FDA Grants Torisel NDA Priority Review Status

Main Category: Cancer / Oncology
Also Included In: Urology / Nephrology;  Clinical Trials / Drug Trials
Article Date: 20 Dec 2006 - 0:00 PDT

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Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the U.S. Food and Drug Administration (FDA) has accepted the file and granted priority review status to the Company's New Drug Application (NDA) for the investigational drug Torisel(TM) (temsirolimus). Wyeth Pharmaceuticals is seeking an indication for Torisel for the treatment of advanced renal cell carcinoma (RCC). A priority designation can be given to an NDA for a drug that, if approved, would be a significant improvement compared with existing treatments.

The FDA previously granted fast track designation and orphan drug status for investigational temsirolimus for the treatment of advanced RCC.

Torisel is the first mTOR (mammalian target of rapamycin) inhibitor to be filed for approval for the treatment of a cancer. It is an investigational drug that specifically inhibits the mTOR kinase, a protein that regulates cell proliferation, cell growth and cell survival.

"Renal cell carcinoma continues to be an extremely difficult-to-treat form of cancer, and there continues to be a need for new therapies. Torisel has demonstrated its potential to help meet that important medical need," says Lee F. Allen, M.D., Ph.D., Vice President of Oncology Clinical Research at Wyeth.

The registration dossier contains interim data from a three-arm, Phase 3 clinical trial of 626 patients who had received no prior systemic therapy. The results showed that Torisel significantly increased overall survival by 49 percent in patients with advanced RCC compared with interferon-alpha, a treatment for advanced RCC.

In the United States, Torisel will be available prior to FDA approval through an Expanded Access Program (EAP). For more information about the Torisel EAP in the United States, please call (800) 234-8423. Additional information about temsirolimus may be obtained by visiting http://www.clinicaltrials.gov.

About Wyeth Pharmaceuticals

Wyeth Pharmaceuticals 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 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. 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.

Wyeth
http://www.wyeth.com