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Bayer, Regeneron enter into agreement with Santen to co-promote Eylea in Japan

Tuesday, May 08 2012 | Comments
Evidence Grade 0 What's This?
Bayer HealthCare AG and Regeneron Pharmaceuticals Inc. entered into an agreement with Santen Pharmaceutical Co. Ltd. to co-promote the ophthalmic drug Eylea (aflibercept) in Japan.

Under the terms of the agreement, Bayer's Japanese subsidiary, Bayer Yakuhin Ltd., will co-promote Eylea with Santen in Japan, where regulatory authorities are reviewing an application to market the drug as a treatment for neovascular age-related macular degeneration (wet AMD).

In addition, Bayer and Regeneron amended their existing global license and collaboration for Eylea, converting the firms' agreement to share profits equally in Japan into a royalty arrangement in which Regeneron is entitled to royalties on net sales of Eylea in this market. The companies noted that the royalty arrangement approximates the economics of the profit split, and that the royalty arrangement could revert to a profit-sharing arrangement under certain circumstances.

Regeneron holds the exclusive rights to the drug in the United States, where it is approved as a treatment for wet AMD. Regeneron has also submitted a supplemental Biologics License Application (sBLA) for Eylea to the Food and Drug Administration seeking approval to market the drug as a treatment for central retinal vein occlusion. The Prescription Drug User Fee Act action data for this sBLA is Sept. 23.

Bayer holds exclusive marketing rights to Eylea outside of the United States, where Bayer and Regeneron share equally in the profits from sales, except in Japan, where profits are divided according to the newly established royalty arrangement.

Eylea, which is also known as vascular endothelial growth factor (VEGF) Trap-Eye, is in Phase III development for other ophthalmic conditions, including diabetic macular edema, myopic choroidal neovascularization and branch retinal vein occlusion.

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