Healthcare Industry News: bazedoxifene
News Release - June 26, 2006
Wyeth Submits Two New Drug Applications for Women's Health Therapies
Simultaneous Initial Submissions Represent a Company First and Wyeth's Ongoing Commitment to Leadership in Women's HealthMADISON, N.J., June 26 (HSMN NewsFeed) -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today that the Company has submitted two New Drug Applications (NDA) to the U.S. Food and Drug Administration (FDA). The first NDA is for the approval of bazedoxifene, a Selective Estrogen Receptor Modulator (SERM) investigated for the prevention of postmenopausal osteoporosis. The second NDA is for desvenlafaxine succinate, a non-hormonal agent studied for the treatment of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.
"If approved, both bazedoxifene and desvenlafaxine succinate will give physicians additional options to help meet the individualized needs of their menopausal patients," says Joseph Camardo, MD, Senior Vice President, Global Medical Affairs, Wyeth Pharmaceuticals. "The simultaneous submission of these two separate NDAs emphasizes Wyeth's position as a leader and innovator in women's health. Wyeth continues to support clinical research and drug development with the goal of meeting the health care needs of women worldwide."
About Osteoporosis
During menopause women begin losing bone mass more rapidly, making them increasingly susceptible to osteoporosis. According to the National Osteoporosis Foundation the number of women of menopausal age who have osteoporosis or are at risk for developing the disease will increase from almost 30 million in 2002 to nearly 41 million in 2020.
About Vasomotor Symptoms
According to the North American Menopause Society, 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. However, many women remain untreated for their vasomotor symptoms.
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.
In September 1994, Wyeth entered into a discovery research collaboration for bazedoxifene with Ligand Pharmaceuticals in San Diego, CA. Wyeth is solely responsible for the clinical development of the compound.
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 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.
Source: Wyeth Pharmaceuticals
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