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Monday, April 23, 2018

NEW OCREVUS (OCRELIZUMAB) DATA AT AAN DEMONSTRATE SIGNIFICANT REDUCTIONS IN DISEASE ACTIVITY AND DISABILITY PROGRESSION IN RELAPSING MULTIPLE SCLEROSIS

April 23, 2018

·      Four years of continuous treatment with OCREVUS showed a sustained reduction in underlying disease activity in relapsing MS (RMS) in analysis from the open-label extension period
·      Additional analyses show OCREVUS delayed cognitive decline and improved cognitive function in RMS, as measured by Symbol Digit Modalities Test
·      OCREVUS reduced the presence of nerve damage and inflammation biomarkers in people with RMS shown in interim data from a Phase III study
·      New safety data are consistent with OCREVUS’ favorable benefit-risk profile for both RMS and primary progressive MS

·      Over 40,000 patients treated with OCREVUS globally

SOUTH SAN FRANCISCO, Calif. – April 23, 2018 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new OCREVUS (ocrelizumab) data were presented at the 70th American Academy of Neurology (AAN) Annual Meeting from April 21-27 in Los Angeles, California. The data showcase the efficacy of OCREVUS in relapsing multiple sclerosis (RMS) through several measures of underlying disease activity and disability progression, including magnetic resonance imaging (MRI), cognitive function, and spinal fluid biomarkers of inflammation and neurodegeneration. New safety data remain consistent with OCREVUS’ favorable benefit-risk profile in both relapsing and primary progressive multiple sclerosis (PPMS).

“The OCREVUS data shared at AAN show the impact of this targeted B cell therapy on slowing disability progression in MS, and further support the approach of early treatment. In the extension studies, patients who received OCREVUS continuously experienced less disease progression than those who began treatment at a later time point,” 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. “It is encouraging that with up to four years of data, we continue to see a robust effect and a consistent safety profile.”


After four years of continuous treatment, the benefits of OCREVUS in reducing underlying disease activity in RMS were sustained, as shown in a platform presentation measuring brain MRI activity through the randomized and open-label extension (OLE) periods of the Phase III studies. Patients who stayed on OCREVUS maintained low numbers of T1 gadolinium-enhancing (T1Gd+) lesions (0.017 pre-OLE to 0.17 T1Gd+ lesions per scan at year four [year two of the OLE phase]) and new/enlarging T2 (N/ET2) lesions [0.052 pre-OLE to 0.080 N/ET2 lesions per scan] through year two of the OLE phase. Patients who switched from Rebif® (interferon beta-1a) to OCREVUS at the start of the OLE period had a near-complete silencing of T1Gd+ lesions per scan at one and two years (0.476 pre-OLE to 0.007 and 0.004 T1Gd+ lesions per scan), as well as an 85 and 97 percent decrease in N/ET2 lesions per scan at years one and two, respectively (2.159 pre-OLE to 0.333 and 0.063 N/ET2 lesions per scan).





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