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News Release

BAXTER SUBMITS FILE TO U.S. FDA FOR MARKETING APPROVAL OF PLASMA/ALBUMIN FREE METHOD RECOMBINANT FACTOR VIII HEMOPHILIA THERAPY

DEERFIELD, ILL. JUNE 27, 2002 -- Baxter Healthcare Corporation today announced that a Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) for marketing approval of Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM). The BLA submission is the first step in the regulatory process for Baxter to gain U.S. licensure for rAHF-PFM for the treatment of hemophilia A. Baxter plans to file for European regulatory approval during the third quarter of 2002.

The regulatory submission is based on results from a global, multi-center, randomized double-blind, cross-over study comparing rAHF-PFM and the control, Recombinate Antihemophilic Factor (Recombinant) (rAHF).

"Submitting the file for this product is one of the most significant milestones across Baxter this year," said Harry M. Jansen Kraemer, Jr., Baxter's chairman and chief executive officer. "Not only is it an important step in our effort to provide Factor VIII product needed to meet growing demand, it reflects the innovative nature of our pipeline and the steady flow of products we hope to bring to market over the next few years."

Baxter Healthcare Corporation is the principal domestic operating business of Baxter International Inc. (NYSE: BAX). Baxter International Inc. 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.)

This news release contains forward-looking statements that involve risks and uncertainties, including technological advances in the medical field, product demand and market acceptance, actions of regulatory bodies, the impact of competitive products and pricing, and other risks detailed in the company's filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.

FOR ADDITIONAL INFORMATION:

Media Contact:
Sally Benjamin Young, 847-948-2304
Deborah Spak, 847-948-2349
Investor Contacts:
Neville Jeharajah, 847-948-2875
Mary Kay Ladone, 847-948-3371
 

 

 
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