Investor Update
Basel, 4 December 2009
Roche reports positive phase II results with ocrelizumab in relapsing-remitting multiple sclerosis (RRMS)
Roche (SIX: RO, ROG; OTCQX: RHHBY) and its development partner Biogen Idec have reported positive phase II data with ocrelizumab, a humanized anti-CD20 monoclonal antibody, in patients with relapsing-remitting multiple sclerosis (RRMS), one of the leading causes of neurological disability in young adults. Ocrelizumab showed a strong effect with a highly statistically significant reduction in signs of disease activity as measured by brain lesions versus placebo, the primary endpoint.
In this ongoing study of 220 treatment naïve and previously treated patients, safety and tolerability data continue to be collected. Roche and Biogen Idec will continue to analyse the study results and will submit the data for presentation at an upcoming medical meeting.
About the Phase II RRMS study
The 220-patient phase II multicentre, randomised, parallel-group, partially-blinded, placebo- and interferon beta-1a-controlled, dose-finding study evaluated the efficacy and safety of two dose regimens of ocrelizumab (600mg and 2g) in patients with RRMS. Patients were treated for 24 weeks, with assessments at four-weekly intervals to measure brain lesions via magnetic resonance imaging (MRI). The primary endpoint of the study was efficacy measured by gadolinium-enhancing T1 lesions observed by MRI scans of the brain at weeks 12, 16, 20 and 24 compared with placebo. The secondary endpoints of the study included annualized relapse rate at week 24; total number of new gadolinium-enhancing T1 lesions at four-weekly intervals; safety and tolerability of two dose regimens compared to placebo and interferon beta-1a, and overall safety of ocrelizumab for up to 96 weeks.
About ocrelizumab
Ocrelizumab is an investigational humanised monoclonal antibody that selectively binds to a particular protein - the CD20 antigen - on the surface of B-cells, which are believed to play a critical role in MS patho-immunology. It then interacts with the body’s own immune system to eliminate CD20-positive B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and eventually return to normal levels. The compound is being co-developed by Roche and Biogen Idec for the treatment of relapsing-remitting multiple sclerosis. Ocrelizumab is also in development for the treatment of rheumatoid arthritis.
About multiple sclerosis
Multiple sclerosis is a disease of the central nervous system which affects communication between the brain and other parts of the body1. Symptoms can include motor weakness, dysfunction, sensory problems and fatigue, visual disturbances, disturbed balance, bladder and bowel problems, pain, cognitive or behavioural problems and sexual dysfunction. According to WHO estimates approximately 1.3 million people worldwide have been diagnosed with multiple sclerosis2. Most people experience their first symptoms between the ages of 20 and 40 years3. RRMS is the most common form of MS and accounts for around 65% of all cases. RRMS is characterised by acute exacerbations with full or partial recovery between attacks.
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 personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
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References:
1) NINDS multiple sclerosis information page, National Institute of Neurological Disorders and Stroke, http://www.ninds.nih.gov/disorders/multiple_sclerosis/multiple_sclerosis.htm, last accessed 30/10/09
2) MS Atlas, World Health Organisation, 2008
3) NINDS multiple sclerosis information page, National Institute of Neurological Disorders and Stroke, http://www.ninds.nih.gov/disorders/multiple_sclerosis/multiple_sclerosis.htm, last accessed 30/10/09