Biogen Idec and Swedish Orphan Biovitrum have tweaked their ongoing partnership for the development of recombinant factor VIII Fc fusion protein (rFVIIIFc) and recombinant factor IX Fc fusion protein (rFIXFc) for hemophilia A and B, respectively. Both products are in clinical development. The amended agreement means that Biogen Idec now has full responsibility for the development and costs associated with both products as well as manufacturing rights.
While Swedish Orphan Biovitrum retains commercial rights in Europe, Russia, Turkey, and the Middle East, the new deal gives Biogen Idec marketing licenses and responsibilities for rest-of-world territories that were previously shared between the two companies. Biogen Idec’s existing rights to North America are unaffected.
“The updated agreement fits with Biogen Idec’s recognition of the potential of these innovative products to make a significant difference in the lives of people with hemophilia A and B and with our own strengths in manufacturing, development, and the global commercialization of products,” remarks James C. Mullen, Biogen Idec’s president and CEO.
Swedish Orphan Biovitrum says its partner’s experience and infrastructure make it an ideal fit for the hemophilia program. “Additionally, we will now be able to focus on delivering value in the rest of our exciting and promising development pipeline and current commercial product portfolio while improving our near-term cost-base,” comments Martin Nicklasson, CEO.
A registrational, open-label, multicenter trial with rFIXFc in hemophilia B patients was initiated in January 2010. 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. rFVIIIFc is currently being evaluated in a Phase I/IIa, open-label dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of rFVIIIFc in hemophilia A patients.