Key Developments For Regeneron Pharmaceuticals, Inc.
Regeneron Pharmaceuticals, Inc. (REGN.O) (Nasdaq)
sanofi-aventis And Regeneron Pharmaceuticals, Inc. Expand Strategic Antibody Collaboration
sanofi-aventis and Regeneron Pharmaceuticals, Inc. announced that they have entered into agreements to expand and extend their existing global collaboration to discover, develop, and commercialize fully-human therapeutic monoclonal antibodies. Sanofi-aventis will increase its annual funding commitment from $100 million to $160 million beginning in 2010, and the research funding will now extend through 2017. The companies aim to advance an average of four to five antibodies into clinical development each year. In addition to its VelocImmune technology, Regeneron will contribute to the collaboration its next generation technologies related to antibody generation. Sanofi-aventis has an option to extend the discovery program for up to an additional three years for further antibody development and preclinical activities. The amendments announced do not change the financial terms of the November 2007 agreement governing the development and commercialization of antibody drug candidates arising from the discovery collaboration.
Regeneron Pharmaceuticals, Inc.'s Rilonacept Granted European Marketing Authorization for Treatment of Cryopyrin-Associated Periodic Syndromes
Regeneron Pharmaceuticals, Inc. announced that it has received marketing authorization in the European Union for rilonacept, an interleukin-1 blocker, for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms, including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children aged 12 years and older. Marketing authorization for rilonacept was granted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) under exceptional circumstances.
Sanofi-aventis and Regeneron Pharmaceuticals, Inc. Announce Discontinuation Of Phase 3 Trial For VANILLA
Sanofi-aventis and Regeneron Pharmaceuticals, Inc. announced the discontinuation of the Phase 3 trial that evaluated aflibercept (VEGF Trap) plus gemcitabine versus placebo plus gemcitabine for the first-line treatment of metastatic pancreatic cancer (VANILLA), based on the recommendations by an Independent Data Monitoring Committee (IDMC). As part of a planned interim efficacy analysis, the IDMC determined the addition of aflibercept to gemcitabine would be unable to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to placebo plus gemcitabine in this study. With the closure of the study, a detailed analysis of the efficacy and safety results will be conducted by the companies and results will be presented at a future medical meeting. Sanofi-aventis and Regeneron have notified the study investigators and appropriate regulatory authorities of the decision to discontinue the study. Patients in the study will continue to be provided access to aflibercept at the determination of the study investigators in consultation with the patients.
Regeneron Pharmaceuticals, Inc. Receives European Medicines Agency Positive Opinion For Marketing Authorization Of Rilonacept For The Treatment Of Cryopyrin-Associated Periodic Syndromes
Regeneron Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion for the marketing authorization in the European Union of rilonacept, an interleukin-1 blocker, for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms, including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children aged 12 years and older. The positive opinion recommends the granting of a marketing authorization for rilonacept under exceptional circumstances. Such authorizations are permissible for products for which a company can demonstrate that comprehensive data cannot be provided, for example because of the rarity of the condition. Each year, Regeneron will need to provide the EMEA with any new information that may become available for review.
First Patient Enrolled In Regeneron Pharmaceuticals, Inc. And Bayer AG's Bayer HealthCare AG VEGF Trap-Eye Phase 3 Program in Central Retinal Vein Occlusion
Regeneron Pharmaceuticals, Inc. announced that the first patient has been enrolled in the Phase 3 program of VEGF Trap-Eye for the treatment of central retinal vein occlusion (CRVO), a leading cause of blindness in adults. Regeneron received a $20 million payment from Bayer AG's Bayer HealthCare AG that was triggered by the dosing of the first patient in the CRVO program. VEGF Trap-Eye, an investigational drug, is being developed by Regeneron and Bayer HealthCare AG for the potential treatment of eye diseases, including the neovascular form of age-related macular degeneration (wet AMD), DME, and CRVO. The Phase 3 program in CRVO consists of two multinational, one-year clinical studies. The COPERNICUS (COntrolled Phase 3 Evaluation of Repeated iNtravitreal administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and Safety) study is being led by Regeneron and the GALILEO (General Assessment Limiting InfiLtration of Exudates in central retinal vein Occlusion with VEGF Trap-Eye) study is being led by Bayer HealthCare. Patients in both studies will receive six monthly intravitreal injections of either VEGF Trap-Eye at a dose of 2 milligrams (mg) or sham control injections. The primary endpoint of both studies is improvement in visual acuity versus baseline after six months of treatment.
