Biogen Idec and Swedish Orphan Biovitrum receive opinion from EMA

Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (STO: SOBI) today announced that the European Medicines Agency’s (EMA) Pediatric Committee (PDCO) has adopted an opinion agreeing to the pediatric investigational plan for the companies’ long-lasting, fully-recombinant Factor IX Fc fusion protein (rFIXFc).

In accordance with the PDCO’s opinion, Biogen Idec and Swedish Orphan Biovitrum plan to initiate a global pediatric trial in previously-treated patients under 12 years of age as soon as sufficient data are available from a study of older patients. Under draft guidelines published by the EMA for the development of Factor IX products, pediatric data from this trial will be required in the initial submission of a Marketing Authorization Application to the European regulatory agency.

“The EMA’s agreement to our pediatric investigational plan is another milestone in our effort to develop innovative therapies for people with hemophilia,” said Glenn Pierce, M.D., Ph.D., Senior Vice President of Hemophilia at Biogen Idec. “With this opinion and the ongoing Phase 3 trials of our long-lasting Factor IX and Factor VIII programs, we continue to make progress toward our goal of improving the way hemophilia is treated worldwide.”

“The opinion from the EMA’s Pediatric Committee is valuable for our promising rFIXFc project, as it allows for the development of rFIXFc in the pediatric population. We are excited about the potential of this innovative product to make a difference in the lives of people with hemophilia,” said Peter Edman, Ph.D., Chief Scientific Officer of Swedish Orphan Biovitrum.

About rFIXFc and the recombinant Fc Fusion protein hemophilia program

rFIXFc is a recombinant Factor IX Fc fusion protein developed using monomeric Fc fusion technology. The technology makes use of a natural mechanism that recycles rFIXFc in the circulation to extend its half-life. It is a fully-recombinant clotting factor designed to replace the protein that hemophilia B patients lack and to last longer in the body than commercially-available Factor IX products. rFIXFc is currently being evaluated in a registrational, open-label, multicenter trial (B-LONG) designed to evaluate its safety, pharmacokinetics and efficacy in hemophilia B patients.

Using the same proprietary monomeric Fc fusion technology as rFIXFc, Biogen Idec and Swedish Orphan Biovitrum are also developing a fully-recombinant, long-lasting Factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. rFVIIIFc is currently being evaluated in a registrational, open-label, multicenter trial (A-LONG) designed to evaluate its safety, pharmacokinetics and efficacy in hemophilia A patients. For more information on the rFIXFc and rFVIIIFc trials, please visit www.biogenidechemophilia.com or www.clinicaltrials.gov.

About Hemophilia B

Hemophilia B is a rare, inherited disorder in which the ability of a person’s blood to clot is impaired. Hemophilia B occurs in about one in 25,000 male births annually and is caused by having substantially reduced or no Factor IX protein, which is needed for normal blood clotting. People with hemophilia B therefore need injections of Factor IX to restore the coagulation process and prevent frequent bleeds that could otherwise lead to pain, irreversible joint damage and life-threatening hemorrhages. Prophylactic treatment with infusions twice per week to maintain a sufficient circulating level of coagulation factor is being increasingly used, and long-term studies demonstrate that such regimens increase the patient’s life expectancy and greatly reduce, if not eliminate, progressive joint deterioration.