Biovitrum Advances Novel Factor VIII Long-Acting Hemophilia A Therapy
into Clinical Trials
(Thomson Reuters ONE) - Stockholm, Sweden - Dec 15, 2009 - Biovitrum AB (publ) (STO: BVT)today announced that the first patient was dosed in a phase I/IIastudy of its long-acting fully-recombinant Factor VIII Fc fusion(rFVIIIFc) protein. The phase I/IIa open-label study will assess thesafety, tolerability and pharmacokinetics of rFVIIIFc in severe,previously-treated, hemophilia A patients. The rFVIIIFc program andinternational study are partnered with Biogen Idec (NASDAQ: BIIB).Hemophilia A patients require frequent Factor VIII injections, whichcreate a significant burden for these individuals. The rFVIIIFcmolecule is being investigated for the potential to prolongprotection from bleeding and reduce the frequency of injections forboth prophylaxis and on-demand therapy in Hemophilia A. Preclinicalstudies showed improved half-life of rFVIIIFc, which is based onBiogen Idec's monomeric Fc-fusion technology (recently presented 7December 2009 at the American Society of Hematology conference)."We are excited about bringing rFVIIIFc into the clinical stagetogether with Biogen Idec and, thereby adding another significantcollaboration project to the ongoing recombinant Factor IX Fc fusion(rFIXFc) clinical program. The innovative rFVIIIFc program holdsgreat potential in offering true value to hemophilia A patients, andis thus a prioritized therapeutic and business area withinBiovitrum," said Peter Edman, CSO of Biovitrum.About Hemophilia AHemophilia A is a rare, inherited disorder in which the ability of aperson's blood to clot is impaired. Hemophilia A occurs in about 1 in10,000 male births annually and is caused by having substantiallyreduced or no factor VIII protein, which is needed for normal bloodclotting. People with hemophilia A therefore need injections offactor VIII to restore the coagulation process and prevent frequentbleeds that could otherwise lead to pain, irreversible joint damageand life-threatening hemorrhages. Prophylaxis treatment withinfusions three times per week or every second day to maintain asufficient circulating level of coagulation factor is beingincreasingly used, and long-term studies demonstrate that suchregimens increase the patient's life expectancy and greatly reduce ifnot eliminate progressive joint deterioration. The current globalmarket for recombinant Factor VIII products is over 4 BUSD annually.About BiovitrumBiovitrum is an international pharmaceutical company that marketsspecialist pharmaceuticals in several regions. Using its expertiseand experience Biovitrum takes scientific innovation to patients withsignificant unmet medical need. Research expertise and capabilitiesare focused on development and production of biotechnologytherapeutics within our prioritized areas of hemophilia,inflammation/autoimmune diseases, cancer supportive care andmalabsorption. The company has revenues of approximately SEK 1.2billion and around 400 employees. The company head office is locatedin Sweden and it is listed on the Stockholm OMX Nordic Exchange. Formore information please visit www.biovitrum.com.For more information please contact:Biovitrum AB (publ)Erik Kinnman, EVP Investor RelationsPhone: +46 73 422 15 40erik.kinnman(at)biovitrum.comPeter Edman, CSOPhone: +46 8 697 21 77Biovitrum AB (publ) may be required to disclose the informationprovided herein pursuant to the Swedish Securities Markets Act. Theinformation was provided for public release on December 15, 2009 at08:30 a.m. CET.http://hugin.info/134557/R/1361189/332389.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 15.12.2009 - 08:32 Uhr
Sprache: Deutsch
News-ID 9612
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