Baxter Healthcare announced today that Advate (Octocog Alfa Recombinant Coagulation Factor VIII) has received a unanimous positive opinion for marketing authorization from the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA).

The CPMP recommends that Advate be indicated "for the prevention and control of bleeding episodes in people with haemophilia A."

Advate 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 infections caused by viruses that may be carried in these proteins.

"Baxter is excited about this positive endorsement from the CPMP as it means that we are one step closer to bringing this new advance in the treatment of haemophilia A to both physicians and patients in Europe," said Louise Makin, president of Baxter Biopharmaceuticals, Europe.

Advate will now move towards the final stages in the process of marketing authorization by the European Commission. A CPMP recommendation serves as the basis for European Commission approval, which typically follows in approximately 90 days. Approval from the European Commission will allow Baxter to market Advate in all 15 European Union member states as well as in Norway and Iceland, as these countries, per agreement with the EU, take part in the centralized evaluation procedure for new drug applications. Advate received regulatory approval from the United States Food and Drug Administration (FDA) on July 25, 2003, and has also been submitted for approval to Swissmedic, the Swiss Agency for Therapeutic Products in October 2002, as well as to Health Canada's Drug Directorate in September 2002.

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 Neuchatel, Switzerland. This facility has the capacity to help ensure sufficient supplies of this therapy based on current and anticipated patient needs.

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.

According to the World Health Organization, more than 400,000 people in the world may have haemophilia(i) and it affects 15-20 of every 100,000 males born worldwide(ii). In Europe, about 37,000 people are diagnosed with haemophilia A, and each year, approximately 250 to 280 babies are born with the inherited, blood clotting disorder.

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.