Roche's Multiple Sclerosis Drug Gets Breakthrough Status, Likely to Haunt Biogen

February 17, 2016
By Mark Terry, BioSpace.com Breaking News Staff

Switzerland-based Roche Group (RHHBY) announced today that the U.S. Food and Drug Administration (FDA) had given its drug Ocrevus (ocrelizumab) Breakthrough Therapy Designation. Ocrevus is being developed for the treatment of primary progressive multiple sclerosis (PPMS).

According to the National Multiple Sclerosis Society, PPMS is noted for a “steady worsening of neurologic functioning, without any distinct relapses (also called attacks or exacerbations) or periods of remission.” Although MS in general has a lot of variability, most forms of MS are the result of inflammatory attacks on myelin. PMS has less inflammation, so patients have fewer brain lesions or plaques, but more lesions or plaques in the spinal cord. The average age of onset is also about 10 years later in PPMS than in relapsing MS.

Roche plans to submit data from three Phase III clinical trials to global regulatory organizations in the first half of this year. Top-line data was presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October 2015.

“Ocrelizumab is the first investigational medicine for MS to be granted Breakthrough Therapy Designation by the FDA,” said Sandra Horning, chief medical officer and head of Global Product Development for Roche, in a statement. “With no approved treatments for primary progressive MS, ocrelizumab has the potential to address an important unmet need. We are committed to working with the FDA to bring ocrelizumab to people with primary progressive MS as quickly as possible.”

The drug has a very good safety profile, which Roche indicates sets it apart. Analysts project, if approved, the drug could be a “multibillion-dollar-a-year seller.”

October clinical trial data showed that ocrelizumab reduced relapses by almost half compared to an older drug, Rebif. It also reduced clinical disability by about 25 percent in a separate study of PPMS patients. Rebif is a formulation of interferon beta-1a used to treat inflammation in MS patients. It is marketed by Darmstadt, Germany-based EMD Serono, a division of Merck KgaA .

Analysts also feel that Roche’s ocrelizumab could hammer Cambridge, Mass.-based Biogen . Biogen is a dominant player in the MS medication market, with Avonex and Plegridy bringing in approximately $2.8 billion a year, and its Tysabri bringing in slightly less than $1 billion annually. Biogen’s Tecfidera is also a blockbuster MS drug, which had $1.7 billion in sales in the first half of 2015.

But as competitors go, between Biogen and Roche things get a little complicated when it comes to these drugs. Biogen licensed ocrelizumab to Roche several years ago. As part of that deal, Roche pays Biogen royalties between 13.5 percent and 24 percent on U.S. sales of ocrelizumab, if it gets approved by the FDA, which seems likely. Those profits probably won’t make up for what ocrelizumab will do to its MS franchise, however.

Writing for The Motley Fool last October when Roche first released its data about ocrelizumab, Cory Renauer wrote, “It’s hard to make apples-to-apples efficacy comparisons of ocrelizumab to Tecfidera and Tysabri, but its stellar performance versus Rebif certainly suggests it has what it takes to compete fiercely.”

Although potentially great news for MS patients, it’s probably not good news for Biogen.