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Biogen's Eloctate Approved in the U.S.

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Biogen (BIIB) gained FDA approval for its hemophilia A treatment, Eloctate. Eloctate can be used for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults as well as children with hemophilia A.

Hemophilia A, a rare, chronic, genetic disorder under which blood clotting ability is impaired, can lead to recurrent and extended bleeding episodes. Approval makes Eloctate the only hemophilia A therapy that has the ability to cut the frequency of bleeding episodes with prophylactic infusions every three to five days.

Eloctate is the second product in Biogen’s hemophilia portfolio to gain approval this year. In late March, Biogen’s hemophilia B product, Alprolix was approved in the U.S. Alprolix is also approved in Canada and Australia. Eloctate is currently under review in these countries as well as Japan.

A convenient dosing schedule (supported by a longer duration of action and a suitable safety profile) could help these products capture share from existing products in the hemophilia market.

While Alprolix is already available, Eloctate will be launched in July.

We expect 2014 to be catalyst rich for Biogen. The company remains in a strong position in the multiple sclerosis market. While Tecfidera should continue performing well, Tysabri and Avonex should remain strong contributors to the top line. This year, Biogen could launch a third product, apart from Eloctate and Alprolix. Experimental multiple sclerosis treatment, Plegridy, is currently under FDA review with a response expected in the second half of the year.

Biogen is a Zacks Rank #3 (Hold) stock. Some better-ranked biotech stocks include Gilead Sciences Inc. (GILD), Osiris Therapeutics, Inc. (OSIR) and Regeneron Pharmaceuticals, Inc. (REGN). All these are Zacks Rank #1 (Strong Buy) stocks.

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