Healthcare Industry News:  osteoporosis 

Biopharmaceuticals

 News Release - July 25, 2007

Fourth ACTEMRA(TM) (tocilizumab) Phase III Study Demonstrates Significant Clinical Benefit in RA Patients

AMBITION Monotherapy Study with Novel Interleukin-6 Inhibitor Meets Primary Endpoint of Non-Inferiority, Shows Superiority Over Methotrexate

NUTLEY, N.J., July 25 (HSMN NewsFeed) -- Roche today announced that results from the AMBITION (Actemra versus Methotrexate double-Blind Investigative Trial In mONotherapy) trial, the fourth multinational Phase III study of ACTEMRA(TM), not only successfully met its primary endpoint of non-inferiority in patients with moderate to severe rheumatoid arthritis (RA), but also demonstrated superiority over the standard effective dose regimen of methotrexate alone.

AMBITION is the first multinational Phase III study to examine ACTEMRA monotherapy against methotrexate in RA patients who have not been treated with methotrexate within 6 months and have not discontinued methotrexate at any time due to toxicity or lack of efficacy. Results from this study - together with data from the three previous studies - will form the basis of the regulatory filing for marketing approval later this year.

"This first multinational Phase III study evaluating the safety and efficacy of ACTEMRA alone against methotrexate clearly demonstrates that ACTEMRA monotherapy successfully reduces the signs and symptoms of RA. Furthermore, it reinforces the important need to inhibit the interleukin-6 receptors that are involved in the inflammatory process of this devastating disease," said Lars Birgerson, M.D., Ph.D., Global Head Medical Affairs, Roche.

The trial showed that a significantly greater proportion of patients treated with ACTEMRA (8 mg/kg) achieved a significant reduction in the signs and symptoms of RA as evaluated by ACR20 following 24 weeks of treatment. The study analysis included 673 patients from 252 trial sites in 18 countries, including the United States. ACTEMRA was generally well tolerated; the most common adverse events reported more frequently in the ACTEMRA arm of the AMBITION trial were upper respiratory tract infections, headache and nasopharyngitis.

About the AMBITION Trial

The main study of the AMBITION trial is a two-arm, randomized, double- blind, placebo-controlled study designed to evaluate the safety and efficacy of ACTEMRA (8 mg/kg) compared to methotrexate in RA patients. Patients received either ACTEMRA intravenously every four weeks plus placebo capsules weekly or placebo infusions every four weeks plus methotrexate weekly.

Data from the study were analyzed to determine patients' response to treatment by using three standard assessments: ACR score(1), developed by the American College of Rheumatology (ACR), as well as DAS(2), a measurement of RA disease activity, and EULAR response criteria(3), a measurement of treatment response.

The AMBITION trial is one of five Phase III clinical studies designed to evaluate ACTEMRA as a potential new treatment for RA. Three of the Phase III trials - OPTION, TOWARD and RADIATE - are completed and have reported meeting their primary study endpoints. At the European Congress of Rheumatology meeting in June, data results from the OPTION trial demonstrated that treatment with ACTEMRA plus methotrexate resulted in a significant improvement in RA symptoms in patients who had an inadequate response to methotrexate. An additional Phase III trial evaluating ACTEMRA in RA is ongoing; the two-year study - called LITHE - is expected to report one-year data in 2008.

About ACTEMRA (tocilizumab)

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA. Studies suggest that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, may reduce inflammation of the joints. The ACTEMRA clinical development program is designed to evaluate this clinical finding. The most common adverse events reported in ACTEMRA global clinical studies have included upper respiratory tract infections, headache, nasopharyngitis and hypertension. As with other biological disease modifying anti-rheumatic drugs (DMARDs), serious infections have been reported in some patients treated with ACTEMRA. The compound is not currently approved in the United States.

About Rheumatoid Arthritis

Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining in the 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 that leads to loss of function. In addition, the systemic symptoms of RA include fatigue, decreased hemoglobin and osteoporosis and may contribute to shortening life expectancy by affecting major organ systems. After 10 years, less than 50% of patients can continue to work or function normally on a daily basis. RA affects more than 21 million people worldwide with approximately 2.1 million people affected in the United States.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years in the U.S., Roche has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2006, Roche was named one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.

(1) ACR20, ACR50 and ACR70 represent the percentage of reduction (20%, 50% or 70%) in certain RA symptoms and measures like the number of tender and swollen joints, pain, patient's and physician's global assessments and certain laboratory markers. An ACR70 response is considered exceptional and represents a significant improvement in a patient's condition.

(2) The Disease Activity Score (DAS) is a clinical index that measures RA disease activity and combines information from swollen and tender joints, acute phase response and general health into one measurement. The level of disease activity is interpreted as low (DAS less than or equal to 2.4), moderate (2.4 < DAS less than or equal to 3.7, or high (DAS > 3.7). DAS < 1.6 corresponds to being in remission according to the criteria of the American Rheumatism Association (ARA).

(3) The EULAR response criteria is based on the individual amount of change in DAS and the DAS value (low, moderate, high disease activity) reached to classify patients as good, moderate and non-responders.


Source: Roche Group

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