Regeneron Pharmaceuticals, Inc., a fully integrated biopharmaceutical company, and Bayer Yakuhin Ltd., Bayer's Japanese subsidiary, have entered into a co-promotion agreement with Santen Pharmaceutical Co., Ltd. for Eylea (aflibercept) injection in Japan.

As previously announced, Bayer Yakuhin has submitted an application for marketing authorization to the Ministry of Health, Labour 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 & CEO of Bayer Yakuhin, Ltd. “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 that approximates the economics of the profit split.  In certain specified circumstances, the royalty may revert to a profit share arrangement.

Eylea is approved for sale in the United States for the treatment of wet AMD and marketing approval has also been granted in Australia.  Bayer HealthCare has submitted applications in Europe and other countries and has initiated a phase III clinical study for wet AMD in China. Beyond the wet AMD indication, Eylea is in phase III clinical studies for the treatment of 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 United States, and has been granted a Prescription Drug User Fee Act (PDUFA) date of September 23, 2012.

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of Eylea. Eylea was approved in the United States for the treatment of wet AMD in November 2011. Regeneron maintains exclusive rights to Eylea in the United States. Bayer HealthCare owns the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales of Eylea, except for Japan where Regeneron will receive a royalty on net sales.

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 (angiogenesis) supporting the growth of the body's tissues and organs. However, in certain diseases, such as wet AMD, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema. Scarring and loss of fine-resolution central vision often results.

Eylea (aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. EYLEA acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors.

In the United States, Eylea is indicated for the treatment of patients with neovascular age-related macular degeneration (wet AMD).

Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.

Santen is a global company which researches, develops and markets ophthalmic products for physicians worldwide. Among prescription ophthalmic pharmaceuticals, Santen holds the top share within the Japanese market and is one of the leading ophthalmic companies worldwide.

Bayer Yakuhin Ltd., is a healthcare company which combines business activities of Pharmaceuticals, Radiology & Interventional and Animal Health (companion and food animal products).