Biogen Idec And Sobi Initiate Global Clinical Trials Of Long-Lasting Hemophilia A And B Product Candidates In Children

Biogen Idec (NASDAQ:BIIB) and Swedish Orphan Biovitrum (STO:SOBI) today announced the initiation of two global pediatric clinical trials of the companies’ long-lasting recombinant Factor VIII and Factor IX Fc fusion proteins (rFVIIIFc and rFIXFc) in hemophilia A and B.

rFVIIIFc and rFIXFc are fully-recombinant clotting factors developed using Biogen Idec's novel and proprietary monomeric Fc-fusion technology, which makes use of a natural mechanism to recycle rFVIIIFc and rFIXFc in the circulation in the body. Biogen Idec and Sobi are studying this technology to see whether it extends half-life and enables the proteins to last longer in the body than commercially-available factor products.

“Children with hemophilia share a need for long-lasting factor products that may prolong protection from bleeding and reduce the frequency of intravenous infusions,” said Glenn Pierce, M.D., Ph.D., senior vice president of Global Medical Affairs and chief medical officer of Biogen Idec’s hemophilia therapeutic area. “The pediatric clinical trials are an important complement to the ongoing adult studies and further demonstrate our commitment to develop new treatments for the hemophilia community.”

“With these studies, we extend the clinical development of rFVIIIFc and rFIXFc to address a broader patient population including children with hemophilia,” said An van Es-Johansson, M.D., head of clinical development at Sobi. “The initiation of these studies represents an important milestone for our clinical development program and supports our global registration strategy for the products.”

The clinical trials are open-label, multicenter studies designed to evaluate the safety, pharmacokinetics and efficacy of rFVIIIFc and rFIXFc in previously-treated children with severe hemophilia A or B under the age of 12 years. The first patient has been dosed in the rFIXFc pediatric study, and the rFVIIIFc pediatric study is now actively recruiting patients. Global registration studies of rFVIIIFc and rFIXFc are ongoing in previously-treated patients with severe hemophilia A or B aged 12 years and over, with data readouts expected in the second half of the year.

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