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BAXTER INTRODUCES ADVATE AS BRAND NAME FOR ITS INVESTIGATIONAL HEMOPHILIA
A THERAPY
DEERFIELD, Ill., February
4, 2003 -- Baxter International Inc. (NYSE:BAX) today 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.
ABOUT HEMOPHILIA
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.
ABOUT BAXTER
Baxter International
Inc., through its subsidiaries, assists health-care professionals and
their patients with 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.
(Baxter and ADVATE
are trademarks of Baxter International Inc.)
FOR ADDITIONAL
INFORMATION:
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Media Contacts:
Deborah Spak, (847) 948-2349
Investor Contacts:
- Neville Jeharajah,
Baxter, (847) 948-2875
Mary Kay Ladone, Baxter, (847) 948-3371
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