New Clinical Data Show Benefits of Femara(R) for Women With Breast Cancer Even After Prolonged Period of no Anti-Cancer Treatment Post tamoxifen

FRIMLEY, England, March 23 /PRNewswire/ --

- New Data From Major International Study Showed Femara Use Led to 69% Reduction in Risk of Breast Cancer Returning, Even Years After Completing Standard tamoxifen Therapy

- Femara Showed 72% Reduction in Risk of Distant Metastases (Progression to Other Parts of the Body) in Postmenopausal Women With Early Breast Cancer who Switched to Femara After Placebo in Study

- Results Presented Today at Key European Breast Cancer Medical Conference

Women with hormone-sensitive early breast cancer who switched to Femara(R) (letrozole, an aromatase inhibitor) from placebo as part of a landmark trial experienced significant improvements in overall survival, disease-free survival and risk of distant metastases, according to data presented today at the 5th European Breast Cancer Conference (EBCC), Nice.[1]

The MA-17 trial was designed to determine whether longer-term treatment with an aromatase inhibitor post tamoxifen therapy, would offer any clinical benefit to postmenopausal women with early breast cancer. As such, the women taking part in the study had already completed a standard five year course of tamoxifen, and were then given either Femara or placebo.

In 2003, compelling results of an interim analysis showed that Femara reduced the risk of breast cancer coming back by 42% compared with placebo. These data prompted an independent Data Safety Monitoring Board to recommend the unblinding of study results. Since then, approximately 1,655 women taking placebo have chosen to switch to Femara, while another 613 women did not pursue further treatment.

In this new analysis, postmenopausal women who switched from placebo to Femara experienced a 69% reduction in the risk that their breast cancer would return (recurrence). There also was a 72% reduction in the risk that the cancer would spread to a distant part of the body (metastasis). A 47% reduction in the risk of dying from their disease was also observed. The gap in treatment between ending 5 years of standard tamoxifen therapy and then starting treatment with Femara for these women was anything between three months to five years. These observations must be confirmed by additional analysis and longer-term follow-up. These data are not currently included in the approved licensed indication for Femara.

"The results presented today provide the first clinical evidence that women can benefit from Femara even years after the completion of standard treatment. The findings may have a substantial impact on the overall treatment outcomes for postmenopausal women." said Dr. Andrew Wardley, study investigator and consultant medical oncologist at The Christie Hospital, Manchester, and The South Manchester University Hospital NHS Trust.

Liz Caroll, Head of Clinical Services at Breast Cancer Care commented: "Women who come to the end of tamoxifen therapy can feel very anxious and live with a constant fear that their cancer could return. Now, there is additional hope as this trial shows that women could have a gap between treatment, and still benefit. This intervention will be warmly welcomed by many women amongst those we support and could save many more lives."

About MA-17

MA-17 is an independent Phase III, international, double-blinded, randomized, multi-centre trial. It is coordinated by the National Cancer Institute of Canada Clinical Trials Group at Queens University in Kingston, Ontario, Canada with funding from the Canadian Cancer Society and supported by Novartis. The letrozole vs placebo arm of the study (presented at the 5th EBCC) involved 5187 postmenopausal women with ER+ and/or PgR+ or receptor-unknown who were originally randomized to receive letrozole (LET) or placebo (PLAC) after 5 years of tamoxifen treatment. Results were taken after a median follow up time of 30 months.

About Femara

Femara is now the first and only aromatase inhibitor (AI) licensed for treatment across the entire breast cancer treatment spectrum - before surgery, directly post-surgery, after five years of standard tamoxifen treatment and in advanced cancer.[2] A once-a-day oral aromatase inhibitor, it is currently indicated in the UK for:

- Adjuvant (post-surgery) treatment of postmenopausal women with hormone receptor positive invasive early breast cancer

- The treatment of early invasive breast cancer in postmenopausal women who have completed prior standard adjuvant tamoxifen therapy

- Newly diagnosed postmenopausal women with advanced breast cancer

- Postmenopausal women with advanced breast cancer in whom tamoxifen, or other anti-oestrogen therapy has failed

- Neoadjuvant (pre-operative) therapy in postmenopausal women with localised hormone receptor-positive breast cancer, to allow subsequent breast conserving surgery in women not originally considered candidates for breast conserving therapy

About the National Cancer Institute of Canada Clinical Trials Group

The National Cancer Institute of Canada Clinical Trials Group (NCIC CTG), funded by the Canadian Cancer Society and based at Queen's University in Kingston, Ontario, Canada, develops, conducts and analyzes national and international trials of cancer therapy, including trials for new cancer drugs, cancer prevention and supportive care to improve quality of life for people with cancer. Since its inception in 1971, the NCIC CTG has enrolled more than 40,000 patients from Canada and around the world in over 300 clinical trials.

About Novartis

Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com

[1] Goss P. et al Updated Analysis of the NCIC CTG MA.17 (letrozole vs placebo to letrozole vs placebo) post-unblinding.. Oral presentation 5th European Breast Cancer conference, 23rd March 2006

[2] Femara Summary of Product Characteristics. November 2005