Regeneron Pharmaceuticals Inc. (REGN), said Monday the U.S. Food and Drug Administration has granted it priority review for its new investigational eye solution to treat neovascular form of age-related macular degeneration, or wet AMD - a disorder that causes vision loss due to abnormal growth of blood vessels. Regeneron's shares gained over 6.8 percent, following the news.
The priority review for Regeneron's VEGF Trap-Eye means the FDA will take a decision on the drug's Biologics License Application by August 20 this year. Usually a drug is given Priority Review status when it is believed to offer major advances in treatment, or provide a treatment where no adequate therapy exists.
Regeneron and Bayer HealthCare are collaborating on the global development of VEGF Trap-Eye for various eye diseases and disorders. Bayer HealthCare is a part of German healthcare and materials company Bayer AG (BYR.L, BAYRY.PK, BAYZF.PK).
Bayer is responsible for commercialization of the product outside the U.S. Regeneron maintains exclusive commercialization rights in the U.S. Bayer HealthCare intends to submit a regulatory application outside of the United States in the first half of 2011.
VEGF Trap is a fusion protein specifically designed to bind all forms of Vascular Endothelial Growth Factor-A, or VEGF-A, and Placental Growth Factor, or P1GF - which are involved in the abnormal growth of new blood vessels.
VEGF Trap-Eye is specifically purified and formulated for intravitreal administration and is said to counteract the effects of VEGF-A and PlGF, and may provide notable therapeutic effect for various eye disorders.
On April 8 this year, Regeneron announced the commencement of the first of two Phase 3 clinical trials evaluating the efficacy and safety of VEGF Trap-Eye in Diabetic Macular Edema - a leading cause of vision loss in adults under the age of 50 suffering from diabetes.
REGN is trading at $49.0, up $3.16 or 6.89%, on a volume of 1.2 million shares on the Nasdaq.
BAYRY.PK is trading at $77.60, down $2.63 or 3.28%. On the London Stock Exchange, BYR.L closed Friday at 55.70 pence, up 0.24 pence or 0.43%, on a volume of 6.76 million shares.
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