Roche poised for MS coup with success in hard-to-treat progressive form

Roche is aiming to break into the multiple sclerosis field with ocrelizumab, an investigational therapy that marks the Swiss pharma giant's first foray into the disease area. And despite the big guns competing in the space, Roche may be able to corner a piece of the market for itself.

Earlier this week, the company announced positive Phase III data for the drug in primary progressive multiple sclerosis, a less common form of the disease--affecting about 10% to 20% of sufferers--that right now remains untreated. And because of the treatment void, Roche ($RHHBY) will be able to "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 global market for relapsing remitting MS, Bernstein analyst Tim Anderson wrote in a Monday note to clients.

Leverage with payers could prove huge for the company, whose arrival on the MS scene will help "increase intermediate term formulary pressure," fellow Bernstein analyst Ronny Gal wrote in July.

"We are concerned that a combination of more aggressive payers, more product alternatives and potentially more generics will lead the ~$11B U.S. market to 'roll over' around the end of the decade," he told investors.

Bernstein's Tim Anderson

But even in the more crowded RRMS area--which is pivoting toward oral therapies such as Novartis' ($NVS) Gilenya and Biogen's ($BIIB) Tecfidera--Anderson sees opportunities for ocrelizumab to shine. The "reflex opinion" that the med is a better version of Biogen standby Tysabri "could be under-selling the opportunity," he pointed out.

"With two administrations a year, the drug can be worked into regular neurologist visits without added inconvenience to the patient," he pointed out.  If the safety and efficacy presented at the upcoming European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting is solid--"in line with Tecfidera and Gilenya," in other words--why can't it compete as a first-line therapy? he wrote.

All told, consensus estimates collected by Roche currently peg ocrelizumab's sales at 640 CHF (about $656 million) in 2019. "For comparison, Tysabri/Gilenya/Tecfidera sales were $2B/$2.5B/$3B in 2014 and the market continues to grow," Anderson pointed out.

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