Wyeth Provides Update on FDA Review of the Torisel New Drug Application
COLLEGEVILLE, Pa., April 06, 2007 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced that the U.S. Food and Drug Administration (FDA) has extended the review of the New Drug Application (NDA) for Torisel(TM) (temsirolimus), Wyeth's investigational treatment for advanced renal cell carcinoma (RCC). The NDA for Torisel originally was submitted on October 5, 2006 and was granted priority review status. As part of the ongoing review, Wyeth recently submitted additional information on tumor evaluation, as requested by the FDA. On April 5, 2007, the FDA confirmed that as a result of this amendment, the action date for the NDA has been extended by three months, to July 2007, to allow the agency time to complete a full review of these analyses.
Renal cell carcinoma accounts for approximately 85 percent of kidney cancers. The American Cancer Society estimates that 51,190 new cases of kidney cancer will be diagnosed this year, and more than 40 percent of patients will be diagnosed initially with advanced disease.
The pivotal study of Torisel showed that in patients with advanced RCC and poor prognostic features who had received no prior systemic therapy, Torisel significantly increased median overall survival, the primary endpoint, by 49 percent compared with interferon-alpha, an active comparator that has been the clinical standard of care. The most common adverse events (incidence greater than or equal to 30 percent) in patients treated with Torisel or with interferon-alpha were asthenia (weakness), rash, anemia, edema, nausea and anorexia (loss of appetite).
"We are encouraged by the review process so far, and, with the submission of these analyses, we remain optimistic about the prospects for strengthening the product labeling for launch in the third quarter of 2007," says Robert R. Ruffolo, Jr., Ph.D., President, Wyeth Research, and Senior Vice President, Wyeth. "We believe that Torisel has shown the potential in clinical trials to be an important therapeutic option for patients with advanced renal cell carcinoma."
Torisel was designed to inhibit the mTOR (mammalian target of rapamycin) kinase, a protein within all cells that regulates cell proliferation, cell growth and cell survival. If approved, Torisel will be the first mTOR inhibitor for the treatment of a cancer.
During the extended review period, Wyeth will continue to make Torisel available in the United States to patients who meet certain criteria through an Expanded Access Program (EAP). For more information about the Torisel EAP in the United States, patients and health care providers can call (800) 234-8423.
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. These 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.
CONTACT: Media, Candace Steele of Wyeth Pharmaceuticals, +1-484-865-5428,Douglas Petkus of Wyeth, +1-973-660-5218, or Investors, Justin Victoria ofWyeth, +1-973-660-5340
Web site: http://www.wyeth.com//
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Posted: April 2007