CONBRIZA Receives Positive CHMP Opinion For The Treatment Of Postmenopausal Osteoporosis In Women At Increased Risk Of Fracture

February 20, 2009 at 11:00 am Leave a comment


The Committee for Medicinal Products for Human Use (CHMP), the scientific
committee of the European Medicines Agency (EMEA), adopted a positive
opinion recommending to grant a marketing authorization for CONBRIZA(TM)
(bazedoxifene) for the treatment of postmenopausal osteoporosis in women at
increased risk of fracture. CONBRIZA, an investigational medicine, is in
development by Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE).



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 selective estrogen receptor modulator (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.



“If approved, Wyeth believes that CONBRIZA could be an important new
treatment option for physicians and their patients,” says Gary L. Stiles,
M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals.
“More therapeutic options are needed for postmenopausal women with
osteoporosis, particularly for those at increased risk of fracture. Wyeth
remains committed to women’s health care, and CONBRIZA is an important
affirmation of that commitment.”



The CHMP is responsible for reviewing medicinal product applications for
safety, quality and efficacy. The Committee’s positive opinion will be
forwarded to the European Commission for a final decision. Final approval
customarily follows the CHMP’s recommendation and is expected in
approximately 60 days.



Wyeth intends to introduce CONBRIZA in Europe following receipt of
necessary reimbursement authorizations. Wyeth is also pursuing regulatory
approval of bazedoxifene for the prevention and treatment of postmenopausal
osteoporosis in the United States.



About Osteoporosis



Osteoporosis affects an estimated 75 million people in Europe, the United
States and Japan. In 2000, there were an estimated 3.79 million osteoporotic
fractures in Europe, resulting in direct costs totaling an estimated EUR31.7
billion. Based on anticipated changes in European demographics, this cost is
expected to increase to an estimated 76.7 billion euros by 2050.



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 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
bazedoxifene will be commercially successful 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
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;
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

[Via http://www.medicalnewstoday.com]

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