Roche preps for make-or-break MS data with eyes on a crowded space

Roche CEO Severin Schwan

Roche's in-development treatment for multiple sclerosis met its main efficacy goals in pair of Phase III trials, but the looming release of full study results will likely influence how well the drug can contend with top-selling products already on the market. And CEO Severin Schwan believes his company has a chance to make a splash in the field.

The antibody treatment, ocrelizumab, is a once-failed arthritis therapy that Roche successfully repurposed for MS. In late-stage trials disclosed in June, the intravenous drug significantly beat out Merck KGaA's Rebif in reducing relapses and slowing the decline of patients' physical abilities, setting the stage for U.S. and European regulatory applications in the first quarter of next year.

But beating the aging Rebif may not be enough for ocrelizumab to carve out a space in an MS market dominated by oral treatments from Biogen ($BIIB) and Novartis ($NVS), plus injectables from Sanofi ($SNY) and others. The key differentiating factor for Roche's drug will be its superior safety profile, Schwan told Reuters, arguing that analysts will be impressed when the company releases full Phase III data at next month's European Committee for Treatment and Research in Multiple Sclerosis.

"MS is a big market of over $20 billion, and we believe the profile of our medicine in terms of efficacy and safety is pretty unique," Schwan told the news service. "I think this is very good for patients, and there is a huge commercial potential for this medicine."

Meanwhile, Roche is awaiting the results of a third Phase III study in primary progressive MS, a harder-treat form of the disease. If those data come back positive, ocrelizumab's value proposition and market share could greatly expand, a prospect Schwan said is "pure upside" from Roche's perspective.

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