MADISON, N.J., Oct. 25 /PRNewswire-FirstCall/ -- Today, Wyeth Pharmaceuticals, a division of Wyeth , presented Phase 2 clinical data at the American Society for Reproductive Medicine annual meeting in New Orleans related to the use of the bazedoxifene/conjugated estrogens complex in postmenopausal women. Bazedoxifene/conjugated estrogens could be the first in a new class of menopausal therapies called tissue selective estrogen complexes (TSECs). In Phase 2 clinical trials, several dose combinations of the TSEC containing bazedoxifene/conjugated estrogens were associated with a decrease in hot flashes compared to placebo, amenorrhea rates similar to placebo, and no increase in endometrial thickness compared to placebo.
"These clinical endpoints address considerations for physicians when evaluating menopausal therapies for their patients," says Gary Stiles, M.D., Executive Vice President and Chief Medical Officer of Wyeth Pharmaceuticals. "If confirmed in Phase 3 clinical trials, we believe the TSEC class may have the potential to change the way women and physicians approach menopausal therapy."
The presentation, "Bazedoxifene Combined with Conjugated Estrogens: A Novel Alternative to Traditional Hormone Therapies," highlighted Phase 2 clinical data regarding the effects of bazedoxifene/conjugated estrogens in healthy menopausal women. Results showed that conjugated estrogens alone increased endometrial thickness. Pairing bazedoxifene with conjugated estrogens resulted in a dose-related decrease in endometrial thickness and was similar to placebo at some dose combinations. Treatment with bazedoxifene paired with conjugated estrogens was associated with amenorrhea rates greater than 84 percent in all participants and was similar to placebo at the doses studied. In addition, there was a significant reduction of hot flashes in all treatment groups compared to placebo.
"Many women experience menopausal symptoms, yet remain untreated," says Vivian Lewis, M.D., University of Rochester. "I would expect physicians to be interested in this research on the TSEC class, as it could provide new options in menopausal therapy."
About TSEC
Preclinical data were presented at the North American Menopause Society (NAMS) on October 12, 2006, regarding the bazedoxifene/conjugated estrogens complex, which could be the first in a new drug class described as a tissue selective estrogen complex (TSEC). The TSEC class was developed to offer a menopausal therapeutic option that, for the first time, partners a selective estrogen receptor modulator (SERM) with estrogens. Phase 3 clinical trials are currently under way to evaluate the safety and efficacy of the bazedoxifene/conjugated estrogens complex.
About Menopause
According to the NAMS, there are approximately 40 million women in the United States of menopausal age. As many as 93 percent of women going through menopause experience vasomotor symptoms such as hot flashes, which can greatly impact a woman's life.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, 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, and nonprescription 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 based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and legal third-party payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, 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." We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Media Contacts: Investor Contact: Candace Steele Justin Victoria Wyeth Pharmaceuticals Wyeth (484) 865-5428 (973) 660-5340 Natalie de Vane Wyeth Pharmaceuticals (484) 865-5139
Wyeth PharmaceuticalsCONTACT: Media Contacts - Candace Steele, +1-484-865-5428, or Natalie deVane, +1-484-865-5139, both of Wyeth Pharmaceuticals; Investor Contact -Justin Victoria of Wyeth, +1-973-660-5340
Web site: http://www.wyeth.com/
