ADVATE Worldwide Distribution Surpasses RECOMBINATE Based on
Comparative Data One Year Post U.S. Launch

DEERFIELD, Ill., October 22, 2004 – A Japanese subsidiary of Baxter International Inc. announced today that it has submitted a regulatory application to the Minister for Health, Labour and Welfare to request approval in Japan to market ADVATE® Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM) for the treatment of hemophilia A. The submission was made through the local regulatory process, which will include an evaluation by the Pharmaceuticals and Medical Devices Agency (PMDA). This is the first step in gaining regulatory approval for ADVATE in Japan.

The regulatory submission in Japan included results from a global, multi-center, randomized, double-blind, cross-over study comparing the pharmacokinetics of ADVATE and RECOMBINATE® Antihemophilic Factor (Recombinant) rAHF, a leading recombinant Factor VIII therapy that has been available from Baxter since 1992. Results from a local clinical study conducted in Japan were also included.

ADVATE is the only hemophilia A therapy made without any plasma protein additives in the cell culture process, purification and final formulation, thereby eliminating the risk of infection from viruses and infectious prions that may be carried in these protein additives.

Worldwide Experience
Following its approval in July 2003 in the United States and subsequently in the European Union, ADVATE has been widely accepted by patients and clinicians. Through September 2004, more than 225 million international units of ADVATE have been distributed worldwide. In just the first year following availability of the product in the United States, more than 150 million international units of ADVATE were distributed worldwide. This is more than twice the distribution within a similar post-launch time frame for RECOMBINATE, which went on to become a leading recombinant Factor VIII concentrate. In the first 12-months post-launch for RECOMBINATE, 69 million international units were distributed.

“ADVATE represents our continued commitment to providing innovative therapies to people with hemophilia,” said Bruce Ewenstein, M.D. global medical director for Baxter’s BioScience business. “Based on the volume of ADVATE in the marketplace, and the reporting of patient experience with the product, we have seen results that continue to support the safety and efficacy of ADVATE and confirm what was documented in clinical trials.”

ADVATE should be administered cautiously in patients with previous hypersensitivity to constituents of Factor VIII preparations or known hypersensitivity to mouse or hamster proteins. The most common related adverse events observed during the ADVATE clinical studies include: strange taste in mouth, headache, dizziness and flushing. The formation of inhibitors has been observed with all Factor VIII products, including ADVATE. Patients should contact their doctor if they are not able to prevent or control bleeding episodes with their regular doses of prescribed Factor VIII therapy.

 

About Hemophilia A
People with hemophilia A do not produce adequate amounts 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, patients with severe hemophilia A have a greatly reduced life expectancy.

 

About Baxter

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

For more information, including ADVATE full prescribing information, please visit www.baxter.com.