Basel, 25 January 2008


MabThera meets study primary endpoint in improving disease symptoms when used as first biologic therapy in patients with rheumatoid arthritis
First Phase III study demonstrating the potential of MabThera when used earlier in the course of treatment

Roche announced today that their innovative drug MabThera (rituximab) can be used effectively and safely as first-line biologic therapy to improve the debilitating symptoms of rheumatoid arthritis (RA).

The pivotal study, SERENE¹, investigated patients suffering from RA who had an inadequate response to methotrexate (MTX) therapy, a commonly used RA drug. The study successfully met its primary endpoint² by showing that significantly more patients treated with MabThera in combination with MTX achieved an improvement in disease signs and symptoms compared to patients treated with MTX alone.

MabThera is the first and only selective B cell therapy licensed for the treatment of patients suffering from RA. It has already demonstrated significant clinical benefits when used later in the treatment cycle but this is the first phase III study to investigate its benefits when used as first-line biologic therapy.    

“These data support the potential for MabThera to be used earlier in the course of treatment for RA. The results are encouraging and show that MabThera represents a promising alternative to current treatment options in patients who have an inadequate response to traditional therapy”, said William M. Burns, CEO Pharmaceuticals Division of Roche.
MabThera is currently licensed in patients with more advanced disease who have had an inadequate response or intolerance to tumour necrosis factor (TNF) inhibitors. Data from this trial will be submitted for presentation at upcoming international scientific meetings.

RA is one of the most common autoimmune diseases, affecting more than 21 million people worldwide, with as many as three million sufferers in Europe alone. It is twice as common in women as in men and also impacts on the average life expectancy, shortening it by three to seven years.

About the SERENE study
SERENE is a phase III international study treating 509 patients with active RA. The study was conducted at 102 study sites across 11 countries. In this randomized, placebo controlled, double blind, parallel group study, patients received either MabThera (500mg or 1000mg) or placebo by intravenous infusion on days 1 and 15, plus weekly MTX. A significantly greater proportion of patients treated with MabThera in combination with MTX achieved an improvement in disease signs and symptoms at week 24, compared to those treated with MTX alone. A preliminary analysis of the data did not reveal any unexpected safety signals and the overall safety profile was consistent with that reported in previous studies. The study also explored pharmacokinetics and the long-term efficacy and safety of further courses of MabThera in this patient population.

About rheumatoid arthritis and MabThera
Rheumatoid arthritis (RA) is an autoimmune disease characterized by inflammation that leads to stiff, swollen and painful joints. This ultimately results in irreversible joint damage and disability. MabThera selectively targets B cells and represents a new highly effective therapeutic approach for RA in addition to existing treatments such as disease-modifying anti-rheumatic drugs (DMARDs) and tumour necrosis factor (TNF) inhibitors.

B cells are known to play a key role in the inflammation associated with RA. As the first and only selective B cell therapy available for the treatment of RA, MabThera represents a proven and truly different alternative for patients who have inadequate response or are not able to tolerate TNF inhibitor therapy. MabThera is the only RA treatment that has demonstrated the ability to preserve joint structure in this patient group and offers an unprecedented duration of response of at least six months with each course. Each course of MabThera also provides the opportunity of sustained or improved relief for patients from the signs and symptoms of their disease.

MabThera is marketed in the US by Genentech and Biogen Idec under the brand name Rituxan.

For a selection of broadcast footage clips relating to MabThera and rheumatoid arthritis please visit www.thenewsmarket.com/roche.

To view and download high resolution stills and media materials please visit the MabThera Virtual Press Office at www.mabthera-ra.com

About Roche in rheumatoid arthritis
One of the most important drivers for growth at Roche over the next few years is expected to be the company’s emerging franchise in autoimmune diseases with rheumatoid arthritis as the first indication. Following the launch of MabThera (rituximab) there are a number of projects in development, potentially allowing Roche to build on further opportunities. MabThera is the first and only selective B-cell therapy for RA, providing a fundamentally different treatment approach by targeting B cells, one of the key players in the pathogenesis of RA. Actemra is Roche’s second novel medicine and is a humanised monoclonal antibody to the interleukin-6 (IL-6) receptor, inhibiting the activity of IL-6 , a protein that plays a major role in the RA inflammation process. Additional projects creating a rich pipeline include compounds in Phase I, II and III clinical trials. Notably, ocrelizumab, a humanised anti-CD20 antibody, has entered phase III development for RA.

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 totaled 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. For further information, please visit www.roche.com .

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References:
1) SERENE refers to Study Evaluating Rituximab’s Efficacy in methotrexate iNadequate rEsponders
2) The proportion of patients who achieved ACR20 at week 24. The ACR response is a standard assessment used to measure patients’ responses to anti-rheumatic therapies, devised by the American College of Rheumatology (ACR). It requires a patient to have a defined percentage reduction in a number of symptoms and measures of their disease. For example, a 20%, 50% or 70% level of reduction (the percentage of reduction of RA symptoms) is represented as ACR20, ACR50 or ACR70.