A pharma giant is moving past one patent cliff
Disappointing data highlights Novartis' challenge to build its next generation of blockbuster medicines, following a series of clinical trial setbacks.
TL;DR
- Novartis CEO Vas Narasimhan believes remibrutinib could become one of the company's largest medicines, projecting over $4 billion in peak annual sales.
- Analysts have reduced peak sales forecasts for remibrutinib after late-stage trials showed it reduced relapses in MS patients less than anticipated.
- Novartis reported improved third-quarter profitability while facing patent expirations for major drugs like Entresto.
- The company is preparing to outline its long-term growth strategy amidst concerns about future patent cliffs for bestsellers Kisqali and Kesimpta.
- Experts suggest remibrutinib has a promising safety profile but may not be as effective as high-efficacy antibodies like Kesimpta for relapsing MS, though it could benefit progressive MS.
- Remibrutinib is a BTK inhibitor, aiming to regulate immune cell activity, distinct from Kesimpta's mechanism as a monoclonal antibody.
- Novartis sees remibrutinib as an opportunity to expand its MS portfolio, targeting newly diagnosed patients, those on oral treatments, and patients eligible for switching from anti-CD20 therapies.
- Analysts note that remibrutinib's success depends on its comparison with rivals like Roche's fenebrutinib, drug pricing, tolerability advantages, and its ability to facilitate patient switches from existing treatments.
- Remibrutinib is also approved for chronic hives and is being tested for hidradenitis suppurativa (HS), with analysts estimating a $2 billion peak sales opportunity in HS despite a lower probability of success.