Positive results from Sobi, Biogen Idec's rFIXFc Phase 3 trial on hemophilia B

Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (Sobi) (STO: SOBI) today announced positive results from B-LONG, a clinical study that evaluated a new long-lasting clotting factor candidate in people with hemophilia B. Hemophilia B is a rare inherited disorder that impairs blood coagulation.    

Top-line results from B-LONG, a global, multi-center, Phase 3 clinical study of the companies' long-lasting recombinant Factor IX Fc fusion protein (rFIXFc), showed that rFIXFc was effective in the control and prevention of bleeding, routine prophylaxis, and perioperative management. Recombinant FIXFc was generally well-tolerated. Additional analyses of the B-LONG study are ongoing and the companies anticipate presenting further results at a future scientific meeting.

Biogen Idec plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2013. Consistent with guidelines published by the European Medicines Agency (EMA) that require a study in children less than 12 years of age prior to filing, Biogen Idec and Sobi expect to file a Marketing Authorization Application with the EMA upon completion of the ongoing Kids B-LONG study.

"The results of the B-LONG study offer the potential for longer-lasting protection from bleeding for patients with hemophilia B," said Glenn Pierce, M.D., Ph.D., Senior Vice President of Global Medical Affairs and Chief Medical Officer of Biogen Idec's hemophilia therapeutic area. "Currently, prophylactic treatment of hemophilia B requires intravenous injections up to three times a week, which makes the prospect of a longer-lasting Factor IX therapy very exciting."

"Our companies are pioneering the application of Fc fusion technology to extend the half-life of clotting factors. Fc fusion technology utilizes a naturally-occurring recycling pathway that has been successfully employed in other therapeutic areas. This approach holds promise for combining more consistent protection with fewer injections," said Geoffrey McDonough, M.D., Chief Executive Officer of Sobi. "The B-LONG study results are highly encouraging and support the potential use of this technology in hemophilia B."