Baxter Receives Marketing Authorisation from SWISSMEDIC for ADVATE to Treat Haemophilia A

ZURICH, Switzerland, February 18/PRNewswire/

New Coagulation Factor VIII Processed in Switzerland - Now Available for Swiss Haemophilia A Patients

Baxter AG, based in Volketswil ZH, today announced that the Swiss Healthcare Organisation SWISSMEDIC has issued a marketing authorisation for ADVATE (Octocog Alfa Recombinant Coagulation Factor VIII); which will allow Baxter to market this innovative product in Switzerland.

ADVATE is indicated for the prevention and control of bleeding episodes in people with haemophilia A. It is the first and only factor VIII made without the addition of any human or animal plasma proteins and albumin in the cell culture process, purification and final formulation, thereby eliminating the risk for transmission of viruses that could be carried in these proteins.

"The approval of ADVATE by SWISSMEDIC is an important advance for haemophilia A patients and treating physicians and we are pleased to confirm our commitment to this community," said Dr. Jürg Gasser, General Manager of Baxter AG. "Following the successful launch of ADVATE in the United States, we are pleased to bring this important new treatment option to patients in Switzerland."

ADVATE received a unanimous positive opinion recommendation from SWISSMEDIC on 20 October 2003. The final approval makes the therapy available in Switzerland and the principality of Liechtenstein. ADVATE was granted its first global approval from the U.S. Food and Drug Administration (FDA) on 25 July 2003. Baxter received a European positive opinion on 23 October 2003 and is awaiting the final market authorization for this region.

ADVATE addresses lingering doubts in the haemophilia community about potential viral transmission from added proteins because it offers the unsurpassed pathogen safety of a plasma/albumin free processing method. ADVATE is the first factor VIII therapy to be created using innovative technology that completely eliminates the need to add any human or animal proteins.

About ADVATE

ADVATE is a blood clotting therapy that helps people with haemophilia A ("blood disorder"), to prevent and control bleeding episodes. Infused directly into the bloodstream, ADVATE works by raising the level of factor VIII in the blood, thus temporarily correcting the FVIII deficiency and any likely bleeding.

ADVATE is processed by Baxter in its state-of-the-art biotechnology facility in Neuchâtel, which was established over the last few years following an investment exceeding 170 million Swiss francs. The facility has the capacity to cover the current and anticipated demand for ADVATE.

Side effects with the use of ADVATE are uncommon, with no serious adverse events related to treatment with ADVATE reported to date. Possible side effects of ADVATE include a strange taste, headaches, dizziness and hot flushes, catheter-related infections, dyspnoea, haematoma, diarrhoea, sweating, itching, joint swelling, oedema, pain in the upper abdomen or lower chest, stiffness, fever, haematocrit or drop in factor VIII levels.

Haemophilia A ("Blood disorder")

People with haemophilia A either produce no factor VIII or insufficient levels of factor VIII, which is necessary to effectively clot blood. Without enough factor VIII, patients can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating and damaging to joints; if untreated, this may be life threatening to patients with severe haemophilia A.

Factor VIII therapy or prophylaxis is recommended on a case-by-case basis, particularly for the treatment of bleeding. Prophylactic therapy helps prevent bleeding and minimises subsequent effects. Haemophilia is a genetically inherited disorder, which primarily affects men. Women can be a carrier of the disorder, but can lead a normal, symptom-free life. Haemophilia was widespread throughout European nobility; the legendary Queen Victoria of Great Britain (1819-1901) was a carrier and Crown Prince Alexis of Russia (1904-1918) was also affected. Haemophilia A is five times more common than haemophilia B (factor IX deficiency).

According to the World Health Organisation (WHO), more than 400,000 people in the world suffer from a severe or moderate form of haemophilia A(1). This corresponds to a prevalence of 15-20 in every 100,000 males born worldwide(2). In Europe, about 25,000 patients are diagnosed with haemophilia A - approximately 400 of these live in Switzerland. The degree of severity (severe, moderate or mild) of haemophilia depends on the level and the degree of activity of factor VIII in the blood. The degree of activity is usually expressed as a percentage of the average clotting activity, which is defined as 100%. (e.g. severe <1%, moderate 1-5%, mild > 5% factor VIII activity).

About Baxter

Baxter AG has been present in Switzerland since 1976. Its main offices are in Volketswil. Other Baxter sites include Wallisellen, Effretikon, Düdingen, San Vittore, Campocologno and Neuchâtel. Baxter employs approximately 700 people in Switzerland.

Baxter AG, Volketswil, is a subsidiary of Baxter International Inc. Baxter International Inc., through its subsidiaries, assists health-care professionals and their patients with treatment of complex medical conditions, including cancer, haemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference to patients' lives.

BAXTER and ADVATE 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, the effect of economic conditions, actions by regulatory authorities, product demand and market acceptance, 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.

References

(1) World Federation of Hemophilia. About WFH. Edn Online [serial online]. Available at: http://www.wfh.org/ShowDoc.asp?Rubrique=.... Accessed August 2003.

(2) World Health Organization. The World Health Report 1997: Conquering suffering, enriching humanity. Geneva, Switzerland: Office of publications, World Health Organization; 1997.

Source: Baxter AG

For additional information: Dr. Jürg Gasser, General Manager of Baxter AG, Volketswil, Fani Kalaitsidis, Business Unit Manager Hemophilia, Baxter AG, Volketswil, Telephone +41-1-908-50-50; Fax +41-1-908-50-40, For additional questions or if you want to receive this document in an electronic version please contact: redaktion@balanx.ch, U.S. Media Contact: Cindy Resman +1-847-948-2815, Investor Contacts: Neville Jeharajah +1-847-948-2875, Mary Kay Ladone +1-847-948-3371

(124821)