Investor Update

Basel, 14 December 2007

MabThera Receives Positive Opinion in Europe for Combination with Any Chemotherapy Regimen in First-Line Treatment for Follicular Non-Hodgkin’s Lymphoma

Physicians will be able to prescribe MabThera with their preferred chemotherapy  regimen  as  initial treatment

Roche announced today that the European Union’s Committee on Human Medical Products (CHMP) has given a positive recommendation for extension of the MabThera label to include use of MabThera combined with any chemotherapy combination as first-line treatment for follicular Non-Hodgkin’s Lymphoma (NHL), the most common form of indolent NHL. Physicians will now be able to prescribe MabThera with their preferred chemotherapy regimen as an initial treatment for their patients.

"The positive opinion is an important step forward in expanding the availability of MabThera as first-line treatment for all patients who could benefit from it," said Manfred Heinzer, Head, Strategic Marketing Oncology  at Roche. "It also confirms the dramatic survival benefit to patients observed with MabThera in first-line treatment of indolent NHL and  provides further hope for the future treatment of  this deadly disease."

The label extension is based on the results of a number of clinical trials that have evaluated the efficacy and safety of MabThera in combination with different chemotherapy regimens.  The pivotal study M39021¹, evaluated the combination of MabThera with CVP chemotherapy and formed the basis for the original marketing authorization in the EU for first-line treatment of follicular lymphoma in 2004.  Further results from three randomized trials using MabThera in combination with either CHOP², CHVP-I³ or MCP⁴ as the chemotherapy regimen consistently demonstrated a significant improvement in overall survival when compared to chemotherapy alone.  Additionally, a meta analysis study⁵ focused on first-line treatment of indolent NHL confirmed that MabThera prolonged the life of patients and their time free of disease.
In Western Europe alone, 20’000 people are newly diagnosed with indolent NHL every year, and around 40’000 are being treated for this disease.  NHL is one of the fastest growing cancers and its incidence has grown by 80% since the early 1970s.⁶

About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma (NHL) affects 1 million people worldwide. Indolent NHL, representing about 45% of NHL patients, is a slow developing but serious cancer of the lymphatic system. It is currently considered incurable.

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 for the treatment of indolent and aggressive Non-Hodgkin’s Lymphoma. MabThera is known as Rituxan in the United States, Japan and Canada. To date, patients have received more than 1 million treatments with MabThera worldwide.

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.

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 the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. In 2006, sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invests approximately 7 billion Swiss francs a year in R&D. Worldwide, the Group employs about 75,000 people. Additional information is available on the Internet at www.roche.com.

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Note to editors:
1) Marcus R et al. CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood. 2005;105(4):1417-23
2) Hiddemann, W et al. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood 2005. 106; 12, 3725-3732.
3) Foussard et al. Update of the FL2000 randomized trial combining rituximab to CHVP-Interferon-α in follicular lymphoma (FL) patients (pts). Proc Am Soc Clin Oncol. 2006; 24s: 424a (Abstract 7508).
4) Herold M et al. Rituximab plus mitoxantrone, chlorambucil, prednisolone (RMCP) is superior to MCP alone in advanced indolent and follicular lymphoma – results of a phase III study (OSHO39). Ann Oncol 2005, Abst. 060.
5) Schulz H et al. Combined Immunochemotherapy with Rituximab Improves Overall Survival in Patients with Follicular and Mantle Cell Lymphoma: Updated Meta-Analysis Results. Blood (ASH Annual Meeting Abstracts), Nov 2006; 108 (11): Abst. 2760.
6) World Health Report 2000, World Health Organization, www.who.int.