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With regard to the safety and tolerability observed in this clinicaltrial, a non-statistically significant increase in the incidence of venousthromboembolic events was observed in all active treatment groups comparedwith the placebo group. No safety concerns related to the reproductivesystems, including breast, were observed in the bazedoxifene treatment groups.
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Wyeth received an approvable letter relating to its pending new drugapplication for bazedoxifene for the prevention of postmenopausal osteoporosisfrom the U.S. Food and Drug Administration (FDA) on April 23, 2007. In July2007, Wyeth submitted a separate new drug application to the FDA forbazedoxifene for the treatment of postmenopausal osteoporosis. The efficacydata for bazedoxifene presented at the meeting represents only a portion ofthe totality of safety and efficacy data that the Company has submitted toFDA.
Bazedoxifene Significantly Reduced the Risk of New Vertebral Fracture
In the oral presentation, "Efficacy of Bazedoxifene in Reducing NewVertebral Fracture Risk in Postmenopausal Women with Osteoporosis: Resultsfrom a Three-Year, Randomized, Placebo- and Active-Controlled Clinical Trial,"which enrolled 7,492 postmenopausal women between the ages of 55 and 85 withmoderate to severe osteoporosis, bazedoxifene showed significant riskreduction, compared with placebo, for new vertebral fractures. Specifically,the three-year incidences of new vertebral fracture were 2.3 percent, 2.5percent, 2.3 percent and 4.1 percent in the bazedoxifene 20 mg, bazedoxifene40 mg, raloxifene 60 mg and placebo groups, respectively.
In addition, a subgroup analysis of 1,782 women at higher risk forfracture showed that bazedoxifene significantly reduced the incidence of non-vertebral fracture. In particular, the non-vertebral fracture incidence was3.0 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 arisk reduction of 46 percent, compared with placebo, when both bazedoxifenedoses were combined.
About Osteoporosis
According to the National Osteoporosis Foundation, the number of women ofmenopausal age who have osteoporosis or are at risk for developing the diseasewill increase from almost 30 million in 2002 to nearly 41 million by 2020.Osteoporosis causes approximately 1.5 million fractures each year in theUnited States alone, and the risk of fracture significantly increases in womenusually after age 50. Non-vertebral fractures are more common than vertebralfractures and account for an estimated 300,000 hip and 250,000 wristfractures, 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 theareas 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 andhealth care products companies. It is a leader in the discovery, development,manufacturing and marketing o
