ADVATE now available to patients in France

ZURICH, Aug. 16, 2004 – Baxter Healthcare S.A. announced today that the French Transparency Commission has issued a positive opinion to grant reimbursement status for ADVATE (Octocog Alfa Recombinant Coagulation Factor VIII).  This decision comes from a board of experts from the French Public Health Authorities and was officially published in the Journal Officiel (the French State Journal) on Aug. 13, 2004.  This approval represents the last step in making this product available to patients within France by putting it on the list of therapies that are reimbursed by the National Health Insurance. 

 

“We are pleased to have received this positive decision from the French regulatory authorities that allows patients access to an important new therapy in France for haemophilia A,” said Hartwig Gajek, MD, medical director in Europe for Baxter’s BioScience business.  

 

ADVATE is the first and only factor VIII made without the addition of any human or animal plasma proteins, such as albumin 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 plasma protein additives.

 

ADVATE was approved by the European Commission in March 2004. The availability of ADVATE in other countries varies based on the timing of similar reimbursement approvals.  ADVATE is currently reimbursed in Austria, Denmark, Germany, Greece, Ireland, Netherlands, Sweden, Switzerland and the United Kingdom.

 

ADVATE is a blood clotting therapy that helps people with haemophilia A prevent and control 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 function properly. 

 

ADVATE is processed by Baxter in its state-of-the-art, multi-purpose, biotechnology facility in Neuchâtel, Switzerland. This facility has the capacity to help ensure sufficient supply of this therapy based on current and anticipated patient needs.

 

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 events observed during the ADVATE clinical studies include: strange taste in mouth, headache, dizziness and flushing.

About Haemophilia A

People with haemophilia 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 haemophilia A have a greatly reduced life expectancy.
 
People with haemophilia A infuse themselves with clotting factors three times a month, on average, unless they are on a preventive regimen, in which case their physician may prescribe infusing a therapy as often as three or four times per week.

 

About Baxter

Baxter Healthcare S.A. is the principal European operating 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 in patients´ lives.

 

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

 

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 of regulatory authorities and other government authorities, reimbursement policies of government agencies and private payers, 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.