Chugai Pharmaceutical Co, Ltd and F Hoffmann-La Roche Ltd announced that the United States (US) Food and Drug Administration (FDA) approved Actemra, the humanized anti-human IL-6 (interleukin-6) receptor monoclonal antibody (tocilizumab, RoACTEMRA in the European Union) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumour necrosis factor (TNF) antagonist therapies. Actemra, the result of research collaboration between Chugai and Osaka University, is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA, and may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs).

RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications. There are several key cytokines, or proteins, involved in the inflammatory process, including IL-6. Research shows that IL-6 levels are elevated in patients with RA. Actemra is the first medication designed to specifically inhibit the biological activity of IL-6.

Outside of Japan, Actemra has been studied in five multi-national phase-III studies, involving more than 4,000 patients, making it the largest clinical development programme for an indication in RA to date. The studies showed that Actemra - alone or in combination with methotrexate or other DMARDs - significantly reduced RA signs and symptoms, regardless of previous therapy, compared with DMARDs alone. This approval is based on data from the following studies:

With this US approval of Actemra following that of EU, our innovative in-house drug will also be available in the US market, through Roche. In the US, Actemra will be marketed by Genentech, a wholly-owned company by Roche. Chugai will supply the final formulation of the drug to Roche and receive royalties based on the sales. Actemra will be available in the US the week of January 18, 2010.

Roche will work closely with the agency to understand the additional data required to support approval in earlier lines of RA therapy. We are committed to comprehensively characterizing both the clinical benefit and the safety of Actemra in earlier lines of therapy through our large clinical and pharmacovigilance programs including the REMS program, and ongoing development and postmarketing studies globally.

In Japan, Actemra was launched in June 2005 by Chugai for Castleman's disease, following approval in April, the same year. Subsequently, it was approved for the additional indications of RA (including prevention of structural damage of joints), polyarticular-course juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in April 2008.

In the EU, approval was granted on January 2009 for the indication of RA and it was launched under the brand name RoACTEMRA. Chugai co-promotes RoACTEMRA in UK, France and Germany, where its wholly-owned subsidiary Chugai Pharma Marketing Ltd. has its marketing bases. Currently Actemra/RoACTEMRA is approved in a growing number of other countries including Mexico, India, Brazil, Switzerland and Australia.

Chugai focuses on bone and joint diseases area as one of the strategic domains, and is committed to contribute to the treatment by providing new therapeutic options for medical professionals and patients.

The sales estimate related to the US approval of Actemra is scheduled to be announced at Chugai’s next full year results announcement.

Actemra, the first antibody drug (humanized monoclonal antibody) originating from Japan, was created by Chugai in collaboration with Osaka University, utilizing genetic recombinant technology to produce a monoclonal antibody against the anti-IL6 receptor.