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