Media Release

Basel, 29 May 2006

Herceptin added to hormonal therapy prolongs progression-free survival for patients with advanced HER2-positive breast cancer

Roche announced today that data from a new study show that the addition of Herceptin (trastuzumab) to the hormonal therapy, Arimidex (anastrozole), increases the length of time that patients live without their cancer progressing (progression-free survival) for patients whose advanced breast cancer is hormone receptor-positive, as well as HER2-positive.

Hormone receptor-positive breast cancer affects two-thirds

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of patients with breast cancer and is typically considered ‘lower-risk’ due to successful treatment with hormonal therapies. However, up to a quarter of these breast cancers are also HER2-positive,

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an aggressive form of the disease that requires special and immediate attention because the tumours are fast-growing and there is a higher likelihood of relapse. This was the first randomised study in this specific subset of ‘co-positive’ patients, whose prognosis has been uncertain thus far.

Eduard Holdener, Global Head of Roche Pharma Development said: “We are glad to learn from this study that the combination therapy offers a new treatment regimen for these breast cancer patients who suffer from an extremely aggressive form of the disease. We will now work with trial investigators to analyse the full set of data from this trial, and submit it for presentation at an upcoming medical meeting in the second half of 2006. We will start preparations to file these data with health authorities around the world.”

To date, over 230,000 patients with HER2-positive breast cancer have been treated with Herceptin worldwide. Herceptin consistently benefits patients regardless of whether it is given in the early stage or advanced settings, or whether it is in combination with chemotherapy, hormonal therapy, or as a single agent.  

About the Study
The TAnDEM study, conducted by Roche is a randomised, Phase III trial, which evaluated Herceptin plus Arimidex versus Armidex alone as first-line therapy (or second line hormonal therapy) in postmenopausal women with advanced (metastatic), HER2-positive and hormone receptor-positive (ER-positive and/or PR-positive) breast cancer. Enrolment to the trial began in 2001, and 208 HER2 and hormone receptor co-positive patients were enrolled at 134 sites in 25 countries across the world. Arimidex was scheduled at a dose of 1 mg daily until progression. Herceptin was administered in 2 mg/kg weekly doses (after an initial loading dose of 4 mg/kg) until disease progression.

According to the analysis, the primary efficacy endpoint was met, showing that patients who received Herceptin had a statistically significant improvement in progression-free survival.
Overall safety data in both arms of the trial were acceptable given the known safety profile of each of the drugs in the advanced breast cancer setting. Patients in this study will continue to be followed for any side-effects.

About breast cancer and Herceptin
Eight to nine percent of women will develop breast cancer during their lifetime, making it one of the most common types of cancer in women.

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Each year more than one million new cases of breast cancer are diagnosed worldwide, with a death rate of nearly 400,000 people per year.

In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. This is known as ‘HER2 positivity.’ High levels of HER2 are present in a particularly aggressive form of the disease which responds poorly to chemotherapy. Research shows that HER2-positivity affects approximately 20% – 30%

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of women with breast cancer.

Herceptin is a humanised antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. In addition to its efficacy in the early-stage breast cancer setting, Herceptin also has demonstrated improved survival in the advanced (metastatic) setting, where its addition to chemotherapy allows patients to live up to one-third longer than chemotherapy alone.

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Herceptin received approval in the European Union in 2000 for use in patients with advanced (metastatic) breast cancer, whose tumours overexpress the HER2 protein. In addition to being indicated for use in combination with docetaxel as a first-line therapy in HER2-positive patients who have not received chemotherapy for their metastatic disease, it is also indicated as a first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, and as a single agent in third-line therapy. Herceptin also received approval in the European Union in May 2006 for use in early-stage HER2-positive patients following standard chemotherapy.

Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat over 230,000 HER2-positive breast cancer patients worldwide.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).

All trademarks used or mentioned in this release are legally protected.

Additional information:
- About Genentech
- Roche in Oncology
- Roche Health Kiosk on cancer
- Video clips - in broadcast standard, free of charge

References:
1  K. C. Chu and W. F. Anderson. Rates for breast cancer characteristics by estrogen and progesterone receptor status in the major racial/ethnic groups. Breast Cancer Research and Treatment 74: 199-211, 2002.
2  F. Penault-Llorca, A. Vincent-Salomon, M. C. Mathieu, et al. On Behalf Of The Esther Study Group. Incidence and implications of HER2 and hormonal receptor overexpression in newly diagnosed metastatic breast cancer (MBC). American Society of Clinical Oncology (ASCO) Meeting Meeting Abstracts, 23: 764, 2005.
3  World Health Organization, 2000.
4  Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.
5  Extra JM, Cognetti F, Maraninchi D et al. Long-term survival demonstrated with trastuzumab plus docetaxel: 24-month data from a randomised trial (M77001) in HER2-positive metastatic breast cancer. Abstract #555, American Society for Clinical Oncology (ASCO) Annual Meeting 2005.