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Wyeth Receives Approval from European Medicines Agency for New BeneFix Features

Geschrieben am 20.08.2007 - [Nächster Artikel]

Maidenhead, England (ots/PRNewswire) -

- Enhancements Provide Haemophilia B Patients with a Simpler and
More Convenient Preparation Process for Recombinant Factor IX -

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced
today that it has received approval from the European Medicines
Agency (EMEA) for new enhancements for BeneFix(R) nonacog alfa
(Recombinant Coagulation Factor IX). These enhancements are designed
to offer patients a simpler and more convenient preparation process
compared with the original BeneFix preparation process.

The convenience enhancements for BeneFix include:


-- A 2000 IU dosage strength vial. This is now the largest unit dosage
vial offered for haemophilia B treatment. As a result, many patients
will be able to use fewer vials of BeneFix to achieve their desired
dosage.
-- A prefilled diluent syringe. This feature allows for fewer components
and faster preparation compared to the original BeneFix preparation
process.
-- A 5 ml diluent volume for all dosage strengths, which may decrease the
overall volume of product required for infusion.
-- A needleless reconstitution device, which eliminates the risk of
needlesticks during reconstitution.


"Each of these new features was designed to enable BeneFix
patients to spend less time preparing their factor product, to
prepare it more safely and to have additional time for themselves,"
says Gary L. Stiles, M.D., Executive Vice President and Chief Medical
Officer, Wyeth Pharmaceuticals.

Recently, Wyeth announced that it has assumed all marketing and
distribution rights to BeneFix in Europe following the planned June
30, 2007, conclusion of a 10-year distribution rights agreement
between Baxter Healthcare Corporation and Genetics Institute.
Genetics Institute was acquired by Wyeth in 1996. Wyeth manufactures
and markets recombinant products for both haemophilia A and B
patients.

BeneFix is a coagulation factor that uses a recombinant DNA
technology to produce clotting factor IX, which stops or prevents
bleeding in people with haemophilia B who do not have enough factor
IX of their own. BeneFix is a recombinant product and it is
inherently free from the risk of transmission of human blood-borne
pathogens, such as HIV, hepatitis viruses and parvovirus.

About Haemophilia

Haemophilia B is a rare, inherited blood-clotting disorder. People
with haemophilia B are deficient in a key protein - factor IX - which
is vital in the clotting mechanism to prevent bleeding. Haemophilia B
is characterized by spontaneous haemorrhages or prolonged bleeding,
typically into joints and soft tissue. Most patients with haemophilia
B are dependent on replacement therapy with factor IX.

About BeneFix

BeneFix is indicated for the treatment and prophylaxis of bleeding
in patients with haemophilia B (congenital factor IX deficiency).

About Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products
in the areas of women's health care, infectious disease,
gastrointestinal health, central nervous system, inflammation,
transplantation, haemophilia, oncology, vaccines and nutritional
products. Wyeth is one of the world's largest research-driven
pharmaceutical and health care products companies. It is a leader in
the discovery, development, manufacturing and marketing of
pharmaceuticals, vaccines, biotechnology products and
non-prescription medicines that improve the quality of life for
people worldwide. The Company's major divisions include Wyeth
Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal
Health.

Web site: http://www.wyeth.com

ots Originaltext: Wyeth Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Gill Markham of Wyeth Pharmaceuticals, +44-1628-692536
 
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