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News Release

BAXTER FILES MARKETING AUTHORIZATION APPLICATION TO EMEA FOR FIRST PLASMA/ALBUMIN FREE METHOD RECOMBINANT FACTOR VIII HEMOPHILIA THERAPY

DEERFIELD, Ill., September, 26, 2002 -- Baxter International Inc. announced today that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Evaluation Agency: Committee for Proprietary Medicinal Products for Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM) for the treatment of hemophilia A. The submission has been made through the European Union (EU) Centralized Procedure. The MAA filing is the first step in gaining regulatory approval in the 15-member states of the EU, plus Norway and Iceland.

The MAA submission is based on results from a global, multi-center, randomized, double-blind, cross-over study comparing rAHF-PFM and Recombinate recombinant antihemophilic factor (rAHF). Recombinate, a recombinant Factor VIII therapy, has been available from Baxter since 1992.

During the last 40 years, Baxter has continually been first to provide the hemophilia community with enhanced Factor VIII products. rAHF-PFM is Baxter's latest technological advancement and is the first Factor VIII recombinant therapy to be clinically developed and prepared without the addition of any human- or animal-derived raw materials in the cell culture process, purification or final formulation.

All currently available recombinant Factor VIII therapies use human- or animal-derived raw materials at some point in their production processes or final product formulations. While these therapies have substantially reduced the potential for transmission of viruses, concerns remain within the medical and hemophilia communities about the possible transmission of currently known and unknown viruses or diseases through the continued use of human- or animal-derived additives in hemophilia therapy.

Baxter submitted a Biologics License Application to the U.S. Food and Drug Administration (FDA) on June 27, 2002 for rAHF-PFM, which also seeks licensure of one manufacturing suite in its state-of-the-art, multi-purpose facility in Neuchâtel, Switzerland. The U.S. FDA formally accepted the file for review in August. Baxter's MAA filing also seeks licensure of two manufacturing suites at the Neuchâtel facility.

Hemophilia A is caused by the absence or severe deficiency of Factor VIII, a protein in human blood critical for proper blood coagulation. People with hemophilia A experience spontaneous, internal bleeding associated with pain, chronic joint destruction and, if left untreated, may become life-threatening. However, barring other complications or disorders, clinicians today expect the life expectancy of patients to be near normal, provided they receive proper treatment and care.

Baxter International Inc. (NYSE: BAX) is a global health care company that, through its subsidiaries, provides critical therapies for people with life-threatening conditions. Baxter's bioscience, medication delivery and renal products and services are used to treat patients with some of the most challenging medical conditions including cancer, hemophilia, immune deficiencies, infectious diseases, kidney disease and trauma.


(Baxter and Recombinate are trademarks of Baxter International Inc.)

FOR ADDITIONAL INFORMATION:

Media Contacts:
Deborah Spak, 847-948-2349
Patricia O'Hayer 011 2 650 1924
Investor Contacts:
Neville Jeharajah, 847-948-2875
Mary Kay Ladone, 847-948-3371
 
 

 

 
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