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Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms
Date:7/27/2009

COLLEGEVILLE, Pa., July 27 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced the publication in Fertility and Sterility of data from a Phase 3 clinical study that showed that the investigational compound bazedoxifene/conjugated estrogens (BZA/CE) significantly reduced the frequency and severity of hot flushes and improved measures of vaginal atrophy when compared to placebo. In this study, uterine bleeding was not statistically different from placebo and the rate of endometrial hyperplasia in doses being considered for therapeutic use was <1%. BZA/CE is being studied by Wyeth Pharmaceuticals 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.

The data, published online July 27, 2009 in the peer-reviewed journal Fertility and Sterility, is from the Selective estrogens Menopause And Response to Therapy (SMART-1) clinical trial. SMART-1 was designed to explore the hypothesis that bazedoxifene, when paired with conjugated estrogens, may have the potential to eliminate the need for progestin in menopausal therapy in women with an intact uterus. BZA/CE is characterized by Wyeth as a TSEC (tissue selective estrogen complex) as it combines a selective estrogen receptor modulator (SERM) with conjugated estrogens.

Across the SMART-1 trial, the incidence of treatment-emergent adverse events, breast pain, serious adverse events and withdrawals due to adverse events were similar among the active treatment groups and placebo.

About SMART-1

SMART-1 was a two-year, multinational, multicenter, randomized, double-blind, placebo- and active-control
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