Biogen, Sobi to Report Long-Term Efficacy, Safety Data from A-LONG, ASPIRE, B-Long, B-YOND Trials at World Federation of Hemophilia World Congress

Biogen

and Swedish Orphan Biovitrum AB (publ) (Sobi™)

will present updated data on long-term safety and efficacy of the companies' novel extended half-life therapies, ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] (marketed as ELOCTA® in Europe) for hemophilia A and ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] for hemophilia B. The data from the Phase 3 extension studies, B-YOND (hemophilia B) and ASPIRE (hemophilia A), will be highlighted in oral and poster presentations at the World Federation of Hemophilia (WFH) 2016 World Congress in Orlando, Florida, from July 24–28, 2016. "The breadth of research, for both marketed products and preclinical programs being presented at WFH reflects our commitment to hemophilia and our mission to improve the lives of people living with hemophilia." said Rob Peters, vice president, rare disease research at Biogen. For people with severe hemophilia A and B, most bleeding events occur in joints, with joint damage being the most common complication of the condition.1 Post hoc analyses to be presented at the WFH Congress include longitudinal evaluation of joint health from patients participating in A-LONG and ASPIRE and target joint data from a subset of patients participating in B-LONG and B-YOND. Additionally, preclinical pharmacokinetic data from intravenous and subcutaneous administration of recombinant FVIIIFc-VWF-XTEN, a fusion protein being investigated for the treatment of hemophilia A, that utilizes XTENTM technology licensed from Amunix, will be presented. "ELOCTATE and ALPROLIX are backed by robust clinical data and significant real-world experience. We believe these new data presentations will help healthcare providers to deepen their understanding of the clinical value and utility of these innovative medicines," said Krassimir Mitchev, M.D., Ph.D., vice president and medical therapeutic area head of Haemophilia at Sobi. ELOCTATE and ALPROLIX are the first approved hemophilia A and B Fc fusion therapies to provide extended protection against bleeding episodes. They utilize Fc fusion technology, which uses a naturally occurring pathway to prolong the time the therapy remains in the body. Select presentations include: ELOCTATE/ALPROLIX-Focused Presentations: Longitudinal Modified Hemophilia Joint Health Scores (mHJHS) Outcomes With Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) Prophylaxis in Subjects With Severe Hemophilia A – Oral Presentation # T-02 – Tuesday, July 26, 2:55 – 3:05 ET Longitudinal Analysis of Annualized Bleeding Rates Among Adults/Adolescents Receiving Weekly Prophylaxis With rFVIIIFc in A-LONG and ASPIRE – Poster # P150 – Monday, July 25, 10:00 – 10:45 & 3:45 – 4:30 ET Post Hoc Analysis to Evaluate the Effect of Recombinant Factor IX Fc Fusion Protein (rFIXFc) Prophylaxis in Adults and Adolescents with Target Joints and Hemophilia B – Poster # P83 – Tuesday, July 26, 10:00 – 10:45 ET Preclinical rFVIIIFc-VWF-XTEN Presentation: The pharmacokinetic profiles of intravenously and subcutaneously administered recombinant FVIIIFc-VWF-XTEN in cynomolgus monkey – Oral Presentation W-01 – Wednesday, July 27, 10:45 – 11:00 ET Biogen recently announced that it intends to spin off its hemophilia business as an independent, publicly-traded company. The new company will focus on meaningfully improving the treatment and care of people living with hemophilia, with existing marketed products to include ELOCTATE and ALPROLIX, indicated for the treatment of hemophilia A and B, respectively. The new company will continue to collaborate with Sobi once it is independent.