Roche Bearer Share : RoACTEMRA receives CHMP positive opinion in Europe for use in patients with early rheumatoid arthritis (RA) not previously treated with methotrexate (MTX)

Basel, 28 July 2014

Roche's RoACTEMRA receives CHMP positive opinion in Europe for use in patients with early rheumatoid arthritis (RA) not previously treated with methotrexate (MTX)

• Treating RA patients with early, severe, progressive disease who are in the first two years after diagnosis (early RA) could prevent damage to joints and stop the disease from progressing
• Upon approval, RoACTEMRA would be the first interleukin-6 (IL-6) receptor antagonist available for use in Europe in patients with early RA not previously treated with MTX

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that RoACTEMRA (tocilizumab, also known as ACTEMRA) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for use in Europe in patients not previously treated with MTX with severe, active and progressive RA (early RA). Treating the disease at this critical early phase, within two years after diagnosis, may prevent irreversible damage to joints and long-term disability.1,2

Research suggests that there could be an opportunity to change the course of RA in the early stages of the disease through intense and effective treatment.3 Biologics are not commonly used in early RA,4 but effective treatment could play an important role in halting disease progression.5

"This positive opinion for RoACTEMRA for people with early stage RA is an important step toward making it available to more patients," said Sandra Horning, M.D., Head of Global Product Development and Chief Medical Officer at Roche. "If approved, RoACTEMRA would be the first IL-6 receptor antagonist available for patients in the early stages of the disease."

The CHMP decision is based on data from the phase III FUNCTION study, which assessed the efficacy, safety and prevention of structural joint damage in patients with early moderate-to-severe RA (defined as ≤2 years since diagnosis) not previously treated with MTX. The study met its primary endpoint, demonstrating that patients who received RoACTEMRA in combination with MTX or as a single agent therapy (monotherapy) experienced a significantly greater improvement in disease activity (DAS28 remission) after 24 weeks compared to patients who received MTX alone.1 It was also demonstrated that treatment with RoACTEMRA with and without MTX achieved greater inhibition of structural joint damage compared with MTX alone.1  At 24 weeks, the overall safety of RoACTEMRA in this early RA population was consistent with its known safety profile seen previously in other RoACTEMRA studies in RA.1

RA is an autoimmune disease with prevalence worldwide of approximately 40 million.6 RA causes joints to become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged. RA patients are often treated with a number of medicines, combining protein-based biologic therapies with MTX, the most common disease-modifying antirheumatic drug (DMARD).

RoACTEMRA is the first humanized anti-interleukin 6 (IL-6) receptor antagonist monoclonal antibody approved for use in combination with or as monotherapy without MTX, for the treatment of moderate-to-severe RA in adult patients who have either responded inadequately to, or who are intolerant to, previous therapy with one or more DMARDs or tumor necrosis factor (TNF) antagonists. RoACTEMRA is the first anti-IL-6 approved for both monotherapy and combination use in intravenous and subcutaneous formulations.

The extensive RoACTEMRA clinical development program included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. In addition, the phase IV ADACTA study showed that monotherapy with RoACTEMRA was superior to monotherapy with adalimumab in reducing signs and symptoms of RA in MTX-intolerant patients or patients for whom MTX treatment was considered ineffective or inappropriate. The overall safety profile of both medications was consistent with previously reported data. This data was recognised in the recent European League Against Rheumatism recommendations for the management of RA, where RoACTEMRA was recommended as a first-line biologic and was highlighted for use as monotherapy if patients are intolerant to MTX or conventional DMARDs.4

The RoACTEMRA intravenous formulation is also approved for the treatment of active systemic juvenile idiopathic arthritis (SJIA) and polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older. The RoACTEMRA subcutaneous formulation was approved for use in adult patients in Japan, U.S. and Europe in March 2013, October 2013 and April 2014, respectively.

RoACTEMRA is part of a co-development agreement with Chugai Pharmaceutical Co. It has been approved in Japan since April 2005 for Castleman's disease, followed by approvals for RA, SJIA and PJIA in 2008. More than 300,000 patients have been treated with RoACTEMRA since it first launched. RoACTEMRA is approved in more than 100 countries worldwide including countries in the European Union, the United States, China, India, Brazil, Switzerland and Australia. It is available in more than 90 of these countries.

The Roche Group's immunology medicines include rheumatoid arthritis treatments MabThera/Rituxan (rituximab) and ACTEMRA/RoACTEMRA (tocilizumab), XOLAIR (omalizumab) in asthma and Pulmozyme (dornase alfa) for cystic fibrosis. In addition to its approved portfolio of immunology medicines, Roche late stage pipeline products include etrolizumab being studied in ulcerative colitis and lebrikizumab for severe asthma.

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, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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