Roche Pharmaceuticals

Largest-Ever Studies on Most Common Form of Adult Leukemia, Show Patients Treated With MabThera Live Longer Without Disease Progressing

Basel, Switzerland, November 24 (ots/PRNewswire) - FOR NON-UK MEDIA DISTRIBUTION ONLY - Two Phase III Studies to be Presented at World's Major Hematology Meeting Prove MabThera's Benefits in Treating Chronic Lymphocytic Leukemia (CLL) Roche announced today that full results of the pivotal REACH trial will be presented as part of the late breaking abstract session at the forthcoming 50th Annual Meeting of the American Society Hematology (ASH), in San Francisco. The randomized phase III trial in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) successfully met its primary endpoint by showing that patients treated with MabThera in combination with current standard chemotherapy were able to significantly extend the amount of time they lived without their disease progressing, compared to patients treated with chemotherapy alone. Results of the REACH trial will follow less than one day after the presentation of another pivotal Phase III study - CLL8 - which shows that MabThera can significantly increase the time before the disease progresses in patients who have not previously received any other treatment. Together, the two studies provide the strongest evidence yet of MabThera's potential to treat this devastating form of blood cancer. MabThera will be the main attraction at the annual ASH meeting with more than 270 abstracts being presented covering important trials investigating its use in the treatment of CLL, follicular lymphoma, diffuse large B-cell lymphoma, and the bleeding disorder idiopathic thrombocytopenic purpura, among others. The wealth of new data confirms MabThera as the standard of care in haematological cancers, where it has already been used to treat over 1.5 million patients in its existing indications. Chronic lymphocytic leukemia Date/Time Abstract Abstract Name Number 08.12.2008, 325 Immunochemotherapy with Fludarabine (F), 11:00 Cyclophosphamide (C), and Rituximab (R) (FCR) Versus Fludarabine and Cyclophosphamide (FC) Improves Response Rates and Progression-Free Survival (PFS) of Previously Untreated Patients (pts) with Advanced Chronic Lymphocytic Leukemia (CLL) http://ash.confex.com/ash/2008/webprogram/Paper9237.html 09.12.2008, LBA1 Rituximab, Fludarabine, and Cyclophosphamide (R-FC) 07:30 Prolongs Progression Free Survival in Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Compared with FC Alone: Final Results from the International Randomized Phase III REACH Trial 09.12.2008, 781 Genomic Aberrations, VH Mutation Status and Outcome 08:00 after Fludarabine and Cyclophosphamide (FC) or FC Plus Rituximab (FCR) in the CLL8 Trial http://ash.confex.com/ash/2008/webprogram/Paper7815.html 08.12.2008, 326 Quantitative MRD Assessments Predict Progression 11:15 Free Survival in CLL Patients Treated with Fludarabine and Cyclophosphamide with or without Rituximab - a Prospective Analysis in 471 Patients from the Randomized GCLLSG CLL8 Trial http://ash.confex.com/ash/2008/webprogram/Paper13658.html 08.12.2008, 330 Bendamustine in Combination with Rituximab (BR) for 12:15 Patients with Relapsed Chronic Lymphocytic Leukemia (CLL): A Multicentre Phase II Trial of the German CLL Study Group (GCLLSG) http://ash.confex.com/ash/2008/webprogram/Paper5549.html 07.12.2008, 47 Rituximab and High-Dose Methylprednisolone for the 17:30 Initial Treatment of Chronic Lymphocytic Leukemia Is Associated with Promising Clinical Activity and Minimal Hematologic Toxicity http://ash.confex.com/ash/2008/webprogram/Paper15428.html Follicular lymphoma Date/Time Abstract Abstract Name Number 09.12.2008, 836 Rituximab Maintenance Treatment of Relapsed / 08:00 Resistant Follicular Non-Hodgkin's Lymphoma: Long- Term Outcome of the EORTC 20981 Phase III Randomized Intergroup Study http://ash.confex.com/ash/2008/webprogram/Paper6691.html 07.12.2008 2599 Rituximab in Combination with CHOP in Patients with (poster Follicular Lymphoma: Analysis of Treatment Outcome Board of 552 Patients Treated in a Randomized Trial of the II-693) German Low Grade Lymphoma Study Group (GLSG) after a Follow up of 58 Months http://ash.confex.com/ash/2008/webprogram/Paper9511.html 09.12.2008, 773 Autologous Stem Cell Transplantation (auto-SCT) as 08:00 the Treatment of Choice for Follicular Lymphoma Patients in First Relapse: Final Analysis of the Outcome of 175 Patients Treated in the GELA/GOELAMS FL 2000 Study http://ash.confex.com/ash/2008/webprogram/Paper5180.html Diffuse large B-cell lymphoma Date/Time Abstract Abstract Name Number 09.12.2008, 839 The Addition of Rituximab Eliminates the Negative 08:45 Prognostic Impact of PMBCL Compared to DLBCL in Young Patients with CD20-Positive Aggressive Lymphomas Receiving a CHOP-Like Chemotherapy: Results of a Subgroup Analysis of the Mabthera International Trial Group (MInT) Study http://ash.confex.com/ash/2008/webprogram/Paper9714.html Idiopathic thrombocytic purpura Date/Time Abstract Abstract Name Number 07.12.2008, 1 A Prospective Randomized Study Comparing Rituximab 14:00 and Dexamethasone Vs Dexamethasone Alone in ITP: Results of Final Analysis and Long Term Follow up http://ash.confex.com/ash/2008/webprogram/Paper8341.html 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, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at http://www.roche.com. All trademarks used or mentioned in this release are legally protected. ots Originaltext: Roche Pharmaceuticals Im Internet recherchierbar: http://www.presseportal.ch Contact: For more information, please contact: Peter Bayliss, International Communications Manager, +41-79-572-51-93, peter.bayliss@roche.com.au

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