Biogen Inc. BIIB and partner Swedish Orphan Biovitrum (Sobi) announced that the European Medicines Agency (EMA) has accepted for review their marketing application for Alprolix. The companies are looking to get Alprolix approved for the treatment of hemophilia B. The validation marks the initiation of the EMA's review process.
Biogen has a collaboration agreement with Sobi for the development and commercialization of Alprolix. Biogen has manufacturing and commercialization rights in North America and other regions of the world, while Sobi holds rights in the EU, North Africa, Russia and certain markets in the Middle East.
We note that Alprolix is already approved in the U.S., Canada, Japan and Australia for the control and prevention of bleeding episodes, perioperative management and routine prophylaxis in adults and children suffering from hemophilia B. The drug delivered sales of $76 million in 2014.
We are encouraged by the acceptance of Alprolix for review in the EU. As per data provided by the World Federation of Hemophilia, about 28,430 million people are estimated to be suffering from hemophilia B across the world. Approval in the EU would boost sales of the drug significantly.
Meanwhile, a long-term extension study (BYOND) evaluating the safety and efficacy of Alprolix is currently underway. Apart from Alprolix, which caters to the hemophilia B segment, Biogen also has Eloctate, catering to the hemophilia A segment.
Biogen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. GILD, Hospira Inc. HSP and Emergent BioSolutions, Inc. EBS. All three hold a Zacks Rank #1 (Strong Buy).
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