Roche scores an MS first with a potential blockbuster on its hands

Roche CEO Severin Schwan

An in-development drug from Roche ($RHHBY) performed well against a hard-to-treat form of multiple sclerosis in what the company says is a Phase III first that could shake up a $20 billion market.

Roche's ocrelizumab, a twice-yearly treatment, beat out placebo in a late-stage trial on primary progressive multiple sclerosis, a disease more debilitating than the more common relapsing form of MS. After 12 weeks, ocrelizumab met its primary endpoint by significantly reducing the progression of disability compared with placebo, Roche said, and the antibody treatment charted a similar safety profile.

The top-line success marks a first for any investigational medicine, according to Roche, and the victory in primary progressive MS only burnishes ocrelizumab's potential as the company moves toward global regulatory submissions. The intravenous treatment already succeeded in a pair of Phase III trials in relapsing MS, and Roche CEO Severin Schwan told Reuters earlier this month that the company hadn't factored a win in primary progressive into its model, calling it "pure upside."

Now, Roche is planning to file ocrelizumab for approval early next year, widening its intended label to include both forms of MS. That could provide a major boost to the treatment's eventual market share if and when it faces off against oral treatments from Biogen ($BIIB) and Novartis ($NVS), plus injectables from Sanofi ($SNY) and others.

The next key inflection point for ocrelizumab comes at an MS conference next month where Roche will present detailed safety data on the treatment from its previous Phase III trials. According to Schwan, the company is counting on safety to be high among ocrelizumab's differentiating factors on the crowded MS market, and the presentation is Roche's "most important read-out this year, without any doubt," he said this month.

- read the results