Investor Update

Basel, 24 September 2003

New combination of anti-cancer therapy nearly doubles life expectancy for women with aggressive breast cancer

A new study presented today shows that a combination of two anti-cancer drugs (Herceptin [trastuzumab] plus docetaxel1) nearly doubled median survival time for women with an aggressive form of breast cancer.

According to study results presented at the European Cancer Conference (ECCO) in Copenhagen, half of women with HER2-positive breast cancer treated with Herceptin plus docetaxel survived, on average, 24 months compared to 13 months for patients treated with docetaxel alone. Moreover, patients treated with Herceptin plus docetaxel showed an overall response rate of 61%, compared to 36% for patients receiving docetaxel alone. These survival and response rates are highly statistically significant.

“These exciting results highlight the critical importance of verifying HER2 status upon diagnosis of breast cancer,” said the principal study investigator, Professor Michel Marty, Director of Therapeutic Research at the Institut Gustave-Roussy, Villejuif, France. “Women with HER2-positive breast cancer often have tumours that grow rapidly and resist standard therapies. The combination of Herceptin plus docetaxel extends the time before the disease progresses, with few additional side effects. This should offer hope, and indicate that Herceptin plus docetaxel should be considered as a first line treatment for HER2-positive metastatic breast cancer.”

Speaking about her experience with the combination Herceptin plus docetaxel treatment, as a study participant in Australia, Jane Parry said:

“Without a doubt, participating in this trial saved my life. Before enrolling, I was given 6 to 8 months to live and here I am feeling fit and well three years later. I am so grateful for the extra years I have gained from taking the combination treatment; in particular it means so much to be able to attend my daughter’s graduation this December. I strongly feel it should be mandatory for every woman diagnosed with breast cancer to have the HER2 test to determine whether they are eligible to receive Herceptin.”

Study Design
186 patients were recruited into the study (M77001), 92 patients randomised to receive Herceptin plus docetaxel and 94 randomised to receive docetaxel alone. Docetaxel was scheduled at a dose of 100 mg/m2 every 3 weeks for at least 6 cycles. Herceptin was administered in 2mg/kg weekly doses until disease progression (after an initial loading dose of 4mg/kg). Patients in the docetaxel arm of the study were given the option to cross over to receive Herceptin, following disease progression.

HER2-positive breast cancer refers to a type of breast cancer in which large quantities of the HER2 (Human Epidermal growth factor Receptor 2) protein are present on the surface of the tumour cells. This is known as ‘HER2 overexpression’. HER2 overexpression can lead to a particularly aggressive form of breast cancer which can respond poorly to chemotherapy.

About Herceptin
Herceptin is a targeted therapeutic antibody treatment that received approval in the European Union in 2000 for use in patients with metastatic breast cancer, whose tumours overexpress the HER2 protein. It is indicated for treatment of patients both as first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy. In clinical trials, Herceptin has shown a survival benefit when used as a first-line therapy in combination with chemotherapy given weekly ongoing until disease progression. Herceptin is marketed in the United States by Genentech and internationally by Roche.

About Breast Cancer
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.¹ 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.¹

Roche in Oncology
Within the last five years Roche has become the world’s lead supplier of medicines for oncology. Its franchise includes Herceptin (breast cancer), MabThera (non-Hodgkin's lymphoma), Xeloda (colorectal cancer, breast cancer) NeoRecormon (anaemia in various cancer settings), Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma) and Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and sales of 2.9 billion Swiss francs could be recorded in the first six months of 2003.
Roche Oncology has four research sites (two in the US, Germany and Japan) and four HQ Development sites (two in the US, UK and Switzerland) dedicated to Oncology.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market and is the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the 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 employs roughly 65,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.

¹ Trade Name Taxotere

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