Shares of Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) touched a new 10-year high of $49.44 on Monday. The company said the U.S. Food and Drug Administration gave priority review status 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.
The Tarrytown, New York-based Regeneron said the priority review for its 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.
We are very pleased that the FDA has chosen to grant priority review to VEGF Trap-Eye. We look forward to working closely with the FDA to achieve our goal of bringing a new treatment option that offers a major advance to patients with age-related macular degeneration, said Leonard S. Schleifer, Chief Executive Officer of Regeneron.
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 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 is a fusion protein specifically designed to bind all forms of Vascular Endothelial Growth Factor-A (VEGF-A) and Placental Growth Factor (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 Pl
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.
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.
If approved by regulatory authorities, 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 stock gapped open sharply higher April 18 at $45.96 compared to previous day's close of $45.84. The stock touched a new 10-year high of $49.44 on Monday.
The stock closed Monday's regular trading up 6.13 percent at $48.65 on the NASDAQ Stock Market with a volume of 1.79 million shares. The stock traded between $20.45 and $49.44 during the past 52 weeks.