MabThera approved in Europe for maintenance therapy in patients with common form of lymphoma

Life-saving medicine reduces the risk of death by almost half

Basel, 11 July 2006, Roche announced today that the European Commission has approved MabThera (rituximab) as maintenance therapy for patients with relapsed or refractory follicular Non-Hodgkin’s Lymphoma (NHL), the most common form of indolent NHL. MabThera maintenance therapy reduces the risk of death by almost half (48%) for patients with this form of NHL, compared to standard disease management.

NHL is one of the fastest growing cancers and has grown in incidence by 80% since the early 1970s.1 If the number of cases continues to increase at current rates, NHL will have an incidence similar to that of breast, colon, lung and skin cancer by the year 2025. Indolent NHL is a slow developing cancer and patients may live many years with the disease but standard treatments cannot cure it.

“Maintenance therapy with MabThera is the first treatment in 30 years that prolongs the life of these patients to such an extent,” said William M. Burns, CEO Division Roche Pharma “The quick approval of MabThera maintenance therapy mirrors the dramatic survival benefit this medicine can bring to the patient providing new hope to control the disease.”

MabThera was previously approved in the EU for first-line treatment of both aggressive and indolent NHL (in combination with chemotherapy) and as a second-line monotherapy for indolent NHL. This new indication gives patients with relapsed follicular NHL a better chance to live disease- free for longer, allowing them up to an additional 3 years without new chemotherapy treatments.

Label Extension Based On Pivotal Study
The label extension is based on the impressive results of the EORTC (European Organisation for Research and Treatment of Cancer) 20981 study, performed in 18 countries worldwide, that was presented at the 47th annual conference of the American Society of Hematology in Atlanta in December 2005. For more details on the study design and results, see the ‘further information’ section at the end of this release.

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. To date, patients have received more than 730,000 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 a supplier of innovative products and services for the early detection, 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 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).

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


Additional Information
- Information on the pivotal study EORTC 20981
- Roche in Oncology
- Lymphoma
- The Lymphoma Coalition
- Cancer
- World Health Organization

Footage of leading lymphoma doctors talking about maintenance therapy can be viewed and downloaded via www.thenewsmarket.com/roche

1 World Health Report 2000, World Health Organization, www.who.int.

Contact Information

Alexander Klauser

Media Spokesman

Roche Group

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