Biogen Idec (BIIB) announced that its hemophilia B drug, Alprolix, gained approval in Canada. Health Canada approved the drug for controlling and preventing bleeding as well as for routine prophylaxis in adults and children (≥12 years) suffering from hemophilia B.
We note that Alprolix is the first long-acting therapy for hemophilia B to gain approval. Biogen is currently seeking approval for Alprolix from the U.S. Food and Drug Administration (FDA) for hemophilia B. Feedback should be out in the second quarter of 2014.
Biogen is also seeking FDA approval for another hemophilia candidate − Eloctate for hemophilia A. A feedback from the FDA should be out by mid-2014. The company is conducting pediatric studies on Alprolix and Eloctate. Data from these studies are required for regulatory applications in the EU.
We note that Biogen has another candidate, Plegridy, under review in the U.S. and the EU. The company is looking to get the candidate approved for the treatment of relapsing-remitting multiple sclerosis. A response should be out in the second half of 2014.
We expect 2014 to be a catalyst rich year for Biogen. Apart from receiving a response from regulatory authorities regarding Eloctate, Alprolix and Plegridy, Biogen expects several proof-of-concept or proof of biology read-outs this year, including data on anti-LINGO (acute optic neuritis), BIIB037 (Alzheimer's disease), neublastin (neuropathic pain), STX-100 (idiopathic pulmonary fibrosis) and anti-CD40 (lupus).
Biogen is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Alkermes plc (ALKS), ANI Pharmaceuticals, Inc. (ANIP) and Alexion Pharmaceuticals, Inc. (ALXN). All these stocks carry a Zacks Rank #1 (Strong Buy).
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