Biogen Idec, Swedish Orphan Biovitrum present results from rFIXFc Phase 1/2a study in hemophilia B

Jul 12 2010

Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (STO: SOBI) today announced results from a Phase 1/2a open-label, dose-escalation, safety and pharmacokinetic study of the companies' long-lasting, fully-recombinant factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. The data, which were presented at the World Federation of Hemophilia Congress in Buenos Aires, Argentina, on July 11, 2010, showed that rFIXFc was well tolerated and demonstrated an approximately three-fold increase in half-life compared to historical data for existing therapies.

“Our hemophilia B program demonstrates Biogen Idec's commitment to utilizing pioneering science to create new standards of care for patients”

"Current prophylactic regimens for hemophilia B require intravenous injections twice per week, so there is great desire among physicians and patients for a therapy that will provide prolonged protection from bleeding," said Amy Shapiro, M.D., Medical Director of the Indiana Hemophilia and Thrombosis Center. "Results from the Phase 1/2a trial show that rFIXFc may be able to reduce the number of injections to once weekly or less, which would be an important advancement for the hemophilia community."

"Our hemophilia B program demonstrates Biogen Idec's commitment to utilizing pioneering science to create new standards of care for patients," said Glenn Pierce, M.D., Ph.D., Vice President and Chief Medical Officer of Biogen Idec's hemophilia therapeutic area. "Developed using our novel Fc-fusion technology, rFIXFc has the potential to improve the lives of individuals with hemophilia B by providing longer-lasting protection from bleeding."

Based on positive results from the Phase 1/2a trial, rFIXFc was advanced into a global registrational trial called B-LONG in January. B-LONG is designed to assess the safety, pharmacokinetics and efficacy of rFIXFc in the prevention and treatment of bleeding in 75 previously-treated people with severe hemophilia B. rFIXFc's ability to prevent bleeding using different dosing regimens is being measured by evaluating the number of breakthrough bleeding episodes.

"We look forward to results from the registrational trial and are excited about the potential of rFIXFc to significantly reduce the frequency of injections necessary for people with hemophilia B," said Peter Edman, Ph.D., Chief Scientific Officer of Swedish Orphan Biovitrum.

Using the same proprietary technology as rFIXFc, Biogen Idec and Swedish Orphan Biovitrum are also developing a recombinant, long-lasting Factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. The companies recently announced their decision to advance rFVIIIFc into a registrational trial based on positive results from a Phase 1/2a open-label, cross-over, dose-escalation study designed to evaluate the safety and pharmacokinetics of rFVIIIFc in people with severe hemophilia A. For more information on the rFIXFc and rFVIIIFc trials, please visit www.biogenidechemophilia.com or www.clinicaltrials.gov.