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Latest RAD001 Study Results Show Further Increase in Time Without Tumor Growth in Patients With Advanced Kidney Cancer
Date:9/15/2008

- New data, updated since ASCO, show time without tumor growth now reaches

nearly 5 months with RAD001 vs. 1.9 months with placebo - One quarter of patients in trial remained progression-free beyond ten

months of treatment - RAD001 is first drug to show significant benefit after failure of initial therapy, Sutent(R) or Nexavar(R)**, with potential to address unmet medical

need - RAD001 under review by regulatory authorities; potential to be first

once-daily oral mTOR therapy for advanced kidney cancer

EAST HANOVER, N.J., Sept. 16 /PRNewswire-FirstCall/ -- New data continue to demonstrate the potential benefit of RAD001 (everolimus) for patients with advanced kidney cancer who have failed standard therapies.

Updated study findings from the RECORD-1 (REnal Cell cancer treatment with Oral RAD001 given Daily) study show that patients receiving RAD001 had no tumor growth for nearly 5 months vs. 1.9 months for patients receiving placebo (hazard ratio = 0.33 with 95% CI 0.25 to 0.43; p-value < 0.001). In addition, after more than 10 months of treatment with RAD001, 25% of patients still had no tumor growth.

The updated RECORD-1 data were presented today at the 33rd European Society for Medical Oncology (ESMO) Congress in Stockholm, Sweden.

"These study results show the potential of RAD001 to continue working over an extended period of time in patients with advanced kidney cancer that progressed despite treatment with standard therapies," said Bernard Escudier, MD, Head of Immunotherapy and Innovative Therapy Unit, Gustave-Roussy Institute, Paris, France. "Based on these findings, I believe RAD001 should become part of the treatment paradigm for this patient population."

RAD001 has the potential to fill a currently unmet medical need and become the first approved therapy to demonstrate significant benefit in patients with advanced kidney ca
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SOURCE Novartis Pharmaceuticals Corporation
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