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ADVATE RECEIVES UNANIMOUS POSITIVE OPINION IN EUROPE
FOR THE TREATMENT OF HAEMOPHILIA A
ZURICH and DEERFIELD,
Ill., October 23, 2003 -- Baxter Healthcare S.A. 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.
ABOUT ADVATE
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 Neuchâtel, Switzerland. This facility has the capacity to help
ensure sufficient supplies of this therapy based on current and anticipated
patient needs.
ABOUT HAEMOPHILIA
A
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
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.
ABOUT BAXTER
Baxter Healthcare S.A. is the principal European operating subsidiary
of Baxter International Inc. Baxter International Inc., through its subsidiaries,
assists health-care professionals and their patients with treatment of
complex medical conditions, including cancer, haemophilia, 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.)
This news release
contains forward-looking statements that involve risks and uncertainties,
including technological advances in the medical field, the effect of economic
conditions, actions by regulatory authorities at any stage of the development
and commercialization process, product demand and market acceptance, 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.
(i) World
Federation of Hemophilia. About WFH. Edn Online [serial online]. Available
at: http://www.wfh.org/ShowDoc.asp?Rubrique=7&Document=7. Accessed
August 2003.
(ii) World Health Organization. The world health report 1997: Conquering
suffering enriching humanity. Geneva, Switzerland: Office of publications,
World Health Organization; 1997.
FOR
ADDITIONAL INFORMATION:
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- Media
Contacts:
- Elizabeth
Shea, Baxter 847-948-3297
Hans Vanavermaete, Baxter, +32 2 650 1703
Kirsten Davis, Porter Novelli Brussels, +32 2 413 0340
- Investor
Contacts:
- Neville Jeharajah,
847-948-2875
Mary Kay Ladone, 847-948-3371
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