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Regeneron and Bayer Announce Start of Phase 3 Clinical Program in Diabetic Macular Edema
Date:4/8/2011

it is projected that up to 10 percent of all patients with diabetes will develop DME during their lifetime.

About VEGF Trap-Eye

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body.  Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs.  However, in certain diseases, such as diabetes, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit vascular permeability and lead to edema.  VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with another vascular growth factor, the Placental Growth Factor (PlGF).  VEGF Trap-Eye is a specific and highly potent blocker of VEGF-A and PlGF that has been demonstrated in preclinical models to bind these growth factors with greater affinity than their natural receptors.  Regeneron and Bayer HealthCare are collaborating on the global development of VEGF Trap-Eye.  Bayer HealthCare will market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye.  Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.

Regeneron submitted a Biologics License Application for marketing approval in wet age-related macular degeneration (wet AMD) in the US in February 2011, and Bayer plans to submit a regulatory application outside the US in the first half of 2011.  Phase 3 studies in central retinal vein occlusion (CRVO) and in patients with choroidal neovascularisation (CNV) of the retina as a result of pathologic myopia - a major eye disease common in Asia - are currently underway.

About Regeneron Pharmaceuticals

Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of se
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SOURCE Regeneron Pharmaceuticals, Inc.
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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)
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