Marketing application for FDA-approved therapy has been filed in Japan for wet AMD.
Santen Pharmaceuticals negotiated co-promotion rights to Regeneron Pharmaceuticals and Bayer HealthCare’s Eylea® (aflibercept; VEGF Trap-Eye) injection in Japan. Bayer’s Japanese subsidiary Bayer Yakuhin has already submitted a marketing application to the country’s regulatory authority for use of Eylea in the treatment of neovascular age-related macular degeneration (wet AMD). The deal with Santen means Bayer and Regeneron have in addition changed their previous 50/50 profit-share agreement for Eylea in Japan to a royalty-based deal.
Eylea was approved in the U.S. for the treatment of wet AMD in November 2011. Marketing authorization has also been granted in Australia, and applications in Europe and other markets have been submitted by Bayer. A Phase III wet AMD trial is ongoing in China. Phase III trials are also in progress to evaluate Eylea for the treatment of diabetic macular edema, myopic choroidal neovascularization, and branch retinal vein occlusion. Regeneron has filed an sBLA in the U.S. for Eylea in the treatment of central retinal vein occlusion.
Bayer and Regneron are collaborating on the global development of Eylea. Under terms of the deal, Regeneron retains all rights to the drug in the U.S., and Bayer HealthCare has marketing rights outside the U.S., where the companies will share profits from sales of Eylea equally (excluding Japan).
Eylea is a recombinant fusion protein comprising portions of human VEGF receptors 1 and 2 and extracellular domains fused to the Fc portion of IgG1. The product is formulated for intravitreal administration.