Wyeth Presents Phase 3 Fracture Data for Bazedoxifene, an Investigational Therapy for Os...( COLLEGEVILLE Pa. Sept. 19 /- Wyet...),Health

COLLEGEVILLE, Pa., Sept. 19 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), 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 Fr
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