Basel, 7 December 2004

Breakthrough MabThera data now shows patients with indolent Non-Hodgkin’s Lymphoma can live longer

For the first time, clear data shows that treating Indolent Non-Hodgkin’s Lymphoma (NHL) with MabThera in combination with chemotherapy prolongs patient survival. The study, presented at the annual meeting of the American Society of Haematology (ASH), compared MabThera in combination with chemotherapy (R-MCP¹) vs. chemotherapy alone (MCP²), as first-line treatment for patients suffering from indolent NHL. In both arms, patients responding to this treatment received interferon maintenance therapy until progression. It was found that at 2 years more patients receiving MabThera survived compared to patients receiving chemotherapy alone.

“This study is a major clinical breakthrough in the treatment of indolent lymphoma as until now no standard treatment has been able to prolong patients’ lives,” said Dr. Michael Herold, Head of Haematology and Oncology at HELIOS Klinikum Erfurt, Germany. “These results further emphasise that MabThera should be the standard of care for NHL patients.”

“With this data we are once again seeing that MabThera may alter the natural history of indolent NHL,” commented William M. Burns, Head of Roche’s Pharmaceuticals Division. “After the wealth of impressive survival data in aggressive NHL, it is rewarding to observe that indolent NHL patients can also live longer when treated with MabThera. In addition, the latest data reinforces our label in first-line treatment of indolent NHL which was approved in Europe this year.”

A second trial, also presented at ASH, reinforces that MabThera should be part of the standard treatment for indolent NHL. This data shows that patients who continue to take MabThera therapy for two years following initial treatment gain, on average, two years without the disease progressing (progression free survival) over those who did not continue therapy (median progression free survival 38 months with maintenance treatment versus 15 months without). In this international study³, conducted by the European Organization for the Research and Treatment of Cancer (EORTC), relapsed indolent NHL patients who responded to an initial phase of the trial, were randomly assigned to continue MabThera treatment every three months for two years (maintenance therapy), or no further treatment.

Non-Hodgkin’s lymphoma affects 1.5 million people worldwide. Indolent NHL, representing about 45% of NHL patients, is a slow developing but fatal cancer of the lymphatic system. Indolent NHL patients suffer from multiple relapses intermittent with periods of symptom free existence (remission). NHL is one of the fastest growing cancers and has grown in incidence by 80% since the early 1970s.⁴

In additional to the aforementioned data, over 140 MabThera (rituximab) abstracts have been accepted for presentation at the 2004 American Society of Haematology Congress. The data being presented reports on MabThera studies being conducted in indolent NHL, aggressive NHL (including Myeloid Cell Leukaemia) stem cell transplantation and Chronic Lymphocytic Leukemia (CLL).

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 was initially 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. In August of 2004 MabThera received European approval for first line treatment of Indolent NHL in combination with CVP chemotherapy. MabThera is known as Rituxan in the United States, Japan and Canada. More than 370,000 patients have been treated with MabThera worldwide to date.

Genentech and Biogen Idec 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 the Roche Group, including its members Genentech in the United States and Chugai in Japan, has become the world’s leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented five products with survival benefit in different major tumour indications: Xeloda and Herceptin in advanced stage breast cancer, MabThera in non-Hodgkin’s lymphoma, Avastin in colorectal carcinoma and Tarceva in non-small cell lung cancer and pancreatic carcinoma.

In the United States Herceptin, MabThera, Avastin and Tarceva are marketed either by Genentech alone or together with its partners Biogen Idec Inc. (MabThera) and OSI (Tarceva). Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these medicines.

The Roche oncology portfolio also includes NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcaemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). CERA is the most recent demonstration of Roche’s commitment to anaemia management. The Roche Group’s cancer medicines generated sales of more than 5.6 billion Swiss francs in the first nine months of 2004.

In addition to the medicines, Roche is developing new diagnostic tests that 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, Roche will continue to be the leader in providing cancer-focused treatments and diagnostics.

Roche has four research sites (two in the United States and one each in Germany and Japan) and five development sites (two in the United States and one each in UK, Australia and Switzerland).

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative 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 is a world leader in Diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2003, the Pharmaceuticals Division generated 19.8 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.4 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

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

For further information:
- About lymphoma: www.lymphoma-net.org

Notes to editors:
1  R-MCP – Mitoxantrone, Chlorambucile, Predisolone chemotherapy plus MabThera
2  MCP ­ Mitoxantrone, Chlorambucile, Predisolone chemotherapy
3  Countries that participated in the study: Canada, Australia, The Netherlands, The UK, Norway, Slovenia, Slovakia, Belgium, Hungary, South Africa, Sweden, New Zealand, Denmark, Egypt, France, Switzerland, Italy, Poland.
4  World Health Report 2000, World Health Organization, www.who.int.