Biogen Idec (NASDAQ: BIIB) and Biovitrum AB (STO: BVT) today announced that they plan to advance the companies’ long-acting, fully-recombinant Factor IX Fc fusion protein (rFIXFc) into a registrational clinical trial in hemophilia B patients. The decision to advance the program is based on promising data from a Phase I/IIa open-label, multi-center, safety dose-escalation and pharmacokinetic study of intravenous rFIXFc in severe, previously-treated hemophilia B patients. rFIXFc was well tolerated in the study. In addition, rFIXFc demonstrated a prolonged half-life compared to historical data for existing therapies, supporting advancement of the program.
Hemophilia B requires frequent injections, creating a significant burden for the majority of individuals with the disorder. The potential of rFIXFc, which is based on Biogen Idec's novel and proprietary monomeric Fc-fusion technology, to prolong protection from bleeding and reduce the frequency of injections for both prophylaxis and on-demand therapy will be evaluated in the registrational trial.
The global trial is being designed to assess the safety, pharmacokinetics and efficacy of rFIXFc in the prevention and treatment of bleeding in hemophilia B patients. The trial will commence following communications with regulatory authorities. rFIXFc has received orphan medicinal product designation for the treatment of hemophilia B from both the European (EMEA) and US (FDA) authorities.
“rFIXFc is an example of Biogen Idec’s commitment to developing innovative therapies to address significant unmet medical needs. The rFIXFc program has the potential to improve the lives of individuals with hemophilia B and we are excited about advancing the program,” said Glenn Pierce, Vice President and Chief Medical Officer of Biogen Idec’s hemophilia therapeutic area.
"The Phase I/II results are very encouraging. The decision to initiate our first registrational program represents true progress in our efforts to offer hemophilia B patients treatment that makes a significant difference and is also an important milestone in the ongoing development of Biovitrum,” said Martin Nicklasson, CEO of Biovitrum.
Hemophilia 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.
Biovitrum is an international pharmaceutical company that markets specialist pharmaceuticals in several regions globally. The company head office is located in Sweden. Using its expertise and experience Biovitrum takes scientific innovation to patients with significant medical need. Research expertise and capabilities are focused on development and production of biotechnology therapeutics within our prioritized areas of hemophilia, inflammation/autoimmune diseases and malabsorption. The company has revenues of approximately SEK 1.2 billion and around 400 employees. It is listed on the OMX Nordic Exchange in Stockholm. For more information go to www.biovitrum.com.
This press release contains forward-looking statements regarding the development of long-acting, recombinant Factor IX Fc fusion as a potential treatment for hemophilia B. 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 periodic reports of Biogen Idec 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.
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 October 19, 2009 at 08:30 a.m. CET.
Tracy Vineis, 617-914-6524
Senior Manager, Public Affairs
Biogen Idec Investor Relations Contact:
Eric Hoffman, 617-679-2812
Director, Investor Relations
Biovitrum AB (publ)
Erik Kinnman, +46 73 422 15 40
Vice President Investor Relations
Martin Nicklasson, +46 8 697 20 00