Biovitrum Advances Novel Factor VIII Long-Acting Hemophilia A Therapy into Clinical Trials
Stockholm, Sweden - Dec 15, 2009 - Biovitrum AB (publ) (STO: BVT) today announced that the first patient was dosed in a phase I/IIa study of its long-acting fully-recombinant Factor VIII Fc fusion (rFVIIIFc) protein. The phase I/IIa open-label study will assess the safety, tolerability and pharmacokinetics of rFVIIIFc in severe, previously-treated, hemophilia A patients. The rFVIIIFc program and international study are partnered with Biogen Idec (NASDAQ: BIIB). Hemophilia A patients require frequent Factor VIII injections, which create a significant burden for these individuals. The rFVIIIFc molecule is being investigated for the potential to prolong protection from bleeding and reduce the frequency of injections for both prophylaxis and on-demand therapy in Hemophilia A. Preclinical studies showed improved half-life of rFVIIIFc, which is based on Biogen Idec's monomeric Fc-fusion technology (recently presented 7 December 2009 at the American Society of Hematology conference). "We are excited about bringing rFVIIIFc into the clinical stage together with Biogen Idec and, thereby adding another significant collaboration project to the ongoing recombinant Factor IX Fc fusion (rFIXFc) clinical program. The innovative rFVIIIFc program holds great potential in offering true value to hemophilia A patients, and is thus a prioritized therapeutic and business area within Biovitrum," said Peter Edman, CSO of Biovitrum. About Hemophilia A Hemophilia A is a rare, inherited disorder in which the ability of a person's blood to clot is impaired. Hemophilia A occurs in about 1 in 10,000 male births annually and is caused by having substantially reduced or no factor VIII protein, which is needed for normal blood clotting. People with hemophilia A therefore need injections of factor VIII to restore the coagulation process and prevent frequent bleeds that could otherwise lead to pain, irreversible joint damage and life-threatening hemorrhages. Prophylaxis treatment with infusions three times per week or every second day 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. The current global market for recombinant Factor VIII products is over 4 BUSD annually. About Biovitrum Biovitrum is an international pharmaceutical company that markets specialist pharmaceuticals in several regions. Using its expertise and experience Biovitrum takes scientific innovation to patients with significant unmet medical need. Research expertise and capabilities are focused on development and production of biotechnology therapeutics within our prioritized areas of hemophilia, inflammation/autoimmune diseases, cancer supportive care and malabsorption. The company has revenues of approximately SEK 1.2 billion and around 400 employees. The company head office is located in Sweden and it is listed on the Stockholm OMX Nordic Exchange. For more information please visit www.biovitrum.com. For more information please contact: Biovitrum AB (publ) Erik Kinnman, EVP Investor Relations Phone: +46 73 422 15 40 erik.kinnman@biovitrum.com Peter Edman, CSO Phone: +46 8 697 21 77 Biovitrum AB (publ) may be required to disclose the information provided herein pursuant to the Swedish Securities Markets Act. The information was provided for public release on December 15, 2009 at 08:30 a.m. CET.