Wyeth has submitted to the U.S. Food and Drug Administration (FDA)clinical study reports of two recently completed clinical studies of Viviantconducted 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'sApril 23, 2007 approvable letter for this NDA.
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Whether the complete response and this supplemental submission resolve tothe FDA's satisfaction the issues raised in the approvable letter is not yetknown. The current action date for the prevention NDA is at the end ofDecember 2007, and no labeling discussions have occurred to date. FDA mayissue an action letter by year-end or before, or may extend the review periodby 90 days as a result of the recent submission.
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The FDA action date for Wyeth's separate NDA for Viviant for the treatmentof postmenopausal osteoporosis remains at the end of May 2008.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in theareas 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 andhealth care products companies. It is a leader in the discovery, development,manufacturing and marketing of pharmaceuticals, vaccines, biotechnologyproducts and non-prescription medicines that improve the quality of life forpeople 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 areforward-looking statements based on current expectations of future events andare subject to risks and uncertainties that could cause actual results todiffer materially from those expressed or implied by such statements. Theserisks and uncertainties include the inherent uncertainty of the timing andsuccess of, and expense associated with, research, development, regulatoryapproval and commercialization of our products and pipeline products;government cost-containment initiatives; restrictions on third-party paymentsfor our products; substantial competition in our industry, including frombranded and generic products; data generated on our products; the importanceof strong performance from our principal products and our anticipated newproduct introductions; the highly regulated nature of our business; productliability, intellectual property and other litigation risks and environmentalliabilities; uncertainty regarding our intellectual property rights and thoseof others; difficulties associated with, and regulatory compliance withrespect to, manufacturing of our products; risks associated with our strategicrelationships; economic conditions including interest and currency exchangerate fluctuations; changes in generally accepted accounting principles; tradebuying patterns; the impact of legislation and regulatory compliance; risksand uncertainties associated with global operations and sales; and other risksand uncertainties, including those detailed from time to time in our periodicreports filed with the Securities and Exchange Commission, including ourcurrent reports on Form 8-K, quarterly reports on Form 10-Q and annual reporton Form 10-K, particularly the discussion under the caption "Item 1A, RiskFactors." The forward-looking statements in this press release are qualifiedby these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, futuredevelopments or otherwise.
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