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Wyeth's CONBRIZA Approved in the European Union for Treatment of Postmenopausal Osteoporosis in Women at Increased Risk of Fracture

Geschrieben am 27-04-2009

Collegeville, Pennsylvania (ots/PRNewswire) -

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced
today that the European Commission has granted marketing
authorization for CONBRIZA(TM) (bazedoxifene), a selective estrogen
receptor modulator (SERM), for the treatment of postmenopausal
osteoporosis in women at increased risk of fracture.

The World Health Organization's (WHO) fracture risk treatment
guidelines and assessment tool for calculating a woman's risk of
experiencing an osteoporotic fracture were used in analyses of
clinical data that supported the approval of CONBRIZA. Wyeth was one
of the first companies to apply the WHO guidelines and tool, first
introduced in February 2008.

"Analyses of clinical trial data showed that treatment with
CONBRIZA significantly decreased the risk of all clinical fractures
and non-vertebral fractures for women who were at a greater risk of
osteoporotic fracture," says Gary L. Stiles, M.D., Executive Vice
President, Chief Medical Officer, Wyeth Pharmaceuticals.
"Importantly, the analyses also showed that the higher a woman's risk
of a fracture, the greater the protection she received with CONBRIZA
therapy."

Osteoporosis remains a serious public health concern, affecting
more than 75 million people in Europe, the United States, and Japan.
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.

In 2000, there were an estimated 3.79 million osteoporotic
fractures in Europe, resulting in direct costs totaling an estimated
euro 31.7 billion. Based on anticipated changes in European
demographics, this cost is expected to increase to an estimated euro
76.7 billion by 2050.

Wyeth intends to introduce CONBRIZA in certain European markets
following receipt of necessary reimbursement authorizations in those
markets. Wyeth is also pursuing regulatory approval of bazedoxifene
for the prevention and treatment of postmenopausal osteoporosis in
the United States and other countries worldwide.

CONBRIZA Clinical Trials

The efficacy of CONBRIZA was studied in two multicenter,
double-blind, randomized phase 3 clinical trials involving more than
9,000 postmenopausal women, comparing CONBRIZA to placebo and an
active-control (comparator) drug. The prevention trial, conducted for
two years in 1,583 patients, evaluated bone mineral density; and the
treatment trial examined the incidence of new vertebral fractures in
7,492 patients for three years. Data from these studies indicated
that the SERM characteristics of CONBRIZA were confirmed and further
suggest a favorable endometrial profile. The most serious adverse
reactions reported with CONBRIZA in these studies were venous
thromboembolic events, which were more common than with placebo.

About Wyeth Pharmaceuticals

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. In particular,
there can be no assurance that CONBRIZA will be commercially
successful or that CONBRIZA 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.

ots Originaltext: Wyeth Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Media Contact: Danielle Halstrom, +1-484-865-2020, or Douglas Petkus,
+1-973-660-5218, Investor Contact: Justin Victoria, +1-973-660-5340,
all of Wyeth


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