Regeneron Pharmaceuticals Inc and Bayer HealthCare submits MAA in Japan for EYLEA for wet AMD.
M2 EQUITYBITES-June 29, 2011-Regeneron Pharmaceuticals Inc and Bayer HealthCare submits MAA in Japan for EYLEA for wet AMD(C)2011 M2 COMMUNICATIONS http://www.m2.com
Biopharmaceutical company Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and health care Bayer HealthCare jointly reported on Tuesday the submission of an application to the Ministry of Health, Labor and Welfare (MHLW) in Japan for marketing authorisation for EYLEA.
This Marketing Authorisation Application (MAA) in Japan for EYLEA, also called VEGF Trap-Eye, was initiated by Bayer HealthCare's subsidiary, Bayer Yakuhin Ltd headquartered in Osaka, Japan.
The companies are in partnership for the global development of EYLEA for the treatment of wet AMD, central retinal vein occlusion (CRVO), diabetic macular edema (DME) and myopic choroidal neovascularization (mCNV).
According to the companies, the MHLW submission is based on the two Phase 3 trials, the VIEW 1 study conducted in North America and the VIEW 2 study conducted in Japan, Europe and other countries, successfully meeting the primary endpoint.
Under the agreement, Bayer HealthCare will market EYLEA outside the US, where the companies will share equally the profits from any future sales of EYLEA. Regeneron maintains exclusive rights to EYLEA in the US.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Jun 29, 2011|
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