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(A living plan to be discussed and approved by the Joint Governance Committee) |
Regulatory Authority submissions and consultations |
US An IND shall be opened to allow enrollment of US subjects into the Phase IIa SLE 3-month study (Study A03). An FDA (Type C meeting) shall be sought in 2021 before the start of planned Phase IIa SLE 6-month study (Study A03a) initiation. This interaction shall focus on seeking FDA feedback and agreement on the noncli... |
EU Scientific Advice (SA) from at least two (2) select national competent authorities (e.g., UK, Germany, Netherlands, or Sweden) or from EMA shall be sought in 2021 before the start of Phase IIa SLE 6-month study (Study A03a). In the EU these interactions shall focus on establishing relationships with EU regulators an... |
Pediatrics |
The strategy and timing for pediatric development shall be jointly agreed upon by the Joint Governance Committee. |
EU A Pediatric Investigation Plan (PIP), including request for waiver(s) and deferral(s) for age subgroups, shall be submitted for agreement by the Pediatric Committee (PDCO). The EU PIP planning takes into consideration the availability of results from preclinical and clinical adult data/information. It is possible to... |
US In the US, the Pediatric Study Plan (PSP) shall be developed in parallel or sequential to the EU PIP submission to ensure a global pediatric development plan. Regulatory Deliverable Activities Target Timeline |
1 Submit complete IND for ALPN-101 SLE (US) and, if needed, CTA in appropriate ex-US country(ies) Author, review, finalize IND documents and submit in IND eCTD format Prior to initiating Phase IIa 3-month SLE study |
2 Submit FDA (Type C meeting) and national competent authority/EMA Sci Advice to seek feedback on development program requirements in order to initiate Phase IIa SLE 6-month Clinical Study Author, review, finalize FDA meeting and national competent authority Sci Advice documents regarding Phase IIa SLE 6-month Clinical... |
3 Transfer responsibilities and obligations of ALPN-101 SLE IND Parties to discuss date of transfer and considering any on-going activities that may impact transfer (i.e., Clinical studies) From and after the Option Effective Date |
4 Regulatory Preparatory Development Activities Prior to the Option Effective Date Licensor may prepare Regulatory Documentation related to potential Clinical Studies following completion of the Phase IIa SLE Clinical Studies Prior to Option Effective Date |
Schedule 4.2 |
Option Exercise Disclosure Schedule |
To be attached following the Option Exercise Data Package Trigger Event. |
Schedule 6.6.3(c) |
Special Offset |
1. Offsets Regarding Identified Patent. Notwithstanding Section 6.6.3(c) (Reductions) or Section 6.6.4 (Mechanics of Adjustments to Royalties), in the event that (a) AbbVie or its Affiliate enters into an agreement with a Third Party owning or controlling any issued patent that claims priority from WO 2012/142515 (the ... |
2. Mechanics of Adjustments to Royalties. Notwithstanding Section 6.6.4 (Mechanics of Adjustments to Royalties), any reductions made pursuant to paragraph 1 above, collectively with the other reductions set forth in Section 6.6.3 (Reductions), shall not reduce the royalties that would otherwise be owed under Section 6.... |
3. Right to Challenge. Notwithstanding Section 7.6 (Third Party Licenses and Patents), Licensor shall have the right, but not the obligation, and in close consultation with AbbVie, to challenge the patentability, validity or enforceability of the Identified Patent in any court of competent jurisdiction or before any su... |
Schedule 7.2 |
Licensor Prosecution Countries |
Family No. 003 ICOS LIGAND VARIANT IMMUNOMODULATORY PROTEINS AND USES THEREOF |
Country Atty. Ref. Application No. (Country Filing Date) Publication No. (Publication Date) Status and Comments |
AU 20003.41 2017250358 (9/26/2018) AU-A-2017250358 (10/18/2018) Pending |
BR 20003.42 BR 11 2018 070934 4 (10/10/2018) BR1120180709344 (2/26/2019) Pending |
CA 20003.43 3,019,199 (9/26/2018) CA 3019199 (10/04/2018) Pending |
CN 20003.44 201780036984.0 (12/13/2018) CN 110088126 (08/02/2019) Pending |
EA 20003.45 201892336 (11/14/2018) EA 201892336 (06/28/2019) Pending |
EP 20003.46 17733114.7 (9/28/2018) EP 3442999 (02/20/2019) Pending |
IL 20003.47 262365 (10/14/2018) IL 262365 (11/29/2018) Pending |
IN 20003.48 201817041129 (10/31/2018) IN 201817041129 (03/01/2019) Pending |
JP 20003.49 2018-554101 (12/10/2018) JP 2019514361 (06/06/2019) Pending |
KR 20003.50 10-2018-7033049 (11/14/2018) KR 20190005879 (01/16/2019) Pending |
MX 20003.51 MX/a/2018/012472 (10/11/2018) MX/a/2018/012472 (09/06/2019) Pending |
NZ 20003.52 746741 (9/26/2018) NZ 746741 A1 (09/28/2019) Pending |
SG 20003.53 11201808457P (9/27/2018) SG 11201808457P (10/30/2018) Pending |
HK (EP) 20003.54 19121707.4 (4/1/2019) HK 1261801 (1/3/2020) Pending |
HK (CN) 20003.55 19128847.1 (8/28/2019) Not yet published Pending |
US 20003.00 15/488409 (04/14/2017) US 2017/0320959 (11/9/2017) Pending |
Family No. 022 VARIANT ICOS LIGAND IMMUNOMODULATORY PROTEINS AND RELATED COMPOSITIONS AND METHODS |
Country Atty. Ref. Application No. (Country Filing Date) Publication No. (Publication Date) Status and Comments |
AR 20022.41 20180103041 (10/18/2018) None Pending |
AU 20022.43 2018351000 (4/9/2020) Not yet published Pending |
BR 20022.44 BR 11 2020 007542 6 (4/16/2020) Not yet published Pending |
CA 20022.45 3,078,517 (4/3/2020) Not yet published Pending |
CN 20022.46 Not yet available Not yet published Pending |
EA 20022.47 Not yet available Not yet published Pending |
EP 20022.48 18803814.5 (4/1/2020) Not yet published Pending |
IL 20022.49 273726 (3/31/2020) Not yet published Pending |
IN 20022.50 20201701941 (5/7/2020) Not yet published Pending |
JP 20022.51 2020-521877 (4/17/2020) Not yet published Pending |
KR 20022.52 Not yet available Not yet published Pending |
MX 20022.53 MX/a/2020/004540 (4/30/2020) Not yet published Pending |
NZ 20022.54 763426 (4/9/2020) Not yet published Pending |
SG 20022.55 11202003078V (4/2/2020) Not yet published Pending |
UAE 20022.56 P6000549/20 (4/15/2020) Not yet published Pending |
BH 20022.57 20200069 (4/16/2020) Not yet published Pending |
MY 20022.60 PI2020001960 (4/18/2020) Not yet published Pending |
PH 20022.62 Not yet available Not yet published Pending |
QA 20022.63 QA/202004/00202 (4/15/2020) Not yet published Pending |
SA 20022.64 520411779 (4/16/2020) Not yet published Pending |
TW 20022.42 107136610 (10/17/2018) 201925223 (07/01/2019) Pending |
UA 20022.66 Not yet available Not yet published Pending |
ZA 20022.67 Not yet available Not yet published Pending |
US 20022.00 16/757,344 (4/17/2020) Not yet published Pending |
Family No. 032 METHODS AND USES OF VARIANT ICOS LIGAND (ICOSL) FUSION PROTEINS |
Country Atty. Ref. Application No. (Country Filing Date) Publication No. (Publication Date) Status and Comments |
PCT 20032.40 PCT/US2020/028601 (4/16/2020) Not published yet Pending |
For any other Licensor Product Patent families: AU, BR, CA, CN, EA, EP, IL, IN, JP, KR, MX, NZ, SG, HK and US; and validation in the following EP countries: BE, CH, DE, DK, ES, FR, GB, IE, IT, LU, NL, NO, PL and SW |
Schedule 9.5 |
Press Release |
Alpine Immune Sciences and AbbVie Announce Option and License Agreement for the Development and Commercialization of ALPN-101 |
- Alpine grants AbbVie option to license worldwide rights to ALPN-101, a phase 2-ready, first-in-class dual CD28/ICOS costimulation antagonist, building on AbbVie's commitment to developing novel therapies in Immunology |
- Alpine to receive $60 million in an upfront cash payment; eligible to receive up to $805 million for exercise of the option and success-based development, regulatory and commercial milestones |
- Alpine to conduct a phase 2 study in systemic lupus erythematosus during the option period |
- Alpine will host a conference call today at 8:30 a.m. ET - |
SEATTLE, WA and NORTH CHICAGO, Ill., June 18, 2020 -- Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, and AbbVie Inc. (NYSE: ABBV), a research-based global biopharmaceutical company, ... |
CD28 and ICOS are key costimulatory molecules that likely play critical roles in multiple autoimmune and inflammatory diseases. ALPN-101 is a potent inhibitor of both CD28 and ICOS pathways with demonstrated efficacy in multiple preclinical disease models, superior to blockade of either pathway alone. Favorable safety ... |
"We are very pleased to partner ALPN-101 with AbbVie, a world leader in the development and commercialization of innovative immunology therapies," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "AbbVie is an ideal partner for ALPN-101, with the therapeutic area expertise, R&D com... |
"AbbVie's expertise in Immunology has led to remarkable breakthroughs in the treatment of autoimmune diseases," said Tom Hudson, M.D., Senior Vice President and Chief Scientific Officer, AbbVie. "ALPN-101's dual mechanism of action has compelling potential as a next-generation treatment in systemic lupus erythematosus ... |
Under the terms of the agreement, Alpine will receive an upfront payment of $60 million, and will also be eligible to receive up to an aggregate of $805 million for exercise of the option and success-based development, regulatory and commercial milestones. In addition, Alpine is eligible to receive tiered royalties on ... |
Alpine will host a conference call today at 8:30 a.m. ET to discuss the option and license agreement and outline the company's strategic focus moving forward. |
Conference Call and Webcast Details |
Alpine will host a conference call today at 8:30 a.m. ET to discuss today's announcement. To access the live call by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international) using participant passcode 3770288. To access a live webcast of the call, please visit the Investor Relations section of the Alpine... |
About Alpine Immune Sciences, Inc. |
Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine is backed by world-class research and development capabilities, a highly productive scienti... |
About AbbVie |
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and... |
Forward-Looking Statements |
Alpine Immune Sciences, Inc.: |
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regardin... |
AbbVie: |
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe,""expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions tha... |
Contacts |
Alpine Immune Sciences, Inc.: |
Media |
Jennifer Paganelli, W20 |
212-301-7225 |
jpaganelli@w2ogroup.com |
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