RoACTEMRA approved in Europe to treat patients suffering from Rheumatoid Arthritis

First in class therapy offers new treatment option to patients with moderate to severe form of the disease

Basel, Switzerland | January 21, 2009 | Roche today announced that the European Commission has approved RoACTEMRA (tocilizumab, known as Actemra outside of the EU), to treat patients with rheumatoid arthritis (RA). RoACTEMRA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderate to severe RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, RoACTEMRA can be given as monotherapy in cases of intolerance to methotrexate (MTX) or where continued treatment with MTX is inappropriate. RoACTEMRA is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody developed for the treatment of RA and is a novel approach to help tackle this debilitating disease.

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 such as fatigue and anemia. There are several key cytokines, or proteins, involved in the inflammatory process including tumor necrosis factor (TNF) alpha, interleukin-1 (IL-1) and interleukin-6 (IL-6). IL-6 has been identified as having a pivotal role in the inflammation process. The exact cause of RA is unknown and there is no cure currently available.

“Many patients suffering from rheumatoid arthritis fail to respond to any treatment and few actually achieve lasting remission, which is currently the ultimate goal of treatment for RA. The approval of RoACTEMRA offers new hope for patients suffering from the debilitating effects of rheumatoid arthritis” said William M. Burns, CEO of Roche’s Pharmaceuticals Division. “Roche will work with the authorities in EU member countries to ensure that this groundbreaking therapy will be available to patients as quickly as possible.”

The European Commission’s approval for RoACTEMRA was based on results from the largest clinical program undertaken by a biologic in RA including, five multi-national Phase III studies which demonstrated that treatment with RoACTEMRA – alone or combination with MTX or other DMARDs– significantly reduced RA signs and symptoms, compared with current DMARDs alone. These benefits were regardless of previous therapy or disease severity.

The approval in the EU follows earlier approvals for the product in several countries, including Japan, India and Switzerland.

About ACTEMRA/RoACTEMRA

RoACTEMRA is the result of research collaboration by Chugai and is being co-developed globally with Chugai. RoACTEMRA is the first humanized IL-6 receptor-inhibiting monoclonal antibody. In Japan, ACTEMRA was launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2008, additional indications for RA, polyarticular-course juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan.

RoACTEMRA is generally well tolerated. The overall safety profile of RoACTEMRA is consistent across all global clinical studies. The serious adverse reactions reported in RoACTEMRA 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 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 patients without association with clinical outcomes. Treatments that suppress the immune system, such as RoACTEMRA, may cause an increase in the risk of malignancies.

About Roche in rheumatoid arthritis

One of the most important drivers for growth at Roche over the next few years is expected to be the company’s emerging franchise in autoimmune diseases with RA as the first indication. Following the launch of MabThera (rituximab) there are a number of projects in development, potentially allowing Roche to build on further opportunities. MabThera is the first and only selective B-cell therapy for RA, providing a fundamentally different treatment approach by targeting B cells, one of the key players in the pathogenesis of RA. ACTEMRA/RoACTEMRA is Roche’s second novel medicine and is a humanised monoclonal antibody to the IL-6 receptor, inhibiting the activity of IL-6 , a protein that plays a major role in the RA inflammation process. Additional projects creating a rich pipeline include compounds in Phase I, II and III clinical trials. Notably, ocrelizumab, a humanised anti-CD20 antibody, has entered phase III development for RA.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.

SOURCE: Roche

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