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FDA Advisory Committee Recommends Approval of ACTEMRA(R) (tocilizumab) for the Treatment of Rheumatoid Arthritis

Wednesday, July 30, 2008 General News J E 4
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NUTLEY, N.J., July 29 Roche today announced that theArthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) bya near unanimous (10-1) vote recommended approval of ACTEMRA(R) (tocilizumab),a novel interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, forreducing the signs and symptoms in adults with moderate to severe rheumatoidarthritis (RA).

"The committee's overwhelmingly positive recommendation brings ACTEMRA onestep closer to becoming available to patients who suffer from the painful anddebilitating symptoms associated with RA," said Kenneth Bahrt, M.D., GlobalMedical Director, Autoimmunity, Roche. "Based on the strength of the datapresented, and the positive recommendation by the committee, we are hopefulthat the FDA will approve ACTEMRA for the treatment of RA and provide a newoption to patients who are not achieving adequate symptom relief with currenttherapies."

The committee's vote was made after Roche presented results from fivePhase III clinical trials. The clinical development program was designed toevaluate the effects of ACTEMRA on signs and symptoms of RA, physicalfunction, progression of structural damage, and health-related quality oflife. Of these five studies, three trials were conducted in patients withinadequate response to disease modifying anti-rheumatic drugs (DMARDs), onetrial was conducted in patients who failed anti-tumor necrosis factor (TNF)therapy, and one monotherapy study comparing ACTEMRA to methotrexate, acurrent standard of care, was also conducted. Results of these studiesdemonstrated that treatment with ACTEMRA -- alone or in combination withmethotrexate or other DMARDs -- significantly reduced RA signs and symptoms,regardless of previous therapy or disease severity, compared with currentDMARDs.

About ACTEMRA (tocilizumab)

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibitingmonoclonal antibody. Studies suggest that reducing the activity of IL-6, oneof several key cytokines involved in the inflammatory process, may reduceinflammation of the joints and relieve certain systemic effects of RA. Theextensive clinical development program conducted by Roche includes fiveclinical studies and has enrolled more than 4,000 patients in 41 countries,including the United States. Five Phase III studies are completed and havereported meeting their primary endpoints. The LITHE trial evaluating ACTEMRAin RA is an ongoing two-year study and is expected to report complete dataevaluating the effects of ACTEMRA on the inhibition of structural joint damagein 2009. ACTEMRA is awaiting approval in the United States and Europe.

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

The serious adverse events reported in ACTEMRA clinical trials includeserious infections, diverticular perforations, and hypersensitivity reactionsincluding anaphylaxis. The most common adverse events reported in clinicaltrials were upper respiratory tract infection, nasopharyngitis, headache andhypertension. Increases in liver function tests (ALT and AST) were seen insome patients; these increases were generally mild and reversible, with nohepatic injuries or any observed impact on liver function. Laboratory changes,including increases in lipids (total cholesterol, LDL, HDL, triglycerides) anddecreases in neutrophils and platelets, were seen in some patients withoutassociation with clinical outcomes.

About IL-6

IL-6 is a common protein found in all joints in the body and is a naturalsubstance that can raise inflammation. Everyone has IL-6 in their body, butpeople with RA may
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