WESTON, MA and STOCKHOLM, SWEDEN--(Marketwire - July 12, 2010) -
Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (STO: SOBI) today announced results from a Phase 1/2a open-label, dose-escalation, safety and pharmacokinetic study of the companies’ long-lasting, fully-recombinant factor IX Fc fusion protein (rFIXFc) in hemophilia B patients. The data, which were presented at the World Federation of Hemophilia Congress in Buenos Aires, Argentina, on July 11, 2010, showed that rFIXFc was well tolerated and demonstrated an approximately three-fold increase in half-life compared to historical data for existing therapies.
“Current prophylactic regimens for hemophilia B require two to three intravenous injections per week, so there is great desire among physicians and patients for a therapy that will provide prolonged protection from bleeding,” said Amy Shapiro, M.D., Medical Director of the Indiana Hemophilia and Thrombosis Center. “Results from the Phase 1/2a trial show that rFIXFc may be able to reduce the number of injections to once weekly or less, which would be an important advancement for the hemophilia community.”
“Our hemophilia B program demonstrates Biogen Idec’s commitment to utilizing pioneering science to create new standards of care for patients,” said Glenn Pierce, M.D., Ph.D., Vice President and Chief Medical Officer of Biogen Idec’s hemophilia therapeutic area. “Developed using our novel Fc-fusion technology, rFIXFc has the potential to improve the lives of individuals with hemophilia B by providing longer-lasting protection from bleeding.”
Based on positive results from the Phase 1/2a trial, rFIXFc was advanced into a global registrational trial called B-LONG in January. B-LONG is designed to assess the safety, pharmacokinetics and efficacy of rFIXFc in the prevention and treatment of bleeding in 75 previously-treated people with severe hemophilia B. rFIXFc’s ability to prevent bleeding using different dosing regimens is being measured by evaluating the number of breakthrough bleeding episodes.
“We look forward to results from the registrational trial and are excited about the potential of rFIXFc to significantly reduce the frequency of injections necessary for people with hemophilia B,” said Peter Edman, Ph.D., Chief Scientific Officer of Swedish Orphan Biovitrum.
Using the same proprietary technology as rFIXFc, Biogen Idec and Swedish Orphan Biovitrum are also developing a recombinant, long-lasting Factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. The companies recently announced their decision to advance rFVIIIFc into a registrational trial based on positive results from a Phase 1/2a open-label, cross-over, dose- escalation study designed to evaluate the safety and pharmacokinetics of rFVIIIFc in people with severe hemophilia A. For more information on the rFIXFc and rFVIIIFc trials, please visit www.biogenidechemophilia.com or www.clinicaltrials.gov.
About the Study
Study SYN-FIXFc-07-001, a Phase 1/2a study of rFIXFc in 14 previously- treated patients with severe hemophilia B ( = 2 U/dL endogenous FIX), was designed as an open-label, multi-center, dose-escalation study to evaluate the safety and pharmacokinetics (PK) of a single dose of rFIXFc given as an intravenous injection. The dose levels investigated ranged from 1 to 100 IU/kg, which were determined based on non-clinical data and data from factor IX products in clinical use. The primary objective of the study was to assess the safety of rFIXFc at different doses; the secondary objective was to estimate the PK parameters of rFIXFc at doses ranging from 12.5 to 100 IU/kg.
rFIXFc was generally well tolerated in this single-dose study and there were no signs of injection site reactions, inhibitor development or anti-rFIXFc drug antibodies. There have been no reports of drug-related serious adverse events. A total of two adverse events, headache and altered taste, were reported as related to rFIXFc dosing. Additionally, rFIXFc demonstrated an approximately three-fold increase in half-life (52.5±9.2 hours) compared to data reported in the literature for existing factor IX therapies. Other PK parameters such as mean residence time and area under the curve (AUC) were similarly increased. The incremental recovery of rFIXFc appeared to more closely approximate plasma-derived factor IX, in contrast to results for other recombinant DNA-produced factor IX products. Furthermore, peak serum concentration and AUC also demonstrated an increase proportional to the dose administered. Together, these data support the hypothesis that rFIXFc may provide prolonged protection from bleeding.
About Hemophilia
Hemophilia 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.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients worldwide 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.
About Swedish Orphan Biovitrum
Swedish Orphan Biovitrum is a Swedish based niche specialty pharmaceutical company with an international market presence. The company is focused on providing and developing specialist pharmaceuticals for rare disease patients with high medical needs. The portfolio consists of about 60 marketed products and an emerging late stage clinical development pipe-line. Our focus areas are: hemophilia, inflammation/autoimmune diseases, fat malabsorption, cancer supportive care and inherited metabolic disorders.
Swedish Orphan Biovitrum had pro-forma revenues 2009e of about 2 BSEK and approximately 500 employees. The head office is located in Sweden and the share (STO: SOBI) is listed on NASDAQ OMX Stockholm. For more information please visit www.sobi.com.
For more information contact: Biogen Idec Media Contact: Swedish Orphan Biovitrum Tracy Vineis, Senior Manager, Peter Edman, CSO Public Affairs Phone: +46 8 629 21 77 Phone: +1 (781) 464-3260 peter.edman@sobi.com Biogen Idec Investor Relations Erik Kinnman, VP Investor Relations and Contact: Public Affairs Kia Khaleghpour Phone: +46 73 422 15 40 Associate Director, Investor erik.kinnman@sobi.com Relations Phone: +1 (781) 464-2442 Martin Nicklasson, CEO Phone: +46 8 697 20 00
Safe Harbor
This press release contains forward-looking statements regarding the development of long-lasting hemophilia therapies, which may be identified by words such as “believe,” “expect,” “may,” “plan,” “will” and similar expressions. 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. Any forward-looking statements speak only as of the date of this press release and 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 July 12, 2010 at 8:30 a.m. CET.
[HUG#1430956]
Press Release July 12, 2010: http://hugin.info/134557/R/1430956/377500.pdf
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