Investor Update
Basel, 18 October 2005
Actemra Japanese phase III rheumatoid arthritis data to be presented at the American College of Rheumatology meeting in November
Chugai and Roche announced today that data from the Japanese Phase III programme being conducted in rheumatoid arthritis concludes that for the first time Actemra shows superiority to conventional disease modifying anti-rheumatic drugs (DMARDs) in inhibiting radiographic progression or joint destruction. The abstract of this study, accessible via the official ACR website, will be presented in an oral presentation on November 17th at the American College of Rheumatology (ACR) Annual Scientific Meeting being held in San Diego, USA.
Actemra (tocilizumab), a humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody, is being globally co-developed by Chugai and Roche and while the pivotal rheumatoid arthritis trials have been completed in Japan, there is currently a large phase III programme running in rheumatoid arthritis in territories outside Japan.
The abstract outlines that of the 302 patients evaluated, patients in the Actemra arm showed significantly less radiographic joint destruction compared to the control group as measured by total Sharp score. Furthermore, Actemra was superior to DMARDs in preventing both erosion and joint space narrowing. ACR response rates in the Actemra arm were significantly higher than those in the control arm.
About the study
This phase III clinical trial is a randomized trial in which 306 patients with active early RA of <5 years’ duration were allocated to receive either Actemra as a monotherapy at 8 mg/kg IV every 4 weeks or conventional DMARDs for 52 weeks. The efficacy endpoints included change from baseline to week 52 in van der Heijde modified Sharp score, evaluated in blinded manner, and ACR response rates. The overall incidences of adverse events including laboratory abnormalities were 96% and 87% in the Actemra and control arms respectively. While lipid increases were reported in the Actemra group, the mean cholesterol level stabilized around the upper limit of normal. No tuberculosis was observed and Actemra monotherapy was generally well tolerated.
About Actemra
Actemra is a humanized anti-IL-6 receptor monoclonal antibody whose novel mechanism of action may provide a new and effective form of treatment for adult RA. Phase II studies have been completed in Japan and Europe. Collaborative Phase III clinical development in RA has been completed by Chugai in Japan and is underway outside Japan with more than 4000 patients expected to be enrolled in over 20 countries including several European countries and the USA.
Roche and Chugai are developing Actemra in collaboration with Osaka University. This co-development partnership was set up under the first licensing agreement between the two companies in 2003, where Roche was granted the right to promote in all countries except Japan, South Korea and Taiwan, and the parties would co-promote in the UK, France and Germany.
About Rheumatoid Arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining in joints. This inflammation causes a loss of joint shape and function, resulting in pain, stiffness and swelling, ultimately leading to irreversible joint destruction and disability. Characteristics of RA include redness, swelling, pain, and movement limitation around joints of the hands, feet, elbows, knees and neck. In more severe cases of RA the eyes, lungs or blood vessels may be involved. RA may also shorten life expectancy by affecting major organ systems and after 10 years, less than 50% of patients can continue to work or function normally on a day to day basis. RA is one of the most common forms of autoimmune disease and affects more than 21 million people worldwide..
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 2004 sales by the Pharmaceuticals Division totaled 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.
Actemra Japanese phase III rheumatoid arthritis data to be presented at the American College of Rheumatology meeting in November
Chugai and Roche announced today that data from the Japanese Phase III programme being conducted in rheumatoid arthritis concludes that for the first time Actemra shows superiority to conventional disease modifying anti-rheumatic drugs (DMARDs) in inhibiting radiographic progression or joint destruction. The abstract of this study, accessible via the official ACR website, will be presented in an oral presentation on November 17th at the American College of Rheumatology (ACR) Annual Scientific Meeting being held in San Diego, USA.
Actemra (tocilizumab), a humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody, is being globally co-developed by Chugai and Roche and while the pivotal rheumatoid arthritis trials have been completed in Japan, there is currently a large phase III programme running in rheumatoid arthritis in territories outside Japan.
The abstract outlines that of the 302 patients evaluated, patients in the Actemra arm showed significantly less radiographic joint destruction compared to the control group as measured by total Sharp score. Furthermore, Actemra was superior to DMARDs in preventing both erosion and joint space narrowing. ACR response rates in the Actemra arm were significantly higher than those in the control arm.
About the study
This phase III clinical trial is a randomized trial in which 306 patients with active early RA of <5 years’ duration were allocated to receive either Actemra as a monotherapy at 8 mg/kg IV every 4 weeks or conventional DMARDs for 52 weeks. The efficacy endpoints included change from baseline to week 52 in van der Heijde modified Sharp score, evaluated in blinded manner, and ACR response rates. The overall incidences of adverse events including laboratory abnormalities were 96% and 87% in the Actemra and control arms respectively. While lipid increases were reported in the Actemra group, the mean cholesterol level stabilized around the upper limit of normal. No tuberculosis was observed and Actemra monotherapy was generally well tolerated.
About Actemra
Actemra is a humanized anti-IL-6 receptor monoclonal antibody whose novel mechanism of action may provide a new and effective form of treatment for adult RA. Phase II studies have been completed in Japan and Europe. Collaborative Phase III clinical development in RA has been completed by Chugai in Japan and is underway outside Japan with more than 4000 patients expected to be enrolled in over 20 countries including several European countries and the USA.
Roche and Chugai are developing Actemra in collaboration with Osaka University. This co-development partnership was set up under the first licensing agreement between the two companies in 2003, where Roche was granted the right to promote in all countries except Japan, South Korea and Taiwan, and the parties would co-promote in the UK, France and Germany.
About Rheumatoid Arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining in joints. This inflammation causes a loss of joint shape and function, resulting in pain, stiffness and swelling, ultimately leading to irreversible joint destruction and disability. Characteristics of RA include redness, swelling, pain, and movement limitation around joints of the hands, feet, elbows, knees and neck. In more severe cases of RA the eyes, lungs or blood vessels may be involved. RA may also shorten life expectancy by affecting major organ systems and after 10 years, less than 50% of patients can continue to work or function normally on a day to day basis. RA is one of the most common forms of autoimmune disease and affects more than 21 million people worldwide..
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 2004 sales by the Pharmaceuticals Division totaled 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.
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