Basel, 8 December 2003

Study of MabThera in aggressive non-Hodgkin's lymphoma in patients less than 60 years old halted two years early due to significant efficacy benefits

Roche, Genentech, and Biogen Idec have been informed that a study evaluating anti-cancer drug MabThera (rituximab) in combination with chemotherapy in patients with aggressive non-Hodgkin’s lymphoma (NHL) has been halted early as it has met its primary efficacy endpoint two years earlier than expected. Initial results indicate that MabThera plus chemotherapy was significantly more effective in treating the disease than conventional chemotherapy alone.

The MInT1 study, an international cooperative group phase III trial, evaluated MabThera in combination with chemotherapy in patients below 60 years of age with aggressive non-Hodgkin’s lymphoma. A previous study has demonstrated survival benefit in patients over 60 years old. A pre-planned interim analysis of the study data by an independent Data and Safety Monitoring Committee (DSMC) showed a statistically significant improvement in time to treatment failure for patients receiving MabThera plus chemotherapy. Based on this encouraging result, the DSMC has recommended that the study be halted and the data analysed in full.

“The fact that the MInT study was stopped two years earlier than planned gives great hope to younger (below 60 years) patients with this life-threatening form of cancer,” said William M. Burns, Head of Roche Pharmaceuticals Division. “We have already seen from the GELA2 trial that elderly patients over 60 years achieved a significant survival benefit from eight cycles of MabThera plus chemotherapy - initial findings indicate that patients in the MInT study are also significantly benefiting from MabThera.”

About the study
The phase III study was conducted in 18 countries3 and recruited previously untreated patients below 60 years of age with aggressive NHL. Patients were randomised to receive either MabThera in combination with chemotherapy, or chemotherapy alone. At the time the study was stopped, 326 patients were analysed for treatment efficacy. In this study, time to treatment failure was evaluated as the time from randomisation to the first failure, defined as documented insufficient therapeutic response, disease progression or death.

About MabThera
MabThera is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells. It then recruits the body's natural defences to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.

MabThera is indicated as a single-agent treatment for relapsed or refractory indolent NHL, and received European approval in March 2002 for the treatment of aggressive NHL in combination with CHOP chemotherapy. MabThera is known as Rituxan in the United States, Japan and Canada. More than 300,000 patients have been treated with MabThera worldwide to date.

Genentech and BiogenIdec co-market MabThera in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

Roche in Oncology
Within the last five years Roche has become the world’s leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented three marketed products with survival benefit; Herceptin, MabThera and Xeloda, treating a range of malignancies - breast cancer, non-Hodgkin’s lymphoma and colorectal cancer. Other key products include NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcemia of malignancy) , Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). Roche’s cancer medicines generated sales of 4.5 billion Swiss francs in the first nine months of 2003.

Roche’s products in development also promise survival benefit with Avastin. In a pivotal phase III study Avastin increased survival duration by 30% when combined with first-line chemotherapy for patients with advanced colorectal cancer.

Roche is developing new tests which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.

Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).

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.

About Genentech
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Sixteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes 12 biotechnology products in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA.

About Biogen Idec
Biogen Idec creates new standards of care in oncology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare.

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Notes to editors:
1) MInT – MabThera International Trial
2) GELA – Groupe d’Etude des Lymphomes de l’adulte
3) Countries that participated in the study: Argentina, Australia, Austria, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Israel, Italy, Norway, Poland, Sweden, Switzerland, Spain, UK