BASEL, Switzerland, June 6, 2007-Roche announced today that Toward (1), the second multinational phase III Actemra (tocilizumab) study, successfully reached its primary endpoint and showed that a greater proportion of patients treated with Actemra in combination with traditional disease modifying drugs (DMARDs) achieved a significant improvement in disease signs and symptoms at week 24, compared to the those treated with DMARDs alone. The patients' symptoms were measured using the standard ACR score (2) assessment method. The patients enrolled in the study had active, moderate to severe rheumatoid arthritis (RA) and had experienced an inadequate response to DMARDs.
"The TOWARD trial data further documents the efficacy and safety of Actemra and the value of its IL-6 receptor inhibition. We look forward to further results from this extensive multinational Phase III development programme," commented William Burns, CEO Division Roche Pharmaceuticals.
The TOWARD trial included approximately 40% of patients from the United States and data from this trial will be submitted for presentation at international scientific meetings later this year and in 2008. TOWARD is the second of a programme of five phase III clinical trials running on Actemra, with two other trials due to report later in 2007. In January 2007 Roche reported that OPTION (3), the first of the phase III trials outside Japan, had successfully met its primary endpoint in patients who had an inadequate response to methorexate.
About the TOWARD study The TOWARD (Tocilizumab in cOmbination With traditional DMARD therapy) study was an international study treating 1216 patients with moderate to severe RA. The study was conducted at 130 study sites in 18 countries, including the USA. In th is 2 arm, randomized, double-blind study, patients received either 8mg/kg Actemra intravenously every 4 weeks or placebo in combination with stable anti-rheumatic therapy, including traditional DMARDs but excluding biologics. A greater proportion of patients treated with Actemra in combination with traditional DMARDs achieved a significant improvement in disease signs and symptoms at week 24, compared to those treated with DMARDs alone. The study also explored pharmacokinetics, immune response and pharmacodynamic parameters of Actemra in this patient population.
About Actemra Actemra is the first humanised interleukin-6 (IL-6) receptor inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA, a disease with a high unmet medical need. Roche and Chugai are collaborating on a phase III clinical development programme in RA running outside Japan, with more than 4000 patients enrolled in 41 countries including several European countries and the USA. In Japan, Actemra was launched in June 2005 as a therapy for Castleman's disease and in April 2006 filed for the additional indications of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis.
About rheumatoid arthritis Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by chronic inflammation of multiple joints and fatigue as well as the possibility of osteoporosis, anaemia, and lung, skin and liver effects. This inflammation causes pain, stiffness and swelling, resulting in loss of joint function due to destruction of the bone and cartilage, often leading to progressive disability. Further, as chronic inflammation continues, there may be shortening of life expectancy as a result of effects on major organ systems. After 10 years, less than 50% of patients can continue to work or function normally on a day to day basis. RA affects more than 21 million people worldwide.
About Roche in rheumatoid arthritis One of the most important d rivers 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. Actemra is the result of research collaboration by Chugai and is being co-developed globally with Chugai. Additional projects creating a rich pipeline include compounds in Phase I, II and III clinical trials. Notably, ocrelizumab, a fully humanised anti-CD20 antibody, is just entering 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, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs approximately 75,000 worldwide 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 at www.roche.com.
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Further information - Roche & Autoimmune diseases: www.roche.com/med_events_mb1106
References: (1) TOWARD refers to Tocilizumab in cOmbination With traditional DMARD therapy (2) 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 or 50% level of reduction (the percentage of reduction of RA symptoms) is represented as ACR20, ACR50 or ACR70. An ACR70 response is exceptional for existing treatments and represents a significant improvement in a patient's condition. (3) OPTION refers to the TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders
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