TORONTO, Ontario (December 8, 2003) — New data from a Canadian-led international breast cancer trial, presented at the San Antonio Breast Cancer Symposium represents "new hope" for breast cancer survivors. The effectiveness of Femara® in the trial was so profound that an international committee decided to disclose the results early in order to provide Femara® to those women who were on placebo in the trial. There was a reduction of breast cancer recurrence by almost half.
"Femara® is a powerful weapon in the fight against breast cancer in post-menopausal women. Until these results were available, there was no other treatment option with demonstrated benefit for women after five years of tamoxifen therapy," said Dr. Paul Goss, a medical oncologist and director of breast cancer prevention at Princess Margaret Hospital in Toronto, who has spent two decades researching the role of aromatase inhibitors such as Femara® in the treatment of breast cancer, and the lead researcher of this international clinical trial. "The data presented in San Antonio show we have the first ever safe and effective treatment for breast cancer survivors reducing their risk of recurrence by 43 per cent after five years. This trial has changed the standard of care for breast cancer patients around the world and ushered in a new era of hope for women with breast cancer and their families."
The new data presented at San Antonio also show that women in the Femara® group not only benefited from reduced recurrence of disease, but the treatment also had no negative impact on quality of life. The new quality of life results add significance to the study in that women can now benefit from a substantial reduction in breast cancer recurrence with virtually no impact on their day-to-day life.
One patient, Dorothy Mullins, a Halifax-area resident, was diagnosed with breast cancer in 1996 and she was involved in the trial. "The possibility of my breast cancer recurring was an underlying concern for me," says Dorothy. "Knowing now that with Femara® I have a chance of remaining cancer-free, I feel optimistic about my future."
The annual San Antonio Breast Cancer Symposium is one of the largest medical conferences. This international symposium, which took place from December 3rd to 6th, is directed primarily towards academic and private physicians and researchers involved in breast cancer in medical, surgical, and radiation oncology, as well as other appropriate health care professionals.
STUDY HIGHLIGHTS
The international breast cancer trial of nearly 5,200 women, in Canada (1,404), the United States (3,607) and Europe (176), called MA-17, is the first study to examine the effectiveness of an aromatase inhibitor, Femara®, following five years post-surgery tamoxifen treatment. Study researchers found that Femara®, when taken following five years of tamoxifen therapy, substantially increased the chance of remaining cancer free. In total, 132 women taking placebo had their disease recur compared to 75 on Femara®. Overall, Femara® reduced the risk of recurrence by 43 per cent so that four years after the start of the study, 13 per cent of the women on placebo, but only seven per cent of those on Femara® had disease recurrence. Deaths specifically from breast cancer were also reduced from 17 to nine among women taking Femara®.
"As a physician seeing patients with breast cancer on a daily basis, I'm pleased to be able to offer an excellent treatment option now that provides protection to women with breast cancer after five years of tamoxifen therapy," says Dr. Goss. "All breast cancer survivors should speak to their physicians about the possibility of Femara® treatment if they have been on tamoxifen for five years."
BREAST CANCER STATISTICS
In Canada, it is estimated that 21,100 women will be diagnosed with breast cancer. Excluding lung cancer, breast cancer is the most frequently diagnosed cancer in Canadian women. Breast cancer, the second leading cause of cancer death, accounts for 5,300 deaths in women.
ABOUT FEMARA®
Femara®, an aromatase inhibitor, is an oral once-a-day drug indicated as first-line therapy in post-menopausal women with hormone-receptor sensitive advanced breast cancer. Femara® (letrozole) is also indicated for the hormonal treatment of advanced/metastatic breast cancer in women with natural or artificially-induced post-menopausal status, who have disease progression following antiestrogen therapy.
Femara® is currently available in more than 75 countries worldwide.
FORWARD LOOKING STATEMENT
The foregoing release contains forward-looking statements that can be identified by terminology such as "adds significance," "profound," "substantially increased," or similar expressions, or by express or implied discussions regarding potential future sales of Femara®. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Femara® to be materially different from any future results, performance or achievements expressed or implied by such statements. There are no guarantees that the aforementioned clinical trial will result in Femara® reaching any particular sales levels. In particular, management's expectations regarding commercialization of Femara® could be affected by, among other things, additional analysis of Femara® clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government pricing pressures; and other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected.
ABOUT NOVARTIS CANADA
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. Novartis Pharmaceuticals Canada conducts hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, diabetes, cancer, organ transplantation and glaucoma. In 2002, the Company invested $35 million in research and development. Novartis Pharmaceuticals Canada Inc. employs approximately 780 people in Canada and its headquarters are located in Dorval, Quebec. In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., (including Novartis Nutrition Corporation and Gerber [Canada] Inc.) and CIBA Vision Canada Inc.
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