013. With the move, the company began a new life as a healthcare firm whose major offerings include nutritional, diagnostics and vascular products, along with a portfolio of generic drugs. Immediately after the spin-off, its stock was trading at around $32, and rallied to about $38 at the end of the year. We were bullish on the stock throughout the year and our price estimate of $40 has remained almost unchanged for more than two quarters. We expect the company to continue performing well in 2014, as demand from emerging markets is likely to recover from a recent supply disruption. The company's focus on margin expansion is another factor that should help its performance this year.
See our full analysis for Abbott Labs
Nutritionals And Diagnostics Are Key, Emerging Markets Drive Growth
Nutritionals and Diagnostics together account for over 50% of Abbott's revenue, and both of these divisions have been reporting solid growth in sales over the past few years due to strong demand from emerging markets. Countries like China, India, Russia and Brazil continue to grow at a faster rate than most developed economies and have a rapidly growing middle class. For example, McKinsey & Company predicts that the urban-household income in China will double by 2022 and that the majority of its urban consumers will earn between $9,000 and $34,000 annually by that time. As the middle class continues to grow in these markets, people are likely to increase their focus on healthy living and increase their discretionary spending on nutritional products (food supplements) and point-of-care diagnostics.
Recent Issues In China Should Not Be A Big Problem
In Q3 Abbott's Nutritional sales were negatively impacted by a sales disruption in some emerging markets, including China. The disruption was at least partly due to a voluntary product recall, caused by a contamination scare in some of Abbott's baby formula products. The impact of this recall is likely to be seen in the next few quarters, but is likely to be transitory because the recalled products were found to be safe for consumption during laboratory tests. The demand for world-renowned baby formula brands remains very strong in the Chinese market and we expect Abbott's sales to rebound quickly once its supply chain recovers from the shock.
In another story, Abbott was investigated, along with several other multinational baby formula manufacturers, by Chinese regulators for price fixing and was fined almost $12.6 million in August 2013. In response, it dropped prices of its baby formula products by 4-12%, which could pressure margins. China faced a major milk scandal in 2008 when adulterated milk powder caused 53,000 infants to fall sick, out of which around 13,000 babies had to be hospitalized. Since then, Chinese parents have shown a strong affinity towards trusted brands from multinationals, which should increase demand for Abbott's products because it is one of the most trusted baby formula brands worldwide (read: How Abbott Could Gain From Cutting Formula Prices In China).
Diagnostics Business Likely To Pick Up The Slack
Even if Abbott's Nutritional business reports suppressed growth in the near term due to the problems mentioned above, the company should have no problems reporting respectable revenue growth because its Diagnostics business has been performing well. In Q3 the company reported a 4.3% year-on-year increase in operational sales on the back of an impressive 10.5% operational growth in its diagnostics business. Diagnostics sales grew primarily due to strong demand from emerging markets in Molecular Diagnostics as well as the success of Point-of-Care Diagnostics in the U.S. hospital and Physician Office Lab segments. We expect Abbott's Diagnostics sales to continue increasing over the next few years as it launches innovative Diagnostic products. It is currently developing multiple Diagnostics platforms designed to improve customer service and enhance laboratory productivity.
Efforts To Improve Product Portfolio In Other Segments
In 2013, Abbott made two important acquisitions to boost its offerings in the Vascular and Medical Optics segments. In the Vascular segment it acquired IDEV Technologies, a stent manufacturing company, for $310 million net of cash and debt. IDEV's flagship stent, SUPERA Veritas, already sells in Europe for treating blockages in blood vessels due to peripheral artery disease (PAD), a sickness that ails 27 million people in Europe and North America. It is also under FDA review superficial femoral artery (SFA) treatment in the U.S. In the Medical Optics business, Abbott acquired OptiMedica Corporation for about $250 million net of cash. OptiMedica's flagship product, Catalys, allows surgeons to replace manual steps in cataract surgery with computer-guided laser technology, and provides Abbott an entry point in the large and fast growing laser cataract surgery market. According to Abbott, nearly 22 million surgeries will be performed around the globe in 2013, and this number is likely to increase in the future as the global population gets older.
Cost Cutting Efforts
Abbott is also doing well in controlling costs despite its expansion plans. The company's gross margin for Q3 was around 54%, an increase of 1.6% over the same period last year. Similarly, adjusted operating margins improved by 210 basis points due to a sharp decline in SG&A expenses. The increase in margins is a result of Abbott's continued focus on making its operations more efficient. It has been working on improving production scale and yields, reducing materials costs and improving its product mix. It has also taken some astute cost cutting measures such as building new facilities closer to customers in emerging markets to cut distribution costs. Due to the initiatives mentioned above, we expect Abbott's margins to continue expanding over the next few years.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Abbott Labs ( ABT ) started 2013 by spinning off its proprietary pharmaceutical business as Abbvie ( ABBV ) on January 1, 2013. With the move, the company began a new life as a healthcare firm whose major offerings include nutritional, diagnostics and vascular products, along with a portfolio of generic drugs. The demand for world-renowned baby formula brands remains very strong in the Chinese market and we expect Abbott's sales to rebound quickly once its supply chain recovers from the shock. | Abbott Labs ( ABT ) started 2013 by spinning off its proprietary pharmaceutical business as Abbvie ( ABBV ) on January 1, 2013. See our full analysis for Abbott Labs Nutritionals And Diagnostics Are Key, Emerging Markets Drive Growth Nutritionals and Diagnostics together account for over 50% of Abbott's revenue, and both of these divisions have been reporting solid growth in sales over the past few years due to strong demand from emerging markets. Recent Issues In China Should Not Be A Big Problem In Q3 Abbott's Nutritional sales were negatively impacted by a sales disruption in some emerging markets, including China. | Abbott Labs ( ABT ) started 2013 by spinning off its proprietary pharmaceutical business as Abbvie ( ABBV ) on January 1, 2013. See our full analysis for Abbott Labs Nutritionals And Diagnostics Are Key, Emerging Markets Drive Growth Nutritionals and Diagnostics together account for over 50% of Abbott's revenue, and both of these divisions have been reporting solid growth in sales over the past few years due to strong demand from emerging markets. Since then, Chinese parents have shown a strong affinity towards trusted brands from multinationals, which should increase demand for Abbott's products because it is one of the most trusted baby formula brands worldwide (read: How Abbott Could Gain From Cutting Formula Prices In China). | Abbott Labs ( ABT ) started 2013 by spinning off its proprietary pharmaceutical business as Abbvie ( ABBV ) on January 1, 2013. The disruption was at least partly due to a voluntary product recall, caused by a contamination scare in some of Abbott's baby formula products. Diagnostics Business Likely To Pick Up The Slack Even if Abbott's Nutritional business reports suppressed growth in the near term due to the problems mentioned above, the company should have no problems reporting respectable revenue growth because its Diagnostics business has been performing well. |
27550.0 | 2013-12-26 00:00:00 UTC | Pipeline Update on Santarus Candidate - Analyst Blog | ABBV | https://www.nasdaq.com/articles/pipeline-update-on-santarus-candidate-analyst-blog-2013-12-26 | nan | nan | Investors eagerly await updates on the pipelines of pharma/biotech companies. However, in the case of Santarus, Inc. ( SNTS ), more than the pipeline updates investors will be interested in the company's upcoming acquisition by Salix Pharmaceuticals Ltd.
We note that Santarus has been actively developing its pipeline of late. Earlier this week, Santarus initiated a phase IIb study (n=90) on its pipeline candidate, SAN-300. The multicenter, multinational, randomized, double-blind, placebo-controlled, multiple ascending dose study will be evaluating the safety and tolerability of repeat subcutaneous (SC) doses of SAN-300 in patients suffering from active rheumatoid arthritis (RA) with inadequate response to disease-modifying anti-rheumatic drugs (DMARDs).
Additionally, Santarus will be evaluating the pharmacokinetics and pharmacodynamics of the candidate in RA patients. The company will also assess the preliminary efficacy and immunogenicity of SAN-300 in these patients. However, competition is stiff in the RA market given the presence of treatments like UCB's Cimzia and AbbVie Inc. 's ( ABBV ) Humira, among others.
We remind investors that Santarus was in the news recently when Salix announced its intention to acquire the prior. In Nov 2013, the companies signed a definitive merger agreement under which Salix will acquire all the outstanding common stock of Santarus for $32.00 per share in cash (without interest). This represents a 36% premium to Santarus' closing price on Nov 6. The deal, valued at approximately $2.6 billion, is slated to close in the first quarter of 2014. We expect investor focus to remain on the news.
Santarus, a biopharmaceutical company, carries a Zacks Rank #1 (Strong Buy). Some other stocks in the biopharmaceutical sector that are worth considering include Jazz Pharmaceuticals ( JAZZ ) and Vanda Pharmaceuticals Inc. ( VNDA ). Both the stocks carry same rank as Santarus.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | However, competition is stiff in the RA market given the presence of treatments like UCB's Cimzia and AbbVie Inc. 's ( ABBV ) Humira, among others. ABBVIE INC (ABBV): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report To read this article on Zacks.com click here. The multicenter, multinational, randomized, double-blind, placebo-controlled, multiple ascending dose study will be evaluating the safety and tolerability of repeat subcutaneous (SC) doses of SAN-300 in patients suffering from active rheumatoid arthritis (RA) with inadequate response to disease-modifying anti-rheumatic drugs (DMARDs). | ABBVIE INC (ABBV): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report To read this article on Zacks.com click here. However, competition is stiff in the RA market given the presence of treatments like UCB's Cimzia and AbbVie Inc. 's ( ABBV ) Humira, among others. However, in the case of Santarus, Inc. ( SNTS ), more than the pipeline updates investors will be interested in the company's upcoming acquisition by Salix Pharmaceuticals Ltd. We note that Santarus has been actively developing its pipeline of late. | ABBVIE INC (ABBV): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report To read this article on Zacks.com click here. However, competition is stiff in the RA market given the presence of treatments like UCB's Cimzia and AbbVie Inc. 's ( ABBV ) Humira, among others. However, in the case of Santarus, Inc. ( SNTS ), more than the pipeline updates investors will be interested in the company's upcoming acquisition by Salix Pharmaceuticals Ltd. We note that Santarus has been actively developing its pipeline of late. | However, competition is stiff in the RA market given the presence of treatments like UCB's Cimzia and AbbVie Inc. 's ( ABBV ) Humira, among others. ABBVIE INC (ABBV): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report To read this article on Zacks.com click here. However, in the case of Santarus, Inc. ( SNTS ), more than the pipeline updates investors will be interested in the company's upcoming acquisition by Salix Pharmaceuticals Ltd. We note that Santarus has been actively developing its pipeline of late. |
27551.0 | 2013-12-23 00:00:00 UTC | CHMP Positive on Roche's RoActemra's Subcutaneous Formulation - Analyst Blog | ABBV | https://www.nasdaq.com/articles/chmp-positive-on-roches-roactemras-subcutaneous-formulation-analyst-blog-2013-12-23 | nan | nan | Roche ( RHHBY ) recently received positive news when the Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion on the subcutaneous formulation of rheumatoid arthritis (RA) drug RoActemra.
The CHMP recommended approval of the subcutaneous formulation of RoActemra for use both as monotherapy and in combination with methotrexate.
The positive opinion from the CHMP was based on encouraging data from two phase III studies - SUMMACTA and BREVACTA.
The data from the SUMMACTA study showed that the efficacy and tolerability of subcutaneous RoActemra was comparable with the intravenous (IV) formulation of RoActemra.
We remind investors that RoActemra is approved in the EU for the treatment of moderate-to-severe RA who did not respond adequately or were intolerant to, previous medication with one or more disease-modifying antirheumatic drugs (DMARDs) or tumor necrosis factor (TNF) inhibitors.
RoActemra IV formulation is also approved for the treatment of active systemic juvenile idiopathic arthritis (SJIA) and polyarticular juvenile idiopathic arthritis (PJIA) in patients aging two years and above.
We note that RoActemra is marketed as Actemra in the U.S. The subcutaneous formulation of the drug was approved in the U.S. in Oct 2013.
Roche has launched the subcutaneous injection formulation of Actemra in Japan in May 2013.
Sales of Actemra grew 33% in the first nine months of 2013. The subcutaneous formulation should boost sales of Actmera going forward benefiting from its increased use as a monotherapy in RA.
However, competition is stiff in the RA market given the presence of treatments like UCB 's ( UCBJF ) Cimzia and AbbVie Inc.' s ( ABBV ) Humira, among others.
Roche currently carries a Zack Rank #3 (Hold). Right now, Shire ( SHPG ) appears to be well placed with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | However, competition is stiff in the RA market given the presence of treatments like UCB 's ( UCBJF ) Cimzia and AbbVie Inc.' s ( ABBV ) Humira, among others. ABBVIE INC (ABBV): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. The positive opinion from the CHMP was based on encouraging data from two phase III studies - SUMMACTA and BREVACTA. | ABBVIE INC (ABBV): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. However, competition is stiff in the RA market given the presence of treatments like UCB 's ( UCBJF ) Cimzia and AbbVie Inc.' s ( ABBV ) Humira, among others. Roche ( RHHBY ) recently received positive news when the Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion on the subcutaneous formulation of rheumatoid arthritis (RA) drug RoActemra. | ABBVIE INC (ABBV): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. However, competition is stiff in the RA market given the presence of treatments like UCB 's ( UCBJF ) Cimzia and AbbVie Inc.' s ( ABBV ) Humira, among others. Roche ( RHHBY ) recently received positive news when the Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion on the subcutaneous formulation of rheumatoid arthritis (RA) drug RoActemra. | However, competition is stiff in the RA market given the presence of treatments like UCB 's ( UCBJF ) Cimzia and AbbVie Inc.' s ( ABBV ) Humira, among others. ABBVIE INC (ABBV): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. The positive opinion from the CHMP was based on encouraging data from two phase III studies - SUMMACTA and BREVACTA. |
27552.0 | 2013-12-03 00:00:00 UTC | Pharma & Biotech Stock Outlook - Dec 2013 - Zacks Analyst Interviews | ABBV | https://www.nasdaq.com/articles/pharma-biotech-stock-outlook-dec-2013-zacks-analyst-interviews-2013-12-03 | nan | nan | With 2013 coming to an end, the worst of the patent cliff faced by the pharmaceutical sector is over. Major blockbuster drugs like Merck's ( MRK ) Singulair, Pfizer's ( PFE ) Lipitor, Forest Laboratories ' ( FRX ) Lexapro, Sanofi / Bristol-Myers Squibbs ' ( SNY / BMY ) Plavix and Eli Lilly's (LLY) Zyprexa representing combined branded sales worth more than $15 billion in lost patent protection over the last couple of years.
However, the effect of the genericization of these products was felt mostly in 2012. While the industry won't be completely free from genericization, the major patent expiries are over and done with.
Several companies which had been struggling to post growth in the face of genericization over the past few years should see accelerated growth in 2014. New products should start contributing significantly to results and increased pipeline visibility and appropriate utilization of cash should increase confidence in the sector.
Some products that are slated to lose patent protection later this year and next year include:
AstraZeneca's ( AZN ) Nexium could also start facing generics from 2014 in the U.S., where sales were $2.2 billion in 2012.
Collaborations, Acquisitions and Restructuring
The pharma sector witnessed major merger and acquisitions (M&A) activity over the last couple of years. The trend continued this year and going forward, we expect small bolt-on acquisitions to continue. In-licensing activities and collaborations for the development of pipeline candidates have also increased significantly. Several pharma companies are focusing on in-licensing mid-to-late stage pipeline candidates that look promising, instead of developing a product from scratch, which involves a lot of funds and time.
Small biotech companies are open to in-licensing activities and collaborations. Most of these companies find it challenging to raise cash, thereby making it difficult for them to survive and continue with the development of promising pipeline candidates. Therefore, it makes sense for them to seek deals with pharma companies that are sitting on huge piles of cash.
We recommend biotech stocks that have attractive pipeline candidates or technology that can be used for the development of novel therapeutics. Therapeutic areas which could see a lot of in-licensing activity include oncology, central nervous system disorders, diabetes and immunology/inflammation. The hepatitis C virus (HCV) market is also attracting a lot of attention.
Some recent acquisitions/deals include Shire's ( SHPG ) upcoming acquisition of ViroPharma ( VPHM ), Salix's ( SLXP ) upcoming acquisition of Santarus ( SNTS ) as well as the acquisition of Optimer Pharmaceuticals and Trius Therapeutics by Cubist Pharmaceuticals ( CBST ). Elan ( ELN ) is also on track to be acquired by Perrigo Company ( PRGO ) by year's end.
Another trend that we are seeing in recent months is the divestment of non-core business segments. Pfizer sold its Capsugel unit and its Nutrition business in Aug 2011 and Nov 2012, respectively. Pfizer then spun off its animal health business into a new company, Zoetis ( ZTS ). Meanwhile, GlaxoSmithKline ( GSK ) divested certain non-core brands from its Consumer Healthcare segment. In Aug 2011, AstraZeneca sold its Astra Tech business to DENTSPLY ( XRAY ).
The monetization of non-core assets will allow the pharma/biotech companies to focus on their areas of expertise. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Johnson & Johnson ( JNJ ) also announced its plans to explore strategic alternatives for its ortho-clinical diagnostics business, including a possible divestiture. Vertex ( VRTX ) monetized its Incivo-related royalties -- Vertex can use the cash generated from this deal for its cystic fibrosis program.
Restructuring activities are also gaining momentum as large pharma companies are looking to cut costs and streamline their operations. Most of these companies are re-evaluating their pipelines and discontinuing programs which do not have a favorable risk-benefit profile. Some of the companies that announced restructuring plans include Merck, Novartis ( NVS ), Eli Lilly, Shire and Sanofi.
Emerging Markets and Biosimilars
Another trend seen in the pharmaceutical sector is a focus on emerging markets. Companies like Mylan ( MYL ), Pfizer, Merck, Eli Lilly, Glaxo and Sanofi are all looking to expand their presence in India, China, Brazil and other emerging markets. Until recently, most of the commercialization efforts were focused on the U.S. market -- the largest pharmaceutical market -- along with Europe and Japan. Emerging markets are slowly and steadily gaining more importance, and several companies are now shifting their focus to these areas.
However, while higher demand for medicines, government initiatives for healthcare, new patient population and increasing use of generics should help drive demand, we point out that emerging markets are also not immune from genericization. Moreover, investigations into bribery charges in China could put a lid on near-term growth.
Meanwhile, growth in Europe will continue to be pressurized by austerity and cost-containment measures.
We are also seeing several companies entering into deals for the development of biosimilars, generic versions of biologics. Companies like Merck, Amgen, Biogen ( BIIB ), and Actavis ( ACT ) are all targeting the highly lucrative biosimilars market.
3Q Earnings
All companies falling under the Medical sector have reported third quarter 2013 results. While earnings-beat and revenue-beat ratios (percentage of companies coming out with positive surprises) were pretty impressive, growth ratios were modest. Third quarter results were characterized by currency headwinds especially in Japan as well as a slowdown in China where bribery investigations remained in the headlines.
Third quarter 2013 earnings "beat ratio" was 74.5% while the revenue "beat ratio" was 51.0%. Total earnings for this sector were up 0.2%, compared to the 1.5% decline recorded in the second quarter of 2013. Total revenues moved up 5.8% in the quarter versus 2.4% growth in the second quarter of 2013.
Looking at the consensus earnings expectations for the fourth quarter, earnings are expected to decline 3.5%. Tough challenges for some companies, negative currency movement and a few patent expiries will affect fourth quarter growth. With the year coming to an end, several companies maintained or narrowed their guidance ranges.
Overall, 2013 earnings are expected to grow 0.6%.
Focus on New Products
2012 saw the FDA approving 35 novel medicines including the following:
Most of these products have been performing well so far in 2013. Stivarga, Kalydeco, Xtandi and Kyprolis, especially, represent strong commercial potential.
So far in 2013, quite a few important products have gained approval including Biogen's oral multiple sclerosis drug Tecfidera, Johnson & Johnson's type II diabetes drug Invokana, Merck's Liptruzet (cholesterol), Forest's Fetzima (major depressive disorder), Pharmacyclics ( PCYC )/Johnson & Johnson's Imbruvica (mantle cell lymphoma) and Roche's ( RHHBY ) Gazyva (chronic lymphocytic leukemia). Biogen's Tecfidera is off to a strong start with sales surpassing expectations by a wide margin.
Upcoming events include FDA advisory panel reviews of the biologic licensing application (BLA) for Bristol-Myers Squibbs' metreleptin (rare forms of lipodystrophy) and dapagliflozin (type II diabetes), and Merck's Grastek (a Timothy grass pollen extract tablet for sublingual use). All these reviews are scheduled to take place in the Dec 11 - 12 timeframe.
A response on the approval status of Auxilium Pharma's ( AUXL ) Xiaflex for Peyronie's and Gilead's sofosbuvir (chronic HCV infection) in the U.S. should also be out in December.
Zacks Industry Rank
Within the Zacks Industry classification, pharma and biotech are broadly grouped into the Medical sector (one of 16 Zacks sectors) and further sub-divided into four industries at the expanded level: large-cap pharma, med-biomed/gene, med-drugs and med-generic drugs.
We rank all the 260-plus industries in the 16 Zacks sectors based on the earnings outlook and fundamental strength of the constituent companies in each industry. To learn more, visit: About Zacks Industry Rank .
As a point of reference, the outlook for industries with Zacks Industry Rank #88 and lower is 'Positive,' between #89 and #176 is 'Neutral' and #177 and higher is 'Negative.'
The Zacks Industry Rank for large-cap pharma is #95, med-biomed/gene is #77, med-drugs is #66, while the med-generic drugs is #40. Analyzing the Zacks Industry Rank for different medical segments, it is obvious that the outlook is Positive for med-drugs, med-biomed/gene and med-generic drugs and Neutral for large-cap pharma stocks.
OPPORTUNITIES
The outlook for the pharma sector has improved significantly with the Zacks Industry Rank moving up from #195 to #95 over the past few months. While several companies will continue to face challenges like EU austerity measures and genericization, the pharma industry is out of the worst of the genericization phase.
Many companies which had faced generic headwinds in the last couple of years should continue to see a sustained improvement in results as we move into 2014. Cost-cutting, downsizing, streamlining of the pipeline, growth in emerging markets and new product launches should support growth.
Among large-cap pharma stocks, Bayer ( BAYRY ), a Zacks Rank #2 (Buy) stock, looks well-positioned with several new products -- Eylea, Stivarga and Xarelto -- in its portfolio. These products represent significant commercial potential.
Forest Labs ( FRX ), another Zacks Rank #2 stock, is doing well with first half fiscal 2014 results beating expectations. The company has launched several new products over the past few quarters and continues to work on expanding its pipeline. This company also raised its earning guidance for fiscal 2014.
Shire ( SHPG ), a Zacks Rank #1 (Strong Buy) stock, looks well-positioned for growth with the company expanding its product portfolio and pipeline through the upcoming acquisition of ViroPharma.
We are positive on Johnson & Johnson ( JNJ ) even though the company currently holds a Zacks Rank #3 (Hold). The company has performed well so far this year and the momentum should continue. Johnson & Johnson upped its 2013 earnings guidance again after announcing third quarter results.
The company has been trying to offset the declining sales of some of its important products by bringing in new products through in-licensing deals and acquisitions. We believe the diversity and strength of the company's underlying businesses will continue to provide strong growth in future.
In the biotech space, we are positive on Biogen ( BIIB ). Tecfidera, the company's recently launched oral multiple sclerosis drug, is off to a strong start with the product delivering sales of $478 million since its launch in early April. While Tecfidera has gained the top spot in the oral multiple sclerosis market in the U.S., Avonex and Tysabri should continue contributing significantly to sales. Tecfidera should gain EU approval shortly. Biogen is also progressing with its hemophilia pipeline. Biogen is another company that raised its 2013 guidance again this year.
We are also positive on Amgen ( AMGN ). Amgen should be able to deliver on its long-term strategy based on expansion in key markets, launch of new manufacturing technologies, and pipeline development. Enbrel should continue performing well. Amgen's late-stage pipeline is also moving along. While Amgen is a Zacks Rank #2 stock, Biogen is a Zacks Rank #3 (Hold) stock. Gilead, a Zacks Rank #3 stock, continues to do well in the HIV segment and is also progressing with its HCV pipeline.
Medivation ( MDVN ), a Zacks Rank #2 company, should continue delivering with its prostate cancer therapy, Xtandi, performing well. Based on the data we have seen so far, we believe Xtandi has blockbuster potential. It is currently in several studies including for the pre-chemo setting. Expansion into the pre-chemo setting would be a major positive for Medivation.
Vanda Pharmaceuticals, Inc. ( VNDA ) also looks well-positioned with the company receiving a positive feedback from the FDA regarding insomnia candidate, tasimelteon. The FDA's advisory panel voted resoundingly in favor of approving the candidate for the treatment of Non-24-Hour Disorder in the totally blind. While the FDA is not required to follow the advice of its advisory panel, it usually does so. A response from the agency should be out by Jan 31, 2014. Vanda is a Zacks Rank #1 stock.
Among generic companies, Actavis ( ACT ) looks well-positioned. We view the acquisition of Actavis Group as a smart strategic move and we believe the company will be able to achieve its guidance easily. We are also positive on the recent acquisition of Warner Chilcott, which makes strategic and financial sense. With fewer major patent expiries slated to occur in the next few years, we are encouraged by Actavis' focus on building its branded and biosimilars pipeline. The company carries a Zacks Rank #2.
WEAKNESSES
We recommend avoiding names that offer little growth or opportunity for a take-out. These include companies which are developing drugs that are likely to face regulatory hurdles. The FDA has been exercising more caution in granting approval to new products and several candidates are facing delays in receiving final approval.
Among large-cap pharma companies, Eli Lilly ( LLY ) is gearing up for another round of patent expiries: Cymbalta in Dec 2013 and Evista next year. We prefer waiting on the sidelines until the company is able to emerge from the impact of genericization.
Companies that currently carry a Zacks Rank #4 (Sell) include Alkermes ( ALKS ), BioLineRx, Ltd. ( BLRX ) and XOMA Corporation ( XOMA ) among others.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. 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Major blockbuster drugs like Merck's ( MRK ) Singulair, Pfizer's ( PFE ) Lipitor, Forest Laboratories ' ( FRX ) Lexapro, Sanofi / Bristol-Myers Squibbs ' ( SNY / BMY ) Plavix and Eli Lilly's (LLY) Zyprexa representing combined branded sales worth more than $15 billion in lost patent protection over the last couple of years. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report AUXILIUM PHARMA (AUXL): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOLINE RX LTD (BLRX): Get Free Report BRISTOL-MYERS (BMY): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report ELAN CP PLC ADR (ELN): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report PHARMACYCLICS (PCYC): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO COMPANY (PRGO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VIROPHARMA (VPHM): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report XOMA CORP (XOMA): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Major blockbuster drugs like Merck's ( MRK ) Singulair, Pfizer's ( PFE ) Lipitor, Forest Laboratories ' ( FRX ) Lexapro, Sanofi / Bristol-Myers Squibbs ' ( SNY / BMY ) Plavix and Eli Lilly's (LLY) Zyprexa representing combined branded sales worth more than $15 billion in lost patent protection over the last couple of years. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report AUXILIUM PHARMA (AUXL): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOLINE RX LTD (BLRX): Get Free Report BRISTOL-MYERS (BMY): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report ELAN CP PLC ADR (ELN): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report PHARMACYCLICS (PCYC): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO COMPANY (PRGO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VIROPHARMA (VPHM): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report XOMA CORP (XOMA): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Zacks Industry Rank Within the Zacks Industry classification, pharma and biotech are broadly grouped into the Medical sector (one of 16 Zacks sectors) and further sub-divided into four industries at the expanded level: large-cap pharma, med-biomed/gene, med-drugs and med-generic drugs. | Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report AUXILIUM PHARMA (AUXL): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOLINE RX LTD (BLRX): Get Free Report BRISTOL-MYERS (BMY): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report ELAN CP PLC ADR (ELN): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report PHARMACYCLICS (PCYC): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO COMPANY (PRGO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VIROPHARMA (VPHM): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report XOMA CORP (XOMA): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Focus on New Products 2012 saw the FDA approving 35 novel medicines including the following: Most of these products have been performing well so far in 2013. |
27553.0 | 2013-12-03 00:00:00 UTC | Pharma & Biotech Stock Outlook - Dec 2013 - Industry Outlook | ABBV | https://www.nasdaq.com/articles/pharma-biotech-stock-outlook-dec-2013-industry-outlook-2013-12-03 | nan | nan | With 2013 coming to an end, the worst of the patent cliff faced by the pharmaceutical sector is over. Major blockbuster drugs like Merck's ( MRK ) Singulair, Pfizer's ( PFE ) Lipitor, Forest Laboratories ' ( FRX ) Lexapro, Sanofi / Bristol-Myers Squibbs ' ( SNY / BMY ) Plavix and Eli Lilly's (LLY) Zyprexa representing combined branded sales worth more than $15 billion in lost patent protection over the last couple of years.
However, the effect of the genericization of these products was felt mostly in 2012. While the industry won't be completely free from genericization, the major patent expiries are over and done with.
Several companies which had been struggling to post growth in the face of genericization over the past few years should see accelerated growth in 2014. New products should start contributing significantly to results and increased pipeline visibility and appropriate utilization of cash should increase confidence in the sector.
Some products that are slated to lose patent protection later this year and next year include:
AstraZeneca's ( AZN ) Nexium could also start facing generics from 2014 in the U.S., where sales were $2.2 billion in 2012.
Collaborations, Acquisitions and Restructuring
The pharma sector witnessed major merger and acquisitions (M&A) activity over the last couple of years. The trend continued this year and going forward, we expect small bolt-on acquisitions to continue. In-licensing activities and collaborations for the development of pipeline candidates have also increased significantly. Several pharma companies are focusing on in-licensing mid-to-late stage pipeline candidates that look promising, instead of developing a product from scratch, which involves a lot of funds and time.
Small biotech companies are open to in-licensing activities and collaborations. Most of these companies find it challenging to raise cash, thereby making it difficult for them to survive and continue with the development of promising pipeline candidates. Therefore, it makes sense for them to seek deals with pharma companies that are sitting on huge piles of cash.
We recommend biotech stocks that have attractive pipeline candidates or technology that can be used for the development of novel therapeutics. Therapeutic areas which could see a lot of in-licensing activity include oncology, central nervous system disorders, diabetes and immunology/inflammation. The hepatitis C virus (HCV) market is also attracting a lot of attention.
Some recent acquisitions/deals include Shire's ( SHPG ) upcoming acquisition of ViroPharma ( VPHM ), Salix's ( SLXP ) upcoming acquisition of Santarus ( SNTS ) as well as the acquisition of Optimer Pharmaceuticals and Trius Therapeutics by Cubist Pharmaceuticals ( CBST ). Elan ( ELN ) is also on track to be acquired by Perrigo Company ( PRGO ) by year's end.
Another trend that we are seeing in recent months is the divestment of non-core business segments. Pfizer sold its Capsugel unit and its Nutrition business in Aug 2011 and Nov 2012, respectively. Pfizer then spun off its animal health business into a new company, Zoetis ( ZTS ). Meanwhile, GlaxoSmithKline ( GSK ) divested certain non-core brands from its Consumer Healthcare segment. In Aug 2011, AstraZeneca sold its Astra Tech business to DENTSPLY ( XRAY ).
The monetization of non-core assets will allow the pharma/biotech companies to focus on their areas of expertise. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Johnson & Johnson ( JNJ ) also announced its plans to explore strategic alternatives for its ortho-clinical diagnostics business, including a possible divestiture. Vertex ( VRTX ) monetized its Incivo-related royalties -- Vertex can use the cash generated from this deal for its cystic fibrosis program.
Restructuring activities are also gaining momentum as large pharma companies are looking to cut costs and streamline their operations. Most of these companies are re-evaluating their pipelines and discontinuing programs which do not have a favorable risk-benefit profile. Some of the companies that announced restructuring plans include Merck, Novartis ( NVS ), Eli Lilly, Shire and Sanofi.
Emerging Markets and Biosimilars
Another trend seen in the pharmaceutical sector is a focus on emerging markets. Companies like Mylan ( MYL ), Pfizer, Merck, Eli Lilly, Glaxo and Sanofi are all looking to expand their presence in India, China, Brazil and other emerging markets. Until recently, most of the commercialization efforts were focused on the U.S. market -- the largest pharmaceutical market -- along with Europe and Japan. Emerging markets are slowly and steadily gaining more importance, and several companies are now shifting their focus to these areas.
However, while higher demand for medicines, government initiatives for healthcare, new patient population and increasing use of generics should help drive demand, we point out that emerging markets are also not immune from genericization. Moreover, investigations into bribery charges in China could put a lid on near-term growth.
Meanwhile, growth in Europe will continue to be pressurized by austerity and cost-containment measures.
We are also seeing several companies entering into deals for the development of biosimilars, generic versions of biologics. Companies like Merck, Amgen, Biogen ( BIIB ), and Actavis ( ACT ) are all targeting the highly lucrative biosimilars market.
3Q Earnings
All companies falling under the Medical sector have reported third quarter 2013 results. While earnings-beat and revenue-beat ratios (percentage of companies coming out with positive surprises) were pretty impressive, growth ratios were modest. Third quarter results were characterized by currency headwinds especially in Japan as well as a slowdown in China where bribery investigations remained in the headlines.
Third quarter 2013 earnings "beat ratio" was 74.5% while the revenue "beat ratio" was 51.0%. Total earnings for this sector were up 0.2%, compared to the 1.5% decline recorded in the second quarter of 2013. Total revenues moved up 5.8% in the quarter versus 2.4% growth in the second quarter of 2013.
Looking at the consensus earnings expectations for the fourth quarter, earnings are expected to decline 3.5%. Tough challenges for some companies, negative currency movement and a few patent expiries will affect fourth quarter growth. With the year coming to an end, several companies maintained or narrowed their guidance ranges.
Overall, 2013 earnings are expected to grow 0.6%.
Focus on New Products
2012 saw the FDA approving 35 novel medicines including the following:
Most of these products have been performing well so far in 2013. Stivarga, Kalydeco, Xtandi and Kyprolis, especially, represent strong commercial potential.
So far in 2013, quite a few important products have gained approval including Biogen's oral multiple sclerosis drug Tecfidera, Johnson & Johnson's type II diabetes drug Invokana, Merck's Liptruzet (cholesterol), Forest's Fetzima (major depressive disorder), Pharmacyclics ( PCYC )/Johnson & Johnson's Imbruvica (mantle cell lymphoma) and Roche's ( RHHBY ) Gazyva (chronic lymphocytic leukemia). Biogen's Tecfidera is off to a strong start with sales surpassing expectations by a wide margin.
Upcoming events include FDA advisory panel reviews of the biologic licensing application (BLA) for Bristol-Myers Squibbs' metreleptin (rare forms of lipodystrophy) and dapagliflozin (type II diabetes), and Merck's Grastek (a Timothy grass pollen extract tablet for sublingual use). All these reviews are scheduled to take place in the Dec 11 - 12 timeframe.
A response on the approval status of Auxilium Pharma's ( AUXL ) Xiaflex for Peyronie's and Gilead's sofosbuvir (chronic HCV infection) in the U.S. should also be out in December.
Zacks Industry Rank
Within the Zacks Industry classification, pharma and biotech are broadly grouped into the Medical sector (one of 16 Zacks sectors) and further sub-divided into four industries at the expanded level: large-cap pharma, med-biomed/gene, med-drugs and med-generic drugs.
We rank all the 260-plus industries in the 16 Zacks sectors based on the earnings outlook and fundamental strength of the constituent companies in each industry. To learn more, visit: About Zacks Industry Rank .
As a point of reference, the outlook for industries with Zacks Industry Rank #88 and lower is 'Positive,' between #89 and #176 is 'Neutral' and #177 and higher is 'Negative.'
The Zacks Industry Rank for large-cap pharma is #95, med-biomed/gene is #77, med-drugs is #66, while the med-generic drugs is #40. Analyzing the Zacks Industry Rank for different medical segments, it is obvious that the outlook is Positive for med-drugs, med-biomed/gene and med-generic drugs and Neutral for large-cap pharma stocks.
OPPORTUNITIES
The outlook for the pharma sector has improved significantly with the Zacks Industry Rank moving up from #195 to #95 over the past few months. While several companies will continue to face challenges like EU austerity measures and genericization, the pharma industry is out of the worst of the genericization phase.
Many companies which had faced generic headwinds in the last couple of years should continue to see a sustained improvement in results as we move into 2014. Cost-cutting, downsizing, streamlining of the pipeline, growth in emerging markets and new product launches should support growth.
Among large-cap pharma stocks, Bayer ( BAYRY ), a Zacks Rank #2 (Buy) stock, looks well-positioned with several new products -- Eylea, Stivarga and Xarelto -- in its portfolio. These products represent significant commercial potential.
Forest Labs ( FRX ), another Zacks Rank #2 stock, is doing well with first half fiscal 2014 results beating expectations. The company has launched several new products over the past few quarters and continues to work on expanding its pipeline. This company also raised its earning guidance for fiscal 2014.
Shire ( SHPG ), a Zacks Rank #1 (Strong Buy) stock, looks well-positioned for growth with the company expanding its product portfolio and pipeline through the upcoming acquisition of ViroPharma.
We are positive on Johnson & Johnson ( JNJ ) even though the company currently holds a Zacks Rank #3 (Hold). The company has performed well so far this year and the momentum should continue. Johnson & Johnson upped its 2013 earnings guidance again after announcing third quarter results.
The company has been trying to offset the declining sales of some of its important products by bringing in new products through in-licensing deals and acquisitions. We believe the diversity and strength of the company's underlying businesses will continue to provide strong growth in future.
In the biotech space, we are positive on Biogen ( BIIB ). Tecfidera, the company's recently launched oral multiple sclerosis drug, is off to a strong start with the product delivering sales of $478 million since its launch in early April. While Tecfidera has gained the top spot in the oral multiple sclerosis market in the U.S., Avonex and Tysabri should continue contributing significantly to sales. Tecfidera should gain EU approval shortly. Biogen is also progressing with its hemophilia pipeline. Biogen is another company that raised its 2013 guidance again this year.
We are also positive on Amgen ( AMGN ). Amgen should be able to deliver on its long-term strategy based on expansion in key markets, launch of new manufacturing technologies, and pipeline development. Enbrel should continue performing well. Amgen's late-stage pipeline is also moving along. While Amgen is a Zacks Rank #2 stock, Biogen is a Zacks Rank #3 (Hold) stock. Gilead, a Zacks Rank #3 stock, continues to do well in the HIV segment and is also progressing with its HCV pipeline.
Medivation ( MDVN ), a Zacks Rank #2 company, should continue delivering with its prostate cancer therapy, Xtandi, performing well. Based on the data we have seen so far, we believe Xtandi has blockbuster potential. It is currently in several studies including for the pre-chemo setting. Expansion into the pre-chemo setting would be a major positive for Medivation.
Vanda Pharmaceuticals, Inc. ( VNDA ) also looks well-positioned with the company receiving a positive feedback from the FDA regarding insomnia candidate, tasimelteon. The FDA's advisory panel voted resoundingly in favor of approving the candidate for the treatment of Non-24-Hour Disorder in the totally blind. While the FDA is not required to follow the advice of its advisory panel, it usually does so. A response from the agency should be out by Jan 31, 2014. Vanda is a Zacks Rank #1 stock.
Among generic companies, Actavis ( ACT ) looks well-positioned. We view the acquisition of Actavis Group as a smart strategic move and we believe the company will be able to achieve its guidance easily. We are also positive on the recent acquisition of Warner Chilcott, which makes strategic and financial sense. With fewer major patent expiries slated to occur in the next few years, we are encouraged by Actavis' focus on building its branded and biosimilars pipeline. The company carries a Zacks Rank #2.
WEAKNESSES
We recommend avoiding names that offer little growth or opportunity for a take-out. These include companies which are developing drugs that are likely to face regulatory hurdles. The FDA has been exercising more caution in granting approval to new products and several candidates are facing delays in receiving final approval.
Among large-cap pharma companies, Eli Lilly ( LLY ) is gearing up for another round of patent expiries: Cymbalta in Dec 2013 and Evista next year. We prefer waiting on the sidelines until the company is able to emerge from the impact of genericization.
Companies that currently carry a Zacks Rank #4 (Sell) include Alkermes ( ALKS ), BioLineRx, Ltd. ( BLRX ) and XOMA Corporation ( XOMA ) among others.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report AUXILIUM PHARMA (AUXL): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOLINE RX LTD (BLRX): Get Free Report BRISTOL-MYERS (BMY): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report ELAN CP PLC ADR (ELN): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report PHARMACYCLICS (PCYC): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO COMPANY (PRGO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VIROPHARMA (VPHM): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report XOMA CORP (XOMA): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Major blockbuster drugs like Merck's ( MRK ) Singulair, Pfizer's ( PFE ) Lipitor, Forest Laboratories ' ( FRX ) Lexapro, Sanofi / Bristol-Myers Squibbs ' ( SNY / BMY ) Plavix and Eli Lilly's (LLY) Zyprexa representing combined branded sales worth more than $15 billion in lost patent protection over the last couple of years. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report AUXILIUM PHARMA (AUXL): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOLINE RX LTD (BLRX): Get Free Report BRISTOL-MYERS (BMY): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report ELAN CP PLC ADR (ELN): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report PHARMACYCLICS (PCYC): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO COMPANY (PRGO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VIROPHARMA (VPHM): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report XOMA CORP (XOMA): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Major blockbuster drugs like Merck's ( MRK ) Singulair, Pfizer's ( PFE ) Lipitor, Forest Laboratories ' ( FRX ) Lexapro, Sanofi / Bristol-Myers Squibbs ' ( SNY / BMY ) Plavix and Eli Lilly's (LLY) Zyprexa representing combined branded sales worth more than $15 billion in lost patent protection over the last couple of years. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report AUXILIUM PHARMA (AUXL): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOLINE RX LTD (BLRX): Get Free Report BRISTOL-MYERS (BMY): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report ELAN CP PLC ADR (ELN): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report PHARMACYCLICS (PCYC): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO COMPANY (PRGO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VIROPHARMA (VPHM): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report XOMA CORP (XOMA): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Zacks Industry Rank Within the Zacks Industry classification, pharma and biotech are broadly grouped into the Medical sector (one of 16 Zacks sectors) and further sub-divided into four industries at the expanded level: large-cap pharma, med-biomed/gene, med-drugs and med-generic drugs. | Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS PLC (ACT): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report AUXILIUM PHARMA (AUXL): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BIOLINE RX LTD (BLRX): Get Free Report BRISTOL-MYERS (BMY): Free Stock Analysis Report CUBIST PHARM (CBST): Free Stock Analysis Report ELAN CP PLC ADR (ELN): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report PHARMACYCLICS (PCYC): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report PERRIGO COMPANY (PRGO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report VANDA PHARMACT (VNDA): Free Stock Analysis Report VIROPHARMA (VPHM): Free Stock Analysis Report VERTEX PHARM (VRTX): Free Stock Analysis Report XOMA CORP (XOMA): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Focus on New Products 2012 saw the FDA approving 35 novel medicines including the following: Most of these products have been performing well so far in 2013. |
27554.0 | 2013-11-26 00:00:00 UTC | J&J's Olysio Approved in the U.S. - Analyst Blog | ABBV | https://www.nasdaq.com/articles/jjs-olysio-approved-in-the-u.s.-analyst-blog-2013-11-26 | nan | nan | Johnson & Johnson ( JNJ ) received positive news when the U.S. Food and Drug Administration (FDA) approved Olysio for hepatitis C infection.
The FDA approved the use of Olysio, a NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection. Olysio is approved as a part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in adult patients suffering from genotype I infection with liver problems. It can be used in both treatment naïve patients as well as in patients who have failed prior interferon-based therapy.
We note that an approval was on the cards as the Antiviral Drugs Advisory Committee of the FDA recommended the approval on a unanimous basis in Oct 2013.
We remind investors that Janssen Therapeutics, a part of Johnson & Johnson's Janssen Products, submitted its New Drug Application (NDA) for Olysio to the FDA in Mar 2013. Subsequently, the FDA granted "priority review" designation to the NDA in May 2013. Olysio was developed in collaboration with Medivir AB which holds the marketing rights in Nordic countries.
Johnson & Johnson already has a hepatitis C virus (HCV) drug in its portfolio - Incivo. The approval of Olysio will strengthen its HCV franchise. Olysio was approved in Japan under the trade name, Sovriad, in Sep 2013. It is currently under review in Europe.
We note that Johnson & Johnson's HCV pipeline recently got a boost with the acquisition of GlaxoSmithKline's ( GSK ) pipeline candidate, GSK2336805.
GSK2336805, a NS5a replication complex inhibitor, is being developed for the treatment of chronic HCV. Johnson & Johnson will move the candidate into phase II studies in interferon-free combinations with its protease inhibitor Olysio and its non-nucleoside polymerase inhibitor, TMC647055, for the treatment of chronic HCV in adult patients with compensated liver disease.
As per Johnson & Johnson, as many as 3.2 million people in the U.S. are infected with HCV. Hence, the market potential for HCV drugs looks positive but competition is stiff as companies like AbbVie, Inc . ( ABBV ) are also developing treatments for HCV.
Johnson & Johnson currently carries a Zacks Rank #3 (Hold). Right now, large-cap pharma stock that looks attractive include Bayer AG ( BAYRY ), with a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Hence, the market potential for HCV drugs looks positive but competition is stiff as companies like AbbVie, Inc . ( ABBV ) are also developing treatments for HCV. ABBVIE INC (ABBV): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. | ABBVIE INC (ABBV): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. Hence, the market potential for HCV drugs looks positive but competition is stiff as companies like AbbVie, Inc . ( ABBV ) are also developing treatments for HCV. | ABBVIE INC (ABBV): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. Hence, the market potential for HCV drugs looks positive but competition is stiff as companies like AbbVie, Inc . ( ABBV ) are also developing treatments for HCV. | Hence, the market potential for HCV drugs looks positive but competition is stiff as companies like AbbVie, Inc . ( ABBV ) are also developing treatments for HCV. ABBVIE INC (ABBV): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. |
27555.0 | 2013-11-19 00:00:00 UTC | European Approval for Gilead's Vitekta - Analyst Blog | ABBV | https://www.nasdaq.com/articles/european-approval-for-gileads-vitekta-analyst-blog-2013-11-19 | nan | nan | Good news flowed in at Gilead Sciences, Inc ( GILD ) from Europe when the European Commission approved its HIV drug Vitekta (elvitegravir) across two doses- 85 mg and 150 mg. The EC cleared the drug, an integrase inhibitor, for use as part of HIV therapy regimens inclusive of a protease inhibitor boosted by AbbVie Inc. 's ( ABBV ) Norvir (ritonavir).
Gilead stated in its press release that Vitekta works by interfering with HIV replication. The inhibitor blocks the virus from integrating into the genetic material of human cells. Vitekta has proved to be effective in suppressing the disease in patients with drug-resistant HIV strains. The EC approved the drug on the basis of positive 96 week data from a phase III study (145). Data from the study reveled that Vitekta (once daily) was non-inferior to Merck & Co. Inc. 's ( MRK ) HIV drug Isentress (raltegravir: twice daily) - another integrase inhibitor. Despite the positive news, Gilead's stock price declined.
We note that the U.S. approval path for the drug has been far from smooth. In Apr 2013, Gilead received a complete response letter (CRL) on Vitekta from the U.S. Food and Drug Administration (FDA). The U.S. regulatory body declined to approve the drug as a monotherapy on the basis of the submitted data due to shortcomings observed in the documentation and validation of certain quality testing methods. Gilead is working towards resubmission of the new drug application (NDA).
Apart from the European approval for Vitekta, Gilead was in the news when it announced encouraging data from a phase III study (116) on its oncology candidate idelalisib in previously-treated CLL adults. Chemotherapy was not suitable for the patients. We remind investors that Gilead stopped the study earlier than scheduled on the basis of the recommendation of an independent Data Monitoring Committee (DMC) in Oct 2013. The DMC's recommendation followed an interim analysis of the study where the candidate exhibited a positive risk-benefit profile.
Gilead is currently in discussion with the FDA regarding the submission of a NDA on idelalisib for treating CLL patients. We remind investors that in Sep 2013, Gilead filed a NDA with the FDA for idelalisib for treating patients suffering from indolent non-Hodgkin's lymphoma. Gilead has also sought approval for idelalisib in Europe for the above indications.
Another promising candidate at Gilead is sofosbuvir (hepatitis C virus). The candidate is under review both in the U.S. (target date: Dec 8, 2013) and the EU. Gilead is highly optimistic about the potential of sofosbuvir. Apart from the late-stage pipeline, Gilead has multiple candidates in mid/early stages of development. The successful development of the pipeline candidates will help drive growth.
Gilead currently carries a Zacks Rank #2 (Buy). Actelion Ltd. ( ALIOF ) appears to be more attractive with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | The EC cleared the drug, an integrase inhibitor, for use as part of HIV therapy regimens inclusive of a protease inhibitor boosted by AbbVie Inc. 's ( ABBV ) Norvir (ritonavir). ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. The U.S. regulatory body declined to approve the drug as a monotherapy on the basis of the submitted data due to shortcomings observed in the documentation and validation of certain quality testing methods. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. The EC cleared the drug, an integrase inhibitor, for use as part of HIV therapy regimens inclusive of a protease inhibitor boosted by AbbVie Inc. 's ( ABBV ) Norvir (ritonavir). Good news flowed in at Gilead Sciences, Inc ( GILD ) from Europe when the European Commission approved its HIV drug Vitekta (elvitegravir) across two doses- 85 mg and 150 mg. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. The EC cleared the drug, an integrase inhibitor, for use as part of HIV therapy regimens inclusive of a protease inhibitor boosted by AbbVie Inc. 's ( ABBV ) Norvir (ritonavir). Good news flowed in at Gilead Sciences, Inc ( GILD ) from Europe when the European Commission approved its HIV drug Vitekta (elvitegravir) across two doses- 85 mg and 150 mg. | The EC cleared the drug, an integrase inhibitor, for use as part of HIV therapy regimens inclusive of a protease inhibitor boosted by AbbVie Inc. 's ( ABBV ) Norvir (ritonavir). ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report GILEAD SCIENCES (GILD): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report To read this article on Zacks.com click here. The EC approved the drug on the basis of positive 96 week data from a phase III study (145). |
27556.0 | 2013-11-19 00:00:00 UTC | AbbVie Reports HCV Trial Results - Analyst Blog | ABBV | https://www.nasdaq.com/articles/abbvie-reports-hcv-trial-results-analyst-blog-2013-11-19 | nan | nan | AbbVie ( ABBV ) recently released positive initial results from a phase III study, SAPPHIRE-I.
The positive results from the SAPPHIRE study led to a 2.2% rise in the shares. However, much of that gain was mitigated and shares were up 0.89% at the end of the trading session.
The study is being conducted to evaluate AbbVie's investigational three direct-acting-antiviral (3D) regimen plus ribavirin in patients suffering from genotype 1 (GT1) hepatitis C virus (HCV).
The patients were dosed ABT-333 (250mg) and ribavirin (weight-based) twice daily along with a single daily fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg).
It was observed from the randomized, double-blind, placebo-controlled SAPPHIRE- I study (n=631) that 96% of treatment naïve patients achieved a sustained virologic response after 12 weeks of treatment. In addition, only 1.7% of patients suffered a virologic relapse.
We note that SAPPHIRE-I is the first of six phase III trials being conducted to evaluate the efficacy of 3D regimen in GT1 HCV patients.
The company remains on track for major regulatory submissions in the second quarter of 2014.
We are encouraged by the pipeline progress at AbbVie. The company's late-stage pipeline looks impressive with several compounds or indications in phase III development targeting therapeutic areas like HCV, immunology, multiple sclerosis and endometriosis.
AbbVie currently carries a Zacks Rank #3 (Hold). While we are positive on AbbVie's strong late-stage pipeline, dividend yield and growth strategy, we remain concerned about its dependence on Humira.
Companies that currently look attractive include Johnson & Johnson ( JNJ ), Bayer ( BAYRY ), and Shire ( SHPG ). While Shire is a Zacks Rank #1 (Strong Buy) stock, Johnson & Johnson and Bayer are Zacks Rank #2 (Buy) stocks.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | The study is being conducted to evaluate AbbVie's investigational three direct-acting-antiviral (3D) regimen plus ribavirin in patients suffering from genotype 1 (GT1) hepatitis C virus (HCV). While we are positive on AbbVie's strong late-stage pipeline, dividend yield and growth strategy, we remain concerned about its dependence on Humira. AbbVie ( ABBV ) recently released positive initial results from a phase III study, SAPPHIRE-I. | ABBVIE INC (ABBV): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie ( ABBV ) recently released positive initial results from a phase III study, SAPPHIRE-I. The study is being conducted to evaluate AbbVie's investigational three direct-acting-antiviral (3D) regimen plus ribavirin in patients suffering from genotype 1 (GT1) hepatitis C virus (HCV). | The study is being conducted to evaluate AbbVie's investigational three direct-acting-antiviral (3D) regimen plus ribavirin in patients suffering from genotype 1 (GT1) hepatitis C virus (HCV). ABBVIE INC (ABBV): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie ( ABBV ) recently released positive initial results from a phase III study, SAPPHIRE-I. | AbbVie ( ABBV ) recently released positive initial results from a phase III study, SAPPHIRE-I. The study is being conducted to evaluate AbbVie's investigational three direct-acting-antiviral (3D) regimen plus ribavirin in patients suffering from genotype 1 (GT1) hepatitis C virus (HCV). We are encouraged by the pipeline progress at AbbVie. |
27557.0 | 2013-11-12 00:00:00 UTC | Stock Market News for November 12, 2013 - Market News | ABBV | https://www.nasdaq.com/articles/stock-market-news-for-november-12-2013-market-news-2013-11-12 | nan | nan | The Veterans Day holiday kept volumes down on Monday and benchmarks added meager gains during a mostly uneventful trading session. However, the gains were sufficient for the Dow to clinch another record high, the thirty fifth such instance this year. Among the S&P 500 industry groups, health care stocks gained the most, whereas the consumer staples sector incurred huge losses.
For a look at the issues currently facing the markets, make sure to read today's Ahead of Wall Street article
The Dow Jones Industrial Average (DJI) climbed 0.1% to close the day at 15,783.10. The S&P 500 rose 0.1% to finish yesterday's trading session at 1,771.89. The tech-laden Nasdaq Composite Index gained 0.01% to end at 3,919.79. The fear-gauge CBOE Volatility Index (VIX) dropped 2.9% to settle at 12.53. Consolidated volumes on the New York Stock Exchange were roughly 2.54 billion shares. Advancing stocks outnumbered the decliners. For 50% shares that advanced, only 46% declined.
Stocks moved moderately higher on Monday during a thinly traded session owing to the Veterans Day holiday. Nonetheless, the Dow rallied toward a record high for the third time in the month, and the thirty fifth time this year. Such gains are primarily attributable to an encouraging jobs report. Investors now believe that the economy's has gained sufficient strength to withstand the Federal Reserve's tapering of its stimulus program. Such a move is expected to happen as soon as December.
Apart from yesterday's session being low on volumes, there was little news which could impact the benchmarks' movement. Among the few developments, Viropharma Inc. (NASDAQ: VPHM ) shares jumped 25.5 % to $49.41, following news that Shire PLC will purchase the company for $4.2 billion.
Shares of Transocean Ltd. (NYSE: RIG ) gained 3.8% to touch $55.49 per share, after the company announced it had reached an agreement with investor Carl Icahn to pay a dividend of $3 per share. The offshore driller has also reached an agreement with Icahn to reduce the size of its board.
Jobs data published on Friday showed that 204,000 jobs were created in October, better than the consensus estimate of 114,000 jobs. The report led investors to believe that the Federal Reserve would reduce its level of bond purchases by next month itself.
Supporting the above expectations are last week's comments from members of the central bank who said the Federal Reserve should reduce its asset purchases only when it receives clear indications that the economy is improving. However, the three Fed officials did not comment on exactly when they believe the stimulus program should be withdrawn.
Twitter Inc. (NYSE: TWTR ) which made its debut in the stock market on Thursday last week, dropped marginally, by 0.05% to end yesterday's trading day at $41.63 per share. The company ended Thursday trading session at $44.90, a 73% jump from its $26 initial public offering (IPO) price. Prices had increased to more than $50 during the trading day.
Coming back to yesterday's session, the healthcare sector was the biggest gainer among the S&P 500 industry groups and the Health Care SPDR (XLV) gained 0.24%. Stocks such as Johnson & Johnson (NYSE: JNJ ), Merck & Co., Inc. (NYSE: MRK ), Gilead Sciences, Inc. (NASDAQ: GILD ), Bristol-Myers Squibb Co (NYSE: BMY ), and AbbVie Inc. (NYSE: ABBV ) added 0.3%, 0.4%, 0.2%, 0.4%, and 1.1%, respectively.
Consumer staples were the biggest loser among the S&P 500 industry groups as the Consumer Staples SPDR (XLP) lost 0.3%. Stocks such as The Procter & Gamble Company (NYSE: PG ), The Coca-Cola Company (NYSE: KO ), PepsiCo, Inc. (NYSE: PEP ), Altria Group Inc. (NYSE: MO ), and Colgate-Palmolive Company (NYSE: CL ) slipped 0.3%, 0.5%, 0.5%, 0.3%, and 0.3%, respectively.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Stocks such as Johnson & Johnson (NYSE: JNJ ), Merck & Co., Inc. (NYSE: MRK ), Gilead Sciences, Inc. (NASDAQ: GILD ), Bristol-Myers Squibb Co (NYSE: BMY ), and AbbVie Inc. (NYSE: ABBV ) added 0.3%, 0.4%, 0.2%, 0.4%, and 1.1%, respectively. ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report COLGATE PALMOLI (CL): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report COCA COLA CO (KO): Free Stock Analysis Report ALTRIA GROUP (MO): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report PEPSICO INC (PEP): Free Stock Analysis Report PROCTER & GAMBL (PG): Free Stock Analysis Report TRANSOCEAN LTD (RIG): Free Stock Analysis Report VIROPHARMA (VPHM): Free Stock Analysis Report To read this article on Zacks.com click here. For a look at the issues currently facing the markets, make sure to read today's Ahead of Wall Street article The Dow Jones Industrial Average (DJI) climbed 0.1% to close the day at 15,783.10. | Stocks such as Johnson & Johnson (NYSE: JNJ ), Merck & Co., Inc. (NYSE: MRK ), Gilead Sciences, Inc. (NASDAQ: GILD ), Bristol-Myers Squibb Co (NYSE: BMY ), and AbbVie Inc. (NYSE: ABBV ) added 0.3%, 0.4%, 0.2%, 0.4%, and 1.1%, respectively. ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report COLGATE PALMOLI (CL): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report COCA COLA CO (KO): Free Stock Analysis Report ALTRIA GROUP (MO): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report PEPSICO INC (PEP): Free Stock Analysis Report PROCTER & GAMBL (PG): Free Stock Analysis Report TRANSOCEAN LTD (RIG): Free Stock Analysis Report VIROPHARMA (VPHM): Free Stock Analysis Report To read this article on Zacks.com click here. Stocks such as The Procter & Gamble Company (NYSE: PG ), The Coca-Cola Company (NYSE: KO ), PepsiCo, Inc. (NYSE: PEP ), Altria Group Inc. (NYSE: MO ), and Colgate-Palmolive Company (NYSE: CL ) slipped 0.3%, 0.5%, 0.5%, 0.3%, and 0.3%, respectively. | ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report COLGATE PALMOLI (CL): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report COCA COLA CO (KO): Free Stock Analysis Report ALTRIA GROUP (MO): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report PEPSICO INC (PEP): Free Stock Analysis Report PROCTER & GAMBL (PG): Free Stock Analysis Report TRANSOCEAN LTD (RIG): Free Stock Analysis Report VIROPHARMA (VPHM): Free Stock Analysis Report To read this article on Zacks.com click here. Stocks such as Johnson & Johnson (NYSE: JNJ ), Merck & Co., Inc. (NYSE: MRK ), Gilead Sciences, Inc. (NASDAQ: GILD ), Bristol-Myers Squibb Co (NYSE: BMY ), and AbbVie Inc. (NYSE: ABBV ) added 0.3%, 0.4%, 0.2%, 0.4%, and 1.1%, respectively. Shares of Transocean Ltd. (NYSE: RIG ) gained 3.8% to touch $55.49 per share, after the company announced it had reached an agreement with investor Carl Icahn to pay a dividend of $3 per share. | Stocks such as Johnson & Johnson (NYSE: JNJ ), Merck & Co., Inc. (NYSE: MRK ), Gilead Sciences, Inc. (NASDAQ: GILD ), Bristol-Myers Squibb Co (NYSE: BMY ), and AbbVie Inc. (NYSE: ABBV ) added 0.3%, 0.4%, 0.2%, 0.4%, and 1.1%, respectively. ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report COLGATE PALMOLI (CL): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report COCA COLA CO (KO): Free Stock Analysis Report ALTRIA GROUP (MO): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report PEPSICO INC (PEP): Free Stock Analysis Report PROCTER & GAMBL (PG): Free Stock Analysis Report TRANSOCEAN LTD (RIG): Free Stock Analysis Report VIROPHARMA (VPHM): Free Stock Analysis Report To read this article on Zacks.com click here. The S&P 500 rose 0.1% to finish yesterday's trading session at 1,771.89. |
27558.0 | 2013-11-11 00:00:00 UTC | Loss Narrows at Repros, Shares Down - Analyst Blog | ABBV | https://www.nasdaq.com/articles/loss-narrows-at-repros-shares-down-analyst-blog-2013-11-11 | nan | nan | Repros Therapeutics Inc. 's ( RPRX ) share price has been on a declining trend ever since the company received guidance from the U.S. Food and Drug Administration (FDA) related to the Androxal development program on Oct 22, 2013. In view of the guidance, Repros now expects to submit the new drug application (NDA) to the FDA in the fourth quarter of 2014. Earlier, the company had planned on submitting the NDA in mid-2014 with potential launch in 2015.
Investors reacted negatively to the delay in the potential approval of Repros. The stock price of Repros fell significantly since then. Overall, the stock lost 35.5% since the announcement. The release of the third quarter 2013 results did not revive investor confidence in the stock with barely any reversal in trends.
Repros reported third quarter 2013 loss of 26 cents per share, narrower than the year-ago loss of 30 cents per share and the Zacks Consensus Estimate of loss of 33 cents. The narrower loss was due to an increase in the number of shares.
The company's revenue for the third quarter of 2013 was $0.3 million as compared to $0.1 million in the year-ago period. The entire revenues came from interest income.
In the third quarter of 2013, general and administrative expenses decreased 16% to $1.2 million due to lower stock based compensation. Research and development expenses shot up 53% year over year to $4.8 million, reflecting higher pipeline investment.
Androxal, the advanced pipeline candidate at Repros, is being evaluated for the treatment of secondary hypogonadism. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel.
On Jun 25, 2013, the company completed a public offering of 4,312,500 shares at a price of $19.00 per share. Net proceeds from the transaction, approximately $76.8 million, boosted Repros' cash balance which jumped to $81.8 million in Sep 30, 2013 from $24.2 in Dec 31, 2012.
Repros currently carries a Zacks Rank #3 (Hold). We expect investor focus to remain on Androxal updates.
However, companies like Actelion Ltd. ( ALIOF ) and AMAG Pharmaceuticals Inc. ( AMAG ) look more attractive with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report AMAG PHARMA INC (AMAG): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Repros Therapeutics Inc. 's ( RPRX ) share price has been on a declining trend ever since the company received guidance from the U.S. Food and Drug Administration (FDA) related to the Androxal development program on Oct 22, 2013. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report AMAG PHARMA INC (AMAG): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. Repros reported third quarter 2013 loss of 26 cents per share, narrower than the year-ago loss of 30 cents per share and the Zacks Consensus Estimate of loss of 33 cents. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report AMAG PHARMA INC (AMAG): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. Repros Therapeutics Inc. 's ( RPRX ) share price has been on a declining trend ever since the company received guidance from the U.S. Food and Drug Administration (FDA) related to the Androxal development program on Oct 22, 2013. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report AMAG PHARMA INC (AMAG): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. In view of the guidance, Repros now expects to submit the new drug application (NDA) to the FDA in the fourth quarter of 2014. |
27559.0 | 2013-10-28 00:00:00 UTC | Abbott Labs' Mitra Clip Approved in the U.S. - Analyst Blog | ABBV | https://www.nasdaq.com/articles/abbott-labs-mitra-clip-approved-in-the-u.s.-analyst-blog-2013-10-28 | nan | nan | Abbott Laboratories ( ABT ) received positive news when the U.S. Food and Drug Administration (FDA) approved its percutaneous valve repair system, MitraClip.
The FDA approved MitraClip device to treat patients with significant symptomatic degenerative mitral regurgitation (MR) who are at prohibitive risk of mitral valve surgery. Consequently, Abbott Labs will launch its MitraClip device immediately in the U.S.
We note that MitraClip is already approved in the Europe and parts of Asia and Latin America.
Meanwhile, Abbott Labs continues to evaluate the impact of MitraClip treatment on the progression of heart failure through two randomized trials - COAPT in the U.S. and RESHAPE-HF in Europe.
We note that the vascular business is an important part of Abbott Labs' product portfolio. The vascular business generated total sales of $2.2 billion in the first nine months of 2013, down 3.1% year over year.
For the third quarter, vascular sales were up 2.5% on an operational basis driven by continued share gains in international markets. Of the total vascular sales, approximately $384 million came from the sale of drug-eluting stents and the bioresorbable vascular scaffold (BVS) product portfolio.
The approval of MitraClip will strengthen Abbott Labs' vascular business which already has drug-eluting stent, Xience Xpedition and BVS Absorb, under its portfolio.
Moreover, the acquisition of privately-held IDEV Technologies has added SUPERA Veritas stent system to Abbott Labs' product portfolio.
The stent system is approved in Europe for treating blockages in blood vessels due to peripheral artery disease (PAD). Moreover, SUPERA Veritas is approved in the U.S. for the treatment of biliary strictures (narrowing of a bile duct) related to cancer.
Abbott Labs expects to increase sales in low single digits (excluding foreign exchange rates) in the fourth quarter of 2013.
We believe the launch of new products will help Abbott Labs to broaden its vascular business.
We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013.
Abbott Labs currently carries a Zacks Rank #3 (Hold). Right now, large cap pharma stocks like Bayer ( BAYRY ) and Johnson & Johnson ( JNJ ) look attractive, each with a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Laboratories ( ABT ) received positive news when the U.S. Food and Drug Administration (FDA) approved its percutaneous valve repair system, MitraClip. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. We note that the vascular business is an important part of Abbott Labs' product portfolio. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. The approval of MitraClip will strengthen Abbott Labs' vascular business which already has drug-eluting stent, Xience Xpedition and BVS Absorb, under its portfolio. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. Consequently, Abbott Labs will launch its MitraClip device immediately in the U.S. We note that MitraClip is already approved in the Europe and parts of Asia and Latin America. |
27560.0 | 2013-10-25 00:00:00 UTC | Trade the Earnings: AbbVie Inc. | ABBV | https://www.nasdaq.com/articles/trade-earnings-abbvie-inc-2013-10-25 | nan | nan | Earnings Release Date: 10/25/2013
Time: Premarket
Avg. Extended-Hours Dollar Volume: $306,777,401
Earnings Sensitivity (up or down): 2.9%
AbbVie Inc. ( ABBV ) is due to issue its quarterly earnings report before market open today. Given its history, traders can expect very active trading in the upcoming Premarket session immediately following the company's release of its quarterly earnings. An analysis of historical premarket and after-hours trading activity and liquidity conditions in ABBV following an earnings release indicates that the price change in the extended hours is likely to be of moderate value in forecasting additional price movement in the following regular session.
Analysts at MidnightTrader have tracked how ABBV's stock price has reacted to quarterly earnings events the past both in the after-hours and following regular session. The result of that study is below.
Over the last year, when shares of ABBV rose in the extended-hours session in reaction to its earnings announcement, history shows that 50% of the time (2 out of the last 4 quarters) the stock posted additional gains in the following regular session by an average of 3.00%.
Over the last year, when shares of ABBV dropped in the extended-hours in reaction to its earnings announcement, there is limited evidence to suggest a follow-through in the same direction the next day.
Our analysis of over a decade of company specific earnings related news and price data on over 5,000 US companies demonstrates that earnings event related trading opportunities can exist for those trading in the after-hours and premarket sessions. Certain stocks demonstrate a historical tendency to either underprice or overreact to earnings news in the extended-hours (the time when companies typically release earnings) relative to the following regular session close.
This report was created using historical data and analysis provided by the Midnight Trader Pro service at MidnightTrader.com.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
Copyright (C) 2016 MTNewswires.com. All rights reserved. Unauthorized reproduction is strictly prohibited.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Analysts at MidnightTrader have tracked how ABBV's stock price has reacted to quarterly earnings events the past both in the after-hours and following regular session. Over the last year, when shares of ABBV dropped in the extended-hours in reaction to its earnings announcement, there is limited evidence to suggest a follow-through in the same direction the next day. Extended-Hours Dollar Volume: $306,777,401 Earnings Sensitivity (up or down): 2.9% AbbVie Inc. ( ABBV ) is due to issue its quarterly earnings report before market open today. | Over the last year, when shares of ABBV rose in the extended-hours session in reaction to its earnings announcement, history shows that 50% of the time (2 out of the last 4 quarters) the stock posted additional gains in the following regular session by an average of 3.00%. Extended-Hours Dollar Volume: $306,777,401 Earnings Sensitivity (up or down): 2.9% AbbVie Inc. ( ABBV ) is due to issue its quarterly earnings report before market open today. An analysis of historical premarket and after-hours trading activity and liquidity conditions in ABBV following an earnings release indicates that the price change in the extended hours is likely to be of moderate value in forecasting additional price movement in the following regular session. | An analysis of historical premarket and after-hours trading activity and liquidity conditions in ABBV following an earnings release indicates that the price change in the extended hours is likely to be of moderate value in forecasting additional price movement in the following regular session. Extended-Hours Dollar Volume: $306,777,401 Earnings Sensitivity (up or down): 2.9% AbbVie Inc. ( ABBV ) is due to issue its quarterly earnings report before market open today. Analysts at MidnightTrader have tracked how ABBV's stock price has reacted to quarterly earnings events the past both in the after-hours and following regular session. | An analysis of historical premarket and after-hours trading activity and liquidity conditions in ABBV following an earnings release indicates that the price change in the extended hours is likely to be of moderate value in forecasting additional price movement in the following regular session. Over the last year, when shares of ABBV rose in the extended-hours session in reaction to its earnings announcement, history shows that 50% of the time (2 out of the last 4 quarters) the stock posted additional gains in the following regular session by an average of 3.00%. Extended-Hours Dollar Volume: $306,777,401 Earnings Sensitivity (up or down): 2.9% AbbVie Inc. ( ABBV ) is due to issue its quarterly earnings report before market open today. |
27561.0 | 2013-10-25 00:00:00 UTC | Update on Repros' Androxal - Analyst Blog | ABBV | https://www.nasdaq.com/articles/update-on-repros-androxal-analyst-blog-2013-10-25 | nan | nan | Repros Therapeutics Inc. 's ( RPRX ) lead pipeline candidate, Androxal, is being evaluated for the treatment of patients with secondary hypogonadism. The company received guidance from the U.S. Food and Drug Administration (FDA) related to the Androxal development program on Oct 22, 2013.
Repros now expects to submit the new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2014. Earlier, the company had planned on submitting the NDA in mid-2014 with potential launch in 2015.
Investors reacted negatively to the delay in the potential approval of Repros. The stock price of Repros fell significantly the following day. Though the stock price has recovered marginally, overall the stock lost 24.6% since the announcement.
The FDA has requested a meeting to discuss the data from two pivotal studies, ZA-301 and ZA-302 on Androxal. The FDA wants to determine whether the company should include men referred from a fertility clinic (site 9) in its final analysis of Study ZA-301.
We note that earlier this year, the company had announced encouraging top-line data from the first pivotal phase III study (ZA-301) and the second pivotal efficacy study (ZA-302). Both, ZA-301 and ZA-302 - conducted under the FDA's Special Protocol Assessment (SPA) program - had met the two their respective primary endpoints.
As the FDA will consider different sperm endpoints than those outlined in the SPA, the company plans to conduct two studies (12 weeks and 18 weeks) and finalize the design for the same.
The FDA has agreed to studies comparing Androxal to approved testosterone replacement therapies. Repros stands to benefit from the additional trials as data if positive can be added to the label.
Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel.
Repros currently carries a Zacks Rank #3 (Hold). We expect investor focus to remain on Androxal updates.
However, companies like Actelion Ltd. ( ALIOF ) and Roche ( RHHBY ) look more attractive with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report ROCHE HLDG LTD (RHHBY): Get Free Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Repros Therapeutics Inc. 's ( RPRX ) lead pipeline candidate, Androxal, is being evaluated for the treatment of patients with secondary hypogonadism. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report ROCHE HLDG LTD (RHHBY): Get Free Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. As the FDA will consider different sperm endpoints than those outlined in the SPA, the company plans to conduct two studies (12 weeks and 18 weeks) and finalize the design for the same. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report ROCHE HLDG LTD (RHHBY): Get Free Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. We note that earlier this year, the company had announced encouraging top-line data from the first pivotal phase III study (ZA-301) and the second pivotal efficacy study (ZA-302). | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report ROCHE HLDG LTD (RHHBY): Get Free Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Repros now expects to submit the new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2014. |
27562.0 | 2013-10-25 00:00:00 UTC | Earnings & Rev Beat from AbbVie in Q3 - Analyst Blog | ABBV | https://www.nasdaq.com/articles/earnings-rev-beat-from-abbvie-in-q3-analyst-blog-2013-10-25 | nan | nan | AbbVie Inc. ( ABBV ) reported third quarter 2013 earnings of 82 cents per share, beating the Zacks Consensus Estimate of 78 cents. Revenues increased 3.3% to $4.658 billion in the third quarter of 2013, above the Zacks Consensus Estimate of $4.512 billion. Currency movement negatively impacted revenues by 0.3%. Revenues increased despite the loss of exclusivity on TriCor/Trilipix.
Including one-time items, third quarter 2013 earnings came in at 60 cents per share, down 40.6%.
The Quarter in Detail
Key drug, Humira, recorded growth of 19.1% with revenues coming in at $2.77 billion. U.S. sales increased 22.3% ($1.389 billion). Ex- U.S. sales increased 16.1% to $1.381 billion. TriCor/Trilipix revenues fell 88.3% to $39 million.
Other products that performed well included Synthroid (up 22.9% to $161 million), Creon (up 9.8% to $101 million), Zemplar (up 9.9% to $100 million) and Duodopa (up 24.3% to $46 million).
AbbVie said that adjusted SG&A was 26.1% of sales in the third quarter - this reflects the company's investment in its growth brands.
Adjusted R&D was 15.2% of third quarter 2013 sales, reflecting the company's investment in its mid- and late-stage pipeline as well its efforts to expand Humira's label. Humira is currently in phase III studies in patients suffering from hidradenitis suppurativa (HS), a chronic inflammatory skin disease.
AbbVie's pipeline represents significant potential - earlier this year, the company had said that it is targeting 15 regulatory approvals between 2013 and 2017. The company's late-stage pipeline includes several compounds or indications in phase III development targeting therapeutic areas like hepatitis C, immunology, multiple sclerosis and endometriosis.
Phase III results on the company's triple direct-acting antivirals (3-DAAs) plus ribavirin regimen for the treatment of hepatitis C virus (HCV) infection should start coming out later this year. Positive data would allow the company to file for approval in the second quarter of 2014.
Outlook Revised Again
Based on its strong performance so far this year, AbbVie raised the lower end of its 2013 earnings outlook. The company now expects earnings in the range of $3.11 to $3.13 per share (old guidance: $3.07 to $3.13 per share). The Zacks Consensus Estimate of $3.13 is at the higher end of the guidance range.
Our Take
We believe AbbVie is poised for strong growth. Humira should continue driving sales thanks to factors like additional indications, increasing penetration, geographic expansion, and share gains. New indications could boost peak sales potential for Humira by another $1.5 billion.
2013 and 2014 represent a transition period for the company which is facing generic competition for its lipid franchise - TriCor, TriLipix and Niaspan.
AbbVie currently carries a Zacks Rank #3 (Hold). While we are positive on AbbVie's strong late-stage pipeline, dividend yield and growth strategy, we remain concerned about its dependence on Humira. We believe AbbVie will continue pursuing in-licensing deals and collaborations to boost its pipeline.
Companies that currently look attractive include Roche ( RHHBY ), Johnson & Johnson ( JNJ ) and Bayer ( BAYRY ). While Roche is a Zacks Rank #1 (Strong Buy) stock, Johnson & Johnson and Bayer are Zacks Rank #2 (Buy) stocks.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc. ( ABBV ) reported third quarter 2013 earnings of 82 cents per share, beating the Zacks Consensus Estimate of 78 cents. AbbVie said that adjusted SG&A was 26.1% of sales in the third quarter - this reflects the company's investment in its growth brands. AbbVie's pipeline represents significant potential - earlier this year, the company had said that it is targeting 15 regulatory approvals between 2013 and 2017. | AbbVie Inc. ( ABBV ) reported third quarter 2013 earnings of 82 cents per share, beating the Zacks Consensus Estimate of 78 cents. ABBVIE INC (ABBV): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. AbbVie said that adjusted SG&A was 26.1% of sales in the third quarter - this reflects the company's investment in its growth brands. | AbbVie Inc. ( ABBV ) reported third quarter 2013 earnings of 82 cents per share, beating the Zacks Consensus Estimate of 78 cents. ABBVIE INC (ABBV): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. AbbVie said that adjusted SG&A was 26.1% of sales in the third quarter - this reflects the company's investment in its growth brands. | AbbVie's pipeline represents significant potential - earlier this year, the company had said that it is targeting 15 regulatory approvals between 2013 and 2017. AbbVie Inc. ( ABBV ) reported third quarter 2013 earnings of 82 cents per share, beating the Zacks Consensus Estimate of 78 cents. AbbVie said that adjusted SG&A was 26.1% of sales in the third quarter - this reflects the company's investment in its growth brands. |
27563.0 | 2013-10-22 00:00:00 UTC | Good News for Roche - Analyst Blog | ABBV | https://www.nasdaq.com/articles/good-news-for-roche-analyst-blog-2013-10-22 | nan | nan | Roche ( RHHBY ) received encouraging news when the U.S. Food and Drug Administration (FDA) approved a subcutaneous (SC) formulation of its rheumatoid arthritis (RA) drug Actemra.
Actemra is approved for the treatment of adults with moderately to severely active RA who have used one or more disease-modifying antirheumatic drugs (DMARDs). Actemra was originally approved by the FDA in 2010 as an intravenous (IV) formulation medicine.
The approval for subcutaneous formulation is based on positive data from the phase III trials, SUMMACTA and BREVACTA. In the randomized double blind SUMMACTA trial (n=1,262), the SC formulation of Actemra 162 mg given weekly plus DMARDs was more effective than 8 mg/kg of Actemra given intravenously.
Meanwhile, results from the randomized, double-blind BREVACTA study showed that RA patients, who received the SC formulation of Actemra every two weeks plus DMARDs, were significantly more likely to have achieved a 20% reduction in tender and swollen joint counts in addition to a corresponding improvement in other medical conditions.
We remind investors that Roche has launched the subcutaneous injection formulation of Actemra in Japan in May 2013.
Sales of Actemra grew 33% in the first nine months of 2013. The subcutaneous formulation should boost sales of Actmera going forward benefiting from its increased use as a monotherapy in RA.
However, competition is stiff in the RA market given the presence of treatments like UCB's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira, among others.
Roche currently carries a Zack Rank #1 (Strong Buy). Right now, Bayer ( BAYRY ) appears to be well placed with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | However, competition is stiff in the RA market given the presence of treatments like UCB's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira, among others. ABBVIE INC (ABBV): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. Actemra is approved for the treatment of adults with moderately to severely active RA who have used one or more disease-modifying antirheumatic drugs (DMARDs). | ABBVIE INC (ABBV): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. However, competition is stiff in the RA market given the presence of treatments like UCB's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira, among others. Roche ( RHHBY ) received encouraging news when the U.S. Food and Drug Administration (FDA) approved a subcutaneous (SC) formulation of its rheumatoid arthritis (RA) drug Actemra. | ABBVIE INC (ABBV): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. However, competition is stiff in the RA market given the presence of treatments like UCB's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira, among others. Roche ( RHHBY ) received encouraging news when the U.S. Food and Drug Administration (FDA) approved a subcutaneous (SC) formulation of its rheumatoid arthritis (RA) drug Actemra. | However, competition is stiff in the RA market given the presence of treatments like UCB's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira, among others. ABBVIE INC (ABBV): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. Roche ( RHHBY ) received encouraging news when the U.S. Food and Drug Administration (FDA) approved a subcutaneous (SC) formulation of its rheumatoid arthritis (RA) drug Actemra. |
27564.0 | 2013-10-21 00:00:00 UTC | Update on Discovery Labs' RDS Drugs - Analyst Blog | ABBV | https://www.nasdaq.com/articles/update-on-discovery-labs-rds-drugs-analyst-blog-2013-10-21 | nan | nan | Discovery Laboratories, Inc. 's ( DSCO ) portfolio consists of Surfaxin, an intratracheal suspension for the prevention of respiratory distress syndrome (RDS) in premature infants who are at high risk of the disease.
The U.S. Food and Drug Administration (FDA) had approved the drug in Mar 2012. Discovery Labs had then planned to launch Surfaxin in late 2012. However, in the third quarter of 2012, the company delayed the launch of Surfaxin based on a review of an analytical testing and quality control process of the drug. It was found that an improvement was required in one of the analytical chemistry methods used to assess Surfaxin and an update to product specifications related to Surfaxin was warranted.
Consequently, Discovery Labs submitted updated product specifications to the FDA after improving and revalidating the analytical chemistry method. In Apr 2013, the FDA requested clarification related to updated product specifications for Surfaxin. The company submitted its response in Jun 2013. In Oct 2013, the FDA approved the product specifications update related to Surfaxin. The company expects to launch the drug in the fourth quarter of 2013.
Meanwhile, Discovery Labs expects to initiate a phase II program on another RDS candidate, Aerosurf, by year end. The company has submitted an investigational new drug (IND) application to the FDA for Aerosurf.
AbbVie Inc. 's ( ABBV ) Survanta is approved for the prevention and treatment of RDS in premature infants.
Discovery Labs currently carries a Zacks Rank #4 (Sell). At present, companies like Roche ( RHHBY ) and Actelion Ltd. ( ALIOF ) look attractive with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie Inc. 's ( ABBV ) Survanta is approved for the prevention and treatment of RDS in premature infants. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report DISCOVERY LABS (DSCO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. Discovery Laboratories, Inc. 's ( DSCO ) portfolio consists of Surfaxin, an intratracheal suspension for the prevention of respiratory distress syndrome (RDS) in premature infants who are at high risk of the disease. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report DISCOVERY LABS (DSCO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. AbbVie Inc. 's ( ABBV ) Survanta is approved for the prevention and treatment of RDS in premature infants. Consequently, Discovery Labs submitted updated product specifications to the FDA after improving and revalidating the analytical chemistry method. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report DISCOVERY LABS (DSCO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. AbbVie Inc. 's ( ABBV ) Survanta is approved for the prevention and treatment of RDS in premature infants. It was found that an improvement was required in one of the analytical chemistry methods used to assess Surfaxin and an update to product specifications related to Surfaxin was warranted. | AbbVie Inc. 's ( ABBV ) Survanta is approved for the prevention and treatment of RDS in premature infants. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report DISCOVERY LABS (DSCO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. Consequently, Discovery Labs submitted updated product specifications to the FDA after improving and revalidating the analytical chemistry method. |
27565.0 | 2013-10-17 00:00:00 UTC | Bullish on Gilead's Stribild - Analyst Blog | ABBV | https://www.nasdaq.com/articles/bullish-on-gileads-stribild-analyst-blog-2013-10-17 | nan | nan | Stribild is one of the most interesting newly launched drugs in Gilead Sciences, Inc.' s ( GILD ) product portfolio. The drug was launched in the U.S. in Aug 2012 as a first-line therapy for treating adults with HIV-1 infection. Sales of Stribild climbed 8% sequentially to $99.4 million in the second quarter of 2013. The EU approval of the drug in May 2013 has boosted the sales potential of the drug.
Stribild is a combination of elvitegravir, cobicistat and Truvada. We note that Truvada itself is a combination of Viread and Emtriva.
Encouraging long-term data from 2 phase III studies (102 and 103) on Stribild in treat-naïve HIV patients were presented by Gilead at the 14th European AIDS Clinical Society Conference in Belgium. Study 102 compared Stribild to Atripla and study 103 compared Stribild to Norvir (ritonavir)-boosted Reyataz plus Truvada. While Norvir is marketed by AbbVie Inc. ( ABBV ), Reyataz is marketed by Bristol-Myers Squibb Company ( BMY ).
Data from the study 102 revealed that Stribild was non-inferior to Atripla after 144 weeks of treatment. Data from the study 103 demonstrated the non inferiority of Stribild to Norvir (ritonavir)-boosted Reyataz plus Truvada after a similar time period. Durable viral suppression was demonstrated by Stribild in both the studies over the treatment period. Both studies are ongoing in a blinded manner.
We expect the strong performance of Stribild to continue as the HIV market offers significant commercial potential. Approval in additional markets will boost the drug's sales potential further. We view Stribild as one of the long-term growth drivers at Gilead.
Gilead, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Alexion Pharmaceuticals, Inc. ( ALXN ) appears to be more attractive in the biopharma space with a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | While Norvir is marketed by AbbVie Inc. ( ABBV ), Reyataz is marketed by Bristol-Myers Squibb Company ( BMY ). ABBVIE INC (ABBV): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Encouraging long-term data from 2 phase III studies (102 and 103) on Stribild in treat-naïve HIV patients were presented by Gilead at the 14th European AIDS Clinical Society Conference in Belgium. | While Norvir is marketed by AbbVie Inc. ( ABBV ), Reyataz is marketed by Bristol-Myers Squibb Company ( BMY ). ABBVIE INC (ABBV): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Study 102 compared Stribild to Atripla and study 103 compared Stribild to Norvir (ritonavir)-boosted Reyataz plus Truvada. | ABBVIE INC (ABBV): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. While Norvir is marketed by AbbVie Inc. ( ABBV ), Reyataz is marketed by Bristol-Myers Squibb Company ( BMY ). Study 102 compared Stribild to Atripla and study 103 compared Stribild to Norvir (ritonavir)-boosted Reyataz plus Truvada. | While Norvir is marketed by AbbVie Inc. ( ABBV ), Reyataz is marketed by Bristol-Myers Squibb Company ( BMY ). ABBVIE INC (ABBV): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. The EU approval of the drug in May 2013 has boosted the sales potential of the drug. |
27566.0 | 2013-10-15 00:00:00 UTC | Earnings Preview: Will Abbott Labs (ABT) Disappoint in Q3? - Analyst Blog | ABBV | https://www.nasdaq.com/articles/earnings-preview-will-abbott-labs-abt-disappoint-q3-analyst-blog-2013-10-15 | nan | nan | Abbott Laboratories ( ABT ) is scheduled to report third quarter 2013 results before the opening bell on Oct 16, 2013.
Last quarter, Abbott Labs posted a 4.55% positive surprise. Let's see how things are shaping up for the third quarter.
Factors to Influence 3Q Results ?
Abbott Labs is an extremely diversified company with a presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013.
However, the business environment continues to be challenging in 2013 due to austerity measures in developed markets and weak economic conditions elsewhere in the world. We believe the pricing pressure in the EU and health care reforms in the U.S. will continue to have a negative impact on sales.
Abbott Labs' Established Pharmaceuticals Division (EPD) continues to be impacted by lower-than-expected growth in Europe and the emerging markets. Hence, Abbott Labs now expects a declaration in pace of growth in this segment for the remainder of 2013.
Nevertheless, we expect the Nutrition and Diagnostics divisions to somewhat offset the decline in other segments.
Earnings Whispers ?
Our proven model does not conclusively show that Abbott Labs is likely to beat the Zacks Consensus Estimate in the third quarter. This is because a stock needs to have both a positive Earnings ESP and a Zacks Rank #1 (Strong Buy) or at least 2 or 3 for this to happen. Unfortunately, this is not the case here as elaborated below.
Negative Zacks ESP : The Earnings ESP for Abbott Labs is -1.92%. This is because the Most Accurate estimate stands at $0.51 while the Zacks Consensus Estimate is higher at $0.52.
Zacks Rank : Abbott Labs carries a Zacks Rank #3 (Hold), which increases the predictive power of ESP. That said we also need to have a positive ESP to be confident of an earnings beat.
We caution against stocks with Zacks Ranks #4 and #5 (Sell rated stocks) going into the earnings announcement, especially when the company is seeing negative estimate revision momentum.
Stocks to Consider
Here are some other stocks you may want to consider as our model shows that these have the right combination of elements to post an earnings beat this season:
Eli Lilly and Company ( LLY ) has Earnings ESP of +1.92% and holds a Zacks Rank #3 (Hold). Eli Lilly will be reporting third quarter earnings on Oct 23.
Biogen Idec . ( BIIB ) has Earnings ESP of +0.91% and holds a Zacks Rank #2 (Buy). Biogen will be reporting third quarter earnings on Oct 28.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Abbott Labs is an extremely diversified company with a presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report To read this article on Zacks.com click here. However, the business environment continues to be challenging in 2013 due to austerity measures in developed markets and weak economic conditions elsewhere in the world. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs is an extremely diversified company with a presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013. Negative Zacks ESP : The Earnings ESP for Abbott Labs is -1.92%. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs is an extremely diversified company with a presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013. Negative Zacks ESP : The Earnings ESP for Abbott Labs is -1.92%. | Abbott Labs is an extremely diversified company with a presence in the diagnostics, nutrition, generics and medical devices markets after having separated its pharmaceutical business into a new company called AbbVie ( ABBV ) in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs' Established Pharmaceuticals Division (EPD) continues to be impacted by lower-than-expected growth in Europe and the emerging markets. |
27567.0 | 2013-10-07 00:00:00 UTC | Discovery Labs Surges on Surfaxin News - Analyst Blog | ABBV | https://www.nasdaq.com/articles/discovery-labs-surges-on-surfaxin-news-analyst-blog-2013-10-07 | nan | nan | Discovery Laboratories, Inc. ( DSCO ) announced that the U.S. Food and Drug Administration (FDA) has approved product specifications update related to Surfaxin, intratracheal suspension. The company expects to launch the drug in the fourth quarter of 2013. Investors reacted positively to the news with shares prices going up by more than 37%.
Background
We remind investors that the FDA had approved Surfaxin for the prevention of respiratory distress syndrome (RDS) in premature infants who are at high risk of the disease in Mar 2012. Discovery Labs had then planned to launch Surfaxin in late 2012.
However, in the third quarter of 2012, the company delayed the launch of Surfaxin based on a review of an analytical testing and quality control process of the drug. It was found that an improvement was required in one of the analytical chemistry methods used to assess Surfaxin and an update to product specifications related to Surfaxin was warranted.
Consequently, Discovery Labs submitted updated product specifications to the FDA after improving and revalidating the analytical chemistry method. In Apr 2013, the FDA requested clarification related to updated product specifications for Surfaxin. The company submitted its response in Jun 2013.
Our Take
We believe that Surfaxin has the potential to boost the top line significantly given that it is the first FDA-approved synthetic, peptide-containing surfactant available for the prevention of RDS in premature infants. Currently, only animal-derived surfactants are available in the market.
Currently approved animal-derived surfactants include AbbVie Inc. 's ( ABBV ) Survanta for the prevention and treatment of RDS in premature infants.
Discovery Labs currently carries a Zacks Rank #2 (Buy). At present, companies like Ironwood Pharmaceuticals, Inc. ( IRWD ) and Actelion Ltd. ( ALIOF ) look more attractive with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Currently approved animal-derived surfactants include AbbVie Inc. 's ( ABBV ) Survanta for the prevention and treatment of RDS in premature infants. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report DISCOVERY LABS (DSCO): Free Stock Analysis Report IRONWOOD PHARMA (IRWD): Free Stock Analysis Report To read this article on Zacks.com click here. Discovery Laboratories, Inc. ( DSCO ) announced that the U.S. Food and Drug Administration (FDA) has approved product specifications update related to Surfaxin, intratracheal suspension. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report DISCOVERY LABS (DSCO): Free Stock Analysis Report IRONWOOD PHARMA (IRWD): Free Stock Analysis Report To read this article on Zacks.com click here. Currently approved animal-derived surfactants include AbbVie Inc. 's ( ABBV ) Survanta for the prevention and treatment of RDS in premature infants. Discovery Laboratories, Inc. ( DSCO ) announced that the U.S. Food and Drug Administration (FDA) has approved product specifications update related to Surfaxin, intratracheal suspension. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report DISCOVERY LABS (DSCO): Free Stock Analysis Report IRONWOOD PHARMA (IRWD): Free Stock Analysis Report To read this article on Zacks.com click here. Currently approved animal-derived surfactants include AbbVie Inc. 's ( ABBV ) Survanta for the prevention and treatment of RDS in premature infants. Discovery Laboratories, Inc. ( DSCO ) announced that the U.S. Food and Drug Administration (FDA) has approved product specifications update related to Surfaxin, intratracheal suspension. | Currently approved animal-derived surfactants include AbbVie Inc. 's ( ABBV ) Survanta for the prevention and treatment of RDS in premature infants. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report DISCOVERY LABS (DSCO): Free Stock Analysis Report IRONWOOD PHARMA (IRWD): Free Stock Analysis Report To read this article on Zacks.com click here. Discovery Labs had then planned to launch Surfaxin in late 2012. |
27568.0 | 2013-10-07 00:00:00 UTC | Encouraging Data on Novartis' Secukinumab - Analyst Blog | ABBV | https://www.nasdaq.com/articles/encouraging-data-on-novartis-secukinumab-analyst-blog-2013-10-07 | nan | nan | Novartis ( NVS ) continues to progress well with the development of its psoriasis candidate, secukinumab (AIN457).
The company reported encouraging top-line data from a phase III study, FIXTURE (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis), on secukinumab in Jul 2013.
Novartis is now out with positive results from the FIXTURE study. It was observed from the randomized double-blind, placebo-controlled study (n =1,306) that secukinumab showed improved efficacy to Amgen' s ( AMGN ) Enbrel in patients suffering from moderate-to-severe plaque psoriasis.
We note that the phase III study met both primary and key secondary endpoints. The results showed that secukinumab was more effective in clearing skin faster with a long lasting effect than Enbrel.
Novartis also presented data from an additional phase III study, SCULPTURE (StudyComparing secukinumab Use in Long-term Psoriasis maintenance therapy: fixed regimens vs reTreatment Upon start of RElapse), on secukinumab. The data from the study also showed efficacy of secukinumab dosed at monthly intervals.
We note that secukinumab is one of the most promising pipeline candidates at Novartis and we are encouraged by the results from the FIXTURE study. Novartis remains on track to file for approval of the candidate in the EU and the U.S. later in 2013.
We note that secukinumab is also being evaluated for other indications such as psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis among others. The phase III studies for these indications are ongoing with results expected in 2014.
Additionally, secukinumab is in phase II studies for the treatment of multiple sclerosis.
Secukinumab is the first anti IL-17A on which phase III results have been presented. We note that Amgen has an anti IL-17 candidate, brodalumab, in its pipeline. Brodalumab is currently in phase III studies for the psoriasis indication.
Meanwhile, currently approved products include AbbVie's ( ABBV ) Humira among others.
Novartis currently carries a Zacks Rank #3 (Hold). Right now, Roche ( RHHBY ) looks well placed with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Meanwhile, currently approved products include AbbVie's ( ABBV ) Humira among others. ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. It was observed from the randomized double-blind, placebo-controlled study (n =1,306) that secukinumab showed improved efficacy to Amgen' s ( AMGN ) Enbrel in patients suffering from moderate-to-severe plaque psoriasis. | ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. Meanwhile, currently approved products include AbbVie's ( ABBV ) Humira among others. The company reported encouraging top-line data from a phase III study, FIXTURE (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis), on secukinumab in Jul 2013. | ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. Meanwhile, currently approved products include AbbVie's ( ABBV ) Humira among others. The company reported encouraging top-line data from a phase III study, FIXTURE (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis), on secukinumab in Jul 2013. | Meanwhile, currently approved products include AbbVie's ( ABBV ) Humira among others. ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. We note that secukinumab is one of the most promising pipeline candidates at Novartis and we are encouraged by the results from the FIXTURE study. |
27569.0 | 2013-09-30 00:00:00 UTC | Exclusive Generic Launches at Teva - Analyst Blog | ABBV | https://www.nasdaq.com/articles/exclusive-generic-launches-at-teva-analyst-blog-2013-09-30 | nan | nan | Teva Pharmaceutical Industries Ltd.'s ( TEVA ) generics business has been performing below expectations over the past few quarters. Second quarter 2013 generics business sales in the U.S. were soft with revenues declining 8% to $970 million. Lower sales of generic Lexapro, no royalties on generic Lipitor and lower sales of generic Avapro led to the decline in revenues.
However, Teva expects the generics business to pick up in the second half of the year. 20-25 generic product launches are slated for 2013. The company announced two exclusive product launches in the U.S. in September - the first being its generic version of AbbVie's ( ABBV ) cholesterol management treatment, Niaspan (niacin extended-release) tablets (500, 750, and 1000 mg) and the second being its generic version of Adenoscan (adenosine injection), which is marketed by Astellas ( ALPMY ).
Adenoscan is used as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
With Teva being the first to file for both products, the company will enjoy 180 days of marketing exclusivity. As per IMS data, as of Jun 30, 2013, Niaspan annual sales were approximately $1.12 billion in the U.S. Meanwhile, Adenoscan annual sales as of Jun 30, 2013, were about $65 million in the U.S., as per IMS data.
The launch of generic Niaspan is one of the most important generic product launches at Teva this year and should boost the performance of the generics business. Teva currently carries a Zacks Rank #3 (Hold). The company is going through a tough transition period given fewer large generic opportunities, potential new competition for branded products (especially Copaxone) and a higher cost base.
However, we are encouraged by Teva's plans to improve its position. Teva said that it intends to accelerate growth platforms, protect and expand core franchises, expand its global presence, pursue strategic deals and reduce the cost base. We expect investor focus to remain on the execution of the company's new strategy.
At present, companies like Actavis, Inc. ( ACT ) look well-positioned with a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | The company announced two exclusive product launches in the U.S. in September - the first being its generic version of AbbVie's ( ABBV ) cholesterol management treatment, Niaspan (niacin extended-release) tablets (500, 750, and 1000 mg) and the second being its generic version of Adenoscan (adenosine injection), which is marketed by Astellas ( ALPMY ). ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report ASTELLAS PHARMA (ALPMY): Get Free Report TEVA PHARM ADR (TEVA): Free Stock Analysis Report To read this article on Zacks.com click here. Adenoscan is used as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report ASTELLAS PHARMA (ALPMY): Get Free Report TEVA PHARM ADR (TEVA): Free Stock Analysis Report To read this article on Zacks.com click here. The company announced two exclusive product launches in the U.S. in September - the first being its generic version of AbbVie's ( ABBV ) cholesterol management treatment, Niaspan (niacin extended-release) tablets (500, 750, and 1000 mg) and the second being its generic version of Adenoscan (adenosine injection), which is marketed by Astellas ( ALPMY ). Second quarter 2013 generics business sales in the U.S. were soft with revenues declining 8% to $970 million. | The company announced two exclusive product launches in the U.S. in September - the first being its generic version of AbbVie's ( ABBV ) cholesterol management treatment, Niaspan (niacin extended-release) tablets (500, 750, and 1000 mg) and the second being its generic version of Adenoscan (adenosine injection), which is marketed by Astellas ( ALPMY ). ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report ASTELLAS PHARMA (ALPMY): Get Free Report TEVA PHARM ADR (TEVA): Free Stock Analysis Report To read this article on Zacks.com click here. The launch of generic Niaspan is one of the most important generic product launches at Teva this year and should boost the performance of the generics business. | The company announced two exclusive product launches in the U.S. in September - the first being its generic version of AbbVie's ( ABBV ) cholesterol management treatment, Niaspan (niacin extended-release) tablets (500, 750, and 1000 mg) and the second being its generic version of Adenoscan (adenosine injection), which is marketed by Astellas ( ALPMY ). ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report ASTELLAS PHARMA (ALPMY): Get Free Report TEVA PHARM ADR (TEVA): Free Stock Analysis Report To read this article on Zacks.com click here. Second quarter 2013 generics business sales in the U.S. were soft with revenues declining 8% to $970 million. |
27570.0 | 2013-09-27 00:00:00 UTC | Update on Gilead's Portfolio - Analyst Blog | ABBV | https://www.nasdaq.com/articles/update-on-gileads-portfolio-analyst-blog-2013-09-27 | nan | nan | Gilead Sciences, Inc. ( GILD ) performed very well in the second quarter of 2013 driven by its strong product portfolio. The robust sales of newly launched products like Complera/Eviplera and Stribild are very encouraging.
Stribild has performed well since launch in the U.S. in Aug 2012. Sales of the drug climbed 8% sequentially to $99.4 million in the second quarter of 2013. The EU approval of the drug in May 2013 has boosted the sales potential of the drug. Sales of Complera/Eviplera, launched in 2011, climbed 27% sequentially to $188.7 million in the second quarter of 2013. We expect these products to continue performing well.
The product portfolio was further strengthened by the European approval of HIV drug cobicistat (150 mg version). The drug will be marketed in the EU under the trade name Tybost.
The drug acts as a "boosting" agent for the HIV protease inhibitors - such as Reyataz (atazanavir) and Prezista (darunavir) - enabling the HIV therapy to be dosed once daily.
The approval by the EC was based on positive data from a phase III study (114) which showed that cobicistat was non-inferior to AbbVie Inc. 's ( ABBV ) HIV therapy Norvir (ritonavir) over 48 weeks in treatment naïve HIV patients. Approval was also based on pharmacokinetic data which revealed that the addition of cobicistat boosted the exposure of HIV therapies Reyataz and Prezista similar to Norvir. We note that cobicistat is a component of the HIV combination pill Stribild.
Gilead expects 2013 product revenue in the range of $10-$10.2 billion, reflecting an increase of 6%-9% over 2012 levels. We expect Gilead to easily achieve the guidance driven by its strong product portfolio.
Gilead currently carries a Zacks Rank #3 (Hold). However, stocks such as Roche ( RHHBY ) and Eli Lilly and Company ( LLY ) appear to be more attractive. Roche carries a Zacks Rank #1 (Strong Buy) while Eli Lilly carries a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | The approval by the EC was based on positive data from a phase III study (114) which showed that cobicistat was non-inferior to AbbVie Inc. 's ( ABBV ) HIV therapy Norvir (ritonavir) over 48 weeks in treatment naïve HIV patients. ABBVIE INC (ABBV): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. The product portfolio was further strengthened by the European approval of HIV drug cobicistat (150 mg version). | ABBVIE INC (ABBV): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. The approval by the EC was based on positive data from a phase III study (114) which showed that cobicistat was non-inferior to AbbVie Inc. 's ( ABBV ) HIV therapy Norvir (ritonavir) over 48 weeks in treatment naïve HIV patients. Gilead Sciences, Inc. ( GILD ) performed very well in the second quarter of 2013 driven by its strong product portfolio. | The approval by the EC was based on positive data from a phase III study (114) which showed that cobicistat was non-inferior to AbbVie Inc. 's ( ABBV ) HIV therapy Norvir (ritonavir) over 48 weeks in treatment naïve HIV patients. ABBVIE INC (ABBV): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. The product portfolio was further strengthened by the European approval of HIV drug cobicistat (150 mg version). | The approval by the EC was based on positive data from a phase III study (114) which showed that cobicistat was non-inferior to AbbVie Inc. 's ( ABBV ) HIV therapy Norvir (ritonavir) over 48 weeks in treatment naïve HIV patients. ABBVIE INC (ABBV): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. Gilead Sciences, Inc. ( GILD ) performed very well in the second quarter of 2013 driven by its strong product portfolio. |
27571.0 | 2013-09-23 00:00:00 UTC | AbbVie-Ablynx Ink Deal - Analyst Blog | ABBV | https://www.nasdaq.com/articles/abbvie-ablynx-ink-deal-analyst-blog-2013-09-23 | nan | nan | Biopharma company AbbVie ( ABBV ) has signed a worldwide license agreement with Belgian company Ablynx for the development and commercialization of the latter's autoimmune disease candidate, ALX-0061.
The deal, worth more than $840 million, includes an upfront payment of $175 million. AbbVie could make additional payments of up to $665 million on the achievement of development, regulatory, commercial and sales-based milestones. Ablynx is also entitled to double-digit tiered royalties on net sales upon commercialization.
ALX-0061, an anti-IL-6R Nanobody, is being evaluated for the treatment of inflammatory diseases. Results from a phase IIa study showed strong efficacy and safety in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate.
Phase II development for RA and systemic lupus erythematosus (SLE) will be handled by Ablynx. Ablynx will use a part of the $175 million upfront payment for the same. AbbVie will exercise its right to in-license ALX-0061 depending on the achievement of certain pre-defined success criteria.
Once AbbVie in-licenses the candidate, it will be responsible for phase III development and commercialization. Co-promotion rights in Belgium, the Netherlands and Luxembourg will be retained by Ablynx.
Our Take
AbbVie, which has a strong presence in the autoimmune disease market thanks to its blockbuster drug, Humira, should make a strong development and commercialization partner for Ablynx.
Meanwhile, this deal is in line with AbbVie's efforts to expand and strengthen its autoimmune disorder pipeline. Earlier this year, the company had extended its agreement with biotech company, Galapagos NV, for the development of autoimmune disease candidate, GLP0634, for Crohn's disease in addition to RA. AbbVie also signed a deal with Alvine Pharmaceuticals for the global development of a novel oral treatment for patients with celiac disease, an autoimmune disease.
AbbVie currently carries a Zacks Rank #3 (Hold). While we are positive on AbbVie's strong late-stage pipeline, dividend yield and growth strategy, we remain concerned about its dependence on Humira. We believe AbbVie will continue pursuing in-licensing deals and collaborations to boost its pipeline.
At present, large-cap pharma companies like Roche ( RHHBY ), Novo Nordisk ( NVO ) and Bayer ( BAYRY ) look well-positioned. While Roche is a Zacks Rank #1 (Strong Buy) stock, Novo Nordisk and Bayer are Zacks Rank #2 (Buy) stocks.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | While we are positive on AbbVie's strong late-stage pipeline, dividend yield and growth strategy, we remain concerned about its dependence on Humira. Biopharma company AbbVie ( ABBV ) has signed a worldwide license agreement with Belgian company Ablynx for the development and commercialization of the latter's autoimmune disease candidate, ALX-0061. AbbVie could make additional payments of up to $665 million on the achievement of development, regulatory, commercial and sales-based milestones. | ABBVIE INC (ABBV): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report NOVO-NORDISK AS (NVO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. Biopharma company AbbVie ( ABBV ) has signed a worldwide license agreement with Belgian company Ablynx for the development and commercialization of the latter's autoimmune disease candidate, ALX-0061. AbbVie could make additional payments of up to $665 million on the achievement of development, regulatory, commercial and sales-based milestones. | Biopharma company AbbVie ( ABBV ) has signed a worldwide license agreement with Belgian company Ablynx for the development and commercialization of the latter's autoimmune disease candidate, ALX-0061. Our Take AbbVie, which has a strong presence in the autoimmune disease market thanks to its blockbuster drug, Humira, should make a strong development and commercialization partner for Ablynx. ABBVIE INC (ABBV): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report NOVO-NORDISK AS (NVO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. | AbbVie could make additional payments of up to $665 million on the achievement of development, regulatory, commercial and sales-based milestones. Once AbbVie in-licenses the candidate, it will be responsible for phase III development and commercialization. AbbVie also signed a deal with Alvine Pharmaceuticals for the global development of a novel oral treatment for patients with celiac disease, an autoimmune disease. |
27572.0 | 2013-09-23 00:00:00 UTC | Teva's Exclusive Launch of Generic Niacin - Analyst Blog | ABBV | https://www.nasdaq.com/articles/tevas-exclusive-launch-of-generic-niacin-analyst-blog-2013-09-23 | nan | nan | Teva Pharmaceutical Industries Ltd. ( TEVA ) reported that it has launched its generic version of AbbVie 's ( ABBV ) cholesterol management treatment, Niaspan (niacin extended-release) tablets (500, 750, and 1000 mg) in the U.S.
The launch of generic Niaspan is one of the most important generic product launches at Teva this year and should boost the performance of the generics business. With Teva being the first to file, the company will enjoy 180 days of marketing exclusivity. As per IMS data, as of Jun 30, 2013, Niaspan annual sales were approximately $1.12 billion in the U.S.
We note that the performance of Teva's U.S. generics business was soft in the second quarter of 2013 with revenues declining 8% to $970 million. Lower sales of generic Lexapro, no royalties on generic Lipitor and lower sales of generic Avapro led to the decline in revenues. However, Teva expects the generics business to pick up in the second half of the year. 20-25 generic product launches are slated for 2013.
Teva currently carries a Zacks Rank #3 (Hold). The company is going through a tough transition period given fewer large generic opportunities, potential new competition for branded products (especially Copaxone) and a higher cost base.
However, we are encouraged by Teva's plans to improve its position. Teva said that it intends to accelerate growth platforms, protect and expand core franchises, expand its global presence, pursue strategic deals and reduce the cost base. We expect investor focus to remain on the execution of the company's new strategy.
At present, companies like Actavis, Inc. ( ACT ) and Akorn, Inc. ( AKRX ) look well-positioned with both being Zacks Rank #2 (Buy) stocks.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Teva Pharmaceutical Industries Ltd. ( TEVA ) reported that it has launched its generic version of AbbVie 's ( ABBV ) cholesterol management treatment, Niaspan (niacin extended-release) tablets (500, 750, and 1000 mg) in the U.S. ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report AKORN INC (AKRX): Free Stock Analysis Report TEVA PHARM ADR (TEVA): Free Stock Analysis Report To read this article on Zacks.com click here. As per IMS data, as of Jun 30, 2013, Niaspan annual sales were approximately $1.12 billion in the U.S. We note that the performance of Teva's U.S. generics business was soft in the second quarter of 2013 with revenues declining 8% to $970 million. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report AKORN INC (AKRX): Free Stock Analysis Report TEVA PHARM ADR (TEVA): Free Stock Analysis Report To read this article on Zacks.com click here. Teva Pharmaceutical Industries Ltd. ( TEVA ) reported that it has launched its generic version of AbbVie 's ( ABBV ) cholesterol management treatment, Niaspan (niacin extended-release) tablets (500, 750, and 1000 mg) in the U.S. Zacks Investment Research The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Teva Pharmaceutical Industries Ltd. ( TEVA ) reported that it has launched its generic version of AbbVie 's ( ABBV ) cholesterol management treatment, Niaspan (niacin extended-release) tablets (500, 750, and 1000 mg) in the U.S. ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report AKORN INC (AKRX): Free Stock Analysis Report TEVA PHARM ADR (TEVA): Free Stock Analysis Report To read this article on Zacks.com click here. The launch of generic Niaspan is one of the most important generic product launches at Teva this year and should boost the performance of the generics business. | Teva Pharmaceutical Industries Ltd. ( TEVA ) reported that it has launched its generic version of AbbVie 's ( ABBV ) cholesterol management treatment, Niaspan (niacin extended-release) tablets (500, 750, and 1000 mg) in the U.S. ABBVIE INC (ABBV): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report AKORN INC (AKRX): Free Stock Analysis Report TEVA PHARM ADR (TEVA): Free Stock Analysis Report To read this article on Zacks.com click here. The launch of generic Niaspan is one of the most important generic product launches at Teva this year and should boost the performance of the generics business. |
27573.0 | 2013-09-18 00:00:00 UTC | Repros Climbs on Positive Androxal Data - Analyst Blog | ABBV | https://www.nasdaq.com/articles/repros-climbs-on-positive-androxal-data-analyst-blog-2013-09-18 | nan | nan | Shares of Repros Therapeutics Inc. ( RPRX ) reached a 52-week high of $28.30 in the first half of the trading session on Sep 17. Shares of the company soared following the announcement of encouraging top-line data from the second pivotal efficacy study (ZA-302) and six-month safety study (ZA-300) on its lead pipeline candidate, Androxal. The company is evaluating the use of Androxal for the treatment of men with secondary hypogonadism.
The ZA-302 study met both the primary endpoints. The results showed that 81% of the patients had average total testosterone in a normal range. The second primary endpoint was related to the drug's impact on sperm concentration. Results did not reveal any harmful effects of Androxal on sperm function.
Repros also reported encouraging data from the ZA-300 study on Androxal. The company stated that Androxal was generally well-tolerated.
We note that earlier this year, the company had announced encouraging top-line data from the first pivotal phase III study (ZA-301). Both ZA-302 and ZA-301 were conducted under the FDA's Special Protocol Assessment program.
The company is on track to file a New Drug Application to the U.S. Food and Drug Administration (FDA) for Androxal by mid 2014 with potential launch in 2015.
Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel.
Repros currently carries a Zacks Rank #2 (Buy). We expect investor focus to remain on Androxal updates.
Currently, companies like Actelion Ltd. ( ALIOF ) and Biogen Idec Inc. ( BIIB ) look more attractive with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Shares of Repros Therapeutics Inc. ( RPRX ) reached a 52-week high of $28.30 in the first half of the trading session on Sep 17. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. Currently, companies like Actelion Ltd. ( ALIOF ) and Biogen Idec Inc. ( BIIB ) look more attractive with a Zacks Rank #1 (Strong Buy). | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. Shares of the company soared following the announcement of encouraging top-line data from the second pivotal efficacy study (ZA-302) and six-month safety study (ZA-300) on its lead pipeline candidate, Androxal. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. The second primary endpoint was related to the drug's impact on sperm concentration. |
27574.0 | 2013-09-18 00:00:00 UTC | CE Mark for Abbott Product - Analyst Blog | ABBV | https://www.nasdaq.com/articles/ce-mark-for-abbott-product-analyst-blog-2013-09-18 | nan | nan | Abbott Labs ( ABT ) recently announced that it has obtained the CE Marking (Conformite Europeenne) in Europe for its glucose monitoring system - FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System.
The CE mark is a mandatory confirmation for products placed in the European markets.
In Jul 2013, Abbott Labs obtained the U.S. Food and Drug Administration (FDA) clearance for its FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System.
We note that Abbott Labs continues to invest in the development of innovative technologies in its diabetes care business. The company is currently investing in the next-generation sensing technology which it expects to initially launch in the European markets in the second half of 2014.
Abbott Labs expects diabetes care sales growth to be relatively flat in the third quarter of 2013.
Although growth in the emerging markets is forecasted to be strong, Abbott Labs expects the implementation of Centers for Medicare and Medicaid Services (CMS) competitive bidding for Medicare patients to impact sales in the U.S. in the remainder of the year.
Sales from diabetes care business declined marginally in the second quarter of 2013. Share gains in the hospital and retail units in the U.S. were offset by market pricing and reimbursement pressures. International sales climbed 4% driven by the continued uptake of FreeStyle InsuLinx Meter along with growth in the emerging markets continues to positively impact sales in international markets.
We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013.
We believe the diversification bodes well for Abbott Labs and should enable the company to counter the challenging business environment as a result of austerity measures undertaken by developed markets in 2013 coupled with weak economic conditions elsewhere.
Abbott Labs, a large cap pharma company, currently carries a Zacks Rank #3 (Hold). Right now, large cap pharma stocks that look well-placed include Bayer ( BAYRY ) and Novo Nordisk ( NVO ). Both carry a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report NOVO-NORDISK AS (NVO): Free Stock Analysis Report To read this article on Zacks.com click here. In Jul 2013, Abbott Labs obtained the U.S. Food and Drug Administration (FDA) clearance for its FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report NOVO-NORDISK AS (NVO): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. Abbott Labs expects diabetes care sales growth to be relatively flat in the third quarter of 2013. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report NOVO-NORDISK AS (NVO): Free Stock Analysis Report To read this article on Zacks.com click here. Although growth in the emerging markets is forecasted to be strong, Abbott Labs expects the implementation of Centers for Medicare and Medicaid Services (CMS) competitive bidding for Medicare patients to impact sales in the U.S. in the remainder of the year. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report BAYER A G -ADR (BAYRY): Free Stock Analysis Report NOVO-NORDISK AS (NVO): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs ( ABT ) recently announced that it has obtained the CE Marking (Conformite Europeenne) in Europe for its glucose monitoring system - FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System. |
27575.0 | 2013-09-05 00:00:00 UTC | Good News for Abbott Labs - Analyst Blog | ABBV | https://www.nasdaq.com/articles/good-news-for-abbott-labs-analyst-blog-2013-09-05 | nan | nan | Abbott Labs ( ABT ) recently announced encouraging initial results from a study on its ARCHITECTSTAT High Sensitive Troponin-I (hsTnI) test.
The study is being conducted by researchers at the University of Edinburgh. The initial results from the study showed that the test can help the doctors improve the diagnosis and prognosis of patients with symptoms of heart attack.
Abbott further stated in its press release that the test could be particularly helpful for women who might have different symptoms and often are under-diagnosed. The test received CE Mark in Jan 2013. However, the test is not yet approved in the U.S., and is being used only for research purposes.
We note that Abbott Labs continues to invest in the development of next-generation instruments and other advanced technologies in its diagnostics business. In Jun 2013, Abbott Labs launched its hepatitis C virus genotyping test following approval by the U.S. Food and Drug Administration.
Abbott Labs' diagnostics business generated sales of $1.1 billion in the second quarter of 2013, up 5.3% year over year. The business is expected to post high single-digit growth in the third quarter of 2013 (excluding currency impact) driven by solid growth across all categories.
Abbott Labs is currently investing in six new system platforms across its three diagnostic businesses. We are encouraged by Abbott Labs traction in its diagnostics business and expect further momentum from new tests.
We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ( ABBV ), in Jan 2013.
We believe the diversification bodes well for Abbott Labs and should enable the company to counter the challenging business environment as a result of austerity measures undertaken by developed markets in 2013 coupled with weak economic conditions elsewhere.
Abbott Labs currently carries a Zacks Rank #3 (Hold). Right now, Alere Inc . ( ALR ) and Exactech, Inc. ( EXAC ) look well placed in the medical sector. While Alere carries a Zacks Rank #1 (Strong Buy), Exactech carries a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ALERE INC (ALR): Free Stock Analysis Report EXACTECH INC (EXAC): Free Stock Analysis Report To read this article on Zacks.com click here. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ALERE INC (ALR): Free Stock Analysis Report EXACTECH INC (EXAC): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ( ABBV ), in Jan 2013. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ALERE INC (ALR): Free Stock Analysis Report EXACTECH INC (EXAC): Free Stock Analysis Report To read this article on Zacks.com click here. ( ABBV ), in Jan 2013. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ALERE INC (ALR): Free Stock Analysis Report EXACTECH INC (EXAC): Free Stock Analysis Report To read this article on Zacks.com click here. |
27576.0 | 2013-08-27 00:00:00 UTC | 5 Fountain-of-Youth Stocks: Who's Serving Our Youth-Obsessed Culture? | ABBV | https://www.nasdaq.com/articles/5-fountain-youth-stocks-whos-serving-our-youth-obsessed-culture-2013-08-27 | nan | nan | It's never been a better time to be in the business of peddling the fountain of youth. Thanks in large part to retiring baby boomers who are spending their hard-earned pensions and 401(k)s on creams, pills, syringes, and deodorant-like sticks full of magic, the anti-aging market will be a nearly $300 billion industry by 2015.
Taking into account that actual product efficacy is a mixed bag, following are a few of the paths the Western world is paving on its tireless quest to turn back the arthritic hands of time.
Human Growth Hormone
More energy. Tighter and more radiant skin. Increased lean muscle mass. Improved mood. A better sex life. These are the unbelievable benefits being attributed to human growth hormone (hGH).
Hollywood has apparently been lining up for shots of this stuff. Although it's supposed to be tightly regulated and reserved for patients with rare disorders like pituitary adenoma, doctors are injecting the A-listers away and writing them prescriptions for products like Pfizer's ( PFE ) Genoropin so they can conveniently shoot up hGH at home.
The market is also seeing hGH pop up in pill form. Vaguely pharmaceutical-sounding SanMedica International has an oral product called SeroVital-hgh . Nevermind that the FDA hasn't touched it with a 10-foot pole; it got all the endorsement it needed to fly off the shelves when Dr. Oz plugged it on his show.
Testosterone Topicals
Jack Lemmon and Walter Matthau don't know how good they had it. If the incessant TV drug ads are any indication, being a grumpy old man is no longer an acceptable part of aging.
After age 30, men gradually stop beating their chests and are able to commit increasing brain power to subject matters not related to their sex life. . These are symptoms -- along with occasional, aforementioned grumpiness -- of the body's natural decline in testosterone production. They are also what make men grown-ups.
But underarm gels and solutions like AbbVie Inc.'s ( ABBV ) AndroGel and Eli Lilly's ( LLY ) Axiron have been developed to fix "low T," a condition considered by some critics to be a pharmaceutical-company-invented syndrome. The risks run the gamut between cardiovascular distress and self-immolation .
Stem Cell Treatments
No longer just a breakthrough medicine for age-related diseases like cancer, spinal-cord injuries, diabetes, or Parkinson's, stem cell therapy is now being used to "treat" aging. Get a load of these surgical nuggets.
A cosmetic clinic in Beverly Hills tried to give a patient a face-lift by injecting the area around her eyes with the stem cells isolated from her abdomen fat during her tummy tuck along and some dermal filler. While it's a nice use of the two-birds-with-one-stone idiom, the more than $20,000 procedure generated brand-new bone fragments around her eyes .
Scientific American suspects dozens, if not hundreds, of clinics around the country are using similar stem cell treatments that are neither tested nor FDA approved and cost anywhere between $3,000 and $30,000. The StemGenex clinic in La Jolla, CA, for example, will make you a natural Brazilian butt with your very own fat. And if stem cell clinics like Doral, FL's Nuvocell do in fact become the gold standard for hair loss treatment, we'll all be fabulous at our own open-coffined wakes with lustrous, full heads of hair.
Anti-Gray-Hair Pills
It's tragic enough that we've been steadily losing the Florida panther to overdevelopment in the South, but soon the US Fish & Wildlife Service may have another species to add to its endangered list: the silver fox.
In less than two years, the mass market will see the introduction of an anti-gray-hair pill from cosmetics company L'Oreal (EPA.OR). What's currently a "watertight proof of concept" will be in full production by 2015 .
Employing fruit extracts that mimic certain natural enzymes, in theory, the pill will prevent the buildup of hydrogen peroxide in hair follicles -- which causes oxidative stress and graying. "Prevent" is the operative word here. This isn't a gray-reversing supplement, so if you've already been sprayed with (as Bill Cosby put it) "God's graffiti," you're out of luck.
In fact, this treatment is really only designed for those still in the prime of their locks. Those who find complete success with the pill may have to start popping it a full 10 years before they anticipate going gray.
Wrinkle-Fighters, Fat-Busters, Breast Enhancers, and Eyelash Thickeners
Like its trademarked name suggests, the science-based aesthetic product offerings from pharmaceutical giant Allergan ( AGN ) have the age-afraid around the globe covered from head to toe. After all, this company is the mother of Botox, which is expected to become a $3 billion market by 2018.
Also, as the creator of the original Lap-Band system, Allergan may be responsible for getting Chris Christie fit enough for a presidential bid in a few more years, and for giving Halle Berry a few more blockbuster movie nude scenes, thanks to the company's Natrelle breast implants and tissue expanders. Then there's Latisse for the weak-eyelashed among us and, last but certainly not least, a number of creams and lotions for the wrinkle-wrought.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | But underarm gels and solutions like AbbVie Inc.'s ( ABBV ) AndroGel and Eli Lilly's ( LLY ) Axiron have been developed to fix "low T," a condition considered by some critics to be a pharmaceutical-company-invented syndrome. Although it's supposed to be tightly regulated and reserved for patients with rare disorders like pituitary adenoma, doctors are injecting the A-listers away and writing them prescriptions for products like Pfizer's ( PFE ) Genoropin so they can conveniently shoot up hGH at home. Wrinkle-Fighters, Fat-Busters, Breast Enhancers, and Eyelash Thickeners Like its trademarked name suggests, the science-based aesthetic product offerings from pharmaceutical giant Allergan ( AGN ) have the age-afraid around the globe covered from head to toe. | The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. But underarm gels and solutions like AbbVie Inc.'s ( ABBV ) AndroGel and Eli Lilly's ( LLY ) Axiron have been developed to fix "low T," a condition considered by some critics to be a pharmaceutical-company-invented syndrome. These are the unbelievable benefits being attributed to human growth hormone (hGH). | But underarm gels and solutions like AbbVie Inc.'s ( ABBV ) AndroGel and Eli Lilly's ( LLY ) Axiron have been developed to fix "low T," a condition considered by some critics to be a pharmaceutical-company-invented syndrome. Thanks in large part to retiring baby boomers who are spending their hard-earned pensions and 401(k)s on creams, pills, syringes, and deodorant-like sticks full of magic, the anti-aging market will be a nearly $300 billion industry by 2015. Stem Cell Treatments No longer just a breakthrough medicine for age-related diseases like cancer, spinal-cord injuries, diabetes, or Parkinson's, stem cell therapy is now being used to "treat" aging. | But underarm gels and solutions like AbbVie Inc.'s ( ABBV ) AndroGel and Eli Lilly's ( LLY ) Axiron have been developed to fix "low T," a condition considered by some critics to be a pharmaceutical-company-invented syndrome. The market is also seeing hGH pop up in pill form. Stem Cell Treatments No longer just a breakthrough medicine for age-related diseases like cancer, spinal-cord injuries, diabetes, or Parkinson's, stem cell therapy is now being used to "treat" aging. |
27577.0 | 2013-08-21 00:00:00 UTC | Repros Reports Androxal Interim Data - Analyst Blog | ABBV | https://www.nasdaq.com/articles/repros-reports-androxal-interim-data-analyst-blog-2013-08-21 | nan | nan | Repros Therapeutics Inc. ( RPRX ) recently announced six months interim results from the ongoing ZA-303 study on its lead pipeline candidate, Androxal. The study is evaluating the impact of Androxal therapy on bone mineral density in men suffering from secondary hypogonadism .
Interim data from the single-blind, placebo-controlled study suggested that the use of Androxal did not result in bone loss as compared to placebo. Additionally, data hinted that Androxal may improve bone mineral density.
Top-line twelve-month data from the study are expected in the second quarter of 2014. The company plans to file a New Drug Application to the U.S. Food and Drug Administration (FDA) for Androxal by mid 2014.
The company is also evaluating Androxal in other studies for secondary hypogonadism including two pivotal phase III studies conducted under the FDA's Special Protocol Assessment program.
Earlier this year, the company had announced encouraging top-line data from the first pivotal phase III study (ZA-301). The second pivotal phase III study is expected to be completed in the fourth quarter of 2013.
Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel.
Apart from Androxal, Proellex is another interesting pipeline candidate at Repros. Proellex is being developed for uterine fibroids (phase IIb study expected to be initiated in the fourth quarter 2013) and endometriosis (phase II study expected to be completed in the second quarter 2014).
Repros currently carries a Zacks Rank #4 (Sell). We expect investor focus to remain on Androxal updates.
Currently, companies like Actelion Ltd. ( ALIOF ) and Biogen Idec Inc. ( BIIB ) look more attractive with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Repros Therapeutics Inc. ( RPRX ) recently announced six months interim results from the ongoing ZA-303 study on its lead pipeline candidate, Androxal. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. The company is also evaluating Androxal in other studies for secondary hypogonadism including two pivotal phase III studies conducted under the FDA's Special Protocol Assessment program. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. The company is also evaluating Androxal in other studies for secondary hypogonadism including two pivotal phase III studies conducted under the FDA's Special Protocol Assessment program. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. The company is also evaluating Androxal in other studies for secondary hypogonadism including two pivotal phase III studies conducted under the FDA's Special Protocol Assessment program. |
27578.0 | 2013-08-21 00:00:00 UTC | Profit From The Market's Misunderstanding Of This Spinoff Company | ABBV | https://www.nasdaq.com/articles/profit-markets-misunderstanding-spinoff-company-2013-08-21 | nan | nan | There's no such thing as afree lunch , but spinoff companies are as close to free as you can get.
When a company is spun off, there's a high level of forced selling. One of the best ways to think about spinoffs: "There's a natural constituency of sellers and not a natural constituency of buyers," according to "Margin of Safety " author andhedge fund manager Seth Klarman.
Simply, many shareholders who ownshares of theparent company are not interested in owning the spinoff. This can be for a variety of reasons, such as different business fundamentals, weak management, or negativecash flow . In most cases, investors are selling the company for no good reason. While on the other side, the buyers are limited, as themarket is inefficient in digesting data on new spinoff companies.
Spinoffs Versus The Market
Yet, over the longterm , spinoffinvesting tends to outperform the broader market.
This is not new information. A 1993 study titled "Restructuring Through Spinoffs" found that spinoff companies outperformed the S&P 500index by 30% on average during their first three years. A similar study by Lehman Brothers concluded that between 2000 and 2005, spinoff companies outperformed the market by a whopping 45% during their first two years. JPMorgan Chase ( JPM ) came to similar conclusions, finding that spinoffs outpaced the market by 20% during their firstyear and a half between 1985 and 1995.
So far this year, spinoff companies have maintained that standard. The Guggenheim Spin-Off ( CSD ) exchange-tradedfund is up 30% this year, compared with the S&P 500's 16.5%.
Earlier this year, Abbott Laboratories ( ABT ) completed a split after realizing the company had grown into two distinct units. AbbVie ( ABBV ) now trades as the former pharma business of Abbott Labs, while Abbott continues as a health care products and medical devices company.
The idea of breaking up the health care and pharma businesses was to make the companies easier to value. However, it appears the market has gotten this one wrong. Spinoffs are great ways to fix mistakes. As a result, spinoffs generally have weak management, lower margins, lower returns onequity , or negativeearnings . This is not the case with AbbVie. Thestock had a nice run out of the gate, but interest and tradingvolume have since cooled off.
But investors should give AbbVie another look. Sometimes the market fundamentally misunderstands spinoffs. In this case, the market is treating AbbVie like a typical problematic spinoff -- but in reality, AbbVie appears more fundamentally sound than Abbott itself.
Breaking Down The Numbers
AbbVie is trading with a price-to-earnings (P/E ) ratio of 13, which is well below Abbott's 60. AbbVie has an impressive 33%operating margin for the past 12 months, compared with Abbott's 20%. Abbvie is also churning out areturn on capital employed (ROCE, equal tooperating income divided bycapital employed) of 43.5%, compared with Abbott's 21.6%.
While the companies' business models are debatable, there's no denying the strength of AbbVie'scash position anddividend yield . AbbVie has $5.50 in cash per share, which covers 12% of the share price, and the company generated $4 per share in cash flow from operations over the trailing 12 months.
AbbVie has a solid 3.6% dividend yield, which is in line with (and in most cases above) other major pharma companies and dwarfs the 1.6%yield of Abbott, its former parent. Yet unlike some of its peers, AbbVie'sdividend payout (as a percentage of earnings) is below 50%. AbbVie's board has also authorized a $1.5 billion share buyback program, representing just over 2% ofshares outstanding .
What About The Business?
AbbVie's key drug is Humira, an anti-inflammatory product used primarily for rheumatoid arthritis. In 2012, Humira accounted for around half of AbbVie's $18.4 billion pro formarevenues . Last year, the drug accounted for about 50% of the market for rheumatoid arthritis drugs, which is expected grow to more than $25 billion in 2017, up nearly 40% from 2012.
One concern is the fact that Humirawill losepatent protection in 2016 in the United States and in 2018 in Europe. However, AbbVie's total research and development (R&D) pipeline has more than 20compounds in Phase II or Phase III development, including five key products planned for launch before 2016.
Humira is also approved for a number of other uses, which includes HIV, Crohn's disease, psoriatic arthritis and several other ailments. These uses and the drugs in AbbVie's pipeline should help AbbVieoffset any fall-off in Humira revenues.
AbbVie, which gets more than half itsrevenue from outside North America, has a number of growth opportunities in the U.S. and internationally.Emerging markets should see tailwinds from increased spending on health care, and in the U.S., theAffordable Care Act (akaObamacare ) is expected to provide coverage for more than 30 million uninsured Americans next year. All in all, the company has company- and industry-specific tailwinds for which the market appears to be mispricing ABBV.
Risks to consider: As with any pharma company, there are risks thatpatents will be challenged or the company will fail to produce new revenue-generating products. AbbVie faces patent expirations for its top drug Humira in the next several years, which could be a negative if its other products fail to come to market in a timely fashion.
Action to take --> Consider buying shares of AbbVie, which has a well-developed R&D pipeline and a cheap valuation. With just a modest 20 times P/Emultiple on AbbVie management's 2013EPS forecast of $3.10, the stock should trade north of $60. Its solid cash position and robust dividend also give the stock somedownside protection.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie faces patent expirations for its top drug Humira in the next several years, which could be a negative if its other products fail to come to market in a timely fashion. AbbVie ( ABBV ) now trades as the former pharma business of Abbott Labs, while Abbott continues as a health care products and medical devices company. This is not the case with AbbVie. | AbbVie ( ABBV ) now trades as the former pharma business of Abbott Labs, while Abbott continues as a health care products and medical devices company. This is not the case with AbbVie. But investors should give AbbVie another look. | AbbVie ( ABBV ) now trades as the former pharma business of Abbott Labs, while Abbott continues as a health care products and medical devices company. In this case, the market is treating AbbVie like a typical problematic spinoff -- but in reality, AbbVie appears more fundamentally sound than Abbott itself. This is not the case with AbbVie. | AbbVie ( ABBV ) now trades as the former pharma business of Abbott Labs, while Abbott continues as a health care products and medical devices company. AbbVie's key drug is Humira, an anti-inflammatory product used primarily for rheumatoid arthritis. This is not the case with AbbVie. |
27579.0 | 2013-08-21 00:00:00 UTC | Abbott Acquires OptiMedica - Analyst Blog | ABBV | https://www.nasdaq.com/articles/abbott-acquires-optimedica-analyst-blog-2013-08-21 | nan | nan | Abbott Labs ( ABT ) recently announced that it has completed the previously announced acquisition of privately-held OptiMedica Corporation for $250 million in cash.
The acquisition was announced in Jul 2013. This acquisition should expand Abbott Labs' vision care business into the femtosecond laser-assisted cataract surgery market.
OptiMedica's Catalys Precision Laser System carries a CE mark in the EU and has been approved in the U.S. as well. This laser system replaces certain manual steps in cataract surgery with precise, image-guided, femtosecond laser technology.
Hence, the acquisition will further boost the cataract surgery business at Abbott Labs' which currently account for 60% of total sales of the vision care business.
Abbott Labs's vision care business was up 2% in the second quarter of 2013 driven by solid cataract sales attributed to strong double-digit growth in the emerging markets and Tecnis of intraocular lenses (IOL).
Abbott Labs expects further growth in its cataract business to be driven by several important new product launches in 2013.
Key launches include Tecnis OptiBlue in Japan providing access to the largest segment of the Japanese market and Tecnis Toric in the U.S. enabling Abbott Labs to enter the faster growing premium segment of the IOL market.
Further, Abbott Labs expects to launch Tecnis Preloaded IOL in the U.S. in the second half of 2013 which should propel growth.
Hence, Abbott Labs expects mid-single digit growth (excluding currency translation impact) in the third quarter of 2013 driven by traction in the cataract surgery business.
We are impressed by Abbott Lab's efforts to drive growth in its promising vision care business.
We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013.
Abbott Labs currently carries a Zacks Rank #3 (Hold). Right now, Shire ( SHPG ) and Jazz Pharmaceuticals ( JAZZ ) look attractive, each with a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. This acquisition should expand Abbott Labs' vision care business into the femtosecond laser-assisted cataract surgery market. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. This acquisition should expand Abbott Labs' vision care business into the femtosecond laser-assisted cataract surgery market. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. Hence, the acquisition will further boost the cataract surgery business at Abbott Labs' which currently account for 60% of total sales of the vision care business. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report SHIRE PLC-ADR (SHPG): Free Stock Analysis Report To read this article on Zacks.com click here. This acquisition should expand Abbott Labs' vision care business into the femtosecond laser-assisted cataract surgery market. |
27580.0 | 2013-08-13 00:00:00 UTC | Loss Widens at Repros in Q2 - Analyst Blog | ABBV | https://www.nasdaq.com/articles/loss-widens-at-repros-in-q2-analyst-blog-2013-08-13 | nan | nan | Repros Therapeutics Inc. ( RPRX ) reported second quarter 2013 loss of 38 cents per share, wider than the year-ago loss of 21 cents per share. The higher loss was due to an increase in expenses related to Androxal, salary expense and costs related to patents.
The company's revenue for the second quarter of 2013 was $0.1 million primarily consisting of interest income. Repros did not record any revenue in the year-ago period.
In the second quarter of 2013, general and administrative expenses increased 27% to $1.2 million due to higher professional service and travel expenses. Research and development expenses shot up 177% year over year to $6.0 million, reflecting higher pipeline investment.
Androxal, the most advanced pipeline candidate at Repros, is being evaluated for the treatment of secondary hypogonadism. The company is currently evaluating the phase III candidate in two pivotal studies conducted under the U.S. Food and Drug Administration' s Special Protocol Assessment program.
Earlier this year, the company had announced encouraging top-line data from the first pivotal phase III study. The second pivotal phase III study is expected to be completed in the fourth quarter of 2013. The company plans to submit the marketing application for the candidate to the FDA by mid 2014.
Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel.
Apart from Androxal, other pipeline candidates at Repros include Proellex. Proellex is being developed for uterine fibroids (phase IIb study expected to be initiated in the fourth quarter 2013) and endometriosis (phase II study expected to be completed in the second quarter 2014).
Repros currently carries a Zacks Rank #4 (Sell). We expect investor focus to remain on Androxal updates.
Currently, companies like Actelion Ltd. ( ALIOF ) and Biogen Idec Inc. ( BIIB ) look more attractive with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. The company is currently evaluating the phase III candidate in two pivotal studies conducted under the U.S. Food and Drug Administration' s Special Protocol Assessment program. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. Repros Therapeutics Inc. ( RPRX ) reported second quarter 2013 loss of 38 cents per share, wider than the year-ago loss of 21 cents per share. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. Repros Therapeutics Inc. ( RPRX ) reported second quarter 2013 loss of 38 cents per share, wider than the year-ago loss of 21 cents per share. | Currently prescribed therapies for secondary hypogonadism include AbbVie Inc. 's ( ABBV ) AndroGel. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report REPROS THERAPEU (RPRX): Free Stock Analysis Report To read this article on Zacks.com click here. Repros Therapeutics Inc. ( RPRX ) reported second quarter 2013 loss of 38 cents per share, wider than the year-ago loss of 21 cents per share. |
27581.0 | 2013-07-30 00:00:00 UTC | Pharma & Biotech Stock Outlook - July/Aug 2013 - Industry Outlook | ABBV | https://www.nasdaq.com/articles/pharma-biotech-stock-outlook-july-aug-2013-industry-outlook-2013-07-30 | nan | nan | The pharmaceutical industry has been showing signs of recovery from one of the biggest patent cliffs in recent times. Major blockbuster drugs like Merck's ( MRK ) Singulair, Pfizer's ( PFE ) Lipitor, Forest Laboratories' ( FRX ) Lexapro, Sanofi / Bristol-Myers Squibbs' ( SNT / BMY ) Plavix and Eli Lilly's ( LLY ) Zyprexa lost patent protection in the last few quarters. These products alone represented branded sales worth more than $15 billion.
However, the effect of the genericization of these products was felt mostly in 2012. While the industry won't be completely free from genericization, the major patent expiries are over and done with. New products should start contributing significantly to results and increased pipeline visibility and appropriate utilization of cash should increase confidence in the sector.
Some products that lost or are slated to lose patent protection in 2013 include:
Source: 10K
Collaborations, Acquisitions and Restructuring
The pharma sector witnessed major merger and acquisitions (M&A) activity over the last couple of years. Going forward, we expect small bolt-on acquisitions to continue. In-licensing activities and collaborations for the development of pipeline candidates have also increased significantly. Several pharma companies are focusing on in-licensing mid-to-late stage pipeline candidates that look promising, instead of developing a product from scratch, which involves a lot of funds and time.
Small biotech companies are open to in-licensing activities and collaborations. Most of these companies find it challenging to raise cash, thereby making it difficult for them to survive and continue with the development of promising pipeline candidates. Therefore, it makes sense for them to seek deals with pharma companies that are sitting on huge piles of cash.
We would recommend investors put their money in biotech stocks that have attractive pipeline candidates or technology that can be used for the development of novel therapeutics. Therapeutic areas which could see a lot of in-licensing activity include oncology, central nervous system disorders, diabetes and immunology/inflammation. The hepatitis C virus (HCV) market is also attracting a lot of attention.
A couple of biotech companies that have been in the news recently due to acquisition rumors/talks are Onyx Pharmaceuticals ( ONXX ) and Alexion Pharmaceuticals ( ALXN ). Onyx has placed itself on the market after turning down an offer from biotech major, Amgen (AMGN). Meanwhile, Roche ( RHHBY ) is rumored to be interested in Alexion.
Another trend that we are seeing in recent months is the divestment of non-core business segments. Pfizer sold its Capsugel unit and its Nutrition business in Aug 2011 and Nov 2012, respectively. More recently, Pfizer spun off its animal health business into a new company, Zoetis ( ZTS ).
Meanwhile, GlaxoSmithKline ( GSK ) divested certain non-core brands from its Consumer Healthcare segment. In Aug 2011, AstraZeneca ( AZN ) sold its Astra Tech business to DENTSPLY ( XRAY ). The monetization of non-core assets will allow the pharma/biotech companies to focus on their areas of expertise. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Johnson & Johnson ( JNJ ) also announced its plans to explore strategic alternatives for its ortho-clinical diagnostics business, including a possible divestiture.
Emerging Markets and Biosimilars
Another trend seen in the pharmaceutical sector is a focus on emerging markets. Companies like Mylan ( MYL ), Pfizer, Merck, Eli Lilly, Glaxo and Sanofi are all looking to expand their presence in India, China, Brazil and other emerging markets. Until recently, most of the commercialization efforts were focused on the U.S. market -- the largest pharmaceutical market -- along with Europe and Japan.
Emerging markets are slowly and steadily gaining more importance, and several companies are now shifting their focus to these areas. However, while higher demand for medicines, government initiatives for healthcare, new patient population and increasing use of generics should help drive demand, we point out that emerging markets are also not immune from genericization.
Meanwhile, growth in Europe will continue to be pressurized by austerity and cost-containment measures.
We are also seeing several companies entering into deals for the development of biosimilars, generic versions of biologics. Companies like Merck, Amgen, Biogen ( BIIB ), Actavis ( ACT ) and Teva ( TEVA ) are all targeting the highly lucrative biosimilars market.
2Q Earnings
So far, 51.1% of the companies falling under the Medical sector have reported second quarter 2013 results. While earnings-beat ratios (percentage of companies coming out with positive surprises) were pretty impressive, revenue-beat ratios and growth ratios were weak.
To date, second quarter 2013 earnings "beat ratio" was 70.8% while the revenue "beat ratio" was 29.2%. Total earnings for this sector were up 1.9%, below the 3.0% growth recorded in the first quarter of 2013. Total revenues moved up 4.1% in the quarter versus 10.7% growth in the first quarter of 2013.
Looking at the consensus earnings expectations for the rest of the year, earnings are expected to decline 3.6% in the third quarter and grow 1.2% in the fourth quarter. Overall, 2013 earnings are expected to decline 0.2%.
This is mainly due to weakness in the pharma industry which accounts for about two-thirds of the sector's total earnings. Tough comparisons at Pfizer, Merck and others tell the pharmaceutical industry's earnings growth challenge. Both Pfizer and Merck are facing generic competition for key products.
For a detailed look at the earnings outlook for the Medical and other sectors, please check our weekly Zacks Earnings Trends report.
Focus on New Products
2012 saw the FDA approving 35 novel medicines including the following:
Source: FDA
Source: FDA
Most of these products should be major contributors to the top-line in 2013. Stivarga, Kalydeco, Xtandi and Kyprolis, especially, represent strong commercial potential.
So far in 2013, quite a few important products have gained approval including Biogen's oral multiple sclerosis drug Tecfidera, Johnson & Johnson's type II diabetes drug Invokana, Merck's Liptruzet (cholesterol) and Forest's Fetzima (major depressive disorder). Biogen's Tecfidera is off to a strong start with its launch -- quarter sales are surpassing expectations by a wide margin.
Zacks Industry Rank
Within the Zacks Industry classification, pharma and biotech are broadly grouped into the Medical sector (one of 16 Zacks sectors) and further sub-divided into four industries at the expanded level: large-cap pharma, med-biomed/gene, med-drugs and med-generic drugs.
We rank all the 260-plus industries in the 16 Zacks sectors based on the earnings outlook and fundamental strength of the constituent companies in each industry. To learn more, visit: About Zacks Industry Rank .
As a point of reference, the outlook for industries with Zacks Industry Rank #88 and lower is 'Positive,' between $89 and #176 is 'Neutral' and #177 and higher is 'Negative.'
The Zacks Industry Rank for large-cap pharma is #195, med-biomed/gene is #101, med-drugs is #83, while the med-generic drugs is #168. Analyzing the Zacks Industry Rank for different medical segments, it is obvious that while the outlook for large-cap pharma stocks is negative, that for med-drugs is positive. Meanwhile, the outlook for med-biomed/gene and med-generic drugs is neutral.
OPPORTUNITIES
While several companies will continue to face challenges like EU austerity measures and genericization, the pharma industry should be out of the worst of the genericization phase from 2013. Many companies which had faced generic headwinds in the last couple of years should see their results improve from 2013. Cost-cutting, downsizing, streamlining of the pipeline, growth in emerging markets and product approvals should support growth.
Among large-cap pharma stocks, Johnson & Johnson ( JNJ ) currently holds a Zacks Rank #2 (Buy). The company has performed well in the first half of 2013 and the momentum should continue through the remainder of the year. The company has been trying to offset the declining sales of some of its important products by bringing in new products through in-licensing deals and acquisitions. We believe the diversity and strength of the company's underlying businesses will continue to provide strong growth in future. The Synthes deal should continue driving results.
Forest Labs ( FRX ), another Zacks Rank #2 stock, is doing well with first quarter fiscal 2014 results beating expectations. The company has launched several new products over the past few quarters and continues to make impressive progress with its pipeline.
In the biotech space, we are positive on Biogen ( BIIB ). Tecfidera, the company's recently launched oral multiple sclerosis drug, is off to a strong start with launch quarter sales coming in at $192 million (including inventory stocking of $82 million). While Tecfidera has the potential to gain the top spot in the oral multiple sclerosis market, Avonex and Tysabri should continue contributing significantly to sales. Biogen is also progressing with its hemophilia pipeline.
We are also positive on Amgen ( AMGN ). Amgen should be able to deliver on its long-term strategy based on expansion in key markets, launch of new manufacturing technologies, and pipeline development. Enbrel should continue performing well. Amgen's late-stage pipeline is also moving along. While Amgen is a Zacks Rank #2 stock, Biogen is a Zacks Rank #3 (Hold) stock. Gilead, another Zacks Rank #2 stock, continues to do well in the HIV segment and is also progressing with its HCV pipeline.
Medivation ( MDVN ), a Zacks Rank #1 (Strong Buy) company, should continue delivering with its prostate cancer therapy, Xtandi, performing well. Based on the data we have seen so far, we believe Xtandi has blockbuster potential. It is currently in several studies including for the pre-chemo setting. Expansion into the pre-chemo setting would be a major positive for Medivation.
Among generic companies, Actavis ( ACT ) looks well-positioned. We view the acquisition of Actavis Group as a smart strategic move and we believe the company will be able to achieve its guidance easily. We are also positive on the upcoming acquisition of Warner Chilcott (WCRX), which makes strategic and financial sense. With fewer major patent expiries slated to occur in the next few years, we are encouraged by Actavis' focus on building its branded and biosimilars pipeline. The company carries a Zacks Rank #3.
WEAKNESSES
We recommend avoiding names that offer little growth or opportunity for a take-out. These include companies which are developing drugs that are likely to face regulatory hurdles. The FDA has been exercising more caution in granting approval to new products and several candidates are facing delays in receiving final approval.
Bristol-Myers Squibb ( BMY ) currently carries a Zacks Rank #5 (Strong Sell). While the company's second quarter results were in-line with expectations, Bristol-Myers cut its outlook for 2013 reflecting negative currency movement and the recall of Fervex, a local over-the-counter (OTC) product in France and other international markets. Moreover, Eliquis' performance has been disappointing.
The Medicines Company ( MDCO ) also carries a Zacks Rank #5. Earnings estimates for this company have been declining with third quarter results expected to remain flat on a sequential basis.
Other companies that currently carry a Zacks Rank #4 (Sell) include Novo Nordisk ( NVO ), Novartis ( NVS ), Dendreon Corp. ( DNDN ) and XOMA Corporation ( XOMA ), among others.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report ONYX PHARMA INC (ONXX): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report WARNER CHIL PLC (WCRX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Major blockbuster drugs like Merck's ( MRK ) Singulair, Pfizer's ( PFE ) Lipitor, Forest Laboratories' ( FRX ) Lexapro, Sanofi / Bristol-Myers Squibbs' ( SNT / BMY ) Plavix and Eli Lilly's ( LLY ) Zyprexa lost patent protection in the last few quarters. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report ONYX PHARMA INC (ONXX): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report WARNER CHIL PLC (WCRX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Major blockbuster drugs like Merck's ( MRK ) Singulair, Pfizer's ( PFE ) Lipitor, Forest Laboratories' ( FRX ) Lexapro, Sanofi / Bristol-Myers Squibbs' ( SNT / BMY ) Plavix and Eli Lilly's ( LLY ) Zyprexa lost patent protection in the last few quarters. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report ONYX PHARMA INC (ONXX): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report WARNER CHIL PLC (WCRX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Zacks Industry Rank Within the Zacks Industry classification, pharma and biotech are broadly grouped into the Medical sector (one of 16 Zacks sectors) and further sub-divided into four industries at the expanded level: large-cap pharma, med-biomed/gene, med-drugs and med-generic drugs. | Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report ONYX PHARMA INC (ONXX): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report WARNER CHIL PLC (WCRX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. 2Q Earnings So far, 51.1% of the companies falling under the Medical sector have reported second quarter 2013 results. |
27582.0 | 2013-07-30 00:00:00 UTC | Pharma & Biotech Stock Outlook - July/Aug 2013 - Zacks Analyst Interviews | ABBV | https://www.nasdaq.com/articles/pharma-biotech-stock-outlook-july-aug-2013-zacks-analyst-interviews-2013-07-30 | nan | nan | The pharmaceutical industry has been showing signs of recovery from one of the biggest patent cliffs in recent times. Major blockbuster drugs like Merck's ( MRK ) Singulair, Pfizer's ( PFE ) Lipitor, Forest Laboratories' ( FRX ) Lexapro, Sanofi / Bristol-Myers Squibbs' ( SNT / BMY ) Plavix and Eli Lilly's ( LLY ) Zyprexa lost patent protection in the last few quarters. These products alone represented branded sales worth more than $15 billion.
However, the effect of the genericization of these products was felt mostly in 2012. While the industry won't be completely free from genericization, the major patent expiries are over and done with. New products should start contributing significantly to results and increased pipeline visibility and appropriate utilization of cash should increase confidence in the sector.
Some products that lost or are slated to lose patent protection in 2013 include:
Source: 10K
Collaborations, Acquisitions and Restructuring
The pharma sector witnessed major merger and acquisitions (M&A) activity over the last couple of years. Going forward, we expect small bolt-on acquisitions to continue. In-licensing activities and collaborations for the development of pipeline candidates have also increased significantly. Several pharma companies are focusing on in-licensing mid-to-late stage pipeline candidates that look promising, instead of developing a product from scratch, which involves a lot of funds and time.
Small biotech companies are open to in-licensing activities and collaborations. Most of these companies find it challenging to raise cash, thereby making it difficult for them to survive and continue with the development of promising pipeline candidates. Therefore, it makes sense for them to seek deals with pharma companies that are sitting on huge piles of cash.
We would recommend investors put their money in biotech stocks that have attractive pipeline candidates or technology that can be used for the development of novel therapeutics. Therapeutic areas which could see a lot of in-licensing activity include oncology, central nervous system disorders, diabetes and immunology/inflammation. The hepatitis C virus (HCV) market is also attracting a lot of attention.
A couple of biotech companies that have been in the news recently due to acquisition rumors/talks are Onyx Pharmaceuticals ( ONXX ) and Alexion Pharmaceuticals ( ALXN ). Onyx has placed itself on the market after turning down an offer from biotech major, Amgen (AMGN). Meanwhile, Roche ( RHHBY ) is rumored to be interested in Alexion.
Another trend that we are seeing in recent months is the divestment of non-core business segments. Pfizer sold its Capsugel unit and its Nutrition business in Aug 2011 and Nov 2012, respectively. More recently, Pfizer spun off its animal health business into a new company, Zoetis ( ZTS ).
Meanwhile, GlaxoSmithKline ( GSK ) divested certain non-core brands from its Consumer Healthcare segment. In Aug 2011, AstraZeneca ( AZN ) sold its Astra Tech business to DENTSPLY ( XRAY ). The monetization of non-core assets will allow the pharma/biotech companies to focus on their areas of expertise. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Johnson & Johnson ( JNJ ) also announced its plans to explore strategic alternatives for its ortho-clinical diagnostics business, including a possible divestiture.
Emerging Markets and Biosimilars
Another trend seen in the pharmaceutical sector is a focus on emerging markets. Companies like Mylan ( MYL ), Pfizer, Merck, Eli Lilly, Glaxo and Sanofi are all looking to expand their presence in India, China, Brazil and other emerging markets. Until recently, most of the commercialization efforts were focused on the U.S. market -- the largest pharmaceutical market -- along with Europe and Japan.
Emerging markets are slowly and steadily gaining more importance, and several companies are now shifting their focus to these areas. However, while higher demand for medicines, government initiatives for healthcare, new patient population and increasing use of generics should help drive demand, we point out that emerging markets are also not immune from genericization.
Meanwhile, growth in Europe will continue to be pressurized by austerity and cost-containment measures.
We are also seeing several companies entering into deals for the development of biosimilars, generic versions of biologics. Companies like Merck, Amgen, Biogen ( BIIB ), Actavis ( ACT ) and Teva ( TEVA ) are all targeting the highly lucrative biosimilars market.
2Q Earnings
So far, 51.1% of the companies falling under the Medical sector have reported second quarter 2013 results. While earnings-beat ratios (percentage of companies coming out with positive surprises) were pretty impressive, revenue-beat ratios and growth ratios were weak.
To date, second quarter 2013 earnings "beat ratio" was 70.8% while the revenue "beat ratio" was 29.2%. Total earnings for this sector were up 1.9%, below the 3.0% growth recorded in the first quarter of 2013. Total revenues moved up 4.1% in the quarter versus 10.7% growth in the first quarter of 2013.
Looking at the consensus earnings expectations for the rest of the year, earnings are expected to decline 3.6% in the third quarter and grow 1.2% in the fourth quarter. Overall, 2013 earnings are expected to decline 0.2%.
This is mainly due to weakness in the pharma industry which accounts for about two-thirds of the sector's total earnings. Tough comparisons at Pfizer, Merck and others tell the pharmaceutical industry's earnings growth challenge. Both Pfizer and Merck are facing generic competition for key products.
For a detailed look at the earnings outlook for the Medical and other sectors, please check our weekly Zacks Earnings Trends report.
Focus on New Products
2012 saw the FDA approving 35 novel medicines including the following:
Source: FDA
Source: FDA
Most of these products should be major contributors to the top-line in 2013. Stivarga, Kalydeco, Xtandi and Kyprolis, especially, represent strong commercial potential.
So far in 2013, quite a few important products have gained approval including Biogen's oral multiple sclerosis drug Tecfidera, Johnson & Johnson's type II diabetes drug Invokana, Merck's Liptruzet (cholesterol) and Forest's Fetzima (major depressive disorder). Biogen's Tecfidera is off to a strong start with its launch -- quarter sales are surpassing expectations by a wide margin.
Zacks Industry Rank
Within the Zacks Industry classification, pharma and biotech are broadly grouped into the Medical sector (one of 16 Zacks sectors) and further sub-divided into four industries at the expanded level: large-cap pharma, med-biomed/gene, med-drugs and med-generic drugs.
We rank all the 260-plus industries in the 16 Zacks sectors based on the earnings outlook and fundamental strength of the constituent companies in each industry. To learn more, visit: About Zacks Industry Rank .
As a point of reference, the outlook for industries with Zacks Industry Rank #88 and lower is 'Positive,' between $89 and #176 is 'Neutral' and #177 and higher is 'Negative.'
The Zacks Industry Rank for large-cap pharma is #195, med-biomed/gene is #101, med-drugs is #83, while the med-generic drugs is #168. Analyzing the Zacks Industry Rank for different medical segments, it is obvious that while the outlook for large-cap pharma stocks is negative, that for med-drugs is positive. Meanwhile, the outlook for med-biomed/gene and med-generic drugs is neutral.
OPPORTUNITIES
While several companies will continue to face challenges like EU austerity measures and genericization, the pharma industry should be out of the worst of the genericization phase from 2013. Many companies which had faced generic headwinds in the last couple of years should see their results improve from 2013. Cost-cutting, downsizing, streamlining of the pipeline, growth in emerging markets and product approvals should support growth.
Among large-cap pharma stocks, Johnson & Johnson ( JNJ ) currently holds a Zacks Rank #2 (Buy). The company has performed well in the first half of 2013 and the momentum should continue through the remainder of the year. The company has been trying to offset the declining sales of some of its important products by bringing in new products through in-licensing deals and acquisitions. We believe the diversity and strength of the company's underlying businesses will continue to provide strong growth in future. The Synthes deal should continue driving results.
Forest Labs ( FRX ), another Zacks Rank #2 stock, is doing well with first quarter fiscal 2014 results beating expectations. The company has launched several new products over the past few quarters and continues to make impressive progress with its pipeline.
In the biotech space, we are positive on Biogen ( BIIB ). Tecfidera, the company's recently launched oral multiple sclerosis drug, is off to a strong start with launch quarter sales coming in at $192 million (including inventory stocking of $82 million). While Tecfidera has the potential to gain the top spot in the oral multiple sclerosis market, Avonex and Tysabri should continue contributing significantly to sales. Biogen is also progressing with its hemophilia pipeline.
We are also positive on Amgen ( AMGN ). Amgen should be able to deliver on its long-term strategy based on expansion in key markets, launch of new manufacturing technologies, and pipeline development. Enbrel should continue performing well. Amgen's late-stage pipeline is also moving along. While Amgen is a Zacks Rank #2 stock, Biogen is a Zacks Rank #3 (Hold) stock. Gilead, another Zacks Rank #2 stock, continues to do well in the HIV segment and is also progressing with its HCV pipeline.
Medivation ( MDVN ), a Zacks Rank #1 (Strong Buy) company, should continue delivering with its prostate cancer therapy, Xtandi, performing well. Based on the data we have seen so far, we believe Xtandi has blockbuster potential. It is currently in several studies including for the pre-chemo setting. Expansion into the pre-chemo setting would be a major positive for Medivation.
Among generic companies, Actavis ( ACT ) looks well-positioned. We view the acquisition of Actavis Group as a smart strategic move and we believe the company will be able to achieve its guidance easily. We are also positive on the upcoming acquisition of Warner Chilcott (WCRX), which makes strategic and financial sense. With fewer major patent expiries slated to occur in the next few years, we are encouraged by Actavis' focus on building its branded and biosimilars pipeline. The company carries a Zacks Rank #3.
WEAKNESSES
We recommend avoiding names that offer little growth or opportunity for a take-out. These include companies which are developing drugs that are likely to face regulatory hurdles. The FDA has been exercising more caution in granting approval to new products and several candidates are facing delays in receiving final approval.
Bristol-Myers Squibb ( BMY ) currently carries a Zacks Rank #5 (Strong Sell). While the company's second quarter results were in-line with expectations, Bristol-Myers cut its outlook for 2013 reflecting negative currency movement and the recall of Fervex, a local over-the-counter (OTC) product in France and other international markets. Moreover, Eliquis' performance has been disappointing.
The Medicines Company ( MDCO ) also carries a Zacks Rank #5. Earnings estimates for this company have been declining with third quarter results expected to remain flat on a sequential basis.
Other companies that currently carry a Zacks Rank #4 (Sell) include Novo Nordisk ( NVO ), Novartis ( NVS ), Dendreon Corp. ( DNDN ) and XOMA Corporation ( XOMA ), among others.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report ONYX PHARMA INC (ONXX): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report WARNER CHIL PLC (WCRX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Major blockbuster drugs like Merck's ( MRK ) Singulair, Pfizer's ( PFE ) Lipitor, Forest Laboratories' ( FRX ) Lexapro, Sanofi / Bristol-Myers Squibbs' ( SNT / BMY ) Plavix and Eli Lilly's ( LLY ) Zyprexa lost patent protection in the last few quarters. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report ONYX PHARMA INC (ONXX): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report WARNER CHIL PLC (WCRX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Major blockbuster drugs like Merck's ( MRK ) Singulair, Pfizer's ( PFE ) Lipitor, Forest Laboratories' ( FRX ) Lexapro, Sanofi / Bristol-Myers Squibbs' ( SNT / BMY ) Plavix and Eli Lilly's ( LLY ) Zyprexa lost patent protection in the last few quarters. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report ONYX PHARMA INC (ONXX): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report WARNER CHIL PLC (WCRX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. Zacks Industry Rank Within the Zacks Industry classification, pharma and biotech are broadly grouped into the Medical sector (one of 16 Zacks sectors) and further sub-divided into four industries at the expanded level: large-cap pharma, med-biomed/gene, med-drugs and med-generic drugs. | Abbott Labs ( ABT ) split into two separate publicly traded companies; while one company deals in diversified medical products, the other, AbbVie ( ABBV ), is focusing on research-based pharmaceuticals. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ACTAVIS INC (ACT): Free Stock Analysis Report ALEXION PHARMA (ALXN): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ASTRAZENECA PLC (AZN): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report FOREST LABS A (FRX): Free Stock Analysis Report GLAXOSMITHKLINE (GSK): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report MEDIVATION INC (MDVN): Free Stock Analysis Report MERCK & CO INC (MRK): Free Stock Analysis Report MYLAN INC (MYL): Free Stock Analysis Report ONYX PHARMA INC (ONXX): Free Stock Analysis Report PFIZER INC (PFE): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANOFI-AVENTIS (SNY): Free Stock Analysis Report WARNER CHIL PLC (WCRX): Free Stock Analysis Report DENTSPLY INTL (XRAY): Free Stock Analysis Report ZOETIS INC (ZTS): Free Stock Analysis Report To read this article on Zacks.com click here. 2Q Earnings So far, 51.1% of the companies falling under the Medical sector have reported second quarter 2013 results. |
27583.0 | 2013-07-26 00:00:00 UTC | Strong 1H13 at Roche, View Backed - Analyst Blog | ABBV | https://www.nasdaq.com/articles/strong-1h13-at-roche-view-backed-analyst-blog-2013-07-26 | nan | nan | Roche Holdings Ltd.'s ( RHHBY ) core earnings came in at $2.02 per American Depositary Receipt (ADR) in the first half of 2013, compared with $1.85 per ADR reported in the year-ago period.
All growth rates mentioned below are on a year-over-year basis and at constant exchange rates.
Roche's revenues in the first half of 2013 grew 5% from the year-ago period to CHF 23.3 billion, driven by solid demand for its cancer drugs and increased sales of diagnostic tests to clinical laboratories.
Half-Year Details
Roche reports business in two divisions: Pharmaceuticals and Diagnostics.
Sales of the Pharmaceuticals division increased 6% to CHF 18.2 billion, driven by strong sales of Avastin (+12%) and MabThera/Rituxan (+3%) along with solid uptake from the HER2 franchise (+11%). The sharp rise in Avastin sales was due to its increased demand in the ovarian and colorectal cancer indications.
We note that HER2 franchise includes Herceptin and recently launched drugs like Perjeta and Kadcyla.
Roche launched Kadcyla in the U.S. in Feb 2013 while Perjeta obtained approval in the European Union in Mar 2013. Perjeta was launched in the U.S. in Jun 2012.
Sales of rheumatoid arthritis (RA) drug Actemra/RoActemra were up 33%.
Lucentis, indicated for wet age-related macular degeneration (AMD), was up 9%. Moreover, strong sales of Tamiflu (+79%) due to a severe flu season in North America further boosted sales.
However, sales of drugs such as Pegasys (indicated for hepatitis B and hepatitis C) declined 20% due to the expected launch of triple-combination and interferon-free therapies by 2013 end/ early 2014.
Revenues from the Diagnostics division went up 3% to CHF 5.1 billion driven by solid performance of the professional diagnostics (+6%) unit. Tissue diagnostics (+6%) also performed impressively in the first half. However, diabetes care was down 5% due to reimbursement cuts in major markets and intensified pricing pressure.
2013 Outlook Backed
Roche continues to expect sales in 2013 to increase in line with 2012 growth rates. Roche expects core earnings per share to grow at a higher rate than sales in 2013. Roche expects to further increase its dividend in 2013.
Pipeline Update
We remind investors that Roche has stopped developing aleglitazar due to safety signals and lack of efficacy following a regular safety review. Roche was developing the candidate to treat acute coronary syndrome (ACS) in patients suffering from type II diabetes.
Nevertheless, traction in the company's hematology franchise was encouraging with positive data on obinutuzumab (GA101) and RG760, which are being developed to treat non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
GA101 was recently accepted by the U.S. Food and Drug Administration (FDA) for priority review and an approval is expected by end Dec 2013. The candidate has also been filed for approval in Europe.
Meanwhile, Roche plans to move RG7601, which is being developed in collaboration with AbbVie, Inc. ( ABBV ) into late-stage development after reporting positive phase I data in Jun 2013.
Additionally, Roche is moving ahead with its novel non-small cell lung cancer candidate RG7446 following promising phase I results.
Roche is also seeking FDA approval for the use of Perjeta regimen before surgery (neoadjuvant treatment) in HER2+ early-stage breast cancer patients.
Our Take
Given the solid performance in the first half of 2013, we believe the company is likely to achieve its annual targets.
Roche currently carries a Zacks Rank #3 (Hold). Right now, Jazz Pharmaceuticals ( JAZZ ) and Johnson & Johnson ( JNJ ) look attractive. While Jazz Pharma carries a Zacks Rank #1 (Strong Buy), Johnson & Johnson carries a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Meanwhile, Roche plans to move RG7601, which is being developed in collaboration with AbbVie, Inc. ( ABBV ) into late-stage development after reporting positive phase I data in Jun 2013. ABBVIE INC (ABBV): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. Roche's revenues in the first half of 2013 grew 5% from the year-ago period to CHF 23.3 billion, driven by solid demand for its cancer drugs and increased sales of diagnostic tests to clinical laboratories. | ABBVIE INC (ABBV): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. Meanwhile, Roche plans to move RG7601, which is being developed in collaboration with AbbVie, Inc. ( ABBV ) into late-stage development after reporting positive phase I data in Jun 2013. Roche's revenues in the first half of 2013 grew 5% from the year-ago period to CHF 23.3 billion, driven by solid demand for its cancer drugs and increased sales of diagnostic tests to clinical laboratories. | ABBVIE INC (ABBV): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. Meanwhile, Roche plans to move RG7601, which is being developed in collaboration with AbbVie, Inc. ( ABBV ) into late-stage development after reporting positive phase I data in Jun 2013. Roche's revenues in the first half of 2013 grew 5% from the year-ago period to CHF 23.3 billion, driven by solid demand for its cancer drugs and increased sales of diagnostic tests to clinical laboratories. | Meanwhile, Roche plans to move RG7601, which is being developed in collaboration with AbbVie, Inc. ( ABBV ) into late-stage development after reporting positive phase I data in Jun 2013. ABBVIE INC (ABBV): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. Roche's revenues in the first half of 2013 grew 5% from the year-ago period to CHF 23.3 billion, driven by solid demand for its cancer drugs and increased sales of diagnostic tests to clinical laboratories. |
27584.0 | 2013-07-26 00:00:00 UTC | AbbVie Beats on Earnings & Revs in Q2 - Analyst Blog | ABBV | https://www.nasdaq.com/articles/abbvie-beats-on-earnings-revs-in-q2-analyst-blog-2013-07-26 | nan | nan | AbbVie ( ABBV ) reported second quarter 2013 earnings of 82 cents per share, beating the Zacks Consensus Estimate of 79 cents. Revenues increased 4.4% to $4.692 billion in the second quarter of 2013, above the Zacks Consensus Estimate of $4.492 billion. Currency movement negatively impacted revenues by 0.7%.
Including one-time items, second quarter 2013 earnings came in at 66 cents per share, down 17.5%.
The Quarter in Detail
Key drug, Humira, recorded growth of 12.1% with revenues coming in at $2.606 billion. U.S. sales increased 16% ($1.224 billion) due to strong performance in the dermatology and gastroenterology segments. Revenues also benefited from the global launch of Humira for the ulcerative colitis indication. Ex- U.S. sales increased 8.8% to $1.382 billion. TriCor/Trilipix revenues fell 65.6% to $107 million.
Other products that performed well included Synthroid (up 24.4% to $153 million), Creon (up 20.5% to $106 million), Zemplar (up 12.6% to $107 million) and Duodopa (up 25.7% to $44 million).
AbbVie said that adjusted SG&A was 27.9% of sales in the second quarter - this reflects the company's investment in its growth brands.
Adjusted R&D was 14.8% of second quarter 2013 sales, reflecting the company's investment in its mid- and late-stage pipeline as well its efforts to expand Humira's label.
AbbVie's pipeline represents significant potential - earlier this year, the company had said that it is targeting 15 regulatory approvals between 2013 and 2017. The company's late-stage pipeline includes several compounds or indications in phase III development targeting therapeutic areas like hepatitis C, immunology, multiple sclerosis and endometriosis.
Phase III results on the company's triple direct-acting antivirals (DAAs) plus ribavirin regimen for the treatment of hepatitis C virus (HCV) infection should start coming out later this year.
Outlook Revised
Based on its strong performance in the first half of 2013, AbbVie raised the lower end of its 2013 earnings outlook. The company now expects earnings in the range of $3.07 to $3.13 per share (old guidance: $3.03 to $3.13 per share). The Zacks Consensus Estimate of $3.12 is towards the higher end of the guidance range.
Our Take
We believe AbbVie is poised for strong growth. Humira should continue driving sales thanks to factors like additional indications, increasing penetration, geographic expansion, and share gains. New indications could boost peak sales potential for Humira by another $1.5 billion.
2013 and 2014 represent a transition period for the company which is facing generic competition for its lipid franchise - TriCor, TriLipix and Niaspan.
AbbVie currently carries a Zacks Rank #3 (Hold). While we are positive on AbbVie's strong late-stage pipeline, dividend yield and growth strategy, we remain concerned about its dependence on Humira. We believe AbbVie will continue pursuing in-licensing deals and collaborations to boost its pipeline.
Companies that currently look attractive include Johnson & Johnson ( JNJ ), Actelion ( ALIOF ) and Jazz Pharmaceuticals ( JAZZ ). While Actelion and Jazz are Zacks Rank #1 (Strong Buy) stocks, Johnson & Johnson is a Zacks Rank #2 (Buy) stock.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie ( ABBV ) reported second quarter 2013 earnings of 82 cents per share, beating the Zacks Consensus Estimate of 79 cents. AbbVie said that adjusted SG&A was 27.9% of sales in the second quarter - this reflects the company's investment in its growth brands. AbbVie's pipeline represents significant potential - earlier this year, the company had said that it is targeting 15 regulatory approvals between 2013 and 2017. | ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie ( ABBV ) reported second quarter 2013 earnings of 82 cents per share, beating the Zacks Consensus Estimate of 79 cents. AbbVie said that adjusted SG&A was 27.9% of sales in the second quarter - this reflects the company's investment in its growth brands. | AbbVie ( ABBV ) reported second quarter 2013 earnings of 82 cents per share, beating the Zacks Consensus Estimate of 79 cents. ABBVIE INC (ABBV): Free Stock Analysis Report ACTELION LTD (ALIOF): Get Free Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie said that adjusted SG&A was 27.9% of sales in the second quarter - this reflects the company's investment in its growth brands. | AbbVie ( ABBV ) reported second quarter 2013 earnings of 82 cents per share, beating the Zacks Consensus Estimate of 79 cents. AbbVie said that adjusted SG&A was 27.9% of sales in the second quarter - this reflects the company's investment in its growth brands. AbbVie's pipeline represents significant potential - earlier this year, the company had said that it is targeting 15 regulatory approvals between 2013 and 2017. |
27585.0 | 2013-07-09 00:00:00 UTC | Positive Data for Novartis' Candidate - Analyst Blog | ABBV | https://www.nasdaq.com/articles/positive-data-for-novartis-candidate-analyst-blog-2013-07-09 | nan | nan | Novartis ( NVS ) recently announced encouraging top-line data from a phase III study, FIXTURE (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis), on psoriasis candidate, secukinumab (AIN457).
In the randomized, double-blind, placebo-controlled study (n =1,307), secukinumab was evaluated for efficacy in patients suffering from moderate-to-severe plaque psoriasis. It was observed in the study that secukinumab was more effective in clearing skin than Amgen's ( AMGN ) Enbrel.
The study met primary as well as secondary endpoints. The safety profile of secukinumab was consistent with previously reported results from phase II studies in moderate-to-severe plaque psoriasis.
Secukinumab is one of the most promising pipeline candidates at Novartis - we are encouraged by the results and look forward to detailed results that will be presented later this year. Novartis also remains on track to file for approval this year.
We note that secukinumab is also being evaluated for other indications like psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis among others. The phase III studies for these indications are ongoing with results expected in 2014.
Additionally, secukinumab is in phase II studies for the treatment of multiple sclerosis.
Secukinumab is the first anti IL-17A on which phase III results have been presented. We note that Amgen has an anti IL-17 candidate, brodalumab, in its pipeline. Brodalumab is currently in phase III studies for the psoriasis indication.
Meanwhile, currently approved products include AbbVie's ( ABBV ) Humira among others.
Novartis currently carries a Zacks Rank #3 (Hold). Right now, Valeant Pharmaceuticals ( VRX ) looks well placed with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Meanwhile, currently approved products include AbbVie's ( ABBV ) Humira among others. ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report VALEANT PHARMA (VRX): Free Stock Analysis Report To read this article on Zacks.com click here. Novartis ( NVS ) recently announced encouraging top-line data from a phase III study, FIXTURE (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis), on psoriasis candidate, secukinumab (AIN457). | ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report VALEANT PHARMA (VRX): Free Stock Analysis Report To read this article on Zacks.com click here. Meanwhile, currently approved products include AbbVie's ( ABBV ) Humira among others. The safety profile of secukinumab was consistent with previously reported results from phase II studies in moderate-to-severe plaque psoriasis. | ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report VALEANT PHARMA (VRX): Free Stock Analysis Report To read this article on Zacks.com click here. Meanwhile, currently approved products include AbbVie's ( ABBV ) Humira among others. Novartis ( NVS ) recently announced encouraging top-line data from a phase III study, FIXTURE (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis), on psoriasis candidate, secukinumab (AIN457). | Meanwhile, currently approved products include AbbVie's ( ABBV ) Humira among others. ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report NOVARTIS AG-ADR (NVS): Free Stock Analysis Report VALEANT PHARMA (VRX): Free Stock Analysis Report To read this article on Zacks.com click here. The safety profile of secukinumab was consistent with previously reported results from phase II studies in moderate-to-severe plaque psoriasis. |
27586.0 | 2013-07-05 00:00:00 UTC | Priority Review for Roche Candidate - Analyst Blog | ABBV | https://www.nasdaq.com/articles/priority-review-for-roche-candidate-analyst-blog-2013-07-05 | nan | nan | Roche ( RHHBY )'s Biologics License Application (BLA) for oncology candidate obinutuzumab (GA101) was recently accepted by the US Food and Drug Administration (FDA) for priority review.
The company is looking to get obinutuzumab approved for the treatment of patients suffering from chronic lymphocytic leukemia (CLL).
The application was primarily based on final stage 1 data from a phase III trial, CLL11 wherein it was observed that obinutuzumab plus chlorambucil achieved a statistically significant reduction of 86% in the risk of disease worsening or death.
The study was being conducted to evaluate the efficacy and safety of obinutuzumab plus chlorambucil (standard chemotherapy) or Roche's MabThera/Rituxan plus chlorambucil vis-à-vis only chlorambucil in patients suffering from CLL.
A final decision is expected by Dec 20, 2013. We note that the FDA granted 'Breakthrough Therapy Designation' to obinutuzumab in May 2013 following the release of positive data from the CLL11 trial.
This designation should speed up the development and review of the candidate. Roche is also looking to get the candidate approved in the EU where a marketing application was submitted to the European Medicines Agency (EMA) in Apr 2013.
The successful development of obinutuzumab would help Roche replace revenues that may be lost to biosimilar versions of Rituxan once they enter the market.
We note that companies like Amgen ( AMGN ) are working on biosimilar versions of Rituxan.
Rituxan is approved for the treatment of CLL. Rituxan was one of the best selling drugs for Roche in 2012 with sales of CHF 6.7 billion, up 9% year over year.
We remind investors that Roche has another pipeline candidate, RG7601, which is being developed for the treatment of relapsed/refractory (R/R) CLL and R/R non-Hodgkin lymphoma (NHL) in collaboration with AbbVie ( ABBV ).
We are encouraged by the recent pipeline progress at Roche.
Roche currently carries a Zacks Rank #4 (Sell). Right now, Novo Nordisk ( NVO ) looks attractive with a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We remind investors that Roche has another pipeline candidate, RG7601, which is being developed for the treatment of relapsed/refractory (R/R) CLL and R/R non-Hodgkin lymphoma (NHL) in collaboration with AbbVie ( ABBV ). ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report NOVO-NORDISK AS (NVO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. Roche ( RHHBY )'s Biologics License Application (BLA) for oncology candidate obinutuzumab (GA101) was recently accepted by the US Food and Drug Administration (FDA) for priority review. | ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report NOVO-NORDISK AS (NVO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. We remind investors that Roche has another pipeline candidate, RG7601, which is being developed for the treatment of relapsed/refractory (R/R) CLL and R/R non-Hodgkin lymphoma (NHL) in collaboration with AbbVie ( ABBV ). Zacks Investment Research The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report NOVO-NORDISK AS (NVO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. We remind investors that Roche has another pipeline candidate, RG7601, which is being developed for the treatment of relapsed/refractory (R/R) CLL and R/R non-Hodgkin lymphoma (NHL) in collaboration with AbbVie ( ABBV ). Roche ( RHHBY )'s Biologics License Application (BLA) for oncology candidate obinutuzumab (GA101) was recently accepted by the US Food and Drug Administration (FDA) for priority review. | We remind investors that Roche has another pipeline candidate, RG7601, which is being developed for the treatment of relapsed/refractory (R/R) CLL and R/R non-Hodgkin lymphoma (NHL) in collaboration with AbbVie ( ABBV ). ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report NOVO-NORDISK AS (NVO): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report To read this article on Zacks.com click here. We note that companies like Amgen ( AMGN ) are working on biosimilar versions of Rituxan. |
27587.0 | 2013-06-14 00:00:00 UTC | Positive Data on Incyte/LLY's Baricitinib - Analyst Blog | ABBV | https://www.nasdaq.com/articles/positive-data-on-incyte-llys-baricitinib-analyst-blog-2013-06-14 | nan | nan | Incyte Corporation ( INCY ) and partner Eli Lilly and Company ( LLY ) recently announced positive results from the open-label, long-term extension of the phase IIb JADA study on their pipeline candidate, baricitinib.
Baricitinib (formerly LY3009104) is being developed for the treatment of patients suffering from certain autoimmune conditions, including rheumatoid arthritis (RA). The study evaluated the efficacy and safety of baricitinib in the patients for up to 52 weeks across to two doses (4 mg and 8 mg).
Incyte and Eli Lilly earlier reported encouraging data from the 12-week portion of the study. Results from the 12-week study revealed that patients on baricitinib showed significant improvements in in ACR20, ACR50 and ACR70 responses when compared to patients on placebo. Incyte also stated that these improvements were either sustained or improved during an additional 12 weeks of blinded treatment.
Moreover, the clinical improvements observed at week 24 were maintained through 52 weeks in RA patients. For example, 74% patients treated with baricitinib achieved at least 20% reduction in the disease symptoms at 24 weeks and 71% achieved similar response at 52 weeks. The measure is known as American College of Rheumatology (ACR) 20. ACR50 and ACR70 scores were also found to be comparable at 24-weeks and 52 weeks of treatment by the candidate.
The open-label extension study also revealed that safety signals like treatment-emergent adverse events, serious adverse events, infections and serious infections remained consistent with the previous studies of baricitinib. Meanwhile, the 8 mg group of the study reported a death due to a suspected myocardial infarction. We note that out of the 201 patients, 184 completed 52-weeks of therapy in the study. The JADA study is still continuing with patients receiving with only the 4 mg version of the candidate.
However, competition is stiff in the RA market given the presence of treatments like AbbVie Inc. 's( ABBV ) Humira among others.
Incyte and Eli Lilly are also developing baricitinib for the treatment of psoriasis and diabetic nephropathy.
Incyte, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Another biopharma stock, Jazz Pharmaceuticals Public Limited Company ( JAZZ ), currently looks better positioned with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | However, competition is stiff in the RA market given the presence of treatments like AbbVie Inc. 's( ABBV ) Humira among others. ABBVIE INC (ABBV): Free Stock Analysis Report INCYTE CORP (INCY): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report To read this article on Zacks.com click here. Incyte Corporation ( INCY ) and partner Eli Lilly and Company ( LLY ) recently announced positive results from the open-label, long-term extension of the phase IIb JADA study on their pipeline candidate, baricitinib. | ABBVIE INC (ABBV): Free Stock Analysis Report INCYTE CORP (INCY): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report To read this article on Zacks.com click here. However, competition is stiff in the RA market given the presence of treatments like AbbVie Inc. 's( ABBV ) Humira among others. Incyte Corporation ( INCY ) and partner Eli Lilly and Company ( LLY ) recently announced positive results from the open-label, long-term extension of the phase IIb JADA study on their pipeline candidate, baricitinib. | ABBVIE INC (ABBV): Free Stock Analysis Report INCYTE CORP (INCY): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report To read this article on Zacks.com click here. However, competition is stiff in the RA market given the presence of treatments like AbbVie Inc. 's( ABBV ) Humira among others. Incyte Corporation ( INCY ) and partner Eli Lilly and Company ( LLY ) recently announced positive results from the open-label, long-term extension of the phase IIb JADA study on their pipeline candidate, baricitinib. | However, competition is stiff in the RA market given the presence of treatments like AbbVie Inc. 's( ABBV ) Humira among others. ABBVIE INC (ABBV): Free Stock Analysis Report INCYTE CORP (INCY): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report LILLY ELI & CO (LLY): Free Stock Analysis Report To read this article on Zacks.com click here. Incyte Corporation ( INCY ) and partner Eli Lilly and Company ( LLY ) recently announced positive results from the open-label, long-term extension of the phase IIb JADA study on their pipeline candidate, baricitinib. |
27588.0 | 2013-06-14 00:00:00 UTC | Abbott Progresses with Absorb in Japan - Analyst Blog | ABBV | https://www.nasdaq.com/articles/abbott-progresses-with-absorb-in-japan-analyst-blog-2013-06-14 | nan | nan | Abbott Labs ( ABT ) recently announced that it has initiated a randomized controlled study in Japan to evaluate Absorb, its bioresorbable vascular scaffold (BVS) device, in patients suffering from coronary artery disease (CAD).
About 400 patients will be enrolled in the study, ABSORB Japan, that will compare Absorb BVS to the company's Xience family of metallic drug eluting stents. The primary endpoint of the study is target lesion failure (TLF) in the first year, which will test both the safety and efficacy of the device.
Moreover, the trial includes state-of-the-art imaging techniques which will help to study the impact of treatment with Absorb in the blood vessel.
Abbott Labs expects to use results from this trial to support regulatory filings with the Japanese Pharmaceutical and Medical Devices Agency (PMDA) for gaining approval for the device. We note that Absorb obtained CE mark in Europe. However, it is not approved in the US yet.
The vascular business is a core part of Abbott Labs' product portfolio and generated sales of $742 million in the first quarter of 2013, down 7.7% from the year-ago period. Of the total vascular sales, approximately $387 million came from the sale of drug-eluting stents and the BVS product portfolio.
Abbott Labs is continuously working to boost its vascular products portfolio and expects to launch several products in the next five years. The launch of new products should help the company to combat the decline in vascular sales due to pricing pressure, in our view.
We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ( ABBV ), in Jan 2013.
The business environment continues to be challenging in 2013 due to austerity measures undertaken by developed markets and weak economic conditions elsewhere. We believe Abbott Labs' diversification in varied business lines will enable the company to counter the challenging business environment and maintain top-line growth.
Abbott Labs currently carries a Zacks Rank #3 (Hold). Right now, AtriCure, Inc. ( ATRC ) and Baxano Surgical, Inc . ( BAXS ) look well placed. Both carry a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ATRICURE INC (ATRC): Free Stock Analysis Report BAXANO SURGICAL (BAXS): Free Stock Analysis Report To read this article on Zacks.com click here. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ATRICURE INC (ATRC): Free Stock Analysis Report BAXANO SURGICAL (BAXS): Free Stock Analysis Report To read this article on Zacks.com click here. We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ( ABBV ), in Jan 2013. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ATRICURE INC (ATRC): Free Stock Analysis Report BAXANO SURGICAL (BAXS): Free Stock Analysis Report To read this article on Zacks.com click here. ( ABBV ), in Jan 2013. | We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc . ( ABBV ), in Jan 2013. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ATRICURE INC (ATRC): Free Stock Analysis Report BAXANO SURGICAL (BAXS): Free Stock Analysis Report To read this article on Zacks.com click here. |
27589.0 | 2013-06-14 00:00:00 UTC | New Data on UCB's Cimzia - Analyst Blog | ABBV | https://www.nasdaq.com/articles/new-data-on-ucbs-cimzia-analyst-blog-2013-06-14 | nan | nan | UCB ( UCBJF ) recently presented new data from the RAPID-PsA study and RAPID-axSpA study on Cimzia. The data was presented at the European League Against Rheumatism (EULAR) Congress.
According to the recent findings, active psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA) patients treated with Cimzia showed improvements in pain, fatigue and health-related quality of life. Cimzia-treated PsA and axSpA patients have shown better workplace and household productivity, as well as more participation in social and daily activities as compared to those being administered placebo.
Similar observations were seen in ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA) patients treated with Cimzia.
Cimzia is currently approved for Crohn's disease and rheumatoid arthritis. Cimzia sales increased 27% year over year in the first quarter of 2013.
In Feb 2013, UCB filed with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for two additional indications - PsA and axSpA. These regulatory filings were based on the phase III RAPID-PsA and RAPID-axSpA studies.
RAPID-PsA was a double-blind, placebo-controlled, phase III study which showed improvements in the signs and symptoms of PsA compared to placebo in adult patients with or without prior anti-TNF (tumor necrosis factor) exposure.
RAPID-axSpA was a randomized, double-blind, placebo-controlled, phase III study which showed that both dosing regimens of Cimzia reduced the signs and symptoms of axSpA as compared to placebo.
Currently, the psoriatic arthritis market has drugs like AbbVie Inc. 's ( ABBV ) Humira and Johnson & Johnson 's ( JNJ ) Simponi among others.
UCB carries a Zacks Rank #3 (Hold). However, Santarus, Inc. ( SNTS ) looks more attractive with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Currently, the psoriatic arthritis market has drugs like AbbVie Inc. 's ( ABBV ) Humira and Johnson & Johnson 's ( JNJ ) Simponi among others. ABBVIE INC (ABBV): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. In Feb 2013, UCB filed with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for two additional indications - PsA and axSpA. | ABBVIE INC (ABBV): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. Currently, the psoriatic arthritis market has drugs like AbbVie Inc. 's ( ABBV ) Humira and Johnson & Johnson 's ( JNJ ) Simponi among others. According to the recent findings, active psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA) patients treated with Cimzia showed improvements in pain, fatigue and health-related quality of life. | ABBVIE INC (ABBV): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. Currently, the psoriatic arthritis market has drugs like AbbVie Inc. 's ( ABBV ) Humira and Johnson & Johnson 's ( JNJ ) Simponi among others. According to the recent findings, active psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA) patients treated with Cimzia showed improvements in pain, fatigue and health-related quality of life. | Currently, the psoriatic arthritis market has drugs like AbbVie Inc. 's ( ABBV ) Humira and Johnson & Johnson 's ( JNJ ) Simponi among others. ABBVIE INC (ABBV): Free Stock Analysis Report JOHNSON & JOHNS (JNJ): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. UCB ( UCBJF ) recently presented new data from the RAPID-PsA study and RAPID-axSpA study on Cimzia. |
27590.0 | 2013-06-13 00:00:00 UTC | Encouraging Data from Bristol-Myers - Analyst Blog | ABBV | https://www.nasdaq.com/articles/encouraging-data-from-bristol-myers-analyst-blog-2013-06-13 | nan | nan | Bristol-Myers Squibb Company ( BMY ) recently presented encouraging long-term data from a phase IIIb study (AMPLE: n=646) on its rheumatoid arthritis (RA) candidate Orencia. Results were presented at the annual meeting of the European Congress of Rheumatology held in Spain.
The study evaluated the subcutaneous version of Orencia in combination with methotrexate versus AbbVie Inc. 's ( ABBV ) Humira (also combined with methotrexate) over two years in biologic naïve patients suffering from moderate-to-severe RA. The US Food and Drug Administration cleared the subcutaneous formulation of Orencia in 2011. Only the intravenous version was available prior to that.
According to the AMPLE study, treatment with Orencia was found to be as effective as AbbVie's RA therapy. Data from the second year of the study was found to be non-inferior to the results obtained in the first year. We note that in the first year, the study met its primary endpoint as measured by non-inferiority of atleast 20% reduction in the disease symptoms. The measure is known as American College of Rheumatology (ACR) 20.
Moreover, 85% patients in the Orencia arm achieved radiographic non-progression at 2 years compared to 84% in the Humira arm. Furthermore, the overall safety profile was also found to be consistent across both cohorts.
We note that Orencia is marketed for treating adults suffering from moderate-to-severe RA, who have responded inadequately to one or more available therapies for the disease. Approval as a first-line therapy would boost Bristol-Myers' top line further.
We believe that the encouraging long-term data on Orencia is good news for Bristol-Myers, which is looking to combat the loss of revenues due to the genericization of Plavix by introducing new products and signing deals/making acquisitions. Moreover, the threat of genericization looms over many other key drugs at Bristol-Myers.
Bristol-Myers carries a Zacks Rank # 3 (Hold). Companies such as Biogen Idec Inc. ( BIIB ) and Jazz Pharmaceuticals Public Limited Company ( JAZZ ) appear to be favorably placed with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | The study evaluated the subcutaneous version of Orencia in combination with methotrexate versus AbbVie Inc. 's ( ABBV ) Humira (also combined with methotrexate) over two years in biologic naïve patients suffering from moderate-to-severe RA. According to the AMPLE study, treatment with Orencia was found to be as effective as AbbVie's RA therapy. ABBVIE INC (ABBV): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report To read this article on Zacks.com click here. | The study evaluated the subcutaneous version of Orencia in combination with methotrexate versus AbbVie Inc. 's ( ABBV ) Humira (also combined with methotrexate) over two years in biologic naïve patients suffering from moderate-to-severe RA. ABBVIE INC (ABBV): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report To read this article on Zacks.com click here. According to the AMPLE study, treatment with Orencia was found to be as effective as AbbVie's RA therapy. | The study evaluated the subcutaneous version of Orencia in combination with methotrexate versus AbbVie Inc. 's ( ABBV ) Humira (also combined with methotrexate) over two years in biologic naïve patients suffering from moderate-to-severe RA. ABBVIE INC (ABBV): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report To read this article on Zacks.com click here. According to the AMPLE study, treatment with Orencia was found to be as effective as AbbVie's RA therapy. | According to the AMPLE study, treatment with Orencia was found to be as effective as AbbVie's RA therapy. The study evaluated the subcutaneous version of Orencia in combination with methotrexate versus AbbVie Inc. 's ( ABBV ) Humira (also combined with methotrexate) over two years in biologic naïve patients suffering from moderate-to-severe RA. ABBVIE INC (ABBV): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report To read this article on Zacks.com click here. |
27591.0 | 2013-06-12 00:00:00 UTC | Label Expansion for Roche's RoActemra - Analyst Blog | ABBV | https://www.nasdaq.com/articles/label-expansion-for-roches-roactemra-analyst-blog-2013-06-12 | nan | nan | Roche ( RHHBY ) recently announced that it obtained European Medicines Agency (EMA) approval for the label expansion of its rheumatoid arthritis (RA) drug RoActemra.
RoActemra is now approved for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in patients (aged two years or more) who have responded inadequately to previous treatment with methotrexate (MTX).
The EMA approved the use of the drug as a monotherapy or in combination with MTX.
Approval was expected as Roche had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Apr 2013 for the PJIA indication.
The EMA approval was based on encouraging results from the phase III CHERISH study in children suffering from PJIA. Data from the study revealed that patients treated with RoActemra experienced clinically meaningful improvement in signs and symptoms of PJIA.
We note that RoActemra is marketed as Actemra in the US. In Apr 2013, the US Food and Drug Administration (FDA) approved Actemra for the treatment of PJIA.
Actemra was approved in 2012 in the US for moderate-to-severe RA in adults, who did not respond adequately to one or more disease-modifying antirheumatic drugs (DMARD).
Actemra was also approved in the US and EU in Apr 2011 and Aug 2011, respectively, for the treatment of patients (aged two and above) suffering from active systemic juvenile idiopathic arthritis (sJIA).
We are encouraged with Roche's efforts to expand Actemra's label. In May 2013, Roche launched the subcutaneous injection formulation of Actemra in Japan and the subcutaneous version of the drug is currently under review in the US and the EU.
The intravenous version of Actemra is available in Japan since Jun 2005 and Actemra is also approved in Japan for PJIA and sJIA.
However, competition is stiff in the RA market given the presence of treatments like UCB's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira among others.
Roche currently carries a Zack Rank #3 (Hold). Right now, Santarus, Inc. ( SNTS ) appears to be well placed with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | However, competition is stiff in the RA market given the presence of treatments like UCB's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira among others. ABBVIE INC (ABBV): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANTARUS INC (SNTS): Free Stock Analysis Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. Roche ( RHHBY ) recently announced that it obtained European Medicines Agency (EMA) approval for the label expansion of its rheumatoid arthritis (RA) drug RoActemra. | ABBVIE INC (ABBV): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANTARUS INC (SNTS): Free Stock Analysis Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. However, competition is stiff in the RA market given the presence of treatments like UCB's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira among others. RoActemra is now approved for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in patients (aged two years or more) who have responded inadequately to previous treatment with methotrexate (MTX). | ABBVIE INC (ABBV): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANTARUS INC (SNTS): Free Stock Analysis Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. However, competition is stiff in the RA market given the presence of treatments like UCB's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira among others. RoActemra is now approved for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in patients (aged two years or more) who have responded inadequately to previous treatment with methotrexate (MTX). | However, competition is stiff in the RA market given the presence of treatments like UCB's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira among others. ABBVIE INC (ABBV): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANTARUS INC (SNTS): Free Stock Analysis Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. In Apr 2013, the US Food and Drug Administration (FDA) approved Actemra for the treatment of PJIA. |
27592.0 | 2013-06-10 00:00:00 UTC | Pipeline Progress at Roche - Analyst Blog | ABBV | https://www.nasdaq.com/articles/pipeline-progress-at-roche-analyst-blog-2013-06-10 | nan | nan | Roche ( RHHBY ) recently released promising data on oncology candidate, RG7601 (GDC-0199/ABT-199), from a phase I study.
Roche is developing RG7601 for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) and R/R non-Hodgkin lymphoma (NHL) in collaboration with AbbVie ( ABBV ).
It was observed that RG7601 achieved an overall response rate of 84% in the CLL arm of the study (n=55) while a 53% overall response rate was observed among patients in the NHL arm of the study (n=32).
The US Food and Drug Administration (FDA) recently accepted Roche's/AbbVie's amended clinical trial protocols for studies on RG7601 in patients suffering from CLL.
Roche continues to work towards boosting its hematology franchise. We note that Roche already has Rituxan (MabThera) in its portfolio, approved for the treatment of CLL and NHL.
Rituxan was one of the best selling drugs for Roche in 2012 with sales of CHF 6.7 billion, up 9% year over year.
Additionally, Roche has obinutuzumab (GA101) in its pipeline, currently in phase III, for the treatment of CLL and NHL.
Roche announced positive data on obinutuzumab from a phase III study in May 2013. Roche has submitted marketing applications to regulatory authorities including the European Medicines Association (EMA) and the FDA.
The FDA has granted obinutuzumab 'Breakthrough Therapy Designation.'
We believe that the successful development of obinutuzumab and RG7601 will help Roche replace revenues that may be lost to biosimilar versions of Rituxan once they enter the market.
Companies like Amgen ( AMGN ) are working on biosimilar versions of Rituxan.
Roche currently carries a Zacks Rank #3 (Hold). Right now, Salix Pharmaceuticals ( SLXP ) looks attractive with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Roche is developing RG7601 for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) and R/R non-Hodgkin lymphoma (NHL) in collaboration with AbbVie ( ABBV ). The US Food and Drug Administration (FDA) recently accepted Roche's/AbbVie's amended clinical trial protocols for studies on RG7601 in patients suffering from CLL. ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SALIX PHARM-LTD (SLXP): Free Stock Analysis Report To read this article on Zacks.com click here. | ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SALIX PHARM-LTD (SLXP): Free Stock Analysis Report To read this article on Zacks.com click here. Roche is developing RG7601 for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) and R/R non-Hodgkin lymphoma (NHL) in collaboration with AbbVie ( ABBV ). The US Food and Drug Administration (FDA) recently accepted Roche's/AbbVie's amended clinical trial protocols for studies on RG7601 in patients suffering from CLL. | ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SALIX PHARM-LTD (SLXP): Free Stock Analysis Report To read this article on Zacks.com click here. Roche is developing RG7601 for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) and R/R non-Hodgkin lymphoma (NHL) in collaboration with AbbVie ( ABBV ). The US Food and Drug Administration (FDA) recently accepted Roche's/AbbVie's amended clinical trial protocols for studies on RG7601 in patients suffering from CLL. | The US Food and Drug Administration (FDA) recently accepted Roche's/AbbVie's amended clinical trial protocols for studies on RG7601 in patients suffering from CLL. Roche is developing RG7601 for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) and R/R non-Hodgkin lymphoma (NHL) in collaboration with AbbVie ( ABBV ). ABBVIE INC (ABBV): Free Stock Analysis Report AMGEN INC (AMGN): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SALIX PHARM-LTD (SLXP): Free Stock Analysis Report To read this article on Zacks.com click here. |
27593.0 | 2013-06-10 00:00:00 UTC | Warning: The Rebound May Be Over For Big Pharma | ABBV | https://www.nasdaq.com/articles/warning-rebound-may-be-over-big-pharma-2013-06-10 | nan | nan | As investors were picking up the pieces after the dot-com implosion, they came across another troubled sector.
A series of loomingpatent expirations on key drugs meant that major pharmaceutical companies were on the cusp of a decade-longsales drought. Investors responded by dumpingshares , as theAMEX PharmaceuticalIndex plunged from 400 in late 2001 to just 250 ayear later.
A decade later, Big Pharma's "patent cliff" was still a key concern, and this index remained far from its previous highs. Yet in recentquarters , Big Pharma has come back with a vengeance, as shares have moved back to the levels seen all those years ago.
Credit goes to severalfactors , most notably the absence of any new imminent blockbuster-drug patent expirations, and an industrywide focus on shareholder-friendly moves such as share buybacks anddividend hikes.
Ironically, the rising share prices have overwhelmed the impact of many of the dividend boosts.Stocks such as Merck ( MRK ) , Pfizer ( PFE ) and Bristol-Myers Squibb ( BMY ) have moved their dividend yields down from the 5% to 6% range to the 3% to 4% range.
To be sure, a rising tide has lifted all boats, as just about every major drug company has astock chart like the one you see above. Yet as we move ahead, a pair of factors may benefit only a select group of companies. Simplyput , many drug stocks have now seen their bestgains already take root, and investors should focus on stock-picking instead of just owning the sector.
TheAsset Unlock
Over the past few years, some of these companies have realized they are valuable on a sum-of-the-partsbasis and have moved to unlock the value of the various parts. In the past five years, three major spin-offs have occurred.
"All three of these were ultimately well received by themarket as it appears that the sum of the parts was greater than the whole in all cases," saidanalysts at Jefferies Group.
For example, AbbVie ( ABBV ) has risen nearly 25% since it began trading at the start of the year. Shares of Zoetis ( ZTS ) haven't risen as robustly, but the deal was so hotly anticipated that theoffering price was boosted from $22 to $26 just before theIPO , enriching Pfizer's coffers in the process. Mead Johnson (MJN) , for its part, has risen roughly 200% since its February 2009 debut, more than twice thegain of the S&P 500 in that time.
Thanks to those gains, look for more value-enhancing spin-off announcements in the next year or two. Analysts at Jefferies looked at the business structures of all of the leading drugmakers and focused on companies that have the most diversifiedrevenue bases and are thus the likeliest candidates to pursue a spin-off. Looking at these companies on a sum-of-the-parts (SOTP) basis, the firm sees the biggestupside for:
Abbott, which still might spin out its nutrition, diagnostics and medical devices businesses, has 30% upside to its $48 SOTP assessment.
Germany's Bayer (BAYRY) , with a fast-growing crop sciences division, has 35% upside to the $145 SOTP value.
Novartis (NVS) might look to spin off its vaccines or animal health businesses and could unload its one-third stake in Roche Holding (RHHBY) . Such moves wouldyield 20% upside to Jefferies' $85 SOTP assessment.
Watch The Pipelines
The other key trend for Big Pharma is a shift away from patent expirations toward potential new blockbuster drug launches. Analysts have been scrubbing the drug pipelines at the major players and found that a few companies are poised for robust new drug launches over the next few years.
One of the big developments in drug research is the use of antibodies to boost the immune system against cancerous tumors. Several firms are testing drugs in clinical trials, and Bristol-Myers Squibb may be in a position to take a leading role by combining a pair of drugs, Nivolumab and Yervoy.
At the recent American Society of Clinical Oncology annual meeting, this drug combination "stole the show," according to Morgan Stanley's analysts, citing a high degree of rapid efficacy for the drug combo. The niche could represent a $2.5 billion annual revenue opportunity for Bristol-Myers by 2020, according to these analysts. Goldman Sachs concurs with thebullish view of Bristol-Myers citing "the best pipeline story of the group."
Analysts at Citigroup are partial to Novartis, thanks to a new drug platform called CART-19, which has the promise of treating a wide variety of cancers and might one day make up what Citi calls a "mega-blockbuster pipeline." Those analysts think CART-19 could be useful in fighting "refractory solid tumors (including ovarian and pancreas) as well as earlier-stage disease and non-oncologic indications, such as viral infections and autoimmune disease. These indications represent significant potential upside risk to our estimates."
Merrill Lynch analysts highlight Eli Lilly (LLY) as a top pick, noting that "Several promising late-stage pipeline assets are underappreciated, in our view, and could be transformative to Eli Lilly's growth trajectory." They see shares rising from a recent $52 to $65.
Risks to Consider: Big Pharma stocks have risen handily over the past 12 months, but the companies that lack pipeline ormerger andacquisition catalysts may be ripe for profit-taking, especially as they no longeroffer highly enticing yields and are poised for anemic growth in the years ahead.
Action to Take --> While investors scored with virtually all drug stocks in the past 12 months, only stocks with catalysts have a path to further upside. Novartis and Bristol-Myers Squibb appear to be best-positioned for further gains at this juncture.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | For example, AbbVie ( ABBV ) has risen nearly 25% since it began trading at the start of the year. Credit goes to severalfactors , most notably the absence of any new imminent blockbuster-drug patent expirations, and an industrywide focus on shareholder-friendly moves such as share buybacks anddividend hikes. Shares of Zoetis ( ZTS ) haven't risen as robustly, but the deal was so hotly anticipated that theoffering price was boosted from $22 to $26 just before theIPO , enriching Pfizer's coffers in the process. | For example, AbbVie ( ABBV ) has risen nearly 25% since it began trading at the start of the year. These indications represent significant potential upside risk to our estimates." Risks to Consider: Big Pharma stocks have risen handily over the past 12 months, but the companies that lack pipeline ormerger andacquisition catalysts may be ripe for profit-taking, especially as they no longeroffer highly enticing yields and are poised for anemic growth in the years ahead. | For example, AbbVie ( ABBV ) has risen nearly 25% since it began trading at the start of the year. Analysts have been scrubbing the drug pipelines at the major players and found that a few companies are poised for robust new drug launches over the next few years. At the recent American Society of Clinical Oncology annual meeting, this drug combination "stole the show," according to Morgan Stanley's analysts, citing a high degree of rapid efficacy for the drug combo. | For example, AbbVie ( ABBV ) has risen nearly 25% since it began trading at the start of the year. In the past five years, three major spin-offs have occurred. Looking at these companies on a sum-of-the-parts (SOTP) basis, the firm sees the biggestupside for: Abbott, which still might spin out its nutrition, diagnostics and medical devices businesses, has 30% upside to its $48 SOTP assessment. |
27594.0 | 2013-05-30 00:00:00 UTC | Good News for Roche - Analyst Blog | ABBV | https://www.nasdaq.com/articles/good-news-for-roche-analyst-blog-2013-05-30 | nan | nan | Roche Holding AG ( RHHBY ) recently announced that the company has launched the subcutaneous injection formulation of its rheumatoid arthritis (RA) drug Actemra in Japan.
The subcutaneous version of the drug was approved for treating RA patients who do not respond adequately to one or more existing therapies.
We note that Roche, through its subsidiary Chugai Pharmaceuticals Ltd., obtained a manufacturing and marketing approval for the subcutaneous formulation of Actemra in Japan in Mar 2013.
Additionally, Actemra was also listed on the National Health Insurance (NHI) reimbursement price list on May 24, 2013.
Meanwhile, the subcutaneous version of the RA drug is currently under review in the US and the EU.
We note that the intravenous version of Actemra is available in Japan since Jun 2005. Actemra is approved in Japan for additional indications.
We believe that the launch of new subcutaneous formulation of Actemra along with the existing intravenous infusion will further boost the sales potential of Actemra. We remind investors that Actemra is a leading drug of Roche with sales of CHF 842 million in 2012 (up 33% from 2011).
We note that the intravenous version of the drug is available in the EU (branded as RoActemra) since 2009 for treating adult RA patients, who did not respond adequately or were intolerant to, previous medication with one or more disease-modifying antirheumatic drugs (DMARDs) or tumor necrosis factor (TNF) inhibitors.
Subsequently, Actemra was approved by the US Food and Drug Administration (FDA) in Jan 2010 for treating adults suffering from moderately to severely active RA, who have responded inadequately to one or more TNF inhibitors.
The indication was expanded in 2012. Actemra was also approved in the US and EU in Apr 2011 and Aug 2011,respectively, for the treatment of patients (aged two and above) suffering from active systemic juvenile idiopathic arthritis (SJIA).
Moreover, in Apr 2013, the FDA approved Actemra for the treatment of polyarticular-course juvenile idiopathic arthritis (PJIA). We note that Roche is currently seeking EU approval of the drug for PJIA. The Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion for the PJIA indication in Apr 2013 and hence Roche expects an approval shortly.
However, competition is stiff in the RA market for Roche. Actemra primarily faces competition from UCB SA's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira in the RA space.
Roche currently carries a Zack Rank #3 (Hold). Right now, Santarus, Inc. ( SNTS ) appears to be well placed with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Actemra primarily faces competition from UCB SA's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira in the RA space. ABBVIE INC (ABBV): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANTARUS INC (SNTS): Free Stock Analysis Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. Roche Holding AG ( RHHBY ) recently announced that the company has launched the subcutaneous injection formulation of its rheumatoid arthritis (RA) drug Actemra in Japan. | ABBVIE INC (ABBV): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANTARUS INC (SNTS): Free Stock Analysis Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. Actemra primarily faces competition from UCB SA's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira in the RA space. The subcutaneous version of the drug was approved for treating RA patients who do not respond adequately to one or more existing therapies. | ABBVIE INC (ABBV): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANTARUS INC (SNTS): Free Stock Analysis Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. Actemra primarily faces competition from UCB SA's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira in the RA space. Roche Holding AG ( RHHBY ) recently announced that the company has launched the subcutaneous injection formulation of its rheumatoid arthritis (RA) drug Actemra in Japan. | Actemra primarily faces competition from UCB SA's ( UCBJF ) Cimzia and AbbVie Inc.'s ( ABBV ) Humira in the RA space. ABBVIE INC (ABBV): Free Stock Analysis Report ROCHE HLDG LTD (RHHBY): Get Free Report SANTARUS INC (SNTS): Free Stock Analysis Report UCB SA (UCBJF): Get Free Report To read this article on Zacks.com click here. Actemra is approved in Japan for additional indications. |
27595.0 | 2013-05-29 00:00:00 UTC | Gilead's Stribild Approved in the EU - Analyst Blog | ABBV | https://www.nasdaq.com/articles/gileads-stribild-approved-in-the-eu-analyst-blog-2013-05-29 | nan | nan | Good news flowed in at Gilead Sciences, Inc. ( GILD ) from Europe when the European Commission (EC) approved the company's Gilead's HIV combination pill Stribild. Approval was granted for treating HIV infected adults.
The patients are either antiretroviral treatment-naïve or are infected with the dreaded virus without known mutations associated with resistance to any of the three antiretroviral agents present in Stribild (elvitegravir, cobicistat and Truvada). We note that Truvada itself is a combination of Viread and Emtriva.
Approval was based on encouraging data from two late-stage studies -- 102, which compared Stribild to Atripla and 103, which compared Stribild to Norvir (ritonavir)-boosted Reyataz plus Truvada. While Norvir is marketed by AbbVie Inc. ( ABBV ), Reyataz is marketed by Bristol-Myers Squibb Company ( BMY ).
Stribild was approved for the indication in the US in Aug 2012. The drug is also approved in other countries such as Canada, Australia, South Korea, Japan and Turkey. EU approval of the drug has boosted the drug's sales potential. We note that Stribild is Gilead's third single tablet HIV regimen to be approved in the EU after Atripla and Eviplera.
Apart from the strong product portfolio, Gilead possesses an impressive pipeline. The most promising pipeline candidate is sofosbuvir (formerly GS-7977), which is being developed to treat patients infected with hepatitis C virus (HCV). Earlier in the month, Gilead announced that its Marketing Authorisation Application (MAA) for sofosbuvir submitted to the European Medicines Agency (EMA) on Apr 17, 2013, has been validated and is under review.
The EMA granted Gilead's request for accelerated assessment of the company's MAA for sofosbuvir. The acceptance of the request is expected to bring down EMA's review time of the application by two months.
Gilead also intends to seek sofosbuvir approval in other countries. Gilead expects sofosbuvir to be available in the EU by the first half of 2014, assuming approval. Gilead is also seeking US approval for sofosbuvir. Approval of sofosbuvir would not only boost Gilead's top line but would also strengthen its position in the lucrative HCV market.
Gilead, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Celgene Corporation ( CELG ) appears to be more attractive in the biopharma space with a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | While Norvir is marketed by AbbVie Inc. ( ABBV ), Reyataz is marketed by Bristol-Myers Squibb Company ( BMY ). ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report CELGENE CORP (CELG): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. We note that Stribild is Gilead's third single tablet HIV regimen to be approved in the EU after Atripla and Eviplera. | While Norvir is marketed by AbbVie Inc. ( ABBV ), Reyataz is marketed by Bristol-Myers Squibb Company ( BMY ). ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report CELGENE CORP (CELG): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. Approval was based on encouraging data from two late-stage studies -- 102, which compared Stribild to Atripla and 103, which compared Stribild to Norvir (ritonavir)-boosted Reyataz plus Truvada. | ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report CELGENE CORP (CELG): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. While Norvir is marketed by AbbVie Inc. ( ABBV ), Reyataz is marketed by Bristol-Myers Squibb Company ( BMY ). Good news flowed in at Gilead Sciences, Inc. ( GILD ) from Europe when the European Commission (EC) approved the company's Gilead's HIV combination pill Stribild. | While Norvir is marketed by AbbVie Inc. ( ABBV ), Reyataz is marketed by Bristol-Myers Squibb Company ( BMY ). ABBVIE INC (ABBV): Free Stock Analysis Report BRISTOL-MYERS (BMY): Free Stock Analysis Report CELGENE CORP (CELG): Free Stock Analysis Report GILEAD SCIENCES (GILD): Free Stock Analysis Report To read this article on Zacks.com click here. We note that Stribild is Gilead's third single tablet HIV regimen to be approved in the EU after Atripla and Eviplera. |
27596.0 | 2013-05-24 00:00:00 UTC | Daniel Loeb's Top Three Increases of the First Quarter | ABBV | https://www.nasdaq.com/articles/daniel-loebs-top-three-increases-first-quarter-2013-05-24 | nan | nan | Billionaire Daniel Loeb of Third Point LLC has a portfolio consisting of 40 stocks, 12 of those being new buys, valued at $5.3 billion. Loeb is well known in the financial world for writing public letters in which he expresses disapproval of the performance and conduct of other financial executives. In 2012 the guru reported a return of 21.2%, an excess gain of 5.8% over the S&P 500's return.
AbbVie Inc ( ABBV )
Loeb increased his position in AbbVie 609.13%. He bought 2,534,000 shares of the company at an average price of $37.02 per share. Since his buy, the price per share has increased an additional 22.9%. Loeb holds on to 2,950,000 shares of AbbVie. His holdings in the company represent 2.3% of his total portfolio.
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AbbVie is a global biopharmaceutical company that has the ability to discover and advance innovative therapies and meet the health needs of people around the globe. The company's products can be found in over 170 countries and there are 15 primary research and manufacturing facilities around the world.
The analysis on AbbVie reports:
� The per share revenue has been in decline over the past three years.
� The price is close to a one-year high of $47.17.
� The P/E ratio is at a one-year low.
� The P/S ratio is at a one-year low.
AbbVie has a market cap of $72.23 billion; its shares were traded around $45.44 with a P/E ratio of 13.40 and P/S ratio of 4.00. The dividend yield of AbbVie stocks is 1.7%.
International Paper Co. ( IP )
Daniel Loeb bought 5.1 million shares of International Paper Co. in the first quarter, representing a 340% increase in his holdings. He purchased shares for an average price of $43.02. Since his increase, the price per share of International Paper has increased 9.7% from the average purchase price. Loeb owns a total of 6,600,000 shares of International Paper making up 5.8% of his total portfolio.
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International Paper is a global paper and packaging company that is complemented by an extensive North American merchant distribution system, with main markets and manufacturing operations in North America, Europe, Latin America, Russia, Asia and North Africa. The company's businesses are separated into four segments: Industrial Packaging, Printing Papers, Consumer Packaging and Distribution. International Paper is the largest manufacturer of containerboard in the U.S.
The analysis on International Paper reports:
� The operating margin is expanding.
� The price is close to a 10-year high of $48.20.
� The P/B ratio is at its 10-year high of 3.25.
� The P/S ratio is close to its five-year high of 0.75.
International Paper has a market cap of $20.69 billion; its shares traded around $47.20 with a P/E ratio of 24.30 and P/S ratio of 0.70. The dividend yield of International Paper stocks is 2.50%. The company had an annual average earnings growth of 4.6% over the past 10 years.
TransDigm Group ( TDG )
In the first quarter Daniel Loeb increased his holdings in the company by 166.67%. He bought 250,000 shares at an average price of $142.34 per share. Since this buy the price per share has increased 3.3%. As of March 31, 2013, Loeb holds on to 400,000 shares - representing 1.2% of his total portfolio.
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TransDigm is a global designer, producer and supplier of engineered aircraft components for use on nearly all commercial and military aircrafts in service today. Its business is diversified due to the range of products it offers to its customers. Some of its product offerings include: mechanical/electro-mechanical actuators and controls, ignition systems and engine technology, specialized pumps and valves, power conditioning devices cockpit security systems and control technology.
The GuruFocus analysis reports:
� The price is close to a 10-year high of $152.92.
� The P/B ratio is close to a one-year low of 5.69.
� The operating margin is expanding.
� The P/S ratio is close to a 10-year high of 4.89.
TransDigm has a market cap of $7.82 billion; its shares were traded around $147.05 with a P/E ratio of 28.30 and a P/S ratio of 4.40. TransDigm Group had an annual average earnings growth of 21.4% over the past five years.
Daniel Loeb also increased his holdings in Ariad Pharmaceuticals (+10%), Dollar General Corporation (+6.98%) and Constellation Brands (+5.26%).
You can view Daniel Loeb's complete portfolio here. Also check out his Undervalued Stocks, High Growth Companies and High Yield Companies.About GuruFocus: GuruFocus.com tracks the stocks picks and portfolio holdings of the world's best investors. This value investing site offers stock screeners and valuation tools. And publishes daily articles tracking the latest moves of the world's best investors. GuruFocus also provides promising stock ideas in 3 monthly newsletters sent to Premium Members .
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Click here for the Holding History of other gurus AbbVie is a global biopharmaceutical company that has the ability to discover and advance innovative therapies and meet the health needs of people around the globe. AbbVie Inc ( ABBV ) Loeb increased his position in AbbVie 609.13%. Loeb holds on to 2,950,000 shares of AbbVie. | AbbVie Inc ( ABBV ) Loeb increased his position in AbbVie 609.13%. Loeb holds on to 2,950,000 shares of AbbVie. Click here for the Holding History of other gurus AbbVie is a global biopharmaceutical company that has the ability to discover and advance innovative therapies and meet the health needs of people around the globe. | AbbVie Inc ( ABBV ) Loeb increased his position in AbbVie 609.13%. Loeb holds on to 2,950,000 shares of AbbVie. Click here for the Holding History of other gurus AbbVie is a global biopharmaceutical company that has the ability to discover and advance innovative therapies and meet the health needs of people around the globe. | Loeb holds on to 2,950,000 shares of AbbVie. AbbVie Inc ( ABBV ) Loeb increased his position in AbbVie 609.13%. Click here for the Holding History of other gurus AbbVie is a global biopharmaceutical company that has the ability to discover and advance innovative therapies and meet the health needs of people around the globe. |
27597.0 | 2013-05-23 00:00:00 UTC | Biogen Submits Plegridy BLA - Analyst Blog | ABBV | https://www.nasdaq.com/articles/biogen-submits-plegridy-bla-analyst-blog-2013-05-23 | nan | nan | Biogen Idec ( BIIB ) recently submitted a Biologics License Application (BLA) in the US for its multiple sclerosis candidate, Plegridy (peginterferon beta-1a). The company is looking to gain US Food and Drug Administration approval for Plegridy for relapsing forms of multiple sclerosis (RMS).
The BLA submission was based on results from the first year of the two-year global phase III ADVANCE study. Plegridy was compared to placebo in the study. Plegridy (dosed once in two weeks) met the primary endpoint of annualized relapse rate (ARR) at one year. ARR reduction was 36% compared to placebo.
Secondary endpoints included reduction of the risk of 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (by 38%), reduction in the proportion of patients who relapsed (by 39%) and reduction in the number of new or newly enlarging T2-hyperintense lesions on brain MRI scans (by 67%) compared to placebo. The number of gadolinium-enhancing (Gd+) lesions was reduced by 86% in the Plegridy arm.
These results were presented at the annual meeting of the American Academy of Neurology. While a once-in-four weeks dosing regimen of Plegridy was also evaluated in the study, the once- every-two weeks dosing arm was more effective.
Biogen intends to file for EU approval shortly.
Our Take
We are pleased with Biogen's progress with its multiple sclerosis pipeline. A less frequent dosing schedule and a favorable safety and efficacy profile should work in Plegridy's favor once it is launched.
Biogen is the market leader in therapies for the treatment of multiple sclerosis. We believe the company will continue to retain a leading position in the multiple sclerosis market. Biogen received a major boost with its oral multiple sclerosis drug, Tecfidera, gaining FDA approval. We believe Tecfidera could become a leader in the oral multiple sclerosis market. Biogen has another multiple sclerosis candidate, daclizumab, in development with AbbVie ( ABBV ).
Biogen is currently a Zacks Rank #3 (Hold) stock. Companies that look well-positioned include Anika Therapeutics Inc. ( ANIK ) and Alkermes plc ( ALKS ). While Anika is a Zacks Rank #1 (Strong Buy) stock, Alkermes is a Zacks Rank #2 (Buy) stock.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Biogen has another multiple sclerosis candidate, daclizumab, in development with AbbVie ( ABBV ). ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report To read this article on Zacks.com click here. Biogen Idec ( BIIB ) recently submitted a Biologics License Application (BLA) in the US for its multiple sclerosis candidate, Plegridy (peginterferon beta-1a). | ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report To read this article on Zacks.com click here. Biogen has another multiple sclerosis candidate, daclizumab, in development with AbbVie ( ABBV ). Biogen received a major boost with its oral multiple sclerosis drug, Tecfidera, gaining FDA approval. | ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report To read this article on Zacks.com click here. Biogen has another multiple sclerosis candidate, daclizumab, in development with AbbVie ( ABBV ). Biogen Idec ( BIIB ) recently submitted a Biologics License Application (BLA) in the US for its multiple sclerosis candidate, Plegridy (peginterferon beta-1a). | Biogen has another multiple sclerosis candidate, daclizumab, in development with AbbVie ( ABBV ). ABBVIE INC (ABBV): Free Stock Analysis Report ALKERMES INC (ALKS): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report BIOGEN IDEC INC (BIIB): Free Stock Analysis Report To read this article on Zacks.com click here. Plegridy was compared to placebo in the study. |
27598.0 | 2013-05-22 00:00:00 UTC | AbbVie Extends Galapagos Deal - Analyst Blog | ABBV | https://www.nasdaq.com/articles/abbvie-extends-galapagos-deal-analyst-blog-2013-05-22 | nan | nan | AbbVie ( ABBV ) and biotech company, Galapagos NV, recently extended their agreement for the development of autoimmune disease candidate, GLP0634. The original agreement, announced in Feb 2012, related to the worldwide development and commercialization of the oral, next-generation JAK1 inhibitor for multiple autoimmune diseases. The initial focus was on the development of GLP0634 for rheumatoid arthritis.
However, now with the extension of the agreement, AbbVie and Galapagos will evaluate GLP0634 for Crohn's disease as well. The companies said that the Crohn's disease phase II program will be funded and completed by Galapagos. A 20-week, phase IIa/b study in Crohn's disease patients will commence by early 2014. The study will evaluate induction of disease remission and early maintenance of beneficial effects with top-line results due in the second quarter of 2015. This study will be conducted along with a phase IIb rheumatoid arthritis study.
The successful completion of the Crohn's disease phase II study will trigger a $50 million payment from AbbVie. Once phase II development is completed, AbbVie will be responsible for funding and developing the candidate and also for its approval and commercialization. Other financial details of the original agreement remain unchanged.
We note that AbbVie already has a strong presence in the market for autoimmune diseases thanks to its blockbuster drug, Humira.
Meanwhile, earlier this month, AbbVie signed a deal with Alvine Pharmaceuticals, for the global development of a novel oral treatment for patients with celiac disease, an autoimmune disease. The candidate, ALV003, is currently in phase II development.
Under this deal, AbbVie will make an upfront payment of $70 million and will gain an exclusive option to either acquire ALV003-related assets or the equity of the company. AbbVie may exercise its option once Alvine completes a phase IIb study. AbbVie will be liable to make a milestone payment on the commencement of phase III development.
AbbVie currently carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Salix Pharmaceuticals, Ltd. ( SLXP ), Jazz Pharmaceuticals ( JAZZ ) and Santarus, Inc. ( SNTS ). All three are Zacks Rank #1 (Strong Buy) stocks.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | AbbVie ( ABBV ) and biotech company, Galapagos NV, recently extended their agreement for the development of autoimmune disease candidate, GLP0634. However, now with the extension of the agreement, AbbVie and Galapagos will evaluate GLP0634 for Crohn's disease as well. The successful completion of the Crohn's disease phase II study will trigger a $50 million payment from AbbVie. | The successful completion of the Crohn's disease phase II study will trigger a $50 million payment from AbbVie. ABBVIE INC (ABBV): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report SALIX PHARM-LTD (SLXP): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report To read this article on Zacks.com click here. AbbVie ( ABBV ) and biotech company, Galapagos NV, recently extended their agreement for the development of autoimmune disease candidate, GLP0634. | The successful completion of the Crohn's disease phase II study will trigger a $50 million payment from AbbVie. Meanwhile, earlier this month, AbbVie signed a deal with Alvine Pharmaceuticals, for the global development of a novel oral treatment for patients with celiac disease, an autoimmune disease. ABBVIE INC (ABBV): Free Stock Analysis Report JAZZ PHARMACEUT (JAZZ): Free Stock Analysis Report SALIX PHARM-LTD (SLXP): Free Stock Analysis Report SANTARUS INC (SNTS): Free Stock Analysis Report To read this article on Zacks.com click here. | The successful completion of the Crohn's disease phase II study will trigger a $50 million payment from AbbVie. AbbVie ( ABBV ) and biotech company, Galapagos NV, recently extended their agreement for the development of autoimmune disease candidate, GLP0634. However, now with the extension of the agreement, AbbVie and Galapagos will evaluate GLP0634 for Crohn's disease as well. |
27599.0 | 2013-05-22 00:00:00 UTC | CE Mark for Abbott's Xience Xpedition 48 - Analyst Blog | ABBV | https://www.nasdaq.com/articles/ce-mark-for-abbotts-xience-xpedition-48-analyst-blog-2013-05-22 | nan | nan | Abbott Laboratories ( ABT ) recently announced that it received CE Mark in Europe for its drug eluting stent - Xience Xpedition 48 Everolimus Eluting Coronary Stent System.
Xience Xpedition 48 is the latest addition to Abbott Labs' Xience drug-eluting stent franchise. The product is designed to enable treatment for very long blockages in the vessels that supply blood to the heart due to coronary artery disease (CAD).
The Xience drug-eluting stent family is a core part of Abbott Labs' vascular business. We note that Abbott Labs has been consistently making efforts to innovate its Xience drug-eluting stent franchise (includes Xience V, Prime, nano and Xpedition) over the last three years.
Xience nano and Xience Prime were launched in the US in 2011 while Xience Prime and Xience V were launched in Japan in Apr 2012 and Jan 2010, respectively. The launch of Xience Xpedition in the US in Jan 2013 further boosted the franchise. Moreover, Abbott Labs expects Xience Xpedition to gain approval in Japan by mid-2013.
The continued uptake of Xience Xpedition in the US along with the expected launch of Xience Xpedition in Japan coupled with other products should drive growth in the vascular business in the second quarter of 2013.
Following the separation of its research-based pharmaceuticals business into a new company, AbbVie ( ABBV ), in Jan 2013, Abbott Labs became a diversified medical products company with focus on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses.
We believe the diversification bodes well for Abbott Labs and should enable the company to counter the challenging business environment in 2013 as a result of austerity measures undertaken by developed markets in 2013 coupled with weak economic conditionsand a mixed global economy.
Abbott Labs currently carries a Zacks Rank #3 (Hold). Right now, AtriCure, Inc. ( ATRC ) and TranS1 Inc ( TSON ) look well placed with a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | Following the separation of its research-based pharmaceuticals business into a new company, AbbVie ( ABBV ), in Jan 2013, Abbott Labs became a diversified medical products company with focus on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ATRICURE INC (ATRC): Free Stock Analysis Report TRANS1 INC (TSON): Free Stock Analysis Report To read this article on Zacks.com click here. The product is designed to enable treatment for very long blockages in the vessels that supply blood to the heart due to coronary artery disease (CAD). | Following the separation of its research-based pharmaceuticals business into a new company, AbbVie ( ABBV ), in Jan 2013, Abbott Labs became a diversified medical products company with focus on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ATRICURE INC (ATRC): Free Stock Analysis Report TRANS1 INC (TSON): Free Stock Analysis Report To read this article on Zacks.com click here. Abbott Laboratories ( ABT ) recently announced that it received CE Mark in Europe for its drug eluting stent - Xience Xpedition 48 Everolimus Eluting Coronary Stent System. | ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ATRICURE INC (ATRC): Free Stock Analysis Report TRANS1 INC (TSON): Free Stock Analysis Report To read this article on Zacks.com click here. Following the separation of its research-based pharmaceuticals business into a new company, AbbVie ( ABBV ), in Jan 2013, Abbott Labs became a diversified medical products company with focus on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses. We note that Abbott Labs has been consistently making efforts to innovate its Xience drug-eluting stent franchise (includes Xience V, Prime, nano and Xpedition) over the last three years. | Following the separation of its research-based pharmaceuticals business into a new company, AbbVie ( ABBV ), in Jan 2013, Abbott Labs became a diversified medical products company with focus on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses. ABBVIE INC (ABBV): Free Stock Analysis Report ABBOTT LABS (ABT): Free Stock Analysis Report ATRICURE INC (ATRC): Free Stock Analysis Report TRANS1 INC (TSON): Free Stock Analysis Report To read this article on Zacks.com click here. Xience Xpedition 48 is the latest addition to Abbott Labs' Xience drug-eluting stent franchise. |
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