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Thursday, December 22, 2016

Newly published data details positive results from three OCREVUS (ocrelizumab) Phase III studies in relapsing and primary progressive multiple sclerosis (MS)


                                                                  
  

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  • OCREVUS is the first and only investigational medicine to show superior efficacy versus comparators in both relapsing and primary progressive multiple sclerosis in clinical studies
  • OCREVUS demonstrated a favorable safety profile in three large Phase III studies

South San Francisco, CA -- December 21, 2016 --
SOUTH SAN FRANCISCO, Calif. – December 21, 2016 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that data from three Phase III studies of its investigational medicine OCREVUS™ (ocrelizumab) – the OPERA I and OPERA II studies in relapsing multiple sclerosis (RMS) and the ORATORIO study in primary progressive multiple sclerosis (PPMS) – were published in the December 21, 2016 online issue of the New England Journal of Medicine (NEJM).
Data from the OCREVUS Phase III studies showed consistent and clinically meaningful reductions in major markers of disease activity and progression compared with Rebif® (interferon beta-1a) in RMS and with placebo in PPMS. The primary endpoint was met in all three studies, which includes relative reduction of annualized relapse rate in the RMS studies and relative reduction in the progression of clinical disability sustained for at least 12 weeks in the PPMS study. Key secondary endpoints in all three studies were also met, including multiple measures of disability progression and brain lesion activity.
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“These publications that indicate that B cells play a central role in MS are the result of a longstanding collaboration between the scientific community and industry for the benefit of people with MS,” said Stephen Hauser, M.D., Chair of the Scientific Steering Committee of the OPERA studies, Director of the Weill Institute for Neurosciences and Chair of the Department of Neurology at the University of California, San Francisco. 

“In the OPERA I and OPERA II RMS studies, OCREVUS consistently and significantly reduced disease activity and disability progression compared with a standard-of-care high-dose interferon while demonstrating a favorable safety profile. The consistency of these pioneering data, the effect seen in these clinical studies and the favorable safety profile may support treating MS earlier with a high-efficacy disease-modifying medicine.”
Data from two identical studies (OPERA I and OPERA II) in RMS showed OCREVUS was superior to high-dose Rebif (interferon beta-1a), a well-established MS therapy, in reducing three major markers of disease activity: relapses (primary endpoint), disability progression, brain lesion activity over the two-year controlled treatment period.
Data from two identical studies (OPERA I and OPERA II) in RMS showed OCREVUS was superior to high-dose Rebif (interferon beta-1a), a well-established MS therapy, in reducing three major markers of disease activity: relapses (primary endpoint), disability progression, brain lesion activity over the two-year controlled treatment period. 
In a separate PPMS study (ORATORIO), OCREVUS significantly reduced the risk of confirmed disability progression sustained for at least 12 weeks (primary endpoint) and 24 weeks (a key secondary endpoint) compared with placebo. OCREVUS treatment was also superior to placebo on other key measures of disease progression in PPMS patients including the time required to walk 25 feet, the volume of chronic brain lesions and brain volume loss.
“OCREVUS is the first and only investigational medicine to significantly reduce the progression of physical disability in primary progressive MS in a large Phase III study,” said Xavier Montalban, M.D., Ph.D., Chair of the Scientific Steering Committee of the ORATORIO study and Professor of Neurology and Neuroimmunology at Vall d’Hebron University Hospital, Research Institute and Cemcat, Barcelona, Spain. “Over the last decade, other molecules have tried and failed to demonstrate efficacy for PPMS, so the positive results for OCREVUS mark an important step in our understanding of this highly disabling form of the disease.”
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