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Wyeth Pharmaceuticals

Wyeth Presents Data from Five-Year Vertebral Fracture Prevention Study with Bazedoxifene

Collegeville, Pennsylvania (ots/PRNewswire)

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announces
findings from a placebo-controlled Phase 3 study of bazedoxifene 20
mg extended to five years, which indicated a significant reduction
versus placebo in new vertebral fractures in postmenopausal women
with osteoporosis. These and other data were presented at the
American Society for Bone and Mineral Research (ASBMR) Annual Meeting
in Denver, Colo. Bazedoxifene, a selective estrogen receptor
modulator (SERM), is under clinical investigation for the prevention
and treatment of postmenopausal osteoporosis.
"These new data are important in that they suggest the reduction
in vertebral fracture risk with bazedoxifene seen at five years is
comparable to that seen at three years," says Stuart Silverman, M.D.,
Clinical Professor of Medicine at the University of California, Los
Angeles and Cedars-Sinai Medical Center, and the study's lead
About Study 301
The results being presented are from a two-year extension of a
three-year Phase 3 trial, which enrolled 7,492 generally healthy
postmenopausal women aged 55 to 85 years with osteoporosis. The
primary endpoint of the three-year Phase 3 study was the incidence of
new vertebral fractures. Eligible subjects were randomized to daily
treatment with bazedoxifene 20 mg or 40 mg, raloxifene (RLX) 60 mg,
or placebo. At the conclusion of the pivotal three-year study, a
total of 4,216 subjects were enrolled in the extension to five years.
Patients receiving bazedoxifene 20 mg continued on that dosage, while
the RLX 60 mg treatment arm was discontinued (as prespecified in the
protocol) after the three-year database was finalized, and subjects
receiving bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg
after all subjects completed four years of treatment. At five years,
the study showed that the incidence of new vertebral fractures was
significantly reduced in the bazedoxifene 20 mg group (4.5%) and in
the group transitioned from bazedoxifene 40 mg to 20 mg (3.9%)
compared with placebo (6.8%). This corresponds to relative risk
reductions of 35% (P=0.014) and 40% (P=0.005), respectively. The
incidence of venous thromboembolic events in this Phase 3 clinical
trial was higher in bazedoxifene-treated subjects when compared with
placebo. This finding is consistent with what was seen at three
Additional New Bazedoxifene Data Presented at ASBMR
Assessment of the Effect of Bazedoxifene on Non-Vertebral
Fracture Risk (McCloskey EV, et al)
Data were also presented from a post-hoc analysis performed using
the Fracture Risk Assessment Tool (FRAX(R)), which was developed by
the World Health Organization to calculate a woman's 10-year risk of
experiencing an osteoporotic fracture. This post-hoc analysis
indicated that the higher a woman's risk of a fracture, the greater
the reduction in non-vertebral fractures when receiving bazedoxifene
therapy based on her FRAX score.
Safety and Tolerability of Bazedoxifene in Postmenopausal Women
with Osteoporosis: Results of a 5-Year, Randomized,
Placebo-controlled Phase 3 Trial (de Villiers TJ, et al)
Bazedoxifene five-year safety and tolerability data in
postmenopausal women with osteoporosis were also presented. The
incidence of adverse events (AEs), serious AEs and discontinuations
due to AEs was similar to that seen in the placebo group. The
incidence of cardiac or cerebrovascular events, including myocardial
infarction and stroke, in the bazedoxifene treatment groups was
similar to that seen in the placebo group. Subjects treated with
bazedoxifene had a higher incidence of deep venous thrombosis, hot
flushes and leg cramps compared with placebo-treated subjects. The
effect of bazedoxifene on the breast and endometrium was comparable
to placebo.
Cost-effectiveness of Bazedoxifene in the US Incorporating the
FRAX(R) Algorithm (Strom, et al)
Data from an analysis performed using a Marcov cohort model and
published U.S. cost and epidemiological data evaluated the potential
cost-effectiveness and intervention thresholds of bazedoxifene
treatment (20 mg and 40 mg doses combined) compared to placebo.
Cost-effective scenarios were projected for women with strong risk
factors and with a T-score above the threshold for osteoporosis. When
effect was modeled for non-vertebral fractures, the data suggested
that potential cost effectiveness improved further in women from the
age of 60 years with prior fracture and at the threshold of
osteoporosis (T-score=-2.5 SD).
About Bazedoxifene
Wyeth is pursuing regulatory approval of bazedoxifene for the
prevention and treatment of postmenopausal osteoporosis in the United
States and other countries worldwide. In April 2009, the European
Commission granted marketing authorization for CONBRIZA(TM)
(bazedoxifene) for the treatment of postmenopausal osteoporosis in
women at increased risk of fracture. Wyeth intends to introduce
CONBRIZA in certain European markets following receipt of necessary
reimbursement authorizations in those markets.
Bazedoxifene paired with conjugated estrogens (BZA/CE) is also
being studied by Wyeth for the treatment of moderate-to-severe
menopausal vasomotor symptoms such as hot flushes, night sweats and
vulvar and vaginal atrophy, and for the prevention of postmenopausal
About Osteoporosis
Osteoporosis affects an estimated 75 million people in the United
States, Europe and Japan. In the United States, the condition is a
major public health threat for an estimated 44 million Americans, or
55 percent of the people 50 years of age and older. Osteoporosis is
characterized by low bone mass and structural deterioration of bone
tissue, leading to bone fragility and an increased risk of fractures.
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
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
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. In particular,
clinical trial data are subject to differing interpretations, and the
views of regulatory agencies, medical and scientific experts and
others may differ from ours. In addition, there can be no assurance
that bazedoxifene will be commercially successful in the markets
where approved or that bazedoxifene will be approved in the future in
other formulations or indications and/or in other countries,
including the United States. Other risks and uncertainties that could
cause actual results to differ materially from those expressed or
implied by forward looking statements include, among others, risks
related to our proposed merger with Pfizer, including satisfaction of
the conditions of the proposed merger on the proposed timeframe or at
all, contractual restrictions on the conduct of our business included
in the merger agreement, and the potential for loss of key personnel,
disruption in key business activities or any impact on our
relationships with third parties as a result of the announcement of
the proposed merger; 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; 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; the outcome of
government investigations; 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; global
economic conditions; interest and currency exchange rate fluctuations
and volatility in the credit and financial markets; 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, 2008, which was
filed with the Securities and Exchange Commission on February 27,
2009. 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 Media, Gwen Fisher of Wyeth Pharmaceuticals, +1-484-865-5160 or
Douglas Petkus of Wyeth, +1-973-660-5218; or for Investors, Justin
Victoria of Wyeth, +1-973-660-5340

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