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Swiss pharmaceutical giant Novartis is preparing to outline its long-term growth strategy amid upcoming patent expirations for major drugs, placing heavy focus on its experimental multiple sclerosis treatment, remibrutinib. Chief Executive Officer Vas Narasimhan told CNBC that the drug could become “one of our largest medicines in history,” with the company projecting peak annual sales to top $4 billion in relapsing multiple sclerosis alone.
Patent Expirations and Market Expectations
The company recently reported revenue growth despite losing patent protection for its blockbuster heart treatment Entresto. However, analysts at Barclays pointed out that investors are already looking ahead to the next patent cliff around 2032, when key treatments Kisqali and Kesimpta face expiration. According to Barclays, these two drugs alone account for $18 billion in peak sales potential, making replacement therapies “the market’s bigger question.”
To address future growth, Novartis projects total remibrutinib sales could surpass $8 billion across multiple indications. Despite this optimism, Barclays recently reduced its sales forecast for the drug in relapsing multiple sclerosis following late-stage clinical trial results that showed lower relapse reduction than analysts had expected.
How Remibrutinib Compares to Current Treatments
Remibrutinib is part of a class of therapies called BTK inhibitors, which regulate immune system activity that damages nerves in multiple sclerosis patients without completely eliminating the cells. In contrast, existing monoclonal antibody treatments like Novartis’ Kesimpta work by depleting B cells involved in the autoimmune response.
Dr. Amit Bar-Or, a multiple sclerosis specialist at the University of Pennsylvania, told CNBC that while remibrutinib shows a promising safety profile, it appears less effective at preventing relapses than high-efficacy anti-CD20 therapies such as Kesimpta. However, he noted that the drug could offer significant potential if ongoing trials prove beneficial in progressive multiple sclerosis, where current treatment options remain limited. An ongoing trial evaluating remibrutinib in progressive multiple sclerosis is scheduled to deliver results in 2031.
A spokesperson for Novartis told CNBC that remibrutinib is intended to expand the company’s overall multiple sclerosis portfolio rather than replace Kesimpta sales. Novartis targets $6 billion-plus in peak annual sales for Kesimpta, alongside its $4 billion-plus forecast for remibrutinib in relapsing multiple sclerosis. The company plans to market remibrutinib to newly diagnosed patients, individuals taking generic oral drugs, and patients on anti-CD20 therapies who may want to switch.
Analyst Outlook and Additional Indications
Morningstar analyst Jay Lee told CNBC that Novartis’ peak sales forecast for remibrutinib in multiple sclerosis is “within the realm of possibility” but noted that it was not yet “de-risked.” Lee stated that market success will depend on competitive performance against rival drugs like Roche’s fenebrutinib, pricing negotiations, long-term patient retention, and clinical data supporting treatment switching.
“In the near term, I expect the largest market for remibrutinib will be the oral switch market, i.e. patients taking a generic oral treatment who need to switch, particularly due to tolerability reasons,” Lee said.
Investors are also watching the ongoing RESHAPE trial, which enrolled patients aged 40 to 70 taking Roche’s anti-CD20 treatment Ocrevus, with results expected in 2028. Lee explained that capturing market share from competitor drugs “may still work in Novartis’ favor if it means they gain overall RMS patient share from Roche, which currently leads the market.”
Beyond multiple sclerosis, remibrutinib has already received approval to treat specific forms of chronic hives. Novartis is also evaluating the medication for hidradenitis suppurativa, a chronic inflammatory skin condition, with late-stage clinical trial results expected prior to Nov. 19. Barclays estimates this additional indication could represent a $2 billion peak annual sales opportunity, though it assigns the drug a 50% probability of success due to unusual mid-stage trial dose responses and historical failures in that condition.
