Investor Update
Basel, 8 December 2008
New phase III data suggest MabThera is a highly effective treatment for patients with idiopathic thrombocytopenic purpura
MabThera significantly reduces risk of serious bleeding for people with rare life-threatening autoimmune disorder
New data presented at the 50th Annual Meeting of the American Society of Hematology (ASH) today show that people living with previously untreated idiopathic thrombocytopenic purpura (ITP), a bleeding disorder, who received MabThera (rituximab) in combination with standard management, experience much better outcomes than those receiving standard treatment alone. MabThera lessens the ability of the immune system to reduce the platelet count, thereby maintaining a patient’s platelet count for longer, avoiding potentially life-threatening bleeding in vital organs such as the brain.
Data from a phase III study, which is the first randomised study to evaluate the use of MabThera in treating platelet disorders, demonstrate that patients with ITP who were given MabThera and standard treatment were able to maintain their blood platelet count for longer than those who are given standard treatment alone (intent-to-treat analysis: 63% vs 36%, p=0.004; per-protocol analysis: 85% vs 39%, p<0.001).
"People with chronic ITP and very low platelet counts live with the threat of bleeding. The aim of treatment is to stop blood platelet counts falling to help prevent this from happening. These data show that patients receiving MabThera experience an immediate benefit," said Francesco Zaja from the University of Udine, Italy, and principle investigator for the study.
ITP is an autoimmune disease in which the body attacks its own blood cells (platelets) or does not produce enough blood cells to protect itself. This means the blood does not clot properly, resulting in easy bruising, nose bleeds, bleeding from the gums, gut, and bleeding in the brain. ITP is either an acute condition in children or a chronic condition in adults. Chronic ITP predominantly affects adults (median age around 50 years) and is more common in women. It is relatively rare with 5.8-6.6 per 100,000 adults affected by the chronic form of the disorder.
"The long period of time without the disease recurring shows that in some patients MabThera offers the potential for cure," said Francesco Zaja. "This is extremely good news for people with this potentially life-threatening condition as current forms of treatment only aim to relieve symptoms rather than cure the condition itself."
Based on these important new results, Roche will evaluate a potential regulatory filing of MabThera for use in ITP.
About the study
The study is a randomized phase III study designed to assess the monoclonal antibody MabThera in combination with oral corticosteroid dexamethasone in adult patients with first-line ITP. 165 patients previously untreated for ITP with a blood platelet count of ≤ 20 x 109/L were involved in the study, which was conducted between July 2005 and June 2007. Of these, 75 patients received MabThera in combination with dexamethasone and 90 patients received dexamethasone alone. The primary endpoint was sustained response rate, i.e. a blood platelet count of ³50 x 109/L after six months. The results were analysed by an intent-to-treat (ITT) and by a per-protocol (PP) analysis.
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 patients with stage III and IV follicular non-Hodgkin’s Lymphoma and patients with CD20-positive diffuse large B cell non-Hodgkin’s lymphoma. MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. 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.
About MabThera in idiopathic thrombocytopenic purpura (ITP)
ITP is a disease of the immune system leading to a dramatic decrease in the platelet count in the bloodstream. This puts patients at increased risk for bleeding into organs such as the brain or the GI tract, and it can cause severe disease. Associated with the development of ITP are abnormal lymphocytes. MabThera targets those specific abnormal lymphocytes in the bloodstream and in the bone marrow and thereby has the potential to eradicate lymphocytes that are responsible for causing the disease.
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, 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 www.roche.com.
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