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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 12 December 2005\line \line {\b MabThera maintenance therapy dramatically improves survival for patients with lymphoma } \line \line Risk of death halved - Roche files label extension in Europe for maintenance therapy\line \line \line Two years of maintenance therapy with MabThera (rituximab) dramatically improves the chances of survival for patients suffering from one of the most frequent forms of lymphoma, indolent non-Hodgkin\u8217?s Lymphoma (NHL). The trial showed that the risk of death is halved for patients who receive MabThera maintenance therapy, compared to those who receive no maintenance treatment, irrespective of their initial therapy. The outcome of the clinical trial was presented today at the 47th annual meeting of the American Society of Hematology in Atlanta, USA.\line \line Based on this data, Roche will file today with the European authorities for a label extension for MabThera maintenance therapy for patients suffering from indolent lymphoma. 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.\line \line \u8220?We are conscious that these results open a new era in the management of indolent NHL\u8220?, said William M. Burns, CEO of the Pharmaceuticals Division at Roche. \u8220?Maintenance therapy with MabThera showed unprecedented survival benefits in a serious cancer disease which is currently considered incurable.\u8221?\line  \line Professor Marinus van Oers M.D. from the Academic Medical Center of the University of Amsterdam and lead investigator of the pivotal study said: \u8220?Our trial confirms that MabThera maintenance therapy is highly beneficial for all patients, including those who have already received MabThera as part of their initial therapy. We have not seen such an impressive improvement in progression free and overall survival for indolent NHL in the last 30 years. Maintenance therapy with MabThera may well become the new standard of care for these patients.\u8221?\line \line {\b About the study} \line In the EORTC 20981 (European Organisation for Research and Treatment of Cancer) trial, 465 patients with relapsed and refractory indolent NHL were randomised to receive either 3-weekly cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy or MabThera plus CHOP as induction therapy. Responding patients were then again randomised to either MabThera maintenance, or observation (no further treatment).\line \line MabThera maintenance therapy was applied as a single infusion of 375mg/m2 every three months over a period of two years. The primary endpoints were response rates and progression-free survival for the initial treatment phase and the maintenance phase of the study, respectively. The trial was performed in 130 centres in Canada, Australia, Netherlands, UK, Norway, Slovenia, Slovakia, Belgium, Hungary, South Africa, Sweden, New Zealand, Denmark, Egypt, France, Switzerland, Italy and Poland.\line \line {\b Results of the induction phase} \line The results of the induction phase of the trial showed that patients who received MabThera and CHOP (R-CHOP) had a significantly higher rate of complete remission than patients who received CHOP chemotherapy alone (29% vs 16%, p value <0.0001). Furthermore, MabThera and CHOP chemotherapy significantly increased progression free survival compared to CHOP chemotherapy alone (median progression-free survival of 33 months vs 20 months, p value 0.0003).\line \line {\b Results of the maintenance phase} \par}
{\pard
\trowd\trgaph100\cellx1920\cellx3840\cellx5760\cellx7680\cellx9600
\pard\intbl  \cell
\pard\intbl No maintenance \cell
\pard\intbl Maintenance \cell
\pard\intbl p value \cell
\pard\intbl Risk reduction{\super 1}  \cell
\row
\trowd\trgaph100\cellx1920\cellx3840\cellx5760\cellx7680\cellx9600
\pard\intbl All patients \cell
\pard\intbl 77% \cell
\pard\intbl 85% \cell
\pard\intbl 0.011 \cell
\pard\intbl 48% \cell
\row
\trowd\trgaph100\cellx1920\cellx3840\cellx5760\cellx7680\cellx9600
\pard\intbl CHOP subgroup \cell
\pard\intbl 71% \cell
\pard\intbl 82% \cell
\pard\intbl 0.073 \cell
\pard\intbl 48% \cell
\row
\trowd\trgaph100\cellx1920\cellx3840\cellx5760\cellx7680\cellx9600
\pard\intbl R-CHOP subgroup \cell
\pard\intbl 81% \cell
\pard\intbl 88% \cell
\pard\intbl 0.059 \cell
\pard\intbl 50% \cell
\row
}
{\pard\f0\li0\ri0\sa360\sl360\fs18 {\super 1}  Treatment effect of maintenance therapy \u8211? reduction in the risk of death\par}
{\pard
\trowd\trgaph100\cellx1920\cellx3840\cellx5760\cellx7680\cellx9600
\pard\intbl  \cell
\pard\intbl No maintenance \cell
\pard\intbl Maintenance \cell
\pard\intbl p value \cell
\pard\intbl Risk reduction{\super 2}  \cell
\row
\trowd\trgaph100\cellx1920\cellx3840\cellx5760\cellx7680\cellx9600
\pard\intbl All patients \cell
\pard\intbl 15 months \cell
\pard\intbl 52 months \cell
\pard\intbl <0.0001 \cell
\pard\intbl 60% \cell
\row
\trowd\trgaph100\cellx1920\cellx3840\cellx5760\cellx7680\cellx9600
\pard\intbl CHOP subgroup \cell
\pard\intbl 12 months \cell
\pard\intbl 42 months \cell
\pard\intbl <0.0001 \cell
\pard\intbl 70% \cell
\row
\trowd\trgaph100\cellx1920\cellx3840\cellx5760\cellx7680\cellx9600
\pard\intbl R-CHOP subgroup \cell
\pard\intbl 23 months \cell
\pard\intbl 52 months \cell
\pard\intbl  0.0043 \cell
\pard\intbl 46% \cell
\row
}
{\pard\f0\li0\ri0\sa360\sl360\fs18 {\super 2}  Treatment effect of maintenance therapy \u8211? reduction in the risk of progression of the disease, relapse or death\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 {\b About Non-Hodgkin\u8217?s Lymphoma} \line Non-Hodgkin\u8217?s lymphoma (NHL) affects 1.5 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. NHL is one of the fastest growing cancers and has grown in incidence by 80% since the early 1970s.{\super i} \line \line {\b About MabThera} \line 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.\line \line MabThera is indicated for the treatment of indolent and aggressive Non-Hodgkin\u8217?s Lymphoma. MabThera is known as Rituxan in the United States, Japan and Canada. More than 730,000 patients have been treated with MabThera worldwide to date.\line \line 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.\line \line {\b About Roche} \line Headquartered in Basel, Switzerland, Roche is one of the world\u8217?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\u8217?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 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 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.\line \line \par}
{\pard\f0\li0\ri0\sa360\sl360\fs18 All trademarks used or mentioned in this release are legally protected.\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 \line \line {\b Further Information} :\line - Genentech (http://www.gene.com)\line - BiogenIdec (http://www.biogen.com)\line - Roche in Oncology (http://www.roche.com/mboncology-e.pdf)\line - Lymphoma (http://www.lymphoma-net.org)\line - The Lymphoma Coalition (http://www.lymphomacoalition.org)\line - Cancer (http://www.health-kiosk.ch/start_krebs)\line - World Health Organization (http://www.who.int)\par}
{\pard\f0\li0\ri0\sa360\sl360\fs18 {\b Note to editors:} {\b {\super \line i} }  World Health Report 2000, World Health Organization, www.who.int.\par}

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{\pard\sb180\f1\fs22 {\b F. Hoffmann-La Roche Ltd}\line 4070 Basel\line Switzerland \par}
{\pard\sb180\f1\fs22 Corporate Communications\line Roche Group Media Relations \par}
{\pard\sb180\f1\fs22 Tel. +41 61 688 88 88\line Fax +41 61 688 27 75\line www.roche.com \par}
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