Novartis CEO Vas Narasimhan told CNBC on Tuesday that remibrutinib, the company's experimental MS medicine, could generate more than $4 billion in peak annual sales. Days before, Barclays cut its forecast for the drug after late-stage trial results showed the drug reduced relapses by less than analysts expected.
Novartis reported sales growth this week despite losing patent protection for blockbuster Entresto. But Barclays said the market is already focused on the next patent cliff. Bestsellers Kisqali and Kesimpta face patent expirations around 2032, representing $18 billion in peak sales combined.
Amit Bar-Or, a multiple sclerosis specialist at the University of Pennsylvania, told CNBC that remibrutinib offered a promising safety profile but was unlikely to control relapsing MS as effectively as high-efficacy antibodies like Kesimpta. He said the drug's biggest opportunity could emerge if trials show benefit in progressive MS, where treatment options remain limited.
Remibrutinib belongs to a class of medicines called BTK inhibitors. Kesimpta works differently as a monoclonal antibody that binds to CD20 protein, depleting B cells. Unlike Kesimpta, remibrutinib aims to regulate cells' activity without eliminating them.
Clinical results for remibrutinib in relapsing MS appear similar to Roche's fenebrutinib but less effective at preventing relapses than anti-CD20 treatments such as Kesimpta. An ongoing trial testing remibrutinib for progressive MS is expected to read out in 2031.
Novartis targets newly diagnosed patients, those taking oral treatments, and patients on anti-CD20 therapies for remibrutinib. The company sees $6 billion-plus peak annual sales for Kesimpta alongside $4 billion-plus for remibrutinib in relapsing MS.
Morningstar analyst Jay Lee told CNBC that Novartis' $4 billion-plus peak sales forecast for remibrutinib was "within the realm of possibility" but wasn't "de-risked." He expects the largest near-term market to be oral switch patients.
The RESHAPE trial, which enrolled patients aged 40 to 70 taking Roche's Ocrevus, is expected to read out in 2028. Remibrutinib is already approved for certain forms of chronic hives. A late-stage trial for hidradenitis suppurativa (HS) is expected to read out before November 19. Barclays estimates a $2 billion peak annual sales opportunity in HS but assigns the drug only 50% probability of success.