Phase III suvvess for Alprolix in Haemophilia B- Biogen/Sobi

Biogen Idec and Swedish Orphan Biovitrum AB (Sobi) announced the publication of detailed results from the pivotal Phase III study of Alprolix, the investigational long-lasting recombinant factor IX Fc fusion protein candidate for Haemophilia B. The study appears in the Online First edition and will appear in the December 12 print issue of The New England Journal of Medicine .

The study of Alprolix showed that people with severe Haemophilia B safely and effectively prevented or reduced bleeding episodes with prophylactic infusions every one to two weeks. As the first long-lasting investigational therapy for Haemophilia B to complete a Phase III study, Alprolix has the potential to be the first important advance in hemophilia B treatment in more than 16 years. The study, called B-LONG, is the largest Phase III clinical study in Haemophilia B ever completed. It examined the effect of Alprolix therapy delivered with multiple dosing regimens, including prophylactic (weekly or longer), episodic (on-demand) and surgical (perioperative management). Results of B-LONG formed the basis of regulatory applications for Alprolix which are currently under review in several countries including the United States, Canada, Australia and Japan.