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Roche's Drugs, Trials, and FDA Approvals after 1H17

PART:
1 2 3 4 5 6 7 8 9 10 11
Part 5
Roche's Drugs, Trials, and FDA Approvals after 1H17 PART 5 OF 11

Ocrevus Expected to Significantly Drive Roche’s Revenue Growth

Ocrevus revenue trends

In the first half of 2017, Roche’s (RHHBY) Ocrevus generated revenues of CHF1 192.0 million. In that period in the US market, Ocrevus generated revenues of CHF 191.0 million.

In July 2017, the Australian Therapeutic Goods Administration approved marketing authorization of Roche’s Ocrevus for the management of relapsing and primary progressive multiple sclerosis (or PPMS) in Australia.

Previously, in March 2017, the FDA (U.S. Food & Drug Administration) approved Roche’s Ocrevus for the same indication. Ocrevus is presently the first and only approved disease-modifying treatment for PPMS.

In June 2017, Roche presented updated new post-hoc analysis data from the Phase 3 trials with Ocrevus for the treatment of relapsing multiple sclerosis (or RMS) and PPMS.

Ocrevus Expected to Significantly Drive Roche’s Revenue Growth

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About Ocrevus

Ocrevus (ocrelizumab) is a CD20-directed cytolytic antibody used for the treatment of RMS and PPMS.

In the Phase 3 OPERA I and OPERA II trials, Roche’s Ocrevus demonstrated a significant reduction in disease activity and disability progression in individuals with RMS and PPMS. Among the RMS patients, Ocrevus substantially increased the proportion of patients maintaining NEPAD (no evidence of progression or active disease) by 82.0% compared to Rebif at 96 weeks in the pooled statistical analysis of the Phase 3 OPERA I and OPERA II trials. In the Phase 3 ORATORIO trial at 120 weeks among patients with PPMS, 29.9% of the patients on Ocrevus maintained NEPAD compared to 9.4% of patients on a placebo.

The FDA’s approval of Ocrevus was based on data from the OPERA I and OPERA II trials. Roche has also filed for marketing authorization in Europe and other regions.

In the multiple sclerosis drugs market, Roche’s Ocrevus will compete with Novartis’s (NVS) Extavia and Gilenya; Biogen’s (BIIB) Fampyra, Tecfidera, and Tysabri; EMD Serono’s Rebif; Sanofi’s (SNY) Aubagio; and Teva’s Copaxone. The Vanguard International Dividend Appreciation Index ETF (VIGI) invests ~2.9% of its total portfolio holdings in Roche.

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