Biotech Stocks Breaking News: Regeneron Gets Breakthrough Therapy Status

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Regeneron Pharmaceuticals’ (REGN) shares were up 2.7% on the news that the FDA has granted Breakthrough Therapy designation to its eye drug Eylea, for the treatment of diabetic retinopathy in patients suffering from diabetic macular edema (DME).

Breakthrough Therapy designation helps to accelerate the development and review process of experimental drugs that address an unmet medical need. The designation not only includes all of the fast track program features but a more intensive FDA guidance as well.

The Breakthrough Therapy designation for Eylea was granted on the basis of positive results from two phase III studies (VIVID-DME and VISTA-DME). Regeneron intends to submit a supplemental Biologics License Application (sBLA) for this indication by the end of this year.

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We note that Eylea is already approved in the U.S and EU for several indications including the treatment of age-related macular degeneration (wet AMD), DME and macular edema following central retinal vein occlusion (CRVO). Regeneron is currently seeking approval for macular edema following branch retinal vein occlusion (BRVO) in the U.S and EU.

We are encouraged by Eylea gaining the Breakthrough Therapy status. According to the press release issued by Regeneron, out of 29.1 million diabetic adults in the U.S., 7.7 million have diabetic retinopathy. Once approved, the new treatment will provide significant benefit to patients.

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We note that Eylea, which is the key growth driver of the company, recorded sales of $773.8 million in the first half of 2014. Eylea’s label expansion should boost sales further. We expect investor focus to remain on pipeline updates regarding Eylea.

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