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Wednesday, September 14, 2016

PHASE III EFFICACY RESULTS OF INVESTIGATIONAL MEDICINE OCREVUS™ (OCRELIZUMAB) REINFORCED BY EXPLORATORY ANALYSES IN TWO FORMS OF MULTIPLE SCLEROSIS


                                                                  
  

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* 75 percent higher proportion of relapsing multiple sclerosis (RMS) patients achieved No Evidence of Disease Activity (NEDA) with OCREVUS compared with interferon beta-1a (Rebif®)


* 47 percent higher proportion of primary progressive multiple sclerosis (PPMS) patients achieved No Evidence of Progression (NEP) with OCREVUS compared with placebo

SOUTH SAN FRANCISCO, Calif. – September 13, 2016 – Genentech, a member of the Roche group (SIX: RO, ROG; OTCQX: RHHBY), today announced new analyses from the three OCREVUS™ (ocrelizumab) Phase III studies in relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) will be presented during the 32nd congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), from September 14-17 in London, England.

OCREVUS increased disease control in patients with RMS and PPMS in separate post-hoc analyses. In these analyses, two composite endpoints measured disease control using a combination of clinical and MRI outcomes: No Evidence of Disease Activity (NEDA) in patients with RMS and No Evidence of Progression (NEP) in patients with PPMS. These composite endpoints are emerging as new treatment targets.

A NEDA analysis of pooled data from the Phase III OPERA I and OPERA II studies compared no evidence of disease activity during different time periods over two years of study. NEDA is achieved when a patient has no relapses, no confirmed disability progression, no gadolinium-enhancing MRI lesions and no new or enlarging MRI lesions. The data showed that OCREVUS significantly increased the proportion of RMS patients achieving NEDA by 75 percent compared with interferon beta-1a over 96 weeks (0-96 weeks, p<0.0001). Additionally, compared with interferon beta-1a, OCREVUS treatment significantly increased the relative proportion of patients achieving NEDA by 33 percent in weeks 0-24 and by 72 percent in weeks 24-96 (both p<0.0001). A majority of patients achieved NEDA in the first 24 weeks of OCREVUS treatment (60.8 percent) and this proportion increased during weeks 24-96 of the study (72.2 percent).


“Controlling clinical and sub-clinical disease activity as early as possible is an important treatment goal for people living with MS,” said Professor Gavin Giovannoni, Scientific Steering Committee Member of the OPERA I and II studies and Chair of Neurology at Barts and The London School of Medicine and Dentistry. “These new data suggest that ocrelizumab consistently impacts disease progression and has the potential to change how we approach treating both relapsing and primary progressive MS.”

New post-hoc analyses of the ORATORIO study in PPMS patients measured NEP, which includes three measures of physical disability (confirmed disability progression, walking speed and upper extremity function) and reflects no evidence of worsening of a person’s physical disability. Patients who achieved NEP had no evidence of confirmed disability progression sustained for at least 12 weeks and less than 20 percent worsening of performance on the timed 25-foot walk and 9-hole peg test. OCREVUS treatment significantly increased the proportion of PPMS patients with NEP by 47 percent at week 120 compared with placebo (p=0.0006).

“With no approved treatment options, primary progressive MS remains a challenge for physicians and people with MS,” said Xavier Montalban, M.D., Ph.D., Professor of Neurology and Neuroimmunology at Vall d’Hebron University Hospital, Research Institute and Cemcat, Barcelona, Spain. “OCREVUS significantly impacted three key disability measurements, which further highlight its clinical significance in people with primary progressive MS.”

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