Wyeth's CONBRIZA Approved in the European Union for Treatment of Postmenopausal Osteoporosis in Women at Increased Risk of Fract
April 27 2009 - 9:00AM
PR Newswire (US)
COLLEGEVILLE, Pa., April 27 /PRNewswire-FirstCall/ -- 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. DATASOURCE: Wyeth Pharmaceuticals
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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