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EMEA Validates Wyeth Application to Expand the European Label of TORISEL

Geschrieben am 28.01.2008 - [Nächster Artikel]

Maidenhead, England (ots/PRNewswire) - Wyeth Pharmaceuticals, a
division of Wyeth (NYSE:WYE), announced today that the European
Medicines Agency (EMEA) has validated the marketing authorisation
application for Torisel(R) (temsirolimus) for treating relapsed
and/or refractory mantle cell lymphoma (MCL), a rare type of
non-Hodgkin's lymphoma (NHL) that accounts for approximately 6% of
NHL cases and has the lowest five-year survival rate of any lymphoma.

"Relapsed/refactory MCL is an aggressive cancer for which there is
no established standard of care in Europe," observed Dr Michael
Zaiac, Assistant Vice President, Transplanation, Oncology and GI,
Wyeth, Europe Middle East and Africa "If approved for this
indication, Torisel could be an important therapeutic option for this
patient population, for whom there is at present an unmet medical
need."

The EMEA regulatory submission for MCL includes data from a
three-arm Phase 3 clinical trial comparing two dose levels of Torisel
with the investigators' choice of treatment for patients with
relapsed and/or refractory MCL.

Torisel is the only approved cancer therapy that specifically
inhibits the mTOR (mammalian target of rapamycin) kinase, an
important regulator of cell proliferation, cell growth and cell
survival. Having received Orphan Medicinal Product designation in the
EU for the treatment of MCL, Torisel was in November 2007 approved in
the EU as a first-line treatment for patients with advanced renal
cell carcinoma (RCC) who have at least three of six prognostic risk
factors.

Together with the continuing development of several other
haemato-oncology and oncology products, the development of TORISEL
confirms Wyeth's commitment to this important field of medicine.

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, hemophilia, 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 pharmaceutical, 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.

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

$story.getcontactHeadline()
Media Contacts: Wyeth Pharmaceuticals, Gill Markham,
+44(0)1628-692536
 
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