Novartis backs remibrutinib for $4bn-plus sales as next patent cliff looms
Novartis is betting on experimental MS drug remibrutinib for $4bn-plus in peak annual sales, while analysts warn of a patent cliff for Kisqali and Kesimpta around 2032.
At a glance
- Novartis backs experimental MS drug remibrutinib for more than $4 billion in peak annual sales, CEO Vas Narasimhan told CNBC.
- Barclays cut its remibrutinib peak-sales forecast after late-stage trial results fell short of expectations.
- Kisqali and Kesimpta face patent expirations around 2032, representing $18 billion in combined peak sales, Barclays says.
Novartis CEO Vas Narasimhan told CNBC on Tuesday that the Swiss drugmaker's experimental multiple sclerosis treatment remibrutinib could become "one of our largest medicines in history", as the company backed it for more than $4 billion in peak annual sales.
The vote of confidence came days after Barclays cut its own peak-sales forecast for the drug. Detailed results from two late-stage trials showed remibrutinib reduced relapses in MS patients by less than analysts had expected.
Patent cliff ahead
The mixed picture matters because Novartis is preparing to set out its long-term growth strategy in mid-November. The company reported sales growth this week even after losing patent protection for its blockbuster heart drug Entresto. But Barclays analysts said investors are already focused on the next set of expirations: bestsellers Kisqali and Kesimpta lose patent protection around 2032, representing $18 billion in combined peak sales.
Novartis has guided for more than $8 billion in total remibrutinib sales, including uses beyond relapsing MS.
Amit Bar-Or, a multiple sclerosis specialist at the University of Pennsylvania, told CNBC that remibrutinib had a promising safety profile but was unlikely to control relapsing MS as effectively as high-efficacy antibodies such as Novartis' own Kesimpta. He said the drug's biggest chance to expand the market could come if ongoing trials show a benefit in progressive MS, where treatment options remain limited.
How the two drugs differ
Remibrutinib is a BTK inhibitor, designed to reduce the immune activity that damages nerves in MS patients. Kesimpta is a monoclonal antibody that binds to the CD20 protein and depletes the B cells involved in the autoimmune response. Remibrutinib instead aims to regulate those cells without eliminating them.
Bar-Or said remibrutinib's relapsing MS results look similar to Roche's rival BTK inhibitor fenebrutinib but weaker than anti-CD20 treatments at preventing relapses. No head-to-head trials have compared them, making direct comparisons difficult. A trial testing remibrutinib in progressive MS is expected to read out in 2031.
A Novartis spokesperson said the company sees remibrutinib mainly as a way to expand its MS portfolio rather than replace Kesimpta, targeting newly diagnosed patients, people on oral treatments and anti-CD20 patients who could switch. Novartis projects $6 billion-plus in peak sales for Kesimpta alongside $4 billion-plus for remibrutinib in relapsing MS.
Morningstar analyst Jay Lee told CNBC the $4 billion-plus forecast was "within the realm of possibility" but not "de-risked", depending on comparisons with fenebrutinib, pricing negotiations, tolerability and whether trials support switching patients. He expects the oral switch market to be the drug's largest near-term opportunity.
Investors are watching the RESHAPE trial, which enrolled patients aged 40 to 70 taking Roche's Ocrevus and is due to read out in 2028. Remibrutinib is already approved for some forms of chronic hives, and a late-stage trial in the skin condition hidradenitis suppurativa is expected to read out before Nov. 19. Barclays sees a $2 billion peak sales opportunity there but gives it only a 50% chance of success.
Source: CNBC.
Questions and answers
- What is remibrutinib?
- Remibrutinib is Novartis' experimental BTK inhibitor for multiple sclerosis. It aims to regulate immune cells rather than eliminate them, unlike anti-CD20 antibodies such as Kesimpta.
- How much could remibrutinib earn for Novartis?
- Novartis has guided for more than $8 billion in total peak sales, including $4 billion-plus in relapsing MS and potential use in other conditions. Barclays has cut its own forecast for the drug.
- Which Novartis patents expire around 2032?
- Bestsellers Kisqali and Kesimpta lose patent protection around 2032, a combined $18 billion in peak sales, which Barclays calls the market's bigger question.
