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Baxter Announces U.S. Commercial Availability of ADVATE, Signs Multi-Year
Agreements with Leading U.S. Specialty Pharmacy Customers
DEERFIELD, Ill., September
12, 2003 - Following its recent U.S. launch of ADVATE, Antihemophilic
Factor (Recombinant), Plasma/Albumin-Free Method, (rAHF-PFM), Baxter Healthcare
Corporation (NYSE: BAX) today announced that it has signed non-exclusive
multi-year agreements with several leading U.S. specialty pharmacy companies,
including Accredo Health Inc. (NASDAQ: ACDO), Caremark Inc. (NYSE: CMX),
Curative Health Services (NASDAQ: CURE) and Hemophilia Resources of America
to dispense ADVATE for the prevention and control of bleeding episodes
in people with hemophilia A.
"The availability
of ADVATE in the United States is another milestone for Baxter and the
hemophilia community," said Larry Guiheen, president, Biopharmaceuticals
at Baxter. "For more than a decade, Baxter has dedicated itself to
increasing the supply of recombinant therapy, and today, we reaffirm that
commitment by bringing a strong supply of ADVATE to the U.S. hemophilia
community."
ADVATE, approved by
the U.S. Food and Drug Administration (FDA) on July 25, 2003 and made
commercially available in late August 2003, is the first and only recombinant
factor VIII made without any added human or animal plasma proteins and
albumin in the cell culture process, purification and final formulation,
thereby eliminating the risk of infections caused by viruses that may
be carried in these proteins.
Over the past 40 years,
Baxter has been a leader in providing the hemophilia community with increasingly
advanced clotting therapies. In the early 1990s, Baxter launched the first
recombinant factor VIII therapeutic, RECOMBINATE rAHF, which has now become
the leading treatment for hemophilia A. ADVATE, Baxter's latest development,
was a response to the National Hemophilia Foundation's Medical and Scientific
Advisory Council (MASAC) recommendations that "all efforts should
be made to remove human albumin from recombinant factor VIII products"
and " increased efforts should be made to eliminate human and bovine
proteins from the manufacturing process of recombinant products."
"We are pleased
to work with Baxter to make this exciting new class of therapy available
to people with hemophilia A," said Kyle J. Callahan, president of
Accredo's subsidiary Hemophilia Health Services, Inc.
"With this agreement,
we underscore our focus on providing the hemophilia community with the
most advanced treatments and options for their care," said A.D. Frazier,
President and COO of Caremark Rx, Inc.
ADVATE is available
as a single dose vial in four convenient potencies of 250, 500, 1,000
IU per vial and in a super-high potency 1,500 IU per vial, with a smaller
infusion volume (5mL diluent), which means shorter infusion times for
patients. ADVATE comes packaged with a 10mL syringe, butterfly bandage,
alcohol swab and a patient-friendly package insert.
Side effects related
to the use of ADVATE are uncommon. No serious adverse events related to
treatment with ADVATE have been reported to date. Non-serious, moderate
or mild related adverse events may include: a strange taste, itching at
the infusion site, dizziness, headaches, catheter-related infections,
hot flashes, diarrhea, lower limb edema, sweating, nausea, pain in the
upper abdomen or lower chest, decreased red blood cell count, joint swelling
and shortness of breath. Non-serious, but severe related adverse events
may include: fever, headache and decreased coagulation factor VIII levels.
For more information
and full prescribing information on ADVATE, please visit www.advate.com
or call 1-888-4-ADVATE.
Baxter Healthcare
Corporation is the principal domestic operating subsidiary of Baxter International
Inc. (NYSE: BAX). 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, Advate and Recombinate are trademarks of Baxter International
Inc. Baxter is registered in the U.S. Patent and Trademark Office.
FOR
ADDITIONAL INFORMATION:


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