Baxter International Inc. announced that Advate is the proposed proprietary name for its investigational factor VIII therapy - Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF-PFM). This announcement follows the provisional acceptance of the brand name by both the U.S. Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA).

The FDA and EMEA review all proposed proprietary names for drugs and biologics to ensure that they do not make claims that are false or misleading, as well as to ensure that the potential for name confusion between drugs is minimized. Final approval of provisionally accepted names can only be granted upon licensure of the investigational drug.

rAHF-PFM is Baxter's newest technological advancement. Developed in response to requests from the medical and hemophilia community, rAHF-PFM is the first factor VIII recombinant therapy to be prepared without the addition of any human- or animal-derived raw materials in the cell culture process, purification or final formulation.

A Biologics License Application (BLA) was submitted to the FDA in June 2002 and, in September 2002, a Marketing Authorization Application (MAA) was submitted to the EMEA through the European Union (EU) Centralized Procedure. A New Drug Submission (NDS) for rAHF-PFM was also filed with Health Canada's Drug's Directorate in September 2002.

Hemophilia A is caused by the absence or severe deficiency of factor VIII, a protein in human blood critical for proper blood coagulation. Potentially more than 300,000 patients could be diagnosed with hemophilia A worldwide. Patients can experience spontaneous, uncontrolled internal bleeding that often is associated with pain, debilitation, chronic joint destruction and if left untreated, the risk of death.

People with hemophilia infuse themselves with clotting factors on average three times a month, unless they are on a preventive regimen, in which case they may infuse as often as four times per week. Barring complications, clinicians today expect a near normal life expectancy for persons with hemophilia, provided that they receive proper treatment.