Printer Friendly

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

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.

((Comments on this story may be sent to>PDJune 29, 2011>JNM2 EQUITYBITES.PRICEDATENOT APPLICABLE.DAY

COPYRIGHT 2011 Normans Media Ltd.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2011 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:M2 EquityBites (EQB)
Geographic Code:9JAPA
Date:Jun 29, 2011
Previous Article:Missouri American Water awards over USD60,000 to Tornado Relief Programmes in Joplin.
Next Article:American Electric Power elects Lisa Barton as executive vice president of Transmission.

Terms of use | Privacy policy | Copyright © 2020 Farlex, Inc. | Feedback | For webmasters