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Roche Ahead of Competition in Progressive Multiple Sclerosis Treatment Race

World’s first treatment for progressive MS could reach the market in late 2016

Ocrelizumab, an antibody drug developed by Switzerland’s Roche, has moved into the lead in the race to launch the word’s first treatment for progressive multiple sclerosis. The relapsing–remitting form of the disease has several treatments, but there are no approved drugs for progressive MS, which is marked by steadily worsening symptoms. Ocrelizumab is scheduled to be filed for approval in early 2016, implying it could reach the market by the end of 2016 or early 2017.

Although Roche appears to be in the lead position, Reuters reports, smaller players are working hard on rival approaches. It is difficult to say when Roche may face competition, but the French biotech firm MedDay, as well as Biogen, are also hoping to take part in the multibillion-dollar market opportunity.

According to MedDay’s chief executive, the company is hard on Roche’s heels with MD1003, a high-dose formulation of the food additive biotin. Earlier this year MedDay reported success for its drug, but that phase III trial was relatively small, involving only 154 patients in France. The company is also hoping to file sometime in 2016, but it awaiting results of a second trial testing MD1003 in patients with damage to the optic nerve. MedDay has stated the exact timing of submission would depend on discussions with regulators. 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.

Biogen appears to be further behind, having reported results in April from a mid-stage study that suggested its so-called anti-LINGO-1 drug could help with optic-nerve damage.

Roche’s lead provides the company with an opportunity to command a premium price. According to Bernstein analyst Tim Anderson, “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 [relapsing–remitting MS] global market."

Source: Reuters; September 28, 2015.

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