Regeneron Pharmaceuticals, Inc.
) eye drug Eylea received FDA approval for a third indication − the
treatment of diabetic macular edema (DME).
Eylea is already approved for the treatment of neovascular
age-related macular degeneration (wet AMD) and macular edema
following central retinal vein occlusion.
DME (also known as swelling of the macula) is one of the primary
causes of vision loss among the working-age group of the U.S.
population and commonly affects patients suffering from diabetes.
According to the press release issued by Regeneron, out of 29.1
million diabetic adults in the U.S., approximately 1.5 million have
been diagnosed with DME, while nearly 1 million cases remain
Regeneron has an agreement with Bayer (
) for the development and commercialization of Eylea. While
Regeneron holds exclusive rights to sell Eylea within the U.S.,
Bayer has exclusive commercialization rights to the product in the
ex-U.S. markets. Both companies equally share the profits from
Eylea sales, excepting Japan, where Regeneron receives royalties on
Eylea's net sales.
We remind investors that Eylea is currently under review in the EU
for the DME indication. With the European Committee for Medicinal
Products for Human Use (CHMP) recommending the approval of Eylea
for the treatment of DME, we expect Eylea to gain EU approval in
the second half of 2014.
Although Eylea's U.S. approval for DME is based on one-year data
from two phase III studies (VISTA-DME and VIVID-DME), Regeneron
will continue these studies for a total of three years. Eylea is
also in another phase III study (VIVID-EAST-DME).
We are encouraged by Eylea's label expansion which should boost
sales further. In 2013, U.S. revenues for Eylea amounted to $1.4
billion (out of global revenues of $1.9 billion), up 68% year over
Regeneron carries a Zack Rank #3 (Hold). Some better-ranked stocks
in the biotech sector are Actelion Ltd. (
) and Aegerion Pharmaceuticals, Inc. (
). While Actelion carries a Zacks Rank #1 (Strong Buy), Aegerion
holds a Zacks Rank #2 (Buy).
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