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Treatment for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Giant Cell Arteritis

Update: Actemra Now FDA Approved - January 8, 2010

FDA Issues Complete Response Letter for Acterma BLA

FDA Issues Complete Response Letter to Roche for Acterma (tocilizumab) Biologics License Application

NUTLEY, N.J., September 18, 2008 /PRNewswire/ -- Roche today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the Biologics License Application (BLA) for Actemra (tocilizumab), the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

The FDA has not requested any new clinical studies surrounding the efficacy or safety of Actemra as a prerequisite for approval. The FDA has requested additional documentation related to the manufacturing of Actemra and certain other outstanding components, such as final labeling. Roche is committed to working with the FDA to promptly address any outstanding matters. Upon satisfactory completion of the FDA's requests and an approved label, Roche does not foresee any issues that would impact the quality, availability and supply of Actemra in the U.S.

"Roche is committed to working with the FDA to make this important new therapy available to RA patients as soon as possible," said George Abercrombie, CEO and president of Roche. "We will continue to work closely with the agency to address its questions and define the path forward for Actemra. We are confident that we will be able to resolve any outstanding matters in the near future."

Roche submitted the BLA for Actemra to the agency on November 18, 2007. The BLA for Actemra is based on the results of an extensive multi-national clinical development program, which included more than 4,000 patients in 41 countries, including the U.S. These studies demonstrated that treatment with Actemra - alone or combination with methotrexate or other DMARDs (disease modifying anti-rheumatic drugs) - significantly reduced RA signs and symptoms, regardless of previous therapy or disease severity, compared with DMARDs alone. On July 29, 2008, the Arthritis Advisory Committee of the FDA voted 10-1 to recommend approval of Actemra.

Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for RA. Studies demonstrate that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, relieves both inflammation of the joints and certain systemic effects of RA. The extensive clinical development program conducted by Roche includes five clinical studies and has enrolled more than 4,000 patients in 41 countries, including the United States. Four Phase III studies are completed and have reported meeting their primary endpoints. The fifth Phase III study, the LITHE trial evaluating Actemra in RA is an ongoing two-year study, which is expected to report complete data evaluating the effects of Actemra on the inhibition of structural joint damage in 2009. Actemra is under review in the United States and Europe.

Actemra is part of a co-development agreement with Chugai Pharmaceuticals Co. In June 2005, Actemra was launched by Chugai in Japan as a therapy for Castleman's disease; in April 2008, additional indications for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan.

The serious adverse reactions reported in Actemra clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis. The most common adverse reactions reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, hypertension and increased ALT. Increases in liver enzymes (ALT and AST) were seen in some patients; these increases were generally mild and reversible, with no evidence of hepatic injuries. Laboratory changes, including increases in lipids (total cholesterol, LDL, HDL, triglycerides) and decreases in neutrophils and platelets, were seen in some patients without association with clinical outcomes. Treatments that suppress the immune system, such as Actemra, may cause an increase in the risk of malignancies.

IL-6 is a common protein found in all joints in the body and is a natural substance that can raise inflammation. Everyone has IL-6 in their body, but people with RA may have too much. When approved, Actemra will be the first and only medication to specifically target IL-6 in patients with RA.

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, osteoporosis and may contribute to shortening life expectancy by affecting major organ systems. After 10 years, less than 50 percent of patients can continue to work or function normally on a daily basis. RA affects more than 21 million people worldwide with approximately 1.3 million adults affected in the United States.

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 , one of the Top 20 Employers () and ranked the No. 1 Company to Sell For (). In previous years, Roche has been named as a Top Company for Older Workers (AARP) and one of the Best Companies to Work For in America.

All trademarks used or mentioned in this release are protected by law.

Posted: September 2008

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