Novartis CEO Vas Narasimhan expressed confidence in remibrutinib, the company's experimental multiple sclerosis drug, telling CNBC on Tuesday that it could become "one of our largest medicines in history" with potential peak annual sales exceeding $4 billion [1]. However, this optimism contrasts sharply with analyst skepticism following late-stage clinical trial results that showed the drug reduced relapses in relapsing MS patients by less than expected [1]. Barclays subsequently cut its peak sales forecast for remibrutinib after detailed trial data emerged [1].
The remibrutinib development comes as Novartis navigates a critical juncture in its patent portfolio. The company reported improved profitability in the third quarter while emerging from what it describes as "the steepest patent cliff in its history," marked by the loss of key patent protection for blockbuster heart drug Entresto [1]. However, Barclays analysts identified an even more pressing concern: the next patent cliff looming around 2032, when bestsellers Kisqali and Kesimpta face patent expirations representing $18 billion in combined peak sales [1]. Despite analyst concerns about remibrutinib's efficacy in relapsing MS, Novartis has guided for $8 billion-plus in total sales across multiple indications [1].
From a clinical perspective, remibrutinib belongs to the BTK inhibitor class of medicines designed to reduce immune system activity that damages nerves in MS patients [1]. According to Amit Bar-Or, a multiple sclerosis specialist at the University of Pennsylvania, remibrutinib offers a promising safety profile but is unlikely to control relapsing MS as effectively as high-efficacy antibodies like Novartis' own Kesimpta, which works through a different mechanism by depleting B cells [1]. Bar-Or noted that remibrutinib's biggest market expansion opportunity could emerge if ongoing trials demonstrate benefits in progressive multiple sclerosis, where treatment options remain limited [1]. The company is scheduled to outline its long-term growth strategy in mid-November [1].
CONCLUSION
Novartis faces a mixed outlook with remibrutinib: while CEO confidence and potential $8 billion+ peak sales across indications suggest significant upside, analyst skepticism following underwhelming relapsing MS trial results and the looming 2032 patent cliff for $18 billion in peak sales from Kisqali and Kesimpta create substantial near-term headwinds. The drug's ultimate value may hinge on demonstrating efficacy in progressive MS, where unmet medical needs are greater.