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Early Data Presented at ASCO Show Potential of RAD001 to Enhance Efficacy of, and Overcome Resistance to, Breast Cancer Treatments
Date:6/1/2008

- Randomized Phase II data show RAD001 significantly increased efficacy of letrozole tablets in women with newly diagnosed hormone-positive breast

cancer - Phase I studies suggest RAD001 may help overcome a major pathway of

resistance to trastuzumab - Novartis to further explore potential of RAD001 in breast cancer by

initiating new trial in early 2009

EAST HANOVER, N.J., June 2 /PRNewswire/ -- Early proof-of-concept studies presented today show RAD001 (everolimus) may offer a novel treatment strategy for breast cancer by enhancing the efficacy of, and overcoming resistance to, several commonly used breast cancer treatments.

Findings from a Phase II study show that RAD001 enhances tumor shrinkage when given in combination with letrozole tablets (Femara(R)) to postmenopausal women with newly diagnosed estrogen receptor-positive (ER+) breast cancer. Further, initial results from two Phase I trials in which RAD001 was combined with trastuzumab (Herceptin(R)) and chemotherapy agents suggest that the addition of RAD001 overcame resistance to trastuzumab. The combination appears highly active, achieving complete responses in a few patients and partial responses or stable disease in a majority of patients.

These results were among several studies of RAD001 presented at the 44th annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, US. RAD001 is an investigational once-daily oral therapy that may offer a new approach to cancer treatment by continuously inhibiting the mTOR protein, a central regulator of tumor cell division and blood vessel growth in cancer cells.

"The mTOR pathway is a major route to resistance in targeted cancer therapies, and the early data in combination with Herceptin and chemotherapy demonstrate proof of concept that by inhibiting mTOR we may be able to overcome resistance to these medicines,"
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SOURCE Novartis Pharmaceuticals Corporation
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