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Baxter International Inc. (NYSE:BAX) continues to build upon its global leadership position in hemophilia with ADVATE [Antihemophilic Factor (Recombinant)], the first recombinant treatment with no human or animal protein additives for patients with hemophilia A. ADVATE continues to be the most prescribed full-length recombinant FVIII worldwide, with more than 10 years of real-world experience and over 17 billion units distributed.
''Baxter has executed an array of strategic global initiatives designed to improve treatment options and expand access to quality care for hemophilia patients worldwide,'' said Ludwig Hantson, Ph.D., president of Baxter BioScience. ''These important achievements will allow us to build upon our global leadership and drive continued growth across our hemophilia franchise, reaching patients in both large and established markets, as well as emerging markets.''
Recent highlights include:
European Union regulatory approval of a new manufacturing facility in Singapore for the production of a variety of recombinant proteins, including ADVATE and potentially BAX 855 following regulatory approval.
The recent announcement by the National Blood Authority (NBA) in Australia of a four-year award for ADVATE, designated as the national preferred recombinant FVIII product. The award in Australia, which becomes effective July 1, 2014, will provide the 2,300 people diagnosed with hemophilia A access to the therapy. 1 This follows a multi-year award for ADVATE in the UK, which broadens its commercial presence and provides increased access to the treatment for the 5,600 people with hemophilia A in the UK. 1
Regulatory approvals of ADVATE in Turkey and Russia, supporting Baxter’s efforts to increase access to recombinant FVIII therapy in emerging markets. This follows the launch of ADVATE in China, and the building momentum in Brazil resulting from Baxter’s exclusive, long-term partnership with Hemobras. To date, more than 3,000 patients (roughly 30% of the diagnosed hemophilia A population in Brazil 1) are now being treated with Baxter’s recombinant FVIII treatment. With these approvals, ADVATE is now available to hemophilia A patients in 62 countries worldwide.
U.S. FDA approval of a new reconstitution system for ADVATE. The BAXJECT III reconstitution system reduces the number of steps in the reconstitution process for hemophilia A patients and caregivers, as compared to the BAXJECT II Needle-less Transfer device.
About ADVATE [Antihemophilic Factor (Recombinant)]
ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency or classic hemophilia) for:
Control and prevention of bleeding episodes.
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
ADVATE is not indicated for the treatment of von Willebrand disease.