Biogen Idec (BIIB - Free Report) and partner Swedish Orphan Biovitrum AB (Sobi) reported positive top-line data on their hemophilia A candidate, Eloctate from a phase III pediatric study (Kids A-LONG).
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The study, which evaluated the safety, efficacy and pharmacokinetics of Eloctate, showed that twice-weekly prophylactic dosing with Eloctate maintained low bleeding rates in previously treated children (aged below 12 years) suffering from severe hemophilia A. Eloctate was found to be generally well-tolerated with no inhibitors being detected.
Eloctate is currently under the U.S. Food and Drug Administration (FDA) review for the treatment of hemophilia A in adults. A feedback from the FDA should be out by mid-2014.
Meanwhile, Biogen is conducting the phase III Kids B-LONG study with Alprolix for the treatment of hemophilia B in children below 12 years of age. Results from both these studies will help the company file for pediatric indications and also support marketing approval in the EU.
Alprolix is already approved in the U.S. and Canada for the treatment of hemophilia B in adults (> 17 years). Biogen plans to launch Alprolix in the U.S. in early May 2014.
We note that Biogen has another candidate, Plegridy, under review in the U.S. and the EU 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 with several data-readouts expected this year.
Biogen carries a Zacks Rank #3 (Hold). Some better-ranked biotech stocks include Amgen Inc. (AMGN - Free Report) , ZIOPHARM Oncology, Inc. (ZIOP - Free Report) and Alexion Pharmaceuticals, Inc. (ALXN - Free Report) . While Amgen and ZIOPHARM carry a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).