Megablockbuster day for Roche too as MS game-changer Ocrevus gets a green light at the FDA

Severin Schwan, Roche CEO

Tuesday turned out to be the day for a game of megablockbusters. Regeneron and Sanofi snagged an FDA OK for Dupixent, a landmark new eczema therapy, and now Roche came through with a thumbs up for ocrelizumab, which promises to remap the landscape for the multiple sclerosis drug market.

Ocrelizumab — which will now be sold as Ocrevus — could be used to treat most MS patients, a combination of relapsing/remitting and primary progressive patients. That’s a unique distinction that is likely to make this a key focus among doctors who specialize in treating MS. And that could be a game change for everyone in the field.

Roche priced this drug for market penetration at $65,000 a year, a 25% discount to Rebif.

“According to the NMSS, MS medicines on average cost almost 4 times more today than they did 12 years ago,” notes a spokesperson for Roche. “In fact, Rebif – the 14 year-old standard of care that OCREVUS was shown to be clinically superior in two RMS trials – now costs about $86,000. We feel that the industry needs to start to reverse this trend, and believe that pricing Ocrevus 25% less than the comparator in our trials is an important first step.”

EvaluatePharma has pegged consensus forecasts of revenue for 2022 at $4 billion for this therapy, about a billion dollars behind where Dupixent is expected to land. Its presence in the pipeline, combined with a recent approval of its checkpoint Tecentriq and a few other top prospects, has allowed Roche CEO Severin Schwan to largely stay out of an M&A market he has long viewed as overpriced and way too risky.

Investigators say they were able to determine the drug increased the proportion of relapsing/remitting MS patients seeing the elimination of disease activity by 75% over 96 weeks compared to Rebif. Most achieved that status at the end of 24 weeks of treatment with the therapy. And the company also outlined new positive data on the elimination of disease progression among primary progressive MS patients compared to a placebo.

Brian Skorney, Baird

Brian Skorney, Baird analyst

The data paves the way for a new contender that is entering a fast-changing and furiously competitive market. A 40mg generic version of Teva’s Copaxone may be on the way soon as Biogen’s flagship drug Tecfidera continues to see its market deteriorate. That erosion has left Biogen incredibly vulnerable to growing criticism of its business model.

“Recall, we’ve advocated that Tysabri should be an obvious target for Ocrevus in RMS given the associated safety risks, similarities in administration, etc,” noted Baird’s Brian Skorney. “Docs indicated that about 50% of Ocrevus patients would likely be PPMS patients, with 11% coming from Tysabri and another 11% switches from Tecfidera. This implies an almost 20% hit to overall Tysabri demand. However, when asked about long-term trends, generic 40mg Copaxone, and other competitive threats, docs still believe Tecfidera could see a 20%+ decline in scripts by YE18.”

Sandra Horning

“The FDA’s approval of OCREVUS is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B cell targeted therapy,” said Sandra Horning, chief medical officer and head of Global Product Development. “Until now, no FDA-approved treatment has been available to the primary progressive MS community, and some people with relapsing forms of MS continue to experience disease activity and disability progression despite available therapies. We believe OCREVUS, given every six months, has the potential to change the disease course for people with MS, and we are committed to helping those who can benefit gain access to our medicine.”

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