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.
SMART-1 was a two-year, multinational, multicenter, randomized, double-blind, placebo- and active-controlled Phase 3 study that evaluated 3,397 healthy, postmenopausal women with an intact uterus aged 40 to 75 years. The primary end point of the SMART-1 trial was incidence of endometrial hyperplasia at one year. Secondary end points included bone mineral density (BMD) at two years, menopausal vasomotor symptoms at four and 12 weeks, vaginal maturation index at six months, menopause-related quality of life measures, and overall safety and tolerability. The results were published concurrently across four manuscripts at http://www.fertstert.org/inpress.
Titles and Summary of Findings From Published Manuscripts
1. Endometrial Protection in Menopausal Therapy with a Tissue Selective Estrogen Complex (TSEC) Containing Bazedoxifene/Conjugated Estrogens (Pickar JH, et al)
To evaluate endometrial effects, biopsies were performed at screening and at months six, 12, and 24, or when subjects withdrew from the study and more than three months had elapsed since their last assessment. Treatment with BZA/CE doses being considered for therapeutic use were associated with rates of endometrial hyperplasia <1%. These rates were not significantly different from those reported with placebo over two years of study.
2. Bazedoxifene/Conjugated Estrogens (BZA/CE): Incidence of Uterine Bleeding in Postmenopausal Women (Archer DF, et al)
To evaluate the effect of treatment with BZA/CE on uterine bleeding, trial participants were asked to record in a diary whether or not they experienced bleeding and/or spotting. The mean number of bleeding or spotting days with BZA/CE was not statistically different from placebo over two years of therapy.
3. Evaluation of Bazedoxifene/Conjugated Estrogens (BZA/CE) for the Treatment of Menopausal Symptoms and Effects on Metabolic Parameters and Overall Safety Profile (Lobo R, et al)
Results from a sub-analysis suggest that treatment with BZA/CE significantly reduced the frequency and severity of hot flushes and improved measures of vaginal atrophy compared with placebo. In this study, analysis of most clinical laboratory determinations revealed no clinically important differences among treatment groups and no trends of concern. The incidences of breast pain and adverse events were similar between BZA/CE and placebo.
4. Efficacy of Tissue-Selective Estrogen Complex (TSEC) of Bazedoxifene/Conjugated Estrogens (BZA/CE) for Osteoporosis Prevention in At-Risk Postmenopausal Women (Lindsay R, et al)
When compared with placebo, treatment with BZA/CE increased BMD at the lumbar spine and total hip at 24 months. These results suggest that women in the BZA/CE groups gained bone mass while women in the placebo treatment group lost BMD.
Approximately 40 million women in the United States are of menopausal age (45 to 64 years). Of these women, 17 million experience vasomotor symptoms; 9 million experience moderate to severe symptoms. Menopause is different for every woman, and vasomotor symptoms can last from a few months to many years and they can be mild, moderate or severe enough to interfere with daily life. The majority of menopausal women experiencing moderate to severe vasomotor symptoms are not currently treating their symptoms.
About Fertility and Sterility
Fertility and Sterility is the official publication of the American Society of Reproductive Medicine, which publishes peer-reviewed original articles of research relevant to reproductive endocrinology, physiology, immunology, genetics and menopause.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals 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, nutritionals 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 that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, clinical trial data are subject to differing interpretations, and the views of regulatory agencies, medical and scientific experts and others may differ from ours or those expressed in the referenced publication. The Phase 3 clinical trial data presented and published to date reflect only a portion of the totality of data available from Phase 3 studies of BZA/CE and, accordingly, do not represent the totality of data and other information that may affect regulatory review and commercialization of BZA/CE. There can be no assurance that BZA/CE will ever receive regulatory approval or be successfully developed and commercialized. Other risks and uncertainties include, among others, risks related to our proposed merger with Pfizer, including satisfaction of the conditions of the proposed merger on the proposed timeframe or at all, contractual restrictions on the conduct of our business included in the merger agreement, and the potential for loss of key personnel, disruption in key business activities or any impact on our relationships with third parties as a result of the announcement of the proposed merger; the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and 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; emerging data on our products and pipeline 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; the outcome of government investigations; 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; global economic conditions; interest and currency exchange rate fluctuations and volatility in the credit and financial markets; 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" in our Annual Report on Form 10-K for the year ended December 31, 2008, which was filed with the Securities and Exchange Commission on February 27, 2009. 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.
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