MADISON, N.J., March 12 /PRNewswire-FirstCall/ -- 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.
SOURCE Wyeth
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Related links:
http://www.wyeth.com/
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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