Results From a Completed Clinical Study of ADVATE in Children Less Than Six Years Old with Moderately Severe to Severe Hemophilia A Were Published in The Journal of Thrombosis and Haemostasis

DEERFIELD, Ill., October 20, 2008 – Baxter Healthcare Corporation today announced the results of a study of ADVATE ® [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method], the only recombinant factor VIII therapy that is full-length and free of blood-based additives, in previously treated patients (PTPs) less than six years of age with moderately severe to severe hemophilia A. The study, published in the August issue of the Journal of Thrombosis and Haemostasis, adds to the compendium of clinical data for ADVATE. ADVATE is indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes and perioperative management of patients with hemophilia A. ADVATE is not indicated for the treatment of von Willebrand's disease.

“For the first time, there are published data on the use of ADVATE in managing hemophilia in young children,” said Victor Blanchette, M.D., Chief, Division of Hematology/Oncology, Hospital for Sick Children, University of Toronto, Canada. “Further, the study provides an understanding of the therapeutic issues in a subset of patients that are not traditionally included in clinical trials.”

In this study of 53 PTPs with moderately severe to severe hemophilia A, over 90 percent of bleeding episodes were managed with one to two ADVATE infusions, and hemostatic efficacy was rated “excellent” or “good” for nearly 94 percent of treated bleeding episodes.

Patients did not develop a FVIII inhibitor, and there were no serious treatment-related adverse events. Non-serious treatment-related adverse events in two patients were observed including: laryngitis, eye inflammation, memory impairment, tremors and pallor.

In a second study, published in the August issue of Thrombosis and Haemostasis, the use of ADVATE was evaluated in moderately severe to severe PTPs with hemophilia A undergoing major and minor surgeries. Hemostatic efficacy was assessed as “excellent” or “good” in 100 percent of the procedures rated (n=65). Additionally, inhibitor development in patients was not detected. Most adverse events were consistent with well-known complications of hemophilia, FVIII therapy, surgery or hospitalization.

“These studies contribute to our understanding of ADVATE in a variety of populations and treatment settings,” said Bruce Ewenstein, M.D., Ph.D., Vice President, Clinical and Medical Sciences at Baxter . “We are proud of our extensive clinical study program and are committed to ongoing research to continue to meet the needs of the community.”

About the Pediatric Study

The multicenter, open-label, prospective pediatric cohort study included PTPs with moderately severe to severe hemophilia A who were less than six years of age, had a baseline FVIII of less than or equal to two percent, and had at least 50 prior exposure days to other FVIII concentrates.

About the Surgical Setting Study

The multicenter, prospective, open-label, uncontrolled study in the surgical setting included PTPs with moderately severe to severe hemophilia A who were over five years of age, had a baseline FVIII of less than or equal to two percent, had prior treatment with FVIII concentrates for more than 150 exposure days, and required invasive surgical or dental procedures. The majority of patients were over 18 years of age, although nine children ages 7-15 were also included. A total of 65 procedures (22 major, 35 minor and eight dental) were performed in 58 subjects.

About ADVATE

The safety and efficacy of ADVATE has been clinically tested in previously treated pediatric, adolescent and adult patients with various treatment regimens and in various treatment settings. In the pivotal study, the majority of bleeding episodes were resolved with a single infusion of ADVATE. To date, more than 200 unique patients worldwide have completed participation in clinical trials of ADVATE, making it one of the largest hemophilia clinical study programs ever undertaken. In addition, a number of other studies are ongoing; including a study involving previously untreated patients, as well as wide-ranging post-market safety surveillance studies.

Since the US Food and Drug Administration (FDA) approval of ADVATE five years ago, more than four billion units have been distributed, making it the number-one selling hemophilia therapy worldwide.

ADVATE is registered in 43 countries worldwide including the United States, Canada, 27 countries in the European Union, Norway, Iceland, Switzerland, Australia, New Zealand, Puerto Rico, Argentina, Suriname, Japan, South Korea, Taiwan, Hong Kong, Malaysia and Singapore.

Infused directly into the bloodstream, ADVATE works by temporarily raising the level of factor VIII in the blood, thus allowing the body's blood clotting process to properly function. ADVATE is the only recombinant factor VIII therapy processed without blood or blood additives, including human albumin or other plasma protein additives.

ADVATE should be administered cautiously in patients with previous hypersensitivity to constituents of factor VIII preparations or known sensitivity to mouse or hamster proteins. The most common related adverse reactions 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 concentrates, including ADVATE.

About hemophilia A

Hemophilia A is largely an inherited disorder in which one of the proteins, factor VIII, needed to form blood clots is missing or reduced. Without enough factor VIII, people with hemophilia can experience spontaneous, uncontrolled internal bleeding that can be painful, debilitating and damaging to joints. In about 30 percent of cases, there is no family history of the hemophilia and the condition is the result of a spontaneous gene mutation. According to the World Federation of Hemophilia, more than 400,000 people in the world have hemophilia. Approximately one in 5,000 males born in the United States has hemophilia. All races and economic groups are affected equally.

About Baxter

Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.