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Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis

- ACTEMRA(R) is the first humanized interleukin-6 (IL-6)

receptor-inhibiting monoclonal antibody seeking approval to treat

rheumatoid arthritis -

NUTLEY, N.J., Nov. 21 /PRNewswire/ -- Roche announced today the submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval to market ACTEMRA(R) (tocilizumab) to reduce the signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA).

"The filing for ACTEMRA represents a significant milestone for Roche, and brings us another step closer to making this important therapy available to the millions of patients in the United States who suffer from the agonizing pain and debilitating effects associated with rheumatoid arthritis," said George Abercrombie, President and CEO, Hoffmann-La Roche Inc.

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA. Research suggests that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, may reduce inflammation of the joints and relieve certain systemic effects of RA.

The BLA submission to the FDA is based on results from five international Phase III studies which demonstrated ACTEMRA as monotherapy or in combination with disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate significantly reduced the signs and symptoms of rheumatoid arthritis as measured by ACR -- as well as achieving disease activity score (DAS) remission -- compared to DMARD therapies alone. Furthermore, patients who had previously failed anti-tumor necrosis factor (anti-TNF) treatments also showed significant improvement in signs and symptoms of RA after treatment with ACTEMRA.

Roche will file a Marketing Authorization Application (MAA) for ACTEMRA with the European Medicines Agency (EMEA) in early December.


The clinical development program conducted by Roche includes five clinical studies and has enrolled more than 4,000 patients in 40 countries, including the U.S. One of these Phase III trials evaluating ACTEMRA in RA is an ongoing two-year study and is expected to report one-year data evaluating the effect of ACTEMRA on the inhibition of structural damage in 2008.

ACTEMRA is part of a co-development agreement with Chugai, a Japanese company. ACTEMRA was launched in Japan by Chugai in June 2005 as a therapy for Castleman's disease. Additional indications for RA and systemic-onset juvenile idiopathic arthritis were also filed in Japan in April 2006 and are currently under review.

The serious adverse events reported in ACTEMRA clinical trials were serious infections and hypersensitivity reactions including anaphylaxis. The most common adverse events reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache and hypertension. Increases in liver function tests (ALT and AST) were seen in some patients; these increases were generally mild and reversible, with no hepatic injuries or any observed impact on liver function.

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 U.S.

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 2007 Roche was named Top Company of the Year by Med Ad News and one of the Top 20 Employers (Science magazine). In 2006, Roche was 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: or

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