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Wyeth Presents Data from Five-Year Vertebral Fracture Prevention Study with Bazedoxifene
Collegeville, Pennsylvania (ots/PRNewswire) -
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announces findings from a placebo-controlled Phase 3 study of bazedoxifene 20 mg extended to five years, which indicated a significant reduction versus placebo in new vertebral fractures in postmenopausal women with osteoporosis. These and other data were presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Denver, Colo. Bazedoxifene, a selective estrogen receptor modulator (SERM), is under clinical investigation for the prevention and treatment of postmenopausal osteoporosis.
"These new data are important in that they suggest the reduction in vertebral fracture risk with bazedoxifene seen at five years is comparable to that seen at three years," says Stuart Silverman, M.D., Clinical Professor of Medicine at the University of California, Los Angeles and Cedars-Sinai Medical Center, and the study's lead investigator.
About Study 301
The results being presented are from a two-year extension of a three-year Phase 3 trial, which enrolled 7,492 generally healthy postmenopausal women aged 55 to 85 years with osteoporosis. The primary endpoint of the three-year Phase 3 study was the incidence of new vertebral fractures. Eligible subjects were randomized to daily treatment with bazedoxifene 20 mg or 40 mg, raloxifene (RLX) 60 mg, or placebo. At the conclusion of the pivotal three-year study, a total of 4,216 subjects were enrolled in the extension to five years. Patients receiving bazedoxifene 20 mg continued on that dosage, while the RLX 60 mg treatment arm was discontinued (as prespecified in the protocol) after the three-year database was finalized, and subjects receiving bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg after all subjects completed four years of treatment. At five years, the study showed that the incidence of new vertebral fractures was significantly reduced in the bazedoxifene 20 mg group (4.5%) and in the group transitioned from bazedoxifene 40 mg to 20 mg (3.9%) compared with placebo (6.8%). This corresponds to relative risk reductions of 35% (P=0.014) and 40% (P=0.005), respectively. The incidence of venous thromboembolic events in this Phase 3 clinical trial was higher in bazedoxifene-treated subjects when compared with placebo. This finding is consistent with what was seen at three years.
Additional New Bazedoxifene Data Presented at ASBMR
Assessment of the Effect of Bazedoxifene on Non-Vertebral Fracture Risk (McCloskey EV, et al)
Data were also presented from a post-hoc analysis performed using the Fracture Risk Assessment Tool (FRAX(R)), which was developed by the World Health Organization to calculate a woman's 10-year risk of experiencing an osteoporotic fracture. This post-hoc analysis indicated that the higher a woman's risk of a fracture, the greater the reduction in non-vertebral fractures when receiving bazedoxifene therapy based on her FRAX score.
Safety and Tolerability of Bazedoxifene in Postmenopausal Women with Osteoporosis: Results of a 5-Year, Randomized, Placebo-controlled Phase 3 Trial (de Villiers TJ, et al)
Bazedoxifene five-year safety and tolerability data in postmenopausal women with osteoporosis were also presented. The incidence of adverse events (AEs), serious AEs and discontinuations due to AEs was similar to that seen in the placebo group. The incidence of cardiac or cerebrovascular events, including myocardial infarction and stroke, in the bazedoxifene treatment groups was similar to that seen in the placebo group. Subjects treated with bazedoxifene had a higher incidence of deep venous thrombosis, hot flushes and leg cramps compared with placebo-treated subjects. The effect of bazedoxifene on the breast and endometrium was comparable to placebo.
Cost-effectiveness of Bazedoxifene in the US Incorporating the FRAX(R) Algorithm (Strom, et al)
Data from an analysis performed using a Marcov cohort model and published U.S. cost and epidemiological data evaluated the potential cost-effectiveness and intervention thresholds of bazedoxifene treatment (20 mg and 40 mg doses combined) compared to placebo. Cost-effective scenarios were projected for women with strong risk factors and with a T-score above the threshold for osteoporosis. When effect was modeled for non-vertebral fractures, the data suggested that potential cost effectiveness improved further in women from the age of 60 years with prior fracture and at the threshold of osteoporosis (T-score=-2.5 SD).
Wyeth is pursuing regulatory approval of bazedoxifene for the prevention and treatment of postmenopausal osteoporosis in the United States and other countries worldwide. In April 2009, the European Commission granted marketing authorization for CONBRIZA(TM) (bazedoxifene) for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. Wyeth intends to introduce CONBRIZA in certain European markets following receipt of necessary reimbursement authorizations in those markets.
Bazedoxifene paired with conjugated estrogens (BZA/CE) is also being studied by Wyeth for the treatment of moderate-to-severe menopausal vasomotor symptoms such as hot flushes, night sweats and vulvar and vaginal atrophy, and for the prevention of postmenopausal osteoporosis.
Osteoporosis affects an estimated 75 million people in the United States, Europe and Japan. In the United States, the condition is a major public health threat for an estimated 44 million Americans, or 55 percent of the people 50 years of age and older. 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 Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
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, clinical trial data are subject to differing interpretations, and the views of regulatory agencies, medical and scientific experts and others may differ from ours. In addition, there can be no assurance that bazedoxifene will be commercially successful in the markets where approved 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 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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