Roche presented promising pivotal data for its ocrelizumab, including first Phase III evidence of efficacy for the treatment of primary progressive multiple sclerosis (PPMS). 10% of MS patients suffer from PPMS, a form of disease that is characterized by steady worsening of neurological function. There are currently no approved drugs for PPMS. The data, presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in October, could pave the way for regulatory filings of the CD20-targeting antibody in the first quarter of 2016.

B cells are thought to have a key role in MS pathogenesis, because they produce self-reactive antibodies and because they present antigens and secrete cytokines that can lead to abnormal activation of T cells and macrophages. CD20-targeting antibodies, which deplete levels of CD20-expressing B cells, have therefore been considered as possible MS agents for years. Roche's first-in-class CD20-binding rituximab yielded promising signs of efficacy in MS, but development in this indication was discontinued for undisclosed reasons. Ocrelizumab, a fully humanized successor to the chimeric rituximab antibody, now picks up the chase.

In two Phase III trials in relapsing MS, ocrelizumab beat interferon beta-1a, reducing the annualized relapse rate by nearly 50% compared with the interferon beta-1a comparator.

The antibody also outperformed placebo in PPMS. In a 730-patient trial, ocrelizumab reduced the risk of progression of clinical disability sustained for at least 12 weeks by 24% compared with placebo.

BioMedTracker analysts forecast global peak sales of ocrelizumab of over US$2 billion in 2024. The antibody was also in development for rheumatoid arthritis, lupus and ulcerative colitis, but has been suspended in all these indications.