) 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 (
) 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
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
) and Actelion (
). Both stocks sport a Zacks Rank #1 (Strong Buy).
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