Biogen, Sobi Announce Publication of Phase 3 ALPROLIXTM Haemophilia B Study Data in NEJM

Today Biogen Idec

and Swedish Orphan Biovitrum AB (publ) (Sobi)

announced the publication of detailed results from the pivotal Phase 3 study of ALPROLIXTM, the companies' 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 (NEJM). 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 3 study, ALPROLIX has the potential to be the first important advance in haemophilia B treatment in more than 16 years. The study, called B-LONG, is the largest Phase 3 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