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Promising New Recombinant Factor IX Drug Receives FDA Approval for Clinical Studies

Biovitrum AB and Syntonix Pharmaceuticals received U.S. Food and Drug Administration approval to begin phase I/IIa clinical studies to measure the safety, tolerability and pharmacokinetics of their recombinant factor IX (FIXFc) drug in previously treated patients with hemophilia B. The pharmacokinetic portion of the studies will focus largely on the product’s half-life. Extending the half-life of the product could allow for less frequent infusions for individuals with hemophilia B, whether they are treating prophylactically or episodically, as bleeds occur.     

Syntonix’s technologies employ therapeutic proteins, peptides and antibodies to help create longer-acting biopharmaceutical therapies to treat chronic disorders such as anemia, multiple sclerosis and autoimmune disorders. Biovitrum develops and manufactures protein-based therapies for common diseases and those affecting smaller populations.

“Hemophilia is a prioritized therapeutic and business area within Biovitrum,” said Martin Nicklasson, CEO of Biovitrum. “We are excited to develop FIXFc with Syntonix because we believe that the company’s SynFusionTM technology has resulted in a very promising, long-acting recombinant Factor IX product opportunity that has the potential to reduce the frequency of infusions required for hemophilia B patients to manage their disease.”

Biovitrum has headquarters in Sweden and the United Kingdom. Syntonix, a wholly-owned subsidiary of Biogen Idec, is based in Waltham, MA. The two companies first entered into a co-development and commercialization alliance to develop FIXFc in January 2006.

The only recombinant factor IX product currently available in the U.S. is Wyeth Pharmaceutical’s BeneFIX®. 

Source: Biovitrum press release dated March 4, 2008