COLLEGEVILLE, Pa., April 23 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that it is withdrawing its application for an extension to the European Marketing Authorization for TYGACIL(R) (tigecycline). This extension sought approval of TYGACIL for the treatment of community-acquired pneumonia (CAP). Wyeth's action is based on its understanding of the Committee for Medicinal Products for Human Use (CHMP) assessment that the TYGACIL CAP pivotal clinical trials did not include a sufficient number of severely ill CAP patients to alleviate reviewer concerns regarding efficacy in this subpopulation. TYGACIL is currently approved in Europe for the treatment of complicated intra-abdominal infections and complicated skin and soft tissue infections in adults.
"We are disappointed that we were not able to allay the concerns of the CHMP, and are evaluating the appropriate next steps to take in Europe," says Gary L. Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. "In October 2007, the U.S. Food and Drug Administration (FDA) accepted the filing of our supplemental New Drug Application for TYGACIL for the treatment of patients with CAP. We believe that the clinical trial data submitted to the FDA, as well as other regulatory authorities around the world, demonstrate the safety and efficacy of TYGACIL for the proposed CAP indication."
The FDA is currently reviewing this application and a decision is expected during the second quarter of 2008. TYGACIL has been approved for use in patients with CAP in the Philippines and Thailand. Regulatory applications are also pending in Australia, Brazil, Canada, Switzerland and India.
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, 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. These risks and uncertainties include, without limitation, 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; 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" in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008. 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.
SOURCE Wyeth Pharmaceuticals