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Genentech Announces OCREVUS Data On Long-Term Disability Benefits In PPMS

Genentech, a member of the Roche Group (RHHBY), said Thursday that new OCREVUS or ocrelizumab data will be presented at the 4th Congress of the European Academy of Neurology from June 16-19 in Lisbon, Portugal. The new Phase III data analyses showed OCREVUS may provide meaningful disability benefits such as delay in the need for a wheelchair for people with primary progressive multiple sclerosis or PPMS.

Genentech said it continues its commitment to people with progressive forms of MS by initiating two new global Phase IIIb studies that will evaluate the efficacy of OCREVUS in a broad range of people with progressive forms of MS.

In a new exploratory analysis from the extended control period of the Phase III ORATORIO study in PPMS, OCREVUS may significantly delay the time to need a wheelchair by seven years, as measured by the length of time until a person reaches Expanded Disability Status Scale seven or greater (EDSS=7) using 24-week confirmed disability progression (CDP).

People treated with OCREVUS had a 46 percent reduction in the risk of progressing to a wheelchair compared to the placebo-treated group (6.2 percent vs. 9.8 percent risk, respectively, p=0.022). When these results were extended (extrapolated) to calculate the median time-to-wheelchair, the data suggest OCREVUS treatment may delay the need for a wheelchair by seven years (19.2 years for OCREVUS vs. 12.1 years for placebo).

Additionally, the analysis showed that the placebo-treated patient population studied in ORATORIO had similar disability progression rates to an untreated real-world PPMS population. The extrapolated median time to wheelchair (EDSS=7) for placebo-treated people in the ORATORIO study was 12.1 years compared to 12.4 years for people with PPMS in the real-world MSBase registry.

Longer-term safety data presented at EAN representing 3,778 RMS and PPMS patients and 9,474 patient years of exposure to OCREVUS, across all OCREVUS clinical trials, remain consistent with the medicine's favorable benefit-risk profile. As of June 2018, over 50,000 people have been treated globally with OCREVUS.

OCREVUS is now approved in over 60 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland and the European Union. Marketing applications are currently under review in more than 20 countries across the world.

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