Wyeth Osteoporosis Drug Succeeds in 3-Year Study
COLLEGEVILLE, Pa., Sept. 19 -- Wyeth Pharmaceuticals, a division of Wyeth , presented today the first Phase 3 fracture data for bazedoxifene, a selective estrogen receptor modulator, at the American Society for Bone and Mineral Research Annual Meeting. In a three-year study, data showed that bazedoxifene 20 mg and 40 mg significantly reduced the relative risk of new vertebral fractures by 42 percent and 37 percent, respectively, compared with placebo. A post-hoc subgroup analysis of women at higher fracture risk showed that bazedoxifene 20 mg significantly reduced the incidence of non-vertebral fracture by 52 percent relative to placebo.
With regard to the safety and tolerability observed in this clinical trial, a non-statistically significant increase in the incidence of venous thromboembolic events was observed in all active treatment groups compared with the placebo group. No safety concerns related to the reproductive systems, including breast, were observed in the bazedoxifene treatment groups.
Wyeth received an approvable letter relating to its pending new drug application for bazedoxifene for the prevention of postmenopausal osteoporosis from the U.S. Food and Drug Administration (FDA) on April 23, 2007. In July 2007, Wyeth submitted a separate new drug application to the FDA for bazedoxifene for the treatment of postmenopausal osteoporosis. The efficacy data for bazedoxifene presented at the meeting represents only a portion of the totality of safety and efficacy data that the Company has submitted to FDA.
Bazedoxifene Significantly Reduced the Risk of New Vertebral Fracture
In the oral presentation, "Efficacy of Bazedoxifene in Reducing New Vertebral Fracture Risk in Postmenopausal Women with Osteoporosis: Results from a Three-Year, Randomized, Placebo- and Active-Controlled Clinical Trial," which enrolled 7,492 postmenopausal women between the ages of 55 and 85 with moderate to severe osteoporosis, bazedoxifene showed significant risk reduction, compared with placebo, for new vertebral fractures. Specifically, the three-year incidences of new vertebral fracture were 2.3 percent, 2.5 percent, 2.3 percent and 4.1 percent in the bazedoxifene 20 mg, bazedoxifene 40 mg, raloxifene 60 mg and placebo groups, respectively.
In addition, a subgroup analysis of 1,782 women at higher risk for fracture showed that bazedoxifene significantly reduced the incidence of non- vertebral fracture. In particular, the non-vertebral fracture incidence was 3.0 percent, 3.8 percent, 5.9 percent and 6.3 percent in bazedoxifene 20 mg, bazedoxifene 40 mg, raloxifene 60 mg and placebo groups, respectively, with a risk reduction of 46 percent, compared with placebo, when both bazedoxifene doses were combined.
About Osteoporosis
According to the National Osteoporosis Foundation, the number of women of menopausal age who have osteoporosis or are at risk for developing the disease will increase from almost 30 million in 2002 to nearly 41 million by 2020. Osteoporosis causes approximately 1.5 million fractures each year in the United States alone, and the risk of fracture significantly increases in women usually after age 50. Non-vertebral fractures are more common than vertebral fractures and account for an estimated 300,000 hip and 250,000 wrist fractures, in addition to an estimated 250,000 fractures at other non- vertebral sites such as the clavicle, humerus, pelvis and leg.
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 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 based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our 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; data generated on our 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." 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.