Health Canada approves ACTEMRA(TM) (tocilizumab) for the treatment of
moderately to severely active rheumatoid arthritis

First monoclonal antibody to target the IL-6 inhibitor approved based on largest clinical development program in rheumatoid arthritis to date

TORONTO, May 4 /CNW/ - Roche today announced that Health Canada has approved ACTEMRA(TM) (tocilizumab) to treat patients with rheumatoid arthritis (RA), 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.

ACTEMRA is indicated for reducing signs and symptoms in adult patients with moderately to severely active RA who have inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs) and/or tumour necrosis factor (TNF) antagonists.

General use of ACTEMRA in DMARD-inadequate responder (IR) patients is not recommended at this time. Physicians may consider the use of ACTEMRA in the DMARD-IR population on a case by case basis dependent on disease and patient characteristics, experience with the drug, and the benefits and risks of ACTEMRA as compared to other therapeutic options available.(1)

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.

Despite the treatment options currently available, many people with RA do not respond adequately in order to achieve remission, subsequently resulting in disease progression and unnecessary pain and suffering.

"The approval of ACTEMRA in Canada allows for a new way of treating RA and offers another treatment option," says Dr. Janet Pope, a rheumatologist and Professor of Medicine at the University of Western Ontario, London, Ontario. "Results in ACTEMRA clinical trials have shown long-lasting relief from symptoms and stopping progression of the disease - and remission in many people - which is truly the ultimate goal of treatment for RA."

"Since I was first diagnosed with RA at the age of 42, my quality of life quickly deteriorated and I was living with constant pain and overwhelming exhaustion," said Ian McKay. "Being unable to perform daily functions that come so naturally to most of us was very taxing on my family. Today, with ACTEMRA, I have my energy back, and I am living life to its fullest."

Health Canada's approval of ACTEMRA was based on results from the largest clinical program undertaken by an RA biologic manufacturer including five multi-national Phase III studies which demonstrated that treatment with ACTEMRA - alone or combination with methotrexate (MTX) or other DMARDs - significantly reduced RA signs and symptoms, compared with current DMARDs alone, as shown by primary and secondary endpoints including ACR and DAS scores. These benefits were seen regardless of previous therapy or disease severity. ACTEMRA is approved for the treatment of RA in the United States, the European Union, and several other countries including Australia, Switzerland, Brazil and India.

Approved for adult patients with RA who have had an inadequate response to one or more DMARDS and/or TNF antagonists, the recommended starting dose of ACTEMRA is every four weeks as an intravenous infusion over one hour to be administered in infusion clinics. It may be used alone or in combination with MTX or other DMARDs at the following dose: 4 mg/kg followed by an increase to 8 mg/kg based on clinical response.

"This announcement is great news for people living with rheumatoid arthritis," said Cheryl Koehn, President of Arthritis Consumer Experts. "Health Canada's approval of tocilizumab will add to the RA treatment arsenal, which is important given that there continues to be significant unmet need in the treatment of this disease. I am hopeful that the Common Drug Review process and subsequent provincial formulary reviews will be completed in a timely manner, and that reimbursement coverage will be made available for tocilizumab as part of the full range of Health Canada-approved arthritis medications."

Provincial formulary coverage of ACTEMRA in Canada will be sought. In the meantime, people who are prescribed this medication by their rheumatologists may be able to access the medication through Jointeffort, part of the Roche Patient Assistance Program (RPAP). Jointeffort program case workers will navigate private insurance plans to determine an individual's coverage.

About Rheumatoid Arthritis (RA)

RA is thought to affect over 21 million people worldwide, and has both an emotional and physical impact on a person's quality of life. Physically, RA causes individuals to experience morning stiffness, lack of flexibility, tiredness, pain, and joint swelling, while emotionally, it leaves a large number of patients feeling isolated and alone. In Canada, RA affects 300,000 individuals, or one in every 100.(2) Women are affected by RA three times more often than men, and while it more commonly appears between the ages of 25 and 50, RA can affect people of all ages from toddlers to seniors.(3)

RA is a progressive autoimmune disease characterized by inflammation of the membrane lining in the joints throughout the body. This inflammation causes distortion of the joint and impaired function accompanied by pain, stiffness and swelling, ultimately leading to irreversible joint destruction and disability. In addition, the systemic symptoms of RA include fatigue, anemia, and osteoporosis, and may contribute to shortening life expectancy by affecting major organ systems. After 10 years, fewer than 50 per cent of patients can continue to work or function normally on a daily basis.(4) Furthermore, musculoskeletal conditions, including arthritis, are the second most costly category of diseases in Canada at $16.4 billion.(5)

About ACTEMRA

ACTEMRA is the result of a global research co-development collaboration with Chugai of Japan. ACTEMRA 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.

ACTEMRA was generally well-tolerated and the overall safety profile of ACTEMRA was consistent across all global Phase III clinical trials. The most common adverse reactions reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, hypertension and increased ALT. Serious adverse reactions reported in ACTEMRA clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis. 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. Biologic treatments, such as ACTEMRA, that suppress the immune system, may cause an increase in the risk of malignancies.

About Roche in RA

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 RITUXAN(R) (rituximab) there are a number of projects in development, potentially allowing Roche to build on further opportunities. RITUXAN 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 is Roche's second novel medication to treat RA and is a humanized 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.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 81,500 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. Visit www.roche.com for more information.

    
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    References
    -------------------------------
    (1) Canadian ACTEMRA Product Monograph.
    (2) CIHR Arthritis Fact Sheet. Accessed at
http://www.cihr-irsc.gc.ca/e/40020.html. April 2010.
    (3) The Arthritis Society. Accessed at
http://www.arthritis.ca/types%20of%20arthritis/ra/default.asp?s=1, April 2010.
    (4) World Health Organization. Chronic rheumatic conditions.
        Accessed at http://www.who.int/chp/topics/rheumatic/en/, April 2010.
    (5) The Arthritis Society. Accessed at
http://www.arthritis.ca/toolbox/media%20centre/news/releases%202003/29092003/fact/default.asp?s=1,
April 2010.
    

For further information: Leigh Funston, Roche, [phone], [email protected]; Andrea Rosebrugh, NATIONAL Public Relations, [phone], [email protected]