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Baxter International Inc. (NYSE: BAX) showcased its commitment to innovation in hemophilia today with the presentation of new data from 60 oral and poster presentations during the 2014 World Federation of Hemophilia (WFH) World Congress in Melbourne, Australia (May 11-15). The data include safety, efficacy and immunogenicity findings on Baxter’s global leading brands and new treatments for hemophilia A, von Willebrand disease and other coagulation disorders.
''Baxter’s investigational pipeline spans multiple programs, underscoring Baxter’s scientific commitment to advancing care for patients with rare and chronic conditions,'' said Ludwig Hantson, Ph.D., president of Baxter BioScience. ''Baxter remains committed to the research and development of new treatments and product enhancements that improve the safety, efficacy and cost-effectiveness of treatments, as well as broadening access to quality care for hemophilia patients worldwide.''
PRODUCT AND PIPELINE DATA HIGHLIGHTS
Data presented during WFH include several studies of Baxter’s late-stage R&D pipeline, including BAX 855, Baxter’s extended half-life investigational recombinant factor VIII (rFVIII) treatment for hemophilia A. BAX 855 is based on the full-length ADVATE [Antihemophilic Factor (Recombinant)] molecule, and is modified with PEGylation technology to extend its duration of activity in the body. As Baxter continues to evaluate the efficacy and safety of this extended half-life treatment in clinical studies, the data from these studies demonstrate the investigational treatment’s structural and functional integrity.
Multiple studies will be presented on ADVATE, including a meta-analysis of ADVATE-PASS (Post-Authorization Safety Studies), a prospective, uncontrolled, open-label study, documenting the real-world clinical experience with ADVATE. Conducted in multiple countries between July 2003 and January 2014, the results presented at WFH are the first to illustrate the safety and efficacy of routine use of a rFVIII concentrate in patients with hemophilia A and a low titer inhibitor or inhibitor history. Earlier analysis of PASS data also showed a favorable overall safety and efficacy profile for ADVATE.
Several presentations also support OBI-1, Baxter’s investigational recombinant porcine sequence factor VIII treatment. The investigational treatment has completed a phase II/III study and is now under regulatory review in the United States for the treatment of acquired hemophilia A, a rare, potentially life-threatening bleeding disorder that typically affects older adults and occurs equally in males and females. These data offer insights into the safety, efficacy, and immunogenicity of OBI-1 in patients with acquired hemophilia A.