Regeneron's Eye Drug Eylea Cleared in the EU for DME - Analyst Blog

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Regeneron Pharmaceuticals ' ( REGN ) key growth engine Eylea received EU approval for treating patients suffering from visual impairment due to diabetic macular edema (DME). Eylea is now approved for three eye disorders in the EU. Following the approval, partner Bayer ( BAYRY ) intends to launch the drug for the DME indication by Sep 30, 2014. DME or the swelling of the macula is a common cause of blindness among diabetics.

We note that the drug was approved in the U.S. for the DME indication last month (read more: Regeneron's Eylea Gets FDA Nod for Diabetic Macular Edema ).

Eylea is already approved for the treatment of neovascular age-related macular degeneration (wet AMD) and macular edema following central retinal vein occlusion in the EU and the U.S.

We expect the highly successful drug to gain FDA approval for a fourth indication - macular edema following Branch Retinal Vein Occlusion (BRVO) - in October. The European approval for the BRVO indication has been sought by Bayer. Approval for the BRVO indication in the U.S. in October will go a long way in helping the company achieve its 2014 U.S. Eylea sales outlook (in the range of $1.7 billion to $1.8 billion).

Eylea performed encouragingly in the second quarter of 2014 after a weak first quarter. Sales of the eye drug climbed 25.8% year over year to $415 million in the second quarter of 2014. Sales of Eylea in ex-U.S. markets were $247 million. EU approval for the DME indication will boost ex-U.S. sales further. We expect investor focus to remain on the performance of the drug going forward.

Regeneron carries a Zacks Rank #5 (Strong Sell). The unfavorable rank stems mainly from its huge earnings miss in the second quarter 2014. Better-ranked stocks in the health care sector include Gilead Sciences ( GILD ) and Actelion ( ALIOF ). Both stocks sport a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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