US Delays Approval Of Wyeth Osteoporosis Medicine Bazedoxifene
COLLEGEVILLE, Pa., May 23 -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the U.S. Food and Drug Administration (FDA) issued an approvable letter on May 21 for bazedoxifene, a selective estrogen receptor modulator, for the treatment of postmenopausal osteoporosis. In the letter, the FDA requested information similar to that outlined in its approvable letter for bazedoxifene's New Drug Application (NDA) for the prevention of postmenopausal osteoporosis issued in December 2007. This included further analyses concerning the incidence of stroke and venous thrombotic events. The Agency also identified specific questions concerning data collection and reporting and requested additional source documents.
"Today's action is in line with our expectations," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals. "In our conference with the Agency earlier this year, they stated their desire to convene an advisory committee to review the pending new drug applications for both treatment and prevention of postmenopausal osteoporosis. We have been working closely with the FDA to address their questions and we are preparing a complete response which we expect to file by end of 2008. We remain committed to pursuing bazedoxifene as an important new option for the millions of postmenopausal women at risk for osteoporotic fracture."
Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased risk of fractures. According to the National Osteoporosis Foundation, the number of women of menopausal age who have osteoporosis or are at risk for developing the disease will increase from almost 30 million in 2002 to nearly 41 million in 2020. Up to 20 percent of a woman's expected lifetime bone loss can occur in the years immediately following menopause. The treatment of postmenopausal osteoporosis could lead to significant improvement in the overall health for millions of women worldwide as well as reduce costs associated with postmenopausal osteoporosis-related fractures.
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, nutritionals 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 that 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, without limitation, 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 (including that there can be no assurance that our pending new drug applications for bazedoxifene will be approved or that the product will ever be successfully commercialized); 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; 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" in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008. 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.