FDA Nod for Biogen's Alprolix

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Biogen (BIIB) gained U.S. approval for its hemophilia B treatment, Alprolix. A few days back, Alprolix was approved in Canada.

The FDA approved Alprolix for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia B. Biogen said that Alprolix will be available in early May.

Biogen currently has another hemophilia candidate under regulatory review – Eloctate for hemophilia A. A response from the FDA should be out by mid-2014.

A convenient dosing schedule (supported by a longer duration of action and a suitable safety profile) could help Alprolix and Eloctate capture share from existing products in the hemophilia market. However, initial uptake will most likely be modest as the hemophilia market is historically slow-moving with patients and physicians being reluctant to switch treatments without real-world experience.

Alprolix is currently under regulatory review in several countries including Australia and Japan.

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 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 biotech stocks include Alkermes plc (ALKS), Gilead (GILD) and Alexion Pharmaceuticals, Inc. (ALXN). All these stocks carry a Zacks Rank #1 (Strong Buy).

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