Wyeth Receives Approvable Letter From FDA For Bazedoxifene For The Treatment Of Postmenopausal Osteoporosis

Wyeth Pharmaceuticals, a
division of Wyeth (NYSE: WYE), announced 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."



About Osteoporosis



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.


Wyeth Pharmaceuticals

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