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Wyeth Presents New Phase 3 Data and Updates Regulatory Timing for NDA Filing of Bazedoxifene/Conjugated Estrogens
Date:10/5/2007

COLLEGEVILLE, Pa., Oct. 5 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), presented new data today from two Phase 3 studies, which showed that bazedoxifene/conjugated estrogens reduced the number and severity of hot flashes in symptomatic postmenopausal women by up to 80 percent, when compared with placebo. These data, presented at the North American Menopause Society Annual Meeting, also showed that bazedoxifene/conjugated estrogens improved symptoms of vulvar and vaginal atrophy. In addition, secondary data from both studies showed that when compared with placebo, bazedoxifene/conjugated estrogens reduced sleep disturbances and improved menopause-related quality of life.

"The pairing of bazedoxifene, a selective estrogen receptor modulator, or SERM, with conjugated estrogens may lead to a new class of menopausal therapy called tissue selective estrogen complex, or TSEC," says Ginger Constantine, M.D., Vice President, Women's Health Care and Bone Repair, Wyeth Pharmaceuticals. "TSECs pair the benefits of estrogens with SERMs to create a distinct clinical profile, which may provide relief of hot flashes and vaginal dryness as well as bone and uterine protection."

Update on NDA Filing

Wyeth plans to submit its New Drug Application (NDA) to the U.S. Food and Drug Administration for bazedoxifene/conjugated estrogens in the second quarter of 2008 subject to the further analysis and successful completion of product formulation, bioequivalence and clinical studies, and other remaining work necessary to finalize the NDA.

Significant Reduction of Hot Flashes and Relief of Vulvar and Vaginal Atrophy Symptoms

Results of a clinical trial titled "A Phase 3 Study of th
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SOURCE Wyeth
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