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FDA approves Baxters ADVATE for the treatment of hemophilia A

Deerfield, Ill., July 25, 2003 -- Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved ADVATE (Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method) rAHF-PFM for the prevention and control of bleeding episodes in people with hemophilia A. ADVATE is the first and only factor VIII made without any added human or animal plasma proteins and albumin in the cell culture process, purification and final formulation, thereby eliminating the risk of infections caused by viruses that may be carried in these proteins.

Developed by Baxter through its innovative technology and many years in hemophilia research, ADVATE is a genetically engineered, or recombinant, full-length clotting factor VIII that is similar to the natural clotting factor found in a healthy body. The new technology used to prepare ADVATE which is the most advanced factor VIII treatment for hemophilia to date eliminates the addition of human and animal plasma proteins and albumin to provide unsurpassed pathogen safety, while maintaining the proven efficacy of the full-length RECOMBINATE rAHF molecule, the current leader for hemophilia A therapy.

"It's widely recognized by the hemophilia community that there is a need to provide patients with treatments that eliminate the risk for infection. While treatment options to date have provided effective disease management, there has been an acknowledged, lingering concern about the potential for viral transmission with these therapies," said Michael Tarantino, M.D., associate professor of Pediatrics at the University of Illinois and medical director of the Comprehensive Bleeding Disorder Center in Peoria, Ill. "ADVATE is the first therapy to meet this need for safety, virtually eliminating the risk of transmission of human pathogens."

Other genetically engineered factor VIII therapies use human plasma protein solutions and/or other human- or animal-derived materials during proce
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Contact: Cindy Resman, BAXTER
847-948-2815
Porter Novelli
28-Jul-2003


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