(REGN) Bayer Seeks Eylea Approval in Japan

Germany’s Bayer (BAYRY) recently submitted an application to the Japanese Ministry of Health, Labor and Welfare (MHLW) seeking approval to market its eye treatment VEGF (vascular endothelial growth factor) trap-eye (proposed trade name: Eylea) in the country.

The clearance is being sought to market the drug for treating patients suffering from the neovascular form of age-related macular degeneration (wet AMD).

Bayer’s application is based on positive results from the VIEW program (VEGF trap-Eye: Investigation of Efficacy and Safety in Wet AMD) which consisted of two studies, VIEW 1 and VIEW 2. The studies evaluated the efficacy of VEGF trap-eye versus Roche/Novartis’ (RHHBY/NVS) Lucentis (ranibizumab), an anti-angiogenic agent approved for treating wet AMD. Bayer/Regeneron’s eye treatment was found to be non-inferior to Lucentis.

Bayer is co-developing the candidate with Regeneron Pharmaceuticals Inc. (REGN) for treating patients suffering from eye disorders such as wet AMD, central retinal vein occlusion (CRVO), diabetic macular edema (DME) and myopic choroidal neovascularization (mCNV).

Per the agreement, Bayer is responsible for marketing VEGF trap-eye in ex-US markets on approval. The profit emanating from the sales of the candidate in those markets will be shared equally by the companies.  However, the entire US rights pertaining to VEGF trap-eye lie solely with Regeneron.

The companies are also seeking approval for the candidate in the EU for the wet AMD indication. Moreover, the VEGF trap-eye therapy is currently under priority review in the US for the same indication. A response should be out by August 20, 2011. Approval of the candidate in markets across the globe would boost the top line both at Bayer and Regeneron.

Our Recommendation

Currently, we have a Neutral stance on Bayer in the long run. The company carries a Zacks #3 Rank (Hold rating) in the short run. We have similar long-term and short-term stances on Regeneron.

BAYER A G -ADR (BAYRY): Free Stock Analysis Report

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