Biogen Idec and Swedish Orphan Biovitrum Announce First Patient Dosed in Global Registrational Trial of Long-Acting Hemophilia B Therapy
Cambridge, Mass. and Stockholm, Sweden - January 25, 2010 - Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (STO: BVT) today announced that the first patient was dosed in a registrational, open-label, multicenter trial designed to evaluate the safety, pharmacokinetics and efficacy of the companies' long-acting, recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. The trial, called the B-LONG study, will determine the efficacy of rFIXFc in the prevention and treatment of bleeding in approximately 75 previously-treated patients with severe hemophilia B. "Hemophilia B requires frequent injections, often two to three times a week, causing a major burden on individuals with the disorder," said Amy Shapiro, M.D., Principal Investigator of the B-LONG trial and Medical Director of the Indiana Hemophilia and Thrombosis Center. "In a Phase I/IIa study, rFIXFc showed the potential to prolong protection from bleeding in severe, previously-treated patients with hemophilia B." rFIXFc is a fully-recombinant clotting factor developed using Biogen Idec's novel and proprietary monomeric Fc-fusion technology. In the B-LONG trial, rFIXFc's ability to prevent bleeding using different dosing regimens will be measured by evaluating the number of breakthrough bleeding episodes annualized over the study period. The study will also evaluate the efficacy of rFIXFc in on-demand and surgical settings, and compare the pharmacokinetics of a single dose of rFIXFc with a single dose of a commercially available recombinant Factor IX product. "We are excited that rFIXFc is the first long-acting Factor IX therapy to enter registrational trials," said Glenn Pierce, M.D., Ph.D., Vice President and Chief Medical Officer of Biogen Idec's hemophilia therapeutic area. "We are making important progress in our efforts to develop a treatment that can make a difference to the hemophilia B community." "rFIXFc is an innovative therapy that offers the potential to make a positive impact in the lives of people with hemophilia B," said Peter Edman, Ph.D., Chief Scientific Officer of Swedish Orphan Biovitrum. "Enrolling a patient in our first registrational trial is also a notable achievement for Swedish Orphan Biovitrum." Using the same proprietary technology as rFIXFc, Biogen Idec and Swedish Orphan Biovitrum are also developing a fully-recombinant, long-acting Factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. rFVIIIFc is currently being evaluated in a Phase I/IIa, open-label, dose-escalation, multicenter study to evaluate the safety, tolerability and pharmacokinetics of rFVIIIFc in hemophilia A patients. For more information on the rFIXFc and rFVIIIFc trials, please visit www.biogenidechemophilia.com <http://www.biogenidechemophilia.com/>. For more information contact: Biogen Idec Media Contact: Swedish Orphan Biovitrum Tracy Vineis Erik Kinnman, EVP Investor Relations Senior Manager, Public Affairs Phone: +46 73 422 15 40 (617) 914-6524 erik.kinnman@biovitrum.com <mailto:erik.kinnman@biovitrum.com> Biogen Idec Investor Relations Peter Edman, CSO Contact: Phone. +46 8 6972177 Eric Hoffman Director, Investor Relations (617) 679-2812 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 1 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. Prophylaxis treatment with infusions two or three times 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. About Biogen Idec Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com <http://www.biogenidec.com/>. About Swedish Orphan Biovitrum Swedish Orphan Biovitrum is a Swedish based specialty pharmaceutical company with an international market presence. The company is focused on providing and developing orphan and niche specialist pharmaceuticals to patients with high medical needs. The portfolio consists of about 60 marketed products and an emerging late stage clinical development pipeline within rare diseases. Swedish Orphan Biovitrum has pro-forma revenues 2009e of about 2 BSEK and approximately 500 employees. The head office is located in Sweden and the share (STO: BVT) is listed on NASDAQ OMX Stockholm. For more information please visit www.biovitrum.com. Safe Harbor This press release contains forward-looking statements regarding the development of long-acting, recombinant Factor IX Fc fusion and Factor VIII Fc fusion. These statements are based on the companies' current beliefs and expectation. Drug development involves a high degree of risk. Factors which could cause actual results to differ materially from the companies' current expectations include the risk that we may not fully enroll our planned clinical trials, unexpected concerns may arise from additional data or analysis, regulatory authorities may require additional information, further studies, or may fail to approve the drug, or the companies may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec's drug development and other activities, see the Risk Factors section of Biogen Idec's periodic reports filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Swedish Orphan Biovitrum may be required to disclose the information provided herein pursuant to the Swedish Securities Markets Act. The information was provided for public release on January 25, 2010 at 08:30 a.m. CET.