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FDA accepts Biogen’s application for hemophilia A candidate

05/13/2013 0 Comments Contact Our News Editors

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Don Seiffert
Associate Editor MHT- Boston Business Journal
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The U.S. Food and Drug Administration has accepted the second of the two applications for a biologic drug candidate to treat hemophilia that Biogen Idec. (Nasdaq:BIIB) has submitted this year.

On Monday the Weston, Mass.-based biotech announced that the FDA has accepted the Biologics License Application (BLA) for Eloctate for the treatment of hemophilia A. Eloctate is a recombinant factor VIII Fc fusion protein which delays the destruction of an essential blood-clotting protein, allowing for longer intervals in between injections of factor VIII. Treatment for hemophilia A (a rare, inherited disorder which impairs a patients’ ability to clot blood) currently consists of 150 to 180 injections annually.

In a research note last month, Karen Andersen, an analyst at Morningstar, estimated the market for the hemophilia A drug to be about $6 billion, but said that Biogen’s share will be limited by competitors with drugs expected to hit the market in the next couple of years. “Baxter and Bayer have long-acting versions of their current blockbuster recombinant proteins that could reach the market in 2015, and Novo Nordisk could enter as early as 2014,” she wrote.

In March, the FDA accepted Biogen’s BLA for its factor IX candidate, Alprolix, for use in patients with hemophilia B. Both drugs could potentially launch by the end of 2013, according to Andersen.

Biogen’s stock was up 3 percent on Monday to $218.89 as of 10 a.m. The company has gained 43 percent since the beginning of the year, largely on the strength of its third drug for multiple sclerosis, Tecfidera, which was approved in late March. In its most recent quarterly report, Biogen beat consensus estimates for net income by a wide margin, bringing home earnings per share of $1.97 versus estimates of $1.57 a share for the first three months of this year.

Last week, Biogen paid a $3.5 million milestone payment to Isis Pharmaceuticals Inc. in Carlsbad, Calif. for the dosing of the first patient in a Phase 2 trial of ISIS-SMNRx in infants with spinal muscular atrophy (SMA). Biogen and Isis forged an exclusive worldwide collaboration deal worth up to $299 million in January 2012.

Rare Disease of Interest: 
Hemophilia (A & B)
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