Biogen Idec and Swedish Orphan Biovitrum Announce First Patient Dosed in Global Registrational Trial
(Thomson Reuters ONE) - Cambridge, Mass. and Stockholm, Sweden - January 25, 2010 - Biogen Idec (NASDAQ:BIIB) and Swedish Orphan Biovitrum (STO: BVT) today announced that the firstpatient was dosed in a registrational, open-label, multicenter trial designed toevaluate the safety, pharmacokinetics and efficacy of the companies'long-acting, recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia Bpatients. The trial, called the B-LONG study, will determine the efficacy ofrFIXFc in the prevention and treatment of bleeding in approximately 75previously-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 theIndiana Hemophilia and Thrombosis Center. "In a Phase I/IIa study, rFIXFc showedthe potential to prolong protection from bleeding in severe, previously-treatedpatients with hemophilia B."rFIXFc is a fully-recombinant clotting factor developed using Biogen Idec'snovel and proprietary monomeric Fc-fusion technology. In the B-LONG trial,rFIXFc's ability to prevent bleeding using different dosing regimens will bemeasured by evaluating the number of breakthrough bleeding episodes annualizedover the study period. The study will also evaluate the efficacy of rFIXFc inon-demand and surgical settings, and compare the pharmacokinetics of a singledose of rFIXFc with a single dose of a commercially available recombinant FactorIX product."We are excited that rFIXFc is the first long-acting Factor IX therapy to enterregistrational trials," said Glenn Pierce, M.D., Ph.D., Vice President and ChiefMedical Officer of Biogen Idec's hemophilia therapeutic area. "We are makingimportant progress in our efforts to develop a treatment that can make adifference to the hemophilia B community.""rFIXFc is an innovative therapy that offers the potential to make a positiveimpact in the lives of people with hemophilia B," said Peter Edman, Ph.D., ChiefScientific Officer of Swedish Orphan Biovitrum. "Enrolling a patient in ourfirst registrational trial is also a notable achievement for Swedish OrphanBiovitrum."Using the same proprietary technology as rFIXFc, Biogen Idec and Swedish OrphanBiovitrum are also developing a fully-recombinant, long-acting Factor VIII Fcfusion protein (rFVIIIFc) for the treatment of hemophilia A. rFVIIIFc iscurrently being evaluated in a Phase I/IIa, open-label, dose-escalation,multicenter study to evaluate the safety, tolerability and pharmacokinetics ofrFVIIIFc in hemophilia A patients. For more information on the rFIXFc andrFVIIIFc trials, please visit 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(at)biovitrum.com Biogen Idec Investor Relations Peter Edman, CSO Contact: Phone. +46 8 6972177 Eric Hoffman Director, Investor Relations (617) 679-2812About Hemophilia BHemophilia B is a rare, inherited disorder in which the ability of a person'sblood to clot is impaired. Hemophilia B occurs in about 1 in 25,000 male birthsannually and is caused by having substantially reduced or no factor IX protein,which is needed for normal blood clotting. People with hemophilia B thereforeneed injections of factor IX to restore the coagulation process and preventfrequent bleeds that could otherwise lead to pain, irreversible joint damage andlife-threatening hemorrhages. Prophylaxis treatment with infusions two or threetimes per week to maintain a sufficient circulating level of coagulation factoris being increasingly used, and long-term studies demonstrate that such regimensincrease the patient's life expectancy and greatly reduce if not eliminateprogressive joint deterioration.About Biogen IdecBiogen Idec creates new standards of care in therapeutic areas with high unmetmedical needs. Biogen Idec is a global leader in the discovery, development,manufacturing, and commercialization of innovative therapies. Patients in morethan 90 countries benefit from Biogen Idec's significant products that addressdiseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. Forproduct labeling, press releases and additional information about the company,please visit www.biogenidec.com .About Swedish Orphan BiovitrumSwedish Orphan Biovitrum is a Swedish based specialty pharmaceutical companywith an international market presence. The company is focused on providing anddeveloping orphan and niche specialist pharmaceuticals to patients with highmedical needs. The portfolio consists of about 60 marketed products and anemerging late stage clinical development pipeline within rare diseases. SwedishOrphan Biovitrum has pro-forma revenues 2009e of about 2 BSEK and approximately500 employees. The head office is located in Sweden and the share (STO: BVT) islisted on NASDAQ OMX Stockholm. For more information please visitwww.biovitrum.com.Safe HarborThis press release contains forward-looking statements regarding the developmentof long-acting, recombinant Factor IX Fc fusion and Factor VIII Fc fusion. Thesestatements are based on the companies' current beliefs and expectation. Drugdevelopment involves a high degree of risk. Factors which could cause actualresults to differ materially from the companies' current expectations includethe risk that we may not fully enroll our planned clinical trials, unexpectedconcerns may arise from additional data or analysis, regulatory authorities mayrequire additional information, further studies, or may fail to approve thedrug, or the companies may encounter other unexpected hurdles. For more detailedinformation on the risks and uncertainties associated with Biogen Idec's drugdevelopment and other activities, see the Risk Factors section of Biogen Idec'speriodic reports filed with the Securities and Exchange Commission. Thecompanies assume no obligation to update any forward-looking statements, whetheras a result of new information, future events or otherwise.Swedish Orphan Biovitrum may be required to disclose the information providedherein pursuant to the Swedish Securities Markets Act. The information wasprovided for public release on January 25, 2010 at 08:30 a.m. CET.[HUG#1376569] Press release January 25th in PDF version: http://hugin.info/134557/R/1376569/337945.pdf
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Datum: 25.01.2010 - 02:35 Uhr
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