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BAXTER RECEIVES
FDA APPROVAL FOR THIRD MANUFACTURING SUITE AT THOUSAND OAKS
DEERFIELD, Ill., September 10, 2001 - Baxter Healthcare Corporation (NYSE:BAX)
announced today that it has received U.S. Food and Drug Administration
approval for a third production suite at its BioScience facility in Thousand
Oaks, California. This facility is the manufacturing site for Baxter's
recombinant Factor VIII therapy, Recombinate Antihemophilic Factor (rAHF),
which is a clotting factor produced by recombinant DNA technology as a
therapy for people with hemophilia.
The approval
will not affect overall U.S. supply because Suite C is already operating
at full capacity for global customers since receiving European regulatory
approval last year. However, it will allow Baxter greater flexibility
in providing therapy to its U.S. customers.
"Approval of
Suite C is an important milestone in Baxter's on going commitment to the
hemophilia community. We are very pleased to have received FDA approval
just four months after applying," said Thomas Glanzmann, president
of Baxter BioScience.
Baxter Continues
Its Leadership in Hemophilia Research and Treatment
Baxter is the only supplier that has increased the number of rFVIII units
into the North American marketplace every year since it was introduced
in 1992.
Baxter continues to invest in future capacity with construction of a fourth
processing suite (Suite D), also underway at its Thousand Oaks facility,
at a cost in excess of $50 million dollars. The company anticipates regulatory
approval by late 2004 and projects that Suite D will increase capacity
significantly.
Additionally, Baxter
is investing $131 million in a multi-purpose plant in Neuchâtel, Switzerland,
for the processing of recombinant therapies. Neuchâtel is also the site
for the preparation of the investigational therapeutic to be used in ongoing
clinical trials for Baxter's next-generation recombinant Factor VIII therapy.
This next-generation recombinant Factor VIII excludes any added proteins
or raw materials derived from human or animal sources in the manufacture,
purification and formulation of the final product.
In total, by 2005,
Baxter will have production capacity to provide in excess of two billion
units of recombinant Factor VIII, with four suites in Neuchâtel and four
suites at Thousand Oaks.
Demand for Hemophilia
Therapy Has Doubled
Since 1995, demand for recombinant Factor VIII has nearly doubled on a
global basis. The heightened demand is due to several factors, including
increased use to prevent bleeding rather than treating patients when bleeds
occur.
Hemophilia is caused
by the absence or severe deficiency of Factor VIII, a protein in human
blood critical for proper blood coagulation. More than 300,000 people
worldwide have hemophilia. They can experience spontaneous, uncontrolled
internal bleeding that often is associated with pain, chronic joint destruction
and, if left untreated, 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 could infuse
multiple times per week. Barring other complications or disorders, clinicians
today expect a near normal life expectancy, provided patients receive
proper treatment.
Baxter Healthcare
Corporation is the principal U.S. operating susidiary of Baxter International
Inc. (NYSE: BAX). Baxter is a global medical products and services company
that, through its subsidiaries, provides critical therapies for people
with life-threatening conditions. Baxter's products and services in bioscience
(biopharmaceuticals, vaccines, biosurgery and transfusion therapies),
medication delivery and renal therapy are used by health-care providers
and their patients in more than 100 countries.
(Baxter
and Recombinate are trademarks of Baxter International Inc. Baxter is
registered in the U.S. Patent and Trademark Office.)
This news release contains forward-looking statements that
involve risks and uncertainties, including technological advances in the
medical field, product demand and market acceptance, actions of regulatory
bodies, 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.
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- Media Contacts:
- Deborah Spak, (847)
948-2349
Nancy Lovre, (818) 550-4790
- Investor Contacts:
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Neville Jeharajah, (847)
948-2875
Mary Kay Ladone, (847) 948-3371
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