Expanded Clinical Data for ADVATE Confirm Safety and Efficacy in Hemophilia A Patients

August 16, 2005

Applied Clinical Trials

Studies Presented at 20th Congress of International Society on Thrombosis and Haemostasis

DEERFIELD, Ill. – August 11, 2005 – Baxter Healthcare Corporation today announced the presentation of data from two company- sponsored clinical studies at the 20th Congress of the International Society on Thrombosis and Haemostasis held in Sydney, Australia, August 6 – 12. The results provide further evidence for the safety, immunogenicity and efficacy of ADVATE® in the treatment of individuals with hemophilia A.

"We are committed to expanding our data on ADVATE with extensive follow-up clinical investigations and analyses of this product in a variety of medical settings," said Bruce Ewenstein, M.D., Ph.D., global medical director for Hemophilia Therapies at Baxter. "These two studies echo the results of our original clinical trials evaluating the safety, immunogenicity and efficacy of ADVATE in the treatment and prevention of bleeding in previously treated hemophilia A patients."

The first presentation described the preliminary assessment of the interim efficacy and final safety and immunogenicity results of a prospective international, multi-center study evaluating pharmacokinetic properties of ADVATE in 53 patients less than six years of age who were previously treated with factor VIII. According to the results, no patients discontinued ADVATE therapy as a result of an adverse event and no incidence of factor VIII inhibitors (antibodies to factor VIII) were reported in this study. The results showed that of 210 bleeding episodes, 92.4 percent required only one or two infusions and 92.4 percent of treatments were rated as excellent or good. The investigators also concluded that the results reinforce the safety profile of ADVATE including its low-immunogenicity in individuals with hemophilia A who were previously treated with other factor VIII concentrates.

The second presentation described the preliminary results of a multi- center, prospective, open-label, uncontrolled study evaluating the efficacy, safety and immunogenicity of ADVATE in hemophilia A patients undergoing surgery or other invasive procedures. The study evaluated 64 procedures in 57 subjects. An interim assessment of the first 44 procedures performed demonstrated an efficacy rating of excellent/good in 97.7 percent of surgeries. Preliminary assessment of the final safety data in all 64 procedures performed identified seven non-serious adverse events that were potentially related to treatment - none of which were related to inhibitor development. These results support the established safety, efficacy and immunogenicity profile of ADVATE in the surgical management of patients previously treated with factor VIII.

In another presentation by clinicians from the Hemophilia Center at Phoenix Children's hospital and Indiana Hemophilia and Thrombosis Center, information was reported on two previously untreated patients who went on to develop inhibitors that were administered ADVATE in high doses in order to induce immune tolerance to factor VIII. Both patients showed good response to the treatment and achieved factor VIII tolerance, suggesting that recombinant factor VIII concentrates processed without plasma protein or albumin additives are effective in immune tolerance induction to factor VIII. This is the first report documenting the successful use of ADVATE for the induction of immune tolerance. Prospective clinical trials are required to determine the safety and efficacy of ADVATE in this important clinical application.

About ADVATE

ADVATE [Antihemophilic factor (recombinant), plasma/albumin free method] is indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes. 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 produced without blood or blood components, including human albumin or other plasma protein additives. The absence of blood or blood components eliminates the concern about contracting blood-borne diseases from factor VIII therapy.

Baxter developed ADVATE, the most recent advance in recombinant factor VIII therapy, in response to the needs of the hemophilia community, who called for the removal of human albumin and other plasma protein additives from recombinant factor VIII therapies. ADVATE is approved in the United States, Australia and 14 countries in Europe. Worldwide more than 650 million units of ADVATE have been sold.

ADVATE is also indicated in the perioperative management of patients with hemophilia A. ADVATE is not indicated for the treatment of von Willebrand disease.

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

People with hemophilia A do not produce adequate amounts of factor VIII, which is necessary for blood to effectively clot. 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. According to the World Health Organization, more than 400,000 people in the world have hemophilia, corresponding to a prevalence of 15 to 20 in every 100,000 males born worldwide.

About Inhibitors

Inhibitors, which are antibodies created by the immune system, are developed by some people with hemophilia after exposure to factor VIII or IX concentrate. Inhibitors neutralize the infused factor and prevent the blood from clotting.

About Baxter

Baxter Healthcare Corporation is a subsidiary of Baxter International Inc. Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the 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 http://www.baxter.com

Related Content:

News