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Roche Drug First to Clear Clinical Trials for Hard-to-Treat Form of Multiple Sclerosis

Switzerland’s Roche has moved into pole position in the race to launch the world’s first treatment for progressive multiple sclerosis but smaller players are working hard on rival approaches.
While there are a number of treatments for relapsing remitting MS, the most common form of the disease, there are no approved drugs for progressive MS, which is marked by steadily worsening symptoms.
That makes the success of Roche’s antibody drug ocrelizumab in a 732-patient global clinical trial big news. The drug will now be filed for approval in early 2016, implying it could reach the market around a year later.
“It’s a very significant first,” Roche’s head of neuroscience clinical development Paulo Fontoura told Reuters on Monday, adding it was “hard to speculate” when Roche might face competition.
However, Frederic Sedel, chief executive of small unlisted French biotech firm MedDay Pharmaceuticals, believes he is hard on Roche’s heels.
Sedel said in an email that his company planned to meet with regulatory agencies in order to file a rival medicine for progressive MS sometime in 2016.
MedDay is still awaiting results of a second trial testing its drug MD1003 in patients in patients with damage to the optic nerve and the exact timing of submission would depend on discussions with regulators, Sedel said.
Earlier this year MedDay reported success for its drug, which consists of a high-dose formulation of the food additive biotin. But that Phase III trial was relatively small, involving 154 patients in France.
DSM has a deal to manufacture MedDay’s biotin, which is given as a tablet. Roche’s medicine, by contrast, is delivered as a twice-yearly infusion.
Further behind is Biogen, which reported results from a mid-stage study in April that suggested its so-called anti-LINGO-1 drug could help with optic-nerve damage.
And other teams are pursuing different avenues, with a group at University College London studying a drug called phenytoin, which has already been used to treat epilepsy for 60 years.
Various alternative older medicines are also being investigated by academic groups to see if they might work in progressive MS.
In the meantime, though, Roche looks likely to enjoy a first-mover advantage, creating a multibillion-dollar opportunity for ocrelizumab in both relapsing remitting MS (RRMS) and progressive disease.
Importantly, that may mean the Swiss group can command a premium price.
“Roche can argue convincingly for a high price outside the U.S., resist payers in the U.S., and own the segment, without the competition that fragments the $19 billion RRMS global market,” Bernstein analyst Tim Anderson said in a research note.