Regeneron/Sanofi's PCSK9 Drug Gets FDA Priority Review - Analyst Blog

Zacks Equity Research

Updated Tue, Jan 27, 2015, 6:50 PM

Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNY) received encouraging news with the FDA granting priority review to their biologics license application (BLA) for their PCSK9 antibody, Praluent. The companies are looking to get the candidate approved for the treatment of patients suffering from hypercholesterolemia.

With the FDA granting priority review status, a response should be out by Jul 24. We remind investors that Praluent is under review in the EU as well for the same indication.

We remind investors that Amgen (AMGN) has filed a lawsuit against Sanofi and Regeneron in the U.S. District Court of Delaware. Amgen through this lawsuit is looking to prevent the manufacture, use and sale of Praluent.

Amgen’s PCSK9 inhibitor, evolocumab, for the treatment of high cholesterol is currently under FDA review with a response expected by Aug 27. Though Amgen was the first to submit a BLA for a PCSK9 inhibitor, Regeneron and Sanofi accelerated their development program.

We note that several other companies are also developing PCSK9 inhibitors. We believe that Regeneron and Sanofi could have a head start over their competitors if they gain approval for their product in this lucrative blockbuster market.

Late last week, more good news came Regeneron’s way when the European Medicines Agency's Committee for Medicinal Products for Human Use recommended in favor of approving the company’s eye drug, Eylea, for the treatment of visual impairment due to macular edema secondary to central or branch retinal vein occlusion.

Regeneron currently carries a Zacks Rank #3 (Hold) while Sanofi is a Zacks Rank #4 (Sell) stock. Some better-ranked stocks in the health care sector include Alexion Pharmaceuticals, Inc. (ALXN) and Amgen. While Alexion Pharmaceuticals carries a Zacks Rank #1 (Strong Buy), Amgen is a Zacks Rank #2 (Buy) stock.

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Regeneron/Sanofi's PCSK9 Drug Gets FDA Priority Review - Analyst Blog

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