Biogen Idec and Biovitrum to initiate hemophilia trial

Wed. October 21, 2009; Posted: 09:43 AM

Oct 21, 2009 (Datamonitor via COMTEX) -- BIIB | Quote | Chart | News | PowerRating -- Biogen Idec, a US-based biotechnology company, and Biovitrum, a Swedish pharmaceutical company, have reported that they plan to advance the companies' long-acting, fully recombinant Factor IX Fc fusion protein or rFIXFc into a registrational clinical trial in hemophilia B patients.

The decision to advance the program is based on promising data from a Phase I/IIa open-label, multi-center, safety dose-escalation and pharmacokinetic study of intravenous rFIXFc in severe, previously treated hemophilia B patients. rFIXFc was well tolerated in the study.

In addition, rFIXFc demonstrated a prolonged half-life compared to historical data for existing therapies, supporting advancement of the program, said Biogen Idec.

The global trial is being designed to assess the safety, pharmacokinetics and efficacy of rFIXFc in the prevention and treatment of bleeding in hemophilia B patients. The trial will commence following communications with regulatory authorities. rFIXFc has received orphan medicinal product designation for the treatment of hemophilia B from both the European (EMEA) and US (FDA) authorities.

Glenn Pierce, vice president and chief medical officer of Biogen Idec's hemophilia therapeutic area, said: "rFIXFc is an example of Biogen Idec's commitment to developing innovative therapies to address significant unmet medical needs. The rFIXFc program has the potential to improve the lives of individuals with hemophilia B and we are excited about advancing the program."

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