Basel, March 7, 2005 -Novartis announced today that Femara® (letrozole) has received marketing authorization via the Mutual Recognition Procedure in Germany, a major European market, for the treatment of postmenopausal women who have completed five years of standard adjuvant (post-surgery) tamoxifen therapy (extended adjuvant).
More than 40 countries, including the US, Switzerland and the United Kingdom, have issued approvals for Femara for the extended adjuvant indication. This approval is based on the landmark MA-17 study, an independent, internationally conducted trial that included more than 5,100 postmenopausal women which was coordinated by the National Cancer Institute of Canada Clinical Trials Group at Queens University in Kingston, Ontario, and supported by Novartis. Initial results were published in the New England Journal of Medicine in October 2003.
The study showed that Femara reduced the risk of cancer coming back, or disease-free survival, by 42%. This is particularly important because when breast cancer recurs, it very often has spread beyond the breast (metastatic disease), which can have serious consequences. Femara also greatly reduced the chance of breast cancer returning to another part of the body, or distant metastases, by 39%. The appearance of distant metastasis is a well-recognized predictor of mortality.
"This new treatment option represents new hope for postmenopausal women throughout Europe," said Henning Mouridsen, MD, Rigshospitalet Department of Oncology, Copenhagen, Denmark. "Femara is the only aromatase inhibitor proven beneficial after five years of standard tamoxifen treatment, providing a much needed therapy for women with early breast cancer, who, before now, had no options after tamoxifen."
The term extended adjuvant describes the period following standard adjuvant (post-surgery) treatment with tamoxifen. Even years after breast cancer diagnosis and primary treatment, the ongoing risk of breast cancer recurrence remains significant for all patients. Approximately one-third of women with estrogen receptor-positive early breast cancer experience a recurrence and over half of those recurrences occur more than five years after surgery. While tamoxifen is beneficial for five years post-surgery, if used beyond that, the risks associated with it outweigh the benefits. Femara is the only clinically proven therapy to effectively address the unmet medical need to reduce the ongoing risk of breast cancer recurrence following standard tamoxifen treatment.
"We look forward to more approvals for this indication throughout the EU in the near future," said Diane Young, Vice President and global head of Clinical Development at Novartis Oncology. "The availability of Femara as a new post-tamoxifen treatment option will offer more women the chance to live free of breast cancer recurrence."
Novartis is pursuing this indication in all member states of the EU. Following completion of the MRP process, EU member states are expected to use the final endorsed Summary of Product Characteristics to implement marketing authorizations locally.
Aromatase inhibitors, such as Femara, are recommended by the American Society of Clinical Oncology (ASCO) as the treatment of choice for postmenopausal women with early breast cancer, as cited in the "ASCO Technology Assessment on the Use of Aromatase Inhibitors as Adjuvant Therapy for Postmenopausal Women With Hormone Receptor Positive Breast Cancer: Status Report 2004." Aromatase inhibitors also were recommended as a viable treatment option at the International Consensus Conference on the Optimal Primary Therapy of Early Breast Cancer, formed at the Primary Therapy of Early Breast Cancer Meeting in St. Gallen, Switzerland, in January. The recommendations, developed by consensus with input from expert oncologists from Europe and North America, are expected to be published in the Journal of Clinical Oncology in summer 2005.
About Femara
Femara is a leading once-a-day oral aromatase inhibitor that is indicated for first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy, and as neo-adjuvant (pre-operative) therapy. Femara is approved for extended adjuvant treatment of early breast cancer in postmenopausal women who have completed standard adjuvant tamoxifen therapy in more than 40 countries worldwide, now including member countries of the EU as well as the United States. Femara is currently available in more than 80 countries worldwide. Not all indications are available in every country.
Contraindications and adverse events
In the clinical trials supporting the metastatic settings, the most frequently reported adverse reactions were hot flushes, nausea and fatigue. In the extended adjuvant setting, the following adverse events irrespective of causality were reported significantly more often with Femara than with placebo - hot flushes (50.7 % vs. 44.3 %), arthralgia/arthritis (28.5 % vs. 23.2 %) and myalgia (10.2 % vs. 7.0 %). The majority of these adverse events were observed during the first year of treatment. There was a higher but non-significant incidence of osteoporosis and bone fractures in patients who received Femara than in patients who received placebo (7.5 % vs. 6.3 % and 6.7 % vs. 5.9 %, respectively).
The foregoing release contains forward-looking statements that can be identified by terminology such as "represents new hope," "look forward to," "will offer," "are expected to," "near future," or similar expressions, or by express or implied discussions regarding potential additional marketing approvals or 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 can be no guarantee that Femara will receive any additional marketing approvals in any other countries, or that it will reach 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, industry, and general public pricing pressures; and other risks and factors referred to in the Company's current Form 20-F on file with the U.S. 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. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Additional information on Femara
Additional information regarding Femara or Novartis Oncology can be found on the websites www.femara.com or www.novartisoncology.com. Additional media information can be found at www.novartisoncologyvpo.com.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and a net income of USD 5.8 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81 400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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Contacts
John Gilardi
Novartis Global Media Relations
Tel +41 61 324 3018
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John.Gilardi@group.novartis.com
Kim Fox
Novartis Oncology
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Mobile +1 917 415 2425
