Successful Phase III trial for rFIXFc (Biogen/SOBI) for Haemophilia

Top-line results from B-LONG, a Phase III 123-patient study of the long-lasting recombinant Factor IX Fc fusion protein (rFIXFc), from Biogen IDEC and SOBI, showed that the treatment was effective in the control and prevention of bleeding, routine prophylaxis and perioperative management. Indeed, one injection of rFIXFc controlled 90.4% of bleeding episodes and the treatment was well-tolerated.

Biogen and SOBI also noted that a pharmacokinetic analysis of rFIXFc revealed its half-life to be 82 hours compared to 34 hours for the current haemophilia B market leader, BeneFix (recombinant coagulation factor IX) from Pfizer.Biogen plans to submit a Biologics License Application to the FDA in the first half of 2013. Noting that the European Medicines Agency requires a study in children less than 12 years of age prior to filing, the partners will submit the therapy upon completion of the ongoing Kids B-LONG study.