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Torisel

Generic name: temsirolimus
Treatment for: Renal Cell Carcinoma

Update: Torisel Now FDA Approved - May 30, 2007

Wyeth Submits NDA and MAA for Torisel for the Treatment of Advanced Renal Cell Carcinoma

First mTOR Inhibitor to Be Submitted for Cancer Indication

MADISON, N.J., October 6, 2006 -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the Company has initiated its global filing strategy for Torisel(TM) (temsirolimus) with the simultaneous submissions of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMEA). The company is seeking an indication for the treatment of patients with advanced renal cell carcinoma (RCC).

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 primary end point of the study was overall survival. The results showed treatment with Torisel increased median overall survival time by 3.6 months, or 49 percent, compared with treatment with interferon-alpha (10.9 months vs. 7.3 months, p=0.0069). The final analysis will also be submitted to regulatory authorities at a future date.

Torisel is an investigational drug that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, a protein that regulates cell proliferation, cell growth and cell survival. If approved, Torisel would be the first agent in this class indicated for the treatment of a cancer.

"This is an exciting milestone, as Torisel has the potential to help many patients who have advanced RCC, if it is approved by the FDA and EMEA," said Lee F. Allen, M.D., Ph.D., Vice President of Oncology Clinical Research at Wyeth. "These filings also represent an important contribution to oncologists and their patients, since Torisel may provide a new option for the treatment of RCC."

"The interim phase 3 data demonstrate that mTOR inhibition with Torisel could be a viable approach to treating advanced RCC patients with poor-risk features, and that is good news, as new treatment options are constantly needed for these patients," said Gary Hudes, M.D., Director, Genitourinary Malignancies Program, Fox Chase Cancer Center, Philadelphia, and lead investigator of the phase 3 trial of Torisel in RCC.

The NDA and MAA were submitted on October 5. In July 2004, the FDA granted fast track designation for Torisel for first-line poor prognosis subjects with advanced RCC, and in December 2004, the FDA granted orphan drug designation to investigational temsirolimus for the treatment of RCC. In March 2006, Torisel received Orphan Medicinal Product designation for the treatment of RCC in the European Union.

The most significant adverse events reported in arm 1 (interferon-alpha alone), arm 2 (Torisel alone) and arm 3 (Torisel in combination with interferon-alpha) included asthenia (27 percent, 12 percent and 30 percent, respectively), anemia (24 percent, 21 percent and 39 percent, respectively) and dyspnea (8 percent, 9 percent and 11 percent, respectively). Of the 626 patients enrolled in the study, 442 deaths occurred at the time of the interim analysis.

About Renal Cell Carcinoma

Renal cell carcinoma accounts for about 85 percent of all renal cancers. Globally, more than 208,000 new cases of kidney cancer were diagnosed in 2002 -- including about 36,700 in the U.S. and 85,700 in Europe -- according to estimates from the International Agency for Research on Cancer (IARC), part of the World Health Organization (WHO). The incidence of the disease is highest among people between the ages of 50 to 70, and it affects nearly twice as many men as women.

Approximately 25 percent of patients with RCC are initially diagnosed with advanced disease, including locally invasive or metastatic RCC. Patients with advanced kidney cancer have a five-year survival rate of approximately 20 percent.

About Torisel

Torisel is an investigational drug for the treatment of patients with advanced RCC. Wyeth continues to study Torisel in a phase 3 trial of patients with mantle cell lymphoma and is planning and conducting several additional studies in RCC and other solid tumor indications. Additional early oncology trials with Torisel are being conducted through a cooperative research and development agreement with the National Cancer Institute in several other tumor types.

Posted: October 2006

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