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CONBRIZA Receives Positive CHMP Opinion for the Treatment of Postmenopausal Osteoporosis in Women at Increased Risk of Fracture

Collegeville, Pennsylvania (ots/PRNewswire)

The Committee for Medicinal Products for Human Use (CHMP), the
scientific committee of the European Medicines Agency (EMEA), today
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.

Contact:

Media, Gwen Fisher of Wyeth Pharmaceuticals, +1-484-865-5160, or
Douglas Petkus of Wyeth, +1-973-660-5218, or Investors, Justin
Victoria of Wyeth, +1-973-660-5340

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