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News Release

BAXTER RECEIVES FDA APPROVAL FOR THIRD MANUFACTURING SUITE AT THOUSAND OAKS

DEERFIELD, Ill., September 10, 2001 - Baxter Healthcare Corporation (NYSE:BAX) announced today that it has received U.S. Food and Drug Administration approval for a third production suite at its BioScience facility in Thousand Oaks, California. This facility is the manufacturing site for Baxter's recombinant Factor VIII therapy, Recombinate Antihemophilic Factor (rAHF), which is a clotting factor produced by recombinant DNA technology as a therapy for people with hemophilia.

The approval will not affect overall U.S. supply because Suite C is already operating at full capacity for global customers since receiving European regulatory approval last year. However, it will allow Baxter greater flexibility in providing therapy to its U.S. customers.

"Approval of Suite C is an important milestone in Baxter's on going commitment to the hemophilia community. We are very pleased to have received FDA approval just four months after applying," said Thomas Glanzmann, president of Baxter BioScience.

Baxter Continues Its Leadership in Hemophilia Research and Treatment
Baxter is the only supplier that has increased the number of rFVIII units into the North American marketplace every year since it was introduced in 1992.

Baxter continues to invest in future capacity with construction of a fourth processing suite (Suite D), also underway at its Thousand Oaks facility, at a cost in excess of $50 million dollars. The company anticipates regulatory approval by late 2004 and projects that Suite D will increase capacity significantly.

Additionally, Baxter is investing $131 million in a multi-purpose plant in Neuchâtel, Switzerland, for the processing of recombinant therapies. Neuchâtel is also the site for the preparation of the investigational therapeutic to be used in ongoing clinical trials for Baxter's next-generation recombinant Factor VIII therapy. This next-generation recombinant Factor VIII excludes any added proteins or raw materials derived from human or animal sources in the manufacture, purification and formulation of the final product.

In total, by 2005, Baxter will have production capacity to provide in excess of two billion units of recombinant Factor VIII, with four suites in Neuchâtel and four suites at Thousand Oaks.

Demand for Hemophilia Therapy Has Doubled
Since 1995, demand for recombinant Factor VIII has nearly doubled on a global basis. The heightened demand is due to several factors, including increased use to prevent bleeding rather than treating patients when bleeds occur.

Hemophilia is caused by the absence or severe deficiency of Factor VIII, a protein in human blood critical for proper blood coagulation. More than 300,000 people worldwide have hemophilia. They can experience spontaneous, uncontrolled internal bleeding that often is associated with pain, chronic joint destruction and, if left untreated, death.

People with hemophilia infuse themselves with clotting factors on average three times a month, unless they are on a preventive regimen, in which case they could infuse multiple times per week. Barring other complications or disorders, clinicians today expect a near normal life expectancy, provided patients receive proper treatment.

Baxter Healthcare Corporation is the principal U.S. operating susidiary of Baxter International Inc. (NYSE: BAX). Baxter is a global medical products and services company that, through its subsidiaries, provides critical therapies for people with life-threatening conditions. Baxter's products and services in bioscience (biopharmaceuticals, vaccines, biosurgery and transfusion therapies), medication delivery and renal therapy are used by health-care providers and their patients in more than 100 countries.

(Baxter and Recombinate are trademarks of Baxter International Inc. Baxter is registered in the U.S. Patent and Trademark Office.)

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.

Media Contacts:

Deborah Spak, (847) 948-2349
Nancy Lovre, (818) 550-4790
Investor Contacts:

Neville Jeharajah, (847) 948-2875
Mary Kay Ladone, (847) 948-3371

 

 

 
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