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Bayer, Regeneron get EU nod for Eylea, next stop Japan

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Bayer and partner Regeneron ($REGN) have notched another win for Eylea, getting approval for the eye drug in Europe for treating wet age-related macular degeneration.

Eylea is already approved in the U.S. for wet AMD and in macular edema after central retinal vein occlusion (CRVO). It also has gotten wet AMD approval in some Latin American countries, Australia and Japan. Bayer, in fact, added in today's announcement that it will launch the drug "in one of our biggest markets--Japan--very soon."

Eylea's effectiveness has helped it quickly snatch market share from its established rival Lucentis from Roche ($RHHBY). Both drugs have been shown to restore some sight to patients with wet AMD, a disease that can lead to blindness. Eylea, however, comes with a lower cost, and has been found to require fewer treatments--at least in the first year of use.

Regeneron sells the drug in the U.S. and shares it with Bayer elsewhere. Its success has been important to Bayer, but for the much smaller Regeneron it has been phenomenal. Eylea was only approved by the FDA about this time last year but despite head-to-head competition from Lucentis--and from off-label use of the cancer drug Avastin--Eylea has continued to rack up one sales gain after another for Regeneron. For the first half of the year, it brought in $318 million. Sales grew again in the third quarter and now, the company is expecting Eylea revenue of at least $790 million for the year.

- here's the Bayer release

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