Biogen Idec and Swedish Orphan Biovitrum commence dosing in rFIXFc Phase I/IIa trial for hemophilia B

Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (STO: BVT) today announced that the first patient was dosed in a registrational, open-label, multicenter trial designed to evaluate the safety, pharmacokinetics and efficacy of the companies’ long-acting, recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. The trial, called the B-LONG study, will determine the efficacy of rFIXFc in the prevention and treatment of bleeding in approximately 75 previously-treated patients with severe hemophilia B.

“In a Phase I/IIa study, rFIXFc showed the potential to prolong protection from bleeding in severe, previously-treated patients with hemophilia B.”

“Hemophilia B requires frequent injections, often two to three times a week, causing a major burden on individuals with the disorder,” said Amy Shapiro, M.D., Principal Investigator of the B-LONG trial and Medical Director of the Indiana Hemophilia and Thrombosis Center. “In a Phase I/IIa study, rFIXFc showed the potential to prolong protection from bleeding in severe, previously-treated patients with hemophilia B.”

rFIXFc is a fully-recombinant clotting factor developed using Biogen Idec's novel and proprietary monomeric Fc-fusion technology. In the B-LONG trial, rFIXFc’s ability to prevent bleeding using different dosing regimens will be measured by evaluating the number of breakthrough bleeding episodes annualized over the study period. The study will also evaluate the efficacy of rFIXFc in on-demand and surgical settings, and compare the pharmacokinetics of a single dose of rFIXFc with a single dose of a commercially available recombinant Factor IX product.

“We are excited that rFIXFc is the first long-acting Factor IX therapy to enter registrational trials,” said Glenn Pierce, M.D., Ph.D., Vice President and Chief Medical Officer of Biogen Idec’s hemophilia therapeutic area. “We are making important progress in our efforts to develop a treatment that can make a difference to the hemophilia B community.”

“rFIXFc is an innovative therapy that offers the potential to make a positive impact in the lives of people with hemophilia B,” said Peter Edman, Ph.D., Chief Scientific Officer of Swedish Orphan Biovitrum. “Enrolling a patient in our first registrational trial is also a notable achievement for Swedish Orphan Biovitrum.”

Using the same proprietary technology as rFIXFc, Biogen Idec and Swedish Orphan Biovitrum are also developing a fully-recombinant, long-acting Factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. rFVIIIFc is currently being evaluated in a Phase I/IIa, open-label, dose-escalation, multicenter study to evaluate the safety, tolerability and pharmacokinetics of rFVIIIFc in hemophilia A patients. For more information on the rFIXFc and rFVIIIFc trials, please visit www.biogenidechemophilia.com.