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FDA Approves First Rheumatoid Arthritis Indication for Rituxan

First and only selective B-cell therapy provides lasting improvement for rheumatoid arthritis patients

BASEL, Switzerland, March 1, 2006 -- Roche announced today that, after priority review, Genentech and Biogen Idec have received US approval for the first and only selective B-cell therapy Rituxan (rituximab, marketed as MabThera in Europe) for the treatment of adult patients with active rheumatoid arthritis (RA). The approval is specifically for those RA patients who have had an inadequate response to current biologics (anti-tumor necrosis factor (TNF) therapy). This subgroup of RA patients are considered to be the most difficult to treat. Rituxan has been shown to be highly effective in controlling symptoms in these patients - furthermore, the long-lasting benefits are seen after only a single treatment course of two infusions.

This approval is good news for RA patients as it has been shown that 1 in 3 of them do not adequately respond to currently available biologic therapies and further treatment options are desperately needed. In contrast to currently available therapy, Rituxan provides a fundamentally different treatment approach by selectively targeting B cells. B cells play a key role in the chain of inflammatory events that ultimately lead to the damage of bone and cartilage in the joints, both serious outcomes characteristic of RA.

"This US approval marks a major milestone in our emerging autoimmune disease franchise. We are hopeful that this unique treatment approach will bring lasting benefit to a broad range of rheumatoid arthritis patients who do not respond adequately to current therapeutic options. We are now working closely with the European regulatory authorities to also ensure it's availability to rheumatoid arthritis patients in Europe as early as possible," said William M. Burns, CEO, Pharmaceutical Division, Roche. Roche filed a regulatory submission to the European Agency for the Evaluation of Medicinal Products (EMEA) in September 2005. The U.S. approval and the European submission are based on positive data from the REFLEX study. This pivotal study showed that Rituxan is highly effective in controlling symptoms in patients who have had an inadequate response or are intolerant to prior treatment with disease modifying anti-rheumatic drugs, including one or more anti-TNF (biologic) therapies.

Rituxan/MabThera is already available to physicians in the U.S. and Europe for the treatment of a form of lymphatic cancer called non-Hodgkin's lymphoma (NHL).

About the REFLEX study

The REFLEX study (Randomised Evaluation oF Long-term Efficacy of Rituximab in RA) is a multi-centre, randomized, double-blind, placebo-controlled Phase III study. In this trial, patients who received a single course of only two infusions (days 1 and 15) of Rituxan with a stable dose of methotrexate (MTX) displayed a statistically significant improvement in symptoms measured at 24 weeks, compared to those receiving placebo and MTX. Rituxan is well tolerated by patients with Rheumatoid Arthritis and no safety concerns have been identified in more than 800 patients followed for 1 year or more. The results of the REFLEX trial were presented at the American College of Rheumatology (ACR) meeting in San Diego in November 2005.

About Rituxan in Rheumatoid Arthritis

Rituxan is a therapeutic antibody that selectively targets B cells without affecting stem, pro-B or plasma cells, therefore allowing continuation of normal protective function of the immune system. B cells play a key role in the inflammatory cascade of RA and Rituxan aims to break this inflammatory cascade - a series of reactions inflaming the synovia and leading to cartilage loss and bone erosion that is characteristic of the disease. Rituxan has also been studied in a Phase IIb study, which was designed to evaluate the efficacy and safety of varying doses of Rituxan in combination with MTX in patients with active RA who currently have an inadequate response to MTX. Roche has initiated a pivotal Phase III programme consisting of three trials, enrolling 1,700 patients to further investigate the potential clinical benefit of Rituxan in this patient population.

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, morning stiffness, 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. There is still a high unmet medical need as 1 out of 3 RA treated patients do not adequately respond to currently available biologic therapies.

Source: Roche

Posted: March 2006


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