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We invest heavily in R&D, and collaborate with public health agencies, global health organizations, pharmaceutical companies and others.
We continue to expand access to treatments through drug donations, patient support programs and our compassionate use policy, which provides access to investigational medicines.
We continue to deepen our strong, sustainable and diverse portfolio of innovative medicines.
Our core capabilities in R&D are enabled by Regeneron technologies, which accelerate, improve and disrupt the traditional drug discovery and development process, allowing us to help more patients around the world, faster.
We are also leading ambitious initiatives, such as the Regeneron Genetics Center, one of the largest genetics sequencing efforts in the world.
Advance Our Goal: Using the power of science to discover and advance important new medicines while continuing to make substantial investments into R&D.
With innovation at our core, our approach to the discovery, development and delivery of our medicines has resulted in seven FDA-approved products.
In regulatory approvals for EYLEA and Dupixent in new diseases.
We also discovered and developed a potentially effective treatment for Ebola virus infection, a major public health advance with important implications for current and future outbreaks.
We continue to expand and diversify our preclinical and clinical pipeline, which will be critical for sustainable longterm growth.
At the end of progress, with 8,400 patients enrolled in 53 countries.
You can read more about our product pipeline on our website.
We remain focused on powering our R&D engine through the refinement of new technologies and drug categories.
We continue to advance our innovative immuno-oncology portfolio, which includes Libtayo, a PD-therapies being evaluated in multiple types of cancer.
SNAPSHOT / Reinvesting in R&D We remain committed to reinvesting in our pipeline and technology efforts.
In we invested more than $3 billion in R&D.
IMPROVING LIVES https://www.regeneron.com/pipeline We believe that following innovative science leads to important new treatments, and we pursue this science regardless of the size of the patient population.
A number of our rare disease therapies showed promise in including our potential therapy for patients with the most severe form of genetic high cholesterol (homozygous familial hypercholesterolemia or HoFH) and our potential treatment for people with the ultra-rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH).
One highlight: In early encouraging Phase 2 results with an antibody treatment for fibrodysplasia ossificans progressive (FOP), a genetic condition affecting about 800 people around the globe.
FOP is a devastating orphan disease in which patients’ muscles, ligaments and other soft tissues are progressively replaced by bone, which forms a second skeleton and can often lead to premature death.
We are discussing the results with regulators and plan to initiate a study in pediatric patients.
We support the efforts and are proud to be members of several rare disease patient advocacy groups.
We remain committed to working with regulatory agencies around the world to bring these important new medicines to people in need, regardless of how limited the number of patients may be.
“ FOP IS A PROGRESSIVE, DEVASTATING DISEASE WITH NO APPROVED TREATMENT OPTIONS.
THE RELEASE OF THESE DATA IS A SIGNIFICANT STEP FORWARD TOWARDS A MEANINGFUL TREATMENT OPTION AND A BRIGHTER FUTURE AHEAD FOR THE FOP COMMUNITY.
To expedite scientific discovery, we engage in non-clinical research collaborations to provide academic and non-profit research institutions access to our proprietary animal models, cell lines and other technologies.
Through these collaborations, we also provide access to approved medicines or therapeutic pipeline candidates for use in non-human studies.
At the end of 491 approved studies were underway.
In early organization in the world to sequence the exomes of one million people.
This unique resource has the potential to dramatically speed up the drug development process and improve patient care.
ADVANCING GENETICS RESEARCH Developing innovative technology and pursuing a deep understanding of human genetics and biology continues to be a priority and a passion.
Enabled through our collaborations with the Geisinger Health System, the UK Biobank and more than Center (RGC) has built one of the world’s largest databases for genomic analysis of health and disease.
Through our investments in the RGC, we are advancing basic science around the world, discovering new drug targets, providing clinically valuable insights and ultimately making drug development more efficient and precise.
In order to fully tap this new resource, we believe collaboration, transparency and knowledge sharing will be absolutely necessary and, more importantly, are the right things to do.
Responsibility Report In March Biobank released the first tranche of new human sequencing data to health researchers around the world, offering an unprecedented ‘Big Data’ resource to enhance understanding of human biology and aid in therapeutic discovery.
The exome sequence data of the first UK Biobank participants were generated at the RGC through a collaboration between UK Biobank, Regeneron, and GlaxoSmithKline and are linked to detailed de-identified health records, imaging and other health-related data.
Regeneron is also leading a consortium of other biopharma companies to complete exome sequencing of the remaining 2020 and will release this data in similar tranches over the next two years.
This data is accessible to the global research community via the UK Biobank open access resource, now one of the largest open access resources of exome sequence data linked to robust health records in the world.
Genetics is playing an increasingly important role in research, and the actionable information in this resource means there are infinite discoveries to be made that could potentially benefit human health.
At Regeneron, we know that we can’t do it all alone, and we believe this unprecedented new resource will help the broader scientific community enhance their research efforts and lead to more breakthroughs that could improve patients lives.
Responsibility Report Regeneron has always approached pricing with fairness, affordability and access at the forefront.
Patients can face real barriers in receiving the medicine they need.
That was the case for many people who were prescribed Praluent, our medicine for lowering bad cholesterol.
Insurance companies restricted patient access to Praluent by attaching complex, multi-step “utilization management” criteria around its use.
So in March offered a lower net price for payers who would remove this challenging criteria for patients and physicians.
Still, access and affordability remained a challenge for patients who were often unable to afford the prescribed medication due to high co-pay costs or co-insurance imposed by health plans.
That’s why, in February Regeneron and Sanofi announced another major step.
We offered a new list price option, which is price.
For example, the new lower-priced Praluent was expected to reduce out-of-pocket costs for most Medicare patients to approximately $$150 per month, a potential savings of up to $345 per month, depending on their insurance plan.
Similarly, when we prepared for the launch of Dupixent for its first approved patient population in moderate to-severe atopic dermatitis, we engaged in unprecedented dialogue and collaboration to ensure we were pricing it responsibly.
Setting fair, value-based prices for our medicines and breaking down barriers to patient access.
• We consider the long-term investment and risk inherent in science and technology innovation, which is required to bring novel medicines to patients.
• Regeneron maintains a Compassionate Use Program to make certain medicines available to eligible patients before they are commercially available.
After medicines reach the market, we are committed to supporting patients’ access.
We are committed to doing our part and rely on other players in the healthcare system to do theirs.
This includes health insurers and pharmacy benefit managers who play a key role in ensuring affordable access to needed medicines.
For example, in the case of our largest product (EYLEA), to date, we have not increased the price since its approval in ongoing R&D investment.
Medicines are only useful if patients in need can access and afford them.
Our growth is driven by scientific innovation, not price increases.
IMPROVING LIVES At Regeneron, we are deeply committed to understanding the challenges and unmet needs of patients.
Patients are our partners: we learn from and advocate for them every step of the way.
Supporting organizations that offer disease prevention, diagnosis and treatment for people touched by serious diseases.
IMPROVING LIVES SNAPSHOT / Patient Advocacy Groups Patient advocacy groups represent their respective patient communities’ needs, issues and challenges and also seek to raise awareness, empower patients through education and advocate for patients to receive the best care.
They are critical stakeholders in our work, collaborating with us to address important health issues and improve patient care.
Increasing Disease Awareness We believe patients should be knowledgeable about their disease so they can advocate and make informed decisions around their care.
We support organizations that create educational materials and disease management tools for patients and their caregivers.
We know that patients are seeking information from the most trusted sources and we want to ensure that there is up-to-date and relevant information wherever they look.
Elevating the Patient Voice We believe that it is important to include the patient voice early in the R&D and clinical development process.
Under the guidance of patient advocacy groups, we bring patients together with our researchers, clinical development colleagues and health economic outcomes research groups to learn what it means to live with a disease, how patients manage their day-to-day lives and what they and their caregivers want in new therapies.
Through this process, we have changed and added new outcome measures, or what clinicians call “endpoints,” to our clinical trials and have worked collaboratively to test and develop new patient-reported outcomes that have never been studied in the past.
Supporting Patient Access We believe that patients should have access to appropriate, evidence-based medicines to get them to the best health.
Patients are singularly able to tell their story about access challenges and how these obstacles can impact their daily lives and health.
Regeneron has supported advocacy training, distribution of access tools, town halls and coalition building for patients and caregivers so that they can have a greater chance for successful outcomes.
IMPROVING LIVES Regeneron is involved in research on generalized lipodystrophy, a rare disorder characterized by the near total loss of body fat and extreme muscularity.
Patients with lipodystrophy tend to have metabolic complications such as glucose intolerance, diabetes and elevated levels of fat in the blood.
Very early in our drug development work, we wanted to understand patients’ experience living with lipodystrophy.
We developed a relationship with Lipodystrophy United, a patient advocacy group, which helped us hear directly from patients about the impact of living with this disease.
Through this partnership, we interviewed patients, caregivers and doctors to better understand challenges they face when taking medicines.
Given their loss of body fat, we wanted to be proactive in thinking about new ways to develop treatments that would be more comfortable for people living with lipodystrophy.
We plan to apply what we learned to our future efforts.
We are grateful for our partnership with Lipodystrophy United, which has been instrumental in helping us meet and learn from people who live with lipodystrophy.
Last fall, in recognition of World Atopic Dermatitis (AD) Day, our patient advocacy team launched the ‘Agents of Change’ AD Challenge, a multi-year, global grants initiative to mobilize local communities and individuals by inspiring new ideas to address some of the most difficult challenges for those living with AD. People living with AD both see and feel its symptoms on their skin.
Those with moderate-to-severe AD often experience redness, swelling and lesions often causing constant itching and painful cracked, crusty and oozing skin.
All too often, these symptoms are more than skin deep too, having an impact on the mental and emotional well-being of people with AD, causing feelings of anxiety, depression and loneliness.
In our inaugural year, the ‘Agents of Change’ AD Challenge focused on helping to address the bullying that may be experienced by people because of their AD.
The response was overwhelmingly positive, with more than submitted from countries around the world within 48 days.
Ideas focused on bringing attention to AD-related bullying included proposals such as storytelling projects, art and literary contests, early screenings and selfconfidence workshops.
Proposals were reviewed against a pre-defined set of criteria by a panel that included global leaders from the AD community.
In Summer we will announce the top five grant recipients of the 2019 ‘Agents of Change’ AD Challenge, who will each receive funding of up to $10,000 to bring their anti-bullying project to life.
Responsibility Report Our employees focus on putting science, technology and innovation to work to make a difference in patients’ lives.
This effort starts in the labs, moves into the clinic and continues with our commitment to ensuring patients can access the therapies they need.
We offer product support to both healthcare providers and patients, including contacting patients’ health plans to determine the requirements for coverage and reimbursement and educating healthcare providers and patients on the steps needed to start the patient on the medicine.
We also offer co-pay support to eligible patients and various discounts to payers to help make our products more accessible.
In addition to helping patients access their prescribed medicines, some of our patient support programs provide ongoing education to patients about their medicine and how to use it as prescribed by their healthcare provider.
We donate to independent thirdparty charitable foundations, known as Patient Assistance Foundations, who provide financial assistance to patients who might not otherwise be able to afford their medications.
We provide guidelines and training to our employees who might engage with the Foundations, and we review our activities regularly to ensure adherence to our guidelines.
Compassionate Use: Access to Medicines Before a new treatment is widely available to the public, it undergoes rigorous clinical testing to ensure it meets the safety and efficacy criteria required for regulatory approval.
Our Compassionate Use Policy gives certain patients who have serious or life-threatening conditions access to a potentially beneficial medicine.
The patients who receive compassionate use usually have exhausted all, if any, available treatment options or are unable to participate in ongoing clinical trials.
Represents wholesale acquisition cost SNAPSHOT / Providing Financial Assistance to Patients In nearly 600,000 patients including subsidizing $231 million in commercial co-payments so that eligible commercially insured patients can afford their out-of-pocket costs.