Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced a
regulatory update for Viviant.
Wyeth has submitted to the U.S. Food and Drug Administration (FDA)
clinical study reports of two recently completed clinical studies of
Viviant conducted in Asia. These data supplement Wyeth’s pending New Drug
Application (NDA) for Viviant for the prevention of postmenopausal
osteoporosis and its “complete response” to the safety and efficacy issues
raised in the FDA’s April 23, 2007 approvable letter for this NDA.
Whether the complete response and this supplemental submission resolve
to the FDA’s satisfaction the issues raised in the approvable letter is not
yet known. The current action date for the prevention NDA is at the end of
December 2007, and no labeling discussions have occurred to date. FDA may
issue an action letter by year-end or before, or may extend the review
period by 90 days as a result of the recent submission.
The FDA action date for Wyeth’s separate NDA for Viviant for the
treatment of postmenopausal osteoporosis remains at the end of May 2008.
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.
These 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 pipeline
products; government cost-containment initiatives; restrictions on
third-party payments for our products; substantial competition in our
industry, including from branded and generic products; data generated on
our products; 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.
For more information, visit http://www.Wyeth.com.
SOURCE Wyeth