Roche's MS hopeful Ocrevus banks more data for fierce market-share combat

Roche’s much-anticipated multiple sclerosis drug ocrelizumab trounced a standard treatment, Rebif, in a new analysis of Phase III data, adding to competitive stats that could prove an edge in the hotly contested market.

Now dubbed Ocrevus, ocrelizumab beat Rebif at quashing disease activity in relapsing MS, and topped placebo at the same measure in primary progressive MS, a hard to treat form of the disease that currently has no approved treatments.

75% more relapsing MS patients in the Ocrevus arm achieved the primary endpoint, a combination of clinical and MRI measures showing No Evidence of Disease Activity (NEDA), than Rebif patients did. In the progressive form of the disease, 47% more Ocrevus patients achieved a similar measure, No Disease Progression (NDP), Roche Roche said Wednesday.

If approved, Ocrevus is expected to be a tough rival, given its data in progressive MS; no other MS drug has yet proven to be effective in those hard-to-treat patients, and that success is expected to halo Ocrevus in the relapsing market as well.

Indeed, the Roche drug promises to shake up the MS market, certainly by jockeying for share among doctors and patients, but perhaps more acutely, by presenting new competition for payers’ attention. Analysts expect Ocrevus to put a squeeze on other MS drugs as Roche competes for reimbursement deals--and the MS category is already under pressure from payers.

That competition could come sooner than expected, too. The FDA fast-tracked Ocrevus in June, giving it a shot at hitting the U.S. market by year’s end, slightly ahead of its previous schedule.

Analysts estimate sales of $4 billion by 2022.

As an every-6-months infusion, Ocrevus could put more pressure on other infused meds, such as Biogen’s Tysabri and Sanofi’s newer Lemtrada, than on the new generation of pills from Biogen (Tecfidera), Novartis (Gilenya) and Sanofi (Aubagio).

Leerink Partners analyst Geoffrey Porges expects Ocrevus to grab a "significant" piece of the pie. It appears to offer efficacy that's close to best-in-class, Porges said, with "reasonable" safety and tolerability stats, in an arena where many drugs have liabilities in that department, no less). That 6-month dosing schedule could be an added draw, he said.

Convenience might not count much with increasingly tough payers. They’ve been active in MS negotiations of late; 2016 formularies dropped several MS meds, putting coverage at 54% compared with 2014’s 69%, Bernstein analyst Ronny Gal said earlier this year. “Whenever an additional product gets to the market … we will see a round of price correction,” Gal figures. Ocrevus in particular will “increase intermediate term formulary pressure,” he said.

Ocrevus’ approval applications, filed in the U.S. and in Europe, are based on three late-stage studies, two of which showed that Ocrevus beat the standard therapy Rebif in relapsing MS. Another study in people with primary progressive disease showed Ocrevus topping placebo at staving off disability. On the basis of the latter study, Ocrevus won breakthrough status at the FDA for treating primary progressive MS.

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