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GEN News Highlights : Sep 28, 2012

Wet-AMD Therapy Approved in Japan

Regeneron Pharmaceuticals confirmed Japanese regulatory approval of Eylea™ (aflibercept) for the treatment of wet age-related macular degeneration (wet AMD). Clearance was based on data from two Phase III trials (View 1 and View 2), which demonstrated that intravitreal injections of Eylea once a month for three months, and then once every two months, was equivalent to treatment with monthly injections of Lucentis® (ranibizumab) in terms of patients maintaining visual acuity.

Eylea was approved for the wet AMD indication in the U.S. in November 2011, and earlier this month FDA cleared the drug for treating central retinal vein occlusion (CRVO). Australian approval for the wet AMD indication was granted earlier this year. Regeneron’s partner, Bayer HealthCare, has separately received a positive recommendation from the European Regulatory Authority’s Committee for Medicinal Products for Human Use, following the firm’s wet-AMD submission for Eylea. A European filing for the CRVO indication is planned once the wet-AMD approval has been formally granted.

Eylea is a recombinant fusion protein comprising portions of human VEGF receptors 1 and 2 extracellular domains, fused to the Fc portion of human IgG. The drug is designed to act as a soluble decoy receptor that binds VEGF-A and placental growth factor (PIGF) to block binding and activation of their cognate VEGF receptors.

Bayer HealthCare and Regeneron are collaborating on global development of Eylea. Regeneron holds exclusive rights to the drug in the U.S., and Bayer HealthCare has licensed exclusive marketing rights outside the U.S. In Japan the firm will co-promote the drug with Santen Pharmaceutical.