Roche MS candidate beats Rebif in latest PhIII as 2016 FDA decision awaits

Roche’s ($RHHBY) new multiple sclerosis drug has beaten out the aging MS treatment Rebif (interferon beta-1a) in a head-to-head late-stage test as it looks to a potential U.S. green light before the New Year.

In a snapshot abstract released this morning, Ocrevus (ocrelizumab) showed increased disease control in patients with a common (and well catered for) form of the disease known as relapsing multiple sclerosis (RMS), when compared to German Merck’s Rebif.

Specifically, a 75% higher proportion of RMS patients reached “no evidence of disease activity” with Ocrevus when compared to Merck’s older injectable med, Roche said in a statement.

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This builds on previously released data that showed the drug, administered by intravenous infusion every 6 months, when compared with placebo could reduce the risk of disability progression by 24% in patients with the particularly debilitating and rare form of the disease, known as primary progressive multiple sclerosis (PPMS), of which there are currently no treatments.

A more detailed set of data from the Opera I and Opera II studies are set to be released at the end of the week at London’s European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), but on the PPMS side the Swiss major said it will also present “new patient-reported outcomes data from the Oratario study highlighting the unmet need of people with PPMS, including the effect Ocrevus had on fatigue measures.”

“Controlling clinical and sub-clinical disease activity as early as possible is an important treatment goal for people living with MS,” said Professor Gavin Giovannoni, scientific steering committee member of the Opera I and II studies and chair of neurology at Barts and The London School of Medicine and Dentistry.

“These new data suggest that ocrelizumab consistently impacts disease progression and has the potential to change how we approach treating both relapsing and primary progressive MS.”

Back in June, the FDA granted Ocrevus a priority review, speeding up the regulator’s assessment process--which should see the drug gain a U.S. green light by 28 December, months ahead of the Swiss firm’s original goal date. The drug is also on track for a European approval for the middle of next year.

The med is seeking a license for both relapsing multiple sclerosis and primary progressive multiple sclerosis.

RMS already has a number of treatments on the market from Novartis ($NVS), Biogen ($BIIB), German Merck, Sanofi ($SNY), Teva ($TEVA) and others--but there are currently no drugs on the market for the progressive form of the disease, which makes up around 10-15% of all MS patients.

Sales for the treatment, which would for the first time be able to cover 95% of all MS sufferers, are expected to hit anywhere from $3 billion to as much as $7 billion at peak, depending on the optimism of the analyst you speak to. Roche will need it to, as the company will soon start to face the threat of biosimilars to its aging blockbuster cancer drugs.

But it may face some competition from a small, private French biotech called MedDay, which is currently testing its PPMS drug candidate MD1003 in Phase III. The company is hoping for a 2017 European approval, with an FDA filing a little further down the road, although it has hit some roadblocks in testing.

PPMS can in fact be further divided into active or not-active progressive disease based on the existence or not of superimposed inflammatory activity--this represents the most difficult-to-treat population, and is the subpopulation MedDay is targeting with MD1003.

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