New 6-Year Data for Genentech’s Ocrevus (ocrelizumab) Show Earlier Treatment Initiation Nearly Halves Risk of Needing Walking Aid in Relapsing Multiple Sclerosis

Post-hoc analysis from 6 years of Phase III open-label extension studies showed Ocrevus treatment reduced the risk of needing a walking aid (EDSS≥6) by 49% in relapsing multiple sclerosis (RMS) patients compared with patients who switched from interferon beta-1a two years later –

– Separate analysis showed Ocrevus slowed thalamic volume loss in patients with RMS and primary progressive MS (PPMS) vs. interferon beta-1a and placebo, respectively –

– More than 150,000 people have been treated with Ocrevus globally, in clinical trial and real-world settings; data continue to show a consistent and favorable benefit-risk profile –

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South San Francisco, CA — April 27, 2020 —

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new analyses of Phase III OPERA I and OPERA II studies, as well as the open-label extensions, showing that Ocrevus® (ocrelizumab) treatment reduced the risk of disease and disability progression in RMS and PPMS. These new analyses add additional evidence to the benefit-risk profile of Ocrevus, including the impact of MS on people’s daily lives. The data were selected for the 72nd American Academy of Neurology (AAN) Annual Meeting and will be made available online via virtual presentation in the coming weeks (in lieu of an in-person event).

“For people with MS, maintaining mobility for as long as possible is very important. We are encouraged by these new longer-term analyses showing that earlier initiation of Ocrevus treatment may reduce the risk of needing a walking aid by nearly 50 percent over six years,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Slowing MS progression earlier in the disease course – not just treating relapses – may bring additional clinically meaningful outcomes to people living with this disease.”

Effect of Ocrevus on disability progression and risk of needing a walking aid in patients with RMSEarlier treatment with Ocrevus may delay the risk of needing a walking aid compared to those who switched from interferon beta-1a two years later in a new post-hoc analysis from the open-label extension of the Phase III OPERA studies in RMS. The risk was measured by the length of time until a person reached a score on the Expanded Disability Status Scale of 6 or greater (EDSS≥6) that was sustained for at least 48 weeks. People treated with Ocrevus had a 49% reduction in the risk of needing a walking aid compared to those that received interferon beta-1a over 6 years of study (4.3% vs. 7.2%*; p=0.0042). Safety profiles in the double-blind period and open-label extension were generally consistent.

Effect of Ocrevus on disease progression measured by thalamic atrophyOcrevus progressively slowed thalamic atrophy (as measured by change in thalamic volume) in patients with RMS or PPMS. Results from the double-blind periods of the Phase III OPERA I, OPERA II and ORATORIO studies showed significantly less thalamic atrophy compared with interferon beta-1a and placebo, respectively (both p<0.001). The thalamus is a deep grey matter structure within the brain that acts as a relay and integrative center, playing a key role in alertness, motor control and cognition, as well as sensory processing. It is affected by MS-related damage and its atrophy could be a useful marker of therapeutic efficacy.

With rapidly growing real-world experience and more than 150,000 patients treated globally, Ocrevus has twice-yearly (six-monthly) dosing and is the first and only therapy approved for RMS (including relapsing-remitting MS [RRMS] and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome in the U.S.) and PPMS. Ocrevus is approved in 90 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland and the European Union.

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