Wyeth Receives Approvable Letter From FDA For Bazedoxifene For The Prevention Of Postmenopausal Osteoporosis
"The approvable letter for bazedoxifene is in line with our expectations, and we are pleased to stay on track with our plans to introduce this new osteoporosis therapy," says Gary Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. "We will work closely with the FDA to address the items noted in the letter and are moving forward with plans to seek an additional indication for the treatment of postmenopausal osteoporosis for bazedoxifene later this year. We remain confident that bazedoxifene has the potential to become an important option for the millions of postmenopausal women who are at risk for developing an osteoporotic fracture."
The approvable letter indicates, among other things, that before the New Drug Application (NDA) can be approved:
-- FDA must receive and analyze, as part of its benefit-risk assessment, final safety and efficacy data from the recently completed Phase 3 treatment study of bazedoxifene, which was discussed during the Company's earnings call last week.
-- FDA must complete an acceptable establishment evaluation for the manufacturing and testing facilities for bazedoxifene. The FDA concluded its general re-inspection of Wyeth's Guayama facility in early April, and Wyeth has provided a written response to the FDA's observations. We believe the situation at the Guayama facility will be resolved without affecting the timing of new product launches.
Osteoporosis therapies available today generally fall into one of three categories -- postmenopausal hormone therapy, bisphosphonates and SERMs. 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 Bazedoxifene
Bazedoxifene is currently under FDA review for the prevention of postmenopausal osteoporosis. If approved, bazedoxifene would expand the options currently available to physicians for the prevention of osteoporosis.
About Osteoporosis and Menopause
According to the North American Menopause Society, there are approximately 40 million women in the United States of menopausal age. Menopause is different for every woman, with onset usually occurring between the ages of 45 and 55. The average age for menopause is 51.
Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased risk of fractures. Up to 20 percent of a woman's expected lifetime bone loss can occur in the years immediately following menopause. The prevention of osteoporosis could lead to significant improvement in the overall health for millions of postmenopausal women worldwide as well as reduce costs associated with the treatment of osteoporosis-related fractures.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, 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 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 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. In particular, the statements in this press release regarding clinical data and/or the regulatory status of our pipeline products are based on a preliminary analysis of the data and our expectations as to how that data will impact the regulatory approval process, which is subject to risks and uncertainties related to both the timing and success of regulatory approval. In addition, although it remains our goal to resolve the issues raised in the Warning Letter relating to our Guayama, Puerto Rico facility as quickly as possible, we cannot exclude the possibility that these issues will result in further regulatory action or delays in the approval of new products or release of approved products manufactured at the facility. Other risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our 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; data generated on our 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; 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; economic conditions including interest and currency exchange rate fluctuations; 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." 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.
Wyeth Pharmaceuticals
http://www.wyeth.com
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