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VEGF Trap-Eye Submitted for EU Marketing Authorization for Treatment of Wet Age-Related Macular Degeneration
Date:6/7/2011

TARRYTOWN, N.Y. and BERLIN, June 7, 2011 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). Regeneron and Bayer HealthCare are collaborating on the global development of VEGF Trap-Eye for the treatment of wet AMD, central retinal vein occlusion (CRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV).

"The submission of VEGF Trap-Eye for EU marketing authorization represents a significant milestone in our goal to bring this potentially important new therapy to patients with wet AMD across the globe," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron.

The VEGF Trap-Eye submission is based on the positive results from two Phase 3 trials, the VIEW 1 study and the VIEW 2 study.  In these trials, all regimens of VEGF Trap-Eye, including 2 mg VEGF Trap-Eye dosed every two months (following three loading doses), successfully met the primary endpoint of non-inferiority, compared to the current standard of care, ranibizumab 0.5 mg dosed every month.  The primary endpoint analysis was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab at the dose that is currently known to provide the best possible efficacy.  A generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab.  The ocular adverse events were balanced across all treatment groups in both studies.  There were no notable differences in non-ocular adverse events among the study arms.

Regeneron submitted a Biologics License Application (BLA) for marketing approval in wet
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SOURCE Regeneron Pharmaceuticals, Inc.
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Related medicine technology :

1. FDA Schedules Advisory Committee Meeting to Discuss BLA for VEGF Trap-Eye for the Treatment of Wet Age-Related Macular Degeneration
2. Regeneron and Bayer Report Positive Results for VEGF Trap-Eye in Second Phase 3 Study in Central Retinal Vein Occlusion
3. FDA Grants Priority Review for VEGF Trap-Eye for the Treatment of Wet Age-Related Macular Degeneration
4. Regeneron Submits Biologics License Application to FDA for VEGF Trap-Eye for Treatment of Wet Age-Related Macular Degeneration
5. Regeneron to Webcast Investor Briefing on VEGF Trap-Eye Clinical Program on Sunday, February 13th at 9 am ET
6. Regeneron and Bayer Report Positive Results for VEGF Trap-Eye in Phase 3 Study in Central Retinal Vein Occlusion (CRVO) and in Phase 2 Study in Diabetic Macular Edema (DME)
7. Regeneron Schedules December 20, 2010 Teleconference and Webcast to Discuss Results of VEGF Trap-Eye Phase 3 Study in Central Retinal Vein Occlusion (CRVO) and Phase 2 Study in Diabetic Macular Edema (DME)
8. Enrollment Completed in Regeneron and Bayer HealthCare Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration (Wet AMD)
9. Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion
10. Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
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