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"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 desireto convene an advisory committee to review the pending new drug applicationsfor both treatment and prevention of postmenopausal osteoporosis. We havebeen working closely with the FDA to address their questions and we arepreparing a complete response which we expect to file by end of 2008. Weremain committed to pursuing bazedoxifene as an important new option for themillions of postmenopausal women at risk for osteoporotic fracture."
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About Osteoporosis
Osteoporosis is a disease characterized by low bone mass and structuraldeterioration of bone tissue, leading to bone fragility and an increased riskof fractures. According to the National Osteoporosis Foundation, the numberof women of menopausal age who have osteoporosis or are at risk for developingthe disease will increase from almost 30 million in 2002 to nearly 41 millionin 2020. Up to 20 percent of a woman's expected lifetime bone loss can occurin the years immediately following menopause. The treatment of postmenopausalosteoporosis could lead to significant improvement in the overall health formillions of women worldwide as well as reduce costs associated withpostmenopausal osteoporosis-related fractures.
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, nutritionals and non-prescription medicines that improve the qualityof life for people worldwide. The Company's major divisions include WyethPharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts areforward-looking statements that are subject to risks and uncertainties thatcould cause actual results to differ materially from those expressed orimplied by such statements. These risks and uncertainties include, withoutlimitation, the inherent uncertainty of the timing and success of, and expenseassociated with, research, development, regulatory approval andcommercialization of our products and pipeline products (including that therecan be no assurance that our pending new drug applications for bazedoxifenewill be approved or that the product will ever be successfullycommercialized); government cost-containment initiatives; restrictions onthird-party payments for our products; substantial competition in ourindustry, including from branded and generic products; emerging data on ourproducts and pipeline products; the importance of strong performance from ourprincipal products and our anticipated new product introductions; the highly
