With its multiple sclerosis powerhouse Ocrevus expected to lose patent protection by the end of the decade, Roche is looking for ways to extend the market exclusivity for the top-selling drug in the indication.
But the Swiss company can check one potential solution off its list as a phase 3 trial of its high-dose version of Ocrevus in patients with relapsing multiple sclerosis (RMS) has failed to move the needle.
A study testing intravenous formulations of 1,200 mg and 1,800 mg of the drug—depending on the weight of the patient—versus the approved 600 mg dose every 24 weeks failed to meet its primary endpoint. The higher doses showed no additional benefit in slowing the progression of the disease over at least 120 weeks of treatment, Roche said on Wednesday.
The primary endpoint was the time to first onset of 12-week composite disability progression, which was defined by a variety of measures including the time to finish a 25-foot walk test and the time to perform a nine-hole peg test.
“These findings reaffirm that the current Ocrevus IV 600 mg is optimally dosed to significantly slow disability progression,” Levi Garraway, M.D., Ph.D., the chief medical officer of Roche subsidiary Genentech, said in a release.
The company said it will provide data for the trial at a future medical conference.
Coming up short in the trial is a blow to Roche as it was hoping—as late as early this year—that a high-dose formulation could extend its intellectual property (IP) rights, according to Theresa Graham, the CEO of Roche Pharmaceuticals.
“Should high dose be positive and we begin to look at putting it into devices, I think there is definitely some opportunity for expanded IP,” Graham said during the company’s fourth-quarter conference call in January.
By “devices,” Graham was referring to Roche winning approval last year for a new formulation of Ocrevus, which is administered twice a year by way of a subcutaneous shot every six months as opposed to a less convenient infusion.
Combining subcutaneous delivery of Ocrevus with a high-dose formulation could have added “another layer of IP,” Roche’s investor relations chief Bruno Eschil added during the Q4 call, “which should help us prolong the franchise.”
Last year, Ocrevus generated sales of 7.6 billion Swiss francs ($8.1 billion), while fast-rising challenger, Novartis’ Kesimpta, a monthly subcutaneous shot which can be delivered at home, racked up sales of $3.2 billion. The Novartis drug delivered a 49% sales increase in 2024, compared with a 6% year-over-year gain for Ocrevus.