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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.
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.
ots Originaltext: Wyeth Pharmaceuticals
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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