European CHMP Issues Positive Opinion on Wyeth's TORISEL for Treatment of Relapsed/Refractory Mantle Cell Lymphoma

Maidenhead, England (ots/PRNewswire) - Wyeth Europa, a
division of Wyeth (NYSE:WYE), announced today that it has received a
positive opinion from the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMEA) recommending the
approval of the mTOR (mammalian target of rapamycin) inhibitor
TORISEL(R) (temsirolimus) for the treatment of relapsed and/or
refractory mantle cell lymphoma (MCL). The CHMP's opinion will now be
forwarded to the European Commission for a final decision. MCL is a
rare type of non-Hodgkin's lymphoma (NHL) that accounts for
approximately 6 percent of NHL cases and has the lowest five-year
survival of any type of lymphoma. TORISEL received Orphan Medicinal
Product designation for the treatment of MCL in the European Union
(EU) in November 2006.

"Mantle cell lymphoma that has relapsed or is refractory to other
therapies is extremely difficult to treat," says Mikael Dolsten,
M.D., Ph.D., President, Wyeth Research. "The CHMP's positive opinion
underscores the potential for TORISEL to provide an important
therapeutic option for patients in the European Union with this
disease."

The positive opinion was based on results of a phase 3 clinical
study that showed patients with relapsed and/or refractory MCL
treated with TORISEL experienced a statistically significant
improvement in median progression-free survival, compared with
single-agent therapy selected by the investigator (4.8 months vs 1.9
months, P=0.0009).

The most frequently occurring severe or life-threatening (Grade 3
or 4) adverse events in patients with relapsed MCL treated with
TORISEL included thrombocytopenia, anaemia, neutropenia and asthenia.

About TORISEL

TORISEL, a cancer therapy that specifically inhibits the mTOR
kinase, an important regulator of cell proliferation, cell growth and
cell survival, was approved in the EU in November 2007 for the
first-line treatment for patients with advanced renal cell carcinoma
(RCC) who have at least three of six prognostic risk factors. In the
United States, TORISEL is indicated for the treatment of patients
with advanced RCC.

Inhibition of mTOR in treated cancer cells blocked the
translation of genes that regulate the cell cycle. In in vitro
studies using renal cancer cell lines, temsirolimus inhibited the
activity of mTOR and resulted in reduced levels of the
hypoxia-inducible factors HIF-1 and HIF-2 alpha, and the vascular
endothelial growth factor.

Please see TORISEL full product information. Available on
request.

Wyeth Pharmaceuticals

Wyeth Europa, as part of 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 nutritionals 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 Europa
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Media Contacts: Wyeth Europa, Gill Markham, +44(0)1628-692536