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Novartis Submits Applications in U.S. And Europe for Femara As Adjuvant Treatment for Postmenopausal Women With Early Breast Cancer

Posted on: Monday, 11 July 2005, 03:00 CDT

Applications Based on Data From Large Head-to-Head Trial Showing Femara is More Effective Than Tamoxifen in Helping These Women Stay Cancer Free

Pre-Planned Subset Analyses Show Femara Reduces Risk of Cancer Returning by Up to 30% in Node-Positive and Chemotherapy-Treated Patients

BASEL, Switzerland, July 11, 2005 (PRIMEZONE) -- Novartis (NYSE:NVS) has submitted marketing authorization applications in the United States and Europe for the use of Femara(r) (letrozole) in the adjuvant (post-surgery) treatment of postmenopausal women with hormone receptor-positive early breast cancer.

Once approved for this indication, Femara will become the only breast cancer treatment available to significantly reduce the risk of recurrence in the adjuvant setting as well as in extended adjuvant treatment following tamoxifen.

"Femara represents an important advance to help increase a woman's chance of staying cancer free after initial treatment for early breast cancer," said Diane Young, MD, vice president and global head, Clinical Development, Novartis Oncology. "The data filed today add to the already substantial body of evidence supporting the use of Femara in breast cancer."

The submissions are based on data from the Breast International Group (BIG) 1-98 study, a Phase III, randomized, double-blind study that compared the safety and efficacy of adjuvant Femara vs. tamoxifen in more than 8,000 postmenopausal women with hormone receptor-positive early breast cancer. The overall results of BIG 1-98 demonstrated that at a median follow-up of 26 months, Femara prolonged disease-free survival by reducing risk of recurrence by an additional 19% (p=0.003)(a) over the reduction offered by tamoxifen. Women who were treated with Femara experienced a 27% reduction in the risk that their cancer would spread to other parts of the body (distant metastases) compared with tamoxifen (p=0.001), a clinically relevant finding since women who develop distant metastases may be at greater risk of dying from their disease. Femara also provided a 14% reduction in the risk of death, although this did not reach statistical significance (p=0.155).

In two separate pre-planned subset analyses, Femara also reduced the risk of cancer returning by 29% among patients whose initial cancer had already spread to the lymph nodes at the time of diagnosis (node-positive breast cancer) and by 30% in those who had received chemotherapy, two groups that are at increased risk of recurrence. Additionally, in node-positive patients and in patients who received adjuvant chemotherapy, the risk of distant metastases was reduced by more than 30% with Femara compared to tamoxifen.

About BIG 1-98

BIG 1-98 is the only clinical trial designed to incorporate both a head-to-head comparison of Femara with tamoxifen during the first five years following breast cancer surgery and a sequencing of both agents to determine the most effective approach to minimizing the risk of recurrence. Patients were randomized to the following arms: tamoxifen for five years, Femara for five years, tamoxifen for two years followed by Femara for three years, and Femara for two years followed by tamoxifen for three years. Results from the ongoing arms of the study, which are expected to determine whether monotherapy or sequential therapy is more effective, and if sequential therapy, which sequence is more effective, are expected in 2008.

BIG 1-98 was conducted by the International Breast Cancer Study Group (IBCSG), with participation of the Danish Breast Cancer Group, the French FNCLCC group, the Yorkshire Group and many independent centers. The study was supported by Novartis.

The data upon which the filings are based were initially presented at the Primary Therapy of Early Breast Cancer 9th International Conference in St. Gallen, Switzerland, in January 2005. Updated data from this analysis, presented in May at the annual meeting of the American Society for Clinical Oncology (ASCO) in Orlando, Florida, clarified the safety of Femara as compared with that of tamoxifen.

The adverse events in the BIG 1-98 study were consistent with published data on both Femara and tamoxifen. In the BIG 1-98 study, the two treatments were generally well tolerated and the safety profile in the two treatment arms was similar. Only arthralgia/arthritis, bone fractures and osteoporosis were significantly more common in the Femara arm as compared to tamoxifen. Hot flashes/flushes, night sweats, vaginal bleeding and thromboembolic events in turn were significantly more frequent in the tamoxifen group.

Overall, more deaths were reported on tamoxifen (n=192) than on Femara (n=166). More patients on tamoxifen (n=135) died from breast cancer than Femara (n=100). In patients whose breast cancer did not recur, more deaths due to cardiac causes were reported in Femara-treated patients than tamoxifen-treated patients.

The frequency of bone fractures and osteoporosis on both treatments was low but the numbers were higher in the Femara arm (6.4%) compared to tamoxifen (4.8%). Endometrial hyperplasia or cancer was reported more often for tamoxifen (2.1%) than for Femara (0.4%).

In the trial, the number of all cardiovascular events was overall lower in the Femara arm than in the tamoxifen arm (9.7% vs. 10.5%). Irrespective of causality, the following adverse events occurred in the Femara and tamoxifen groups respectively: thromboembolic events (1.2% vs. 2.8%), angina pectoris (0.7% vs. 0.6%), myocardial infarction (0.6% vs. 0.4%) and cardiac failure (0.9% vs. 0.4%). Tamoxifen slightly decreased the cholesterol values, whereas Femara treatment resulted in no relevant overall changes over time in serum total cholesterol.

About Femara

Femara is a leading once-a-day oral aromatase inhibitor currently available in more than 90 countries worldwide. Femara is approved for extended adjuvant treatment of early breast cancer in postmenopausal women who have completed standard adjuvant tamoxifen therapy in 57 countries worldwide, including Europe as well as the United States. In addition, it 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 anti-estrogen therapy, and as neo-adjuvant (pre-operative) therapy. Not all indications are available in every country.

Contraindications, warnings and adverse events

In previous clinical trials, the most common adverse events experienced with Femara have been hot flashes/flushes, arthralgia/arthritis and myalgia. Other commonly reported adverse reactions are: nausea, fatigue, anorexia, appetite increase, peripheral edema, headache, dizziness, vomiting, dyspepsia, constipation, diarrhea, alopecia, increased sweating, rash, bone pain, weight increase, osteoporosis and bone fracture.

Femara is contraindicated in women who are pregnant or breast-feeding as well as in premenopausal women. Femara is contraindicated in patients with known hypersensitivity to Femara or any of its excipients.

The foregoing release contains forward-looking statements that can be identified by terminology such as "once approved,""will become,""important advance,""to help increase,""are expected" or similar expressions, or by express or implied discussions regarding potential new indications, 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 be approved for any additional indications in any market, nor 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.

For more information

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 pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 81,400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

(a) 21% (p=0.002) in U.S. filing due to slightly different definition of disease-free survival by U.S. health authorities.

http://hugin.info/134323/R/1001822/153536.pdf

CONTACT: Novartis Oncology Kim Fox (862) 778-7692 (direct) kim.fox@novartis.com

Novartis Global Media Relations John Gilardi +41 61 324 3018 (direct) +41 79 596 1408 (mobile) john.gilardi@novartis.com

Copyright © 2005 PrimeZone Media Network, Inc.

Source: PrimeZone Media Network

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