TARRYTOWN, N.Y.—Regeneron Pharmaceuticals Inc. and BayerHealthCare have announced that Bayer Yakuhin, Ltd., Bayer's Japanesesubsidiary, has entered into a co-promotion agreement with SantenPharmaceutical Co., Ltd. for EYLEA (afilbercept) Injection in Japan. Inaddition, Bayer Yakuhin has submitted a marketing authorization application tothe Ministry of Health, Labor and Welfare for EYLEA for the treatment ofneovascular age-related macular degeneration (wet AMD).
Additionally, Bayer and Regeneron also amended their currentglobal license and collaboration agreement for EYLEA, changing the 50/50 profitshare for Japan into a royalty arrangement that effectively approximates theearnings of the profit split. In specific circumstances, the new royaltyarrangement may revert back to a profit share arrangement.
"With this agreement and upon marketing authorization, anewly formed Bayer Yakuhin ophthalmology field force and Santen, the leadingophthalmology company in Japan, will promote EYLEA," Sebastian Guth, presidentand CEO of Bayer Yakuhin, said in a press release. "We expect that the combinedresources of the two companies will allow EYLEA to achieve a broader and fasterreach into the Japanese ophthalmology community and potentially benefit a greaternumber of patients."
Bayer HealthCare and Regeneron have worked together since2006, and are collaborating on the global development of EYLEA, which gainedU.S. Food and Drug Administration approval for the treatment of wet AMD inNovember 2011. Under the terms of the agreement, Regeneron holds exclusiverights in the United States and Bayer HealthCare holds exclusive marketingrights outside of the United States, where the two companies will share profitsfrom future sales of EYLEA, except in Japan, where the royalty agreementapplies. Regeneron stands to earn up to $225 million in development and salesmilestones, and if the collaboration is profitable, Regeneron will reimburseBayer HealthCare for 50 percent of development costs related to the partnership.
In addition to securing sale approval in the United States,EYLEA has also gained marketing approval in Australia, and applications havebeen submitted in Europe and other countries. Bayer has begun a Phase IIIclinical study of EYLEA for wet AMD in China as well. The compound is alsoundergoing Phase III clinical studies for the treatment of diabetic macularedema, myopic choroidal neovascularization and branch retinal vein occlusion.An sBLA has been filed for the drug for central retinal vein occlusion in theUnited States by Regeneron, who has been granted a Prescription Drug User FeeAct date of Sept. 23, 2012.
EYLEA Injection, also known as VEGF Trap-Eye, is arecombinant fusion protein. Vascular endothelial growth factor (VEGF) is anaturally occurring protein, and though its normal role is to initiate theformation of new blood vessels, in some diseases it is associated with thegrowth of abnormal new blood vessels in the eye, as with wet AMD. EYLEAfunctions as a soluble decoy receptor that binds VEGF-A, thereby inhibitingbinding on the part of cognate VEGF receptors.
SOURCE: Regeneron press release
