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More Clinical Data Required to Support European Approval of Desvenlafaxine as a Potential Treatment for Vasomotor Symptoms

Geschrieben am 12.03.2008 - [Nächster Artikel]

Madison, New Jersey (ots/PRNewswire) -

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced
today that it would need to conduct additional clinical studies to
address questions from the Committee for Medicinal Products for Human
Use (CHMP) regarding the risk-benefit profile of desvenlafaxine as a
treatment for vasomotor symptoms. As a result, Wyeth voluntarily
withdrew its application for European Marketing Authorisation for
desvenlafaxine for the treatment of vasomotor symptoms (hot flashes)
associated with menopause.

"We believe that desvenlafaxine can provide women with a
non-hormonal option to treat vasomotor symptoms (VMS), and Wyeth
remains committed to developing the molecule for this indication,"
says Gary L. Stiles, M.D., Executive Vice President and Chief Medical
Officer, Wyeth Pharmaceuticals. "Some of the questions raised by the
CHMP can be addressed with our planned clinical trials, including the
12-month study Wyeth is initiating with post-menopausal women early
this year. The Company also is considering whether to conduct
additional studies."

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, 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
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.

The statements in this press release that are not historical
facts are forward-looking statements based on current expectations of
future events and are subject to risks and uncertainties that could
cause actual results to differ materially from those expressed or
implied by such statements. In particular, there can be no assurance
that PRISTIQ (desvenlafaxine) will be commercially successful in the
highly competitive market for antidepressants in the United States,
or that desvenlafaxine will be approved in the future for other
indications (including treatment of vasomotor symptoms associated
with menopause) and/or in other countries. Other risks and
uncertainties include the inherent uncertainty of the timing and
success of, and expense associated with, research, development,
regulatory approval and commercialization of our products and our
pipeline products (including future regulatory action regarding our
pending applications for desvenlafaxine for the treatment of major
depressive disorder and the treatment of vasomotor symptoms, as to
which no assurance can be given); government cost-containment
initiatives; restrictions on third-party payments for our products;
substantial competition in our industry, including from branded and
generic products; emerging data on our products and pipeline products
(including from clinical trials of desvenlafaxine); the importance of
strong performance from our principal products and our anticipated
new product introductions; the highly regulated nature of our
business; product liability, intellectual property and other
litigation risks and environmental liabilities; uncertainty regarding
our intellectual property rights and those of others; difficulties
associated with, and regulatory compliance with respect to,
manufacturing of our products; risks associated with our strategic
relationships; economic conditions including interest and currency
exchange rate fluctuations; changes in generally accepted accounting
principles; trade buying patterns; the impact of legislation and
regulatory compliance; risks and uncertainties associated with global
operations and sales; and other risks and uncertainties, including
those detailed from time to time in our periodic reports filed with
the Securities and Exchange Commission, including our current reports
on Form 8-K, quarterly reports on Form 10-Q and annual report on Form
10-K, particularly the discussion under the caption "Item 1A, RISK
FACTORS." The forward-looking statements in this press release are
qualified by these risk factors. We assume no obligation to publicly
update any forward-looking statements, whether as a result of new
information, future developments or otherwise.

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

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

Contact:
Media: Gwen Fisher, Wyeth Pharmaceuticals, +1-484-865-5160, Investor:
Justin Victoria, Wyeth, +1-973-660-5340, or Douglas Petkus, Wyeth,
+1-973-660-5218
 
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