Bayer HealthCare’s Japanese subsidiary, Bayer Yakuhin and Regeneron Pharmaceuticals have entered into a co-promotion agreement with Santen Pharmaceutical Co. for EYLEA (aflibercept) Injection in Japan. Bayer Yakuhin has submitted an application for marketing authorization to the Ministry of Health, Labor and Welfare (MHLW) for EYLEA for the treatment of neovascular age-related macular degeneration (wet AMD).

“With this agreement and upon marketing authorization, a newly formed Bayer Yakuhin ophthalmology field force and Santen, the leading ophthalmology company in Japan, will promote EYLEA,” said Sebastian Guth, president and chief executive officer of Bayer Yakuhin. “We expect that the combined resources of the two companies will allow EYLEA to achieve a broader and faster reach into the Japanese ophthalmology community and potentially benefit a greater number of patients.”

Bayer and Regeneron have also amended their existing global license and collaboration agreement for EYLEA to convert the 50/50 profit share for Japan into a royalty arrangement equating a profit split.  In certain circumstances, the royalty may revert to a profit share arrangement.

EYLEA is approved for wet AMD in the U.S. and Australia. Bayer HealthCare has submitted applications in Europe and other countries and has initiated a Phase III trial for wet AMD in China. EYLEA is also being studied in diabetic macular edema (DME), myopic choroidal neovascularization (mCNV), and branch retinal vein occlusion (BRVO). Regeneron has filed an sBLA for EYLEA in central retinal vein occlusion (CRVO) in the U.S., with a Prescription Drug User Fee Act date of September 23, 2012.

Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the U.S. and Bayer HealthCare owns the exclusive marketing rights outside the U.S., where the companies will share profits from future sales, except for Japan where Regeneron will receive a royalty on sales.