Investor Update

Basel, 11 December 2007

MabThera improves response in patients with most common form of adult leukaemia
Higher response rates seen in untreated and relapsed CLL patients

Early results from two phase II trials tracking the outcome of patients with chronic lymphocytic leukaemia (CLL) who were treated with the innovative cancer therapy MabThera (rituximab) have revealed very promising results.  The study outcomes, presented at the 49th Annual Meeting of the American Society of Hematology in Atlanta, come from the first prospective trials demonstrating the efficacy of MabThera in CLL patients and highlight the impact MabThera is having on CLL, a disease in which there has not been a significant treatment advance in nearly a decade.  

In the first trial¹, 92% patients with previously untreated CLL achieved a response to treatment when treated with MabThera in combination with chemotherapy This improvement confirms similar results from earlier studies.  The study, which is run by the Spanish Group for CLL (GELLC), is also investigating the impact of MabThera maintenance therapy in CLL patients, as all responding patients in the induction phase will also receive MabThera maintenance therapy.  Further results from the second part of the study are expected in 2008.

The second trial², conducted by the UK CLL study group, focused on patients with relapsed CLL and demonstrated a better response for patients treated with MabThera in combination with chemotherapy than with chemotherapy alone, 70% to 57%.   

"The results from both trials demonstrate the encouraging potential benefits MabThera, in combination with chemotherapy, can provide to patients with CLL,” commented Prof. Emili Montserrat, from the Department of Hematology, University of Barcelona, Spain. " These early results seem to signify that the addition of MabThera to treatment is critical to improving outcomes in CLL patients, where there is currently a high unmet medical need.”

Chronic Lymphocytic Leukaemia (CLL) is the most common type of leukaemia in adults, accounting for approximately 25-30% of all leukaemias.  Incidence of CLL in Western countries is around 2-4 per 100,000 and is twice as common in men as in women.  It mainly affects the elderly with 95% of patients diagnosed after the age of 55. While CLL is generally considered an indolent disease, meaning that it is slow to progress, a significant proportion of patients have rapidly progressing forms of the disease.   

About the GELLC study
A total of 69 patients were prospectively enrolled in the study, which contained an induction phase of MabThera plus chemotherapy (Mabthera + FCM) followed by a maintenance therapy phase of MabThera alone. Thirty eight patients were already evaluable for response to the first part of the treatment. At study entry, 83% of the patients were in advanced clinical stages (Binet B & C), and 64% had increased (>20%) Zap-70 expression, considered as an marker of  poor prognostic.  Overall response rate (ORR) is 92%.  Toxicity has been manageable, with grade III-IV neutropenia being observed in 8% of the cases.
About the UK CLL Forum study
A total of 52 patients were entered into this prospective randomised trial with 26 patients in each arm.  The median age was 65, with 79% men.  The median number of prior therapies was 2, 31 had previously received fludarabine and 6 were fludarabine refractory or had relapsed within 6 months of a fludarabine containing regimen.  Responses were evaluable in 45 patients, with an ORR of 70% for patients receiving RFCM compared to 57% for patients receiving FCM chemotherapy alone.

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, metabolism and central nervous system. Additional information about the Roche Group is available on the Internet at www.roche.com.

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Note to editors:
1) Bosch et al., ASH 2007, Abstract #626
2) Hillmen et al., ASH 2007, Abstract #752