Bayer Files for Another Eylea Indication
The HealthCare segment at Bayer (BAYRY) submitted a marketing approval application for Eylea (VEGF Trap-Eye) in Japan for the treatment of patients suffering from myopic choroidal neovascularization (mCNV). Bayer’s regulatory submission for Eylea in Japan was on the basis of positive results from the phase III MYRROR study.
Results from the study revealed that patients treated with Eylea had a mean improvement in best-corrected visual acuity (:BCVA) of 12.1 letters from baseline compared to a loss of 2 letters in patients receiving sham injections at week 24. The improvement was maintained at the end of week 48 as well.
Eylea was first approved in the U.S. in late 2011 for treating patients suffering from the neovascular form of age-related macular degeneration (wet AMD). Sales of the drug have been on the rise since then. Eylea is also approved in the EU, Japan and many other countries for this indication. The drug is also approved for the treatment of macular edema following central retinal vein occlusion (:CRVO) in the U.S., EU and other countries.
Bayer has a collaboration agreement with Regeneron Pharmaceuticals Inc. (REGN) for the global development of Eylea. Per the terms of the agreement, Regeneron owns the entire U.S. rights pertaining to the eye drug. Bayer is however responsible for marketing Eylea in ex-U.S. markets. The profit earned from the sales of Eylea in those markets is shared equally by the companies. However, in Japan, Regeneron will receive royalties on Eylea’s net sales.
We are encouraged by the company’s progress with Eylea. The company recorded Eylea sales of €85 million for the third quarter of 2013. Successful label expansion of the drug will further boost its sales.
Bayer, a large-cap pharma stock, presently carries a Zacks Rank #2 (Buy). Other players in the large-cap pharma SPACE, which look attractive at current levels, include Johnson & Johnson (JNJ) and Allergan Inc. (AGN). Both these stocks carry the same Zacks Rank as Bayer.
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