More Clinical Data Required to Support European Approval of Desvenlafaxine as a Potential Treatment for Vasomotor Symptoms
Madison, N.J., March 12, 2008 â€“ 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.Â 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.Â
â€œWe 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,â€ says Gary L. Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. â€œSome 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.â€
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of womenâ€™s health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.Â
Wyeth is one of the worldâ€™s largest research-driven pharmaceutical and health care products companies.Â 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.Â The Companyâ€™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.Â 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.Â 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 andÂ 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 â€œItem 1A, RISK FACTORS.â€Â The forward-looking statements in this press release are qualified by these risk factors.Â We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.