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Regeneron Reports Full Year and Fourth Quarter 2010 Financial and Operating Results
Date:2/17/2011

halmic solution)– Ophthalmologic DiseasesVEGF Trap-Eye is a fusion protein locally administered in the eye that is designed to bind Vascular Endothelial Growth Factor-A (VEGF-A) and Placental Growth Factor (PLGF), proteins that are involved in the abnormal growth of new blood vessels.  Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.  Bayer HealthCare LLC has rights to market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye.

Phase 3 studies in wet age-related macular degeneration

In November 2010, Regeneron and Bayer Healthcare reported positive one-year data from two Phase 3 studies (VIEW 1 and VIEW 2) evaluating VEGF Trap-Eye in patients with the neovascular form of age-related macular degeneration (wet AMD).  Based on these results, Regeneron plans to submit a Biologics License Application to the Food and Drug Administration (FDA) for marketing approval in the U.S. in the first half of 2011.  In addition, Bayer Healthcare intends to submit regulatory applications in the first half of 2011 for marketing approval in Europe.

In VIEW 1 and VIEW 2, VEGF Trap-Eye was administered either monthly or every two months, and compared to monthly doses of ranibizumab, which is the current standard of care in wet AMD.  In these studies, all regimens of VEGF Trap-Eye including VEGF Trap-Eye dosed every two months successfully met the primary endpoint of non-inferiority compared to ranibizumab dosed every month.  The primary endpoint was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab.  At least 94% of patients in every VEGF Trap-Eye group, including those dosed every two months, as well as those receiving ranibizumab dosed monthly, maintained visual acuity over 52 weeks.  Visual acuity was measured as a score based on the
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SOURCE Regeneron Pharmaceuticals, Inc.
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Related medicine technology :

1. Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
2. Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion
3. Enrollment Completed in Regeneron and Bayer HealthCare Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration (Wet AMD)
4. Regeneron Announces Presentation at the 18th Annual Credit Suisse Healthcare Conference
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