Novartis’ experimental multiple sclerosis treatment remibrutinib met the main goal in two late-stage trials, while the drugmaker reported a steep quarterly decline in Entresto sales amid U.S. generic competition.
In REMODEL-1, patients taking remibrutinib averaged 0.073 relapses per year, compared with 0.112 for those taking teriflunomide, a 35.2% reduction. REMODEL-2 recorded rates of 0.080 and 0.116, respectively, a 31.2% reduction. Both primary-endpoint results were statistically significant, according to findings published in The Lancet. Novartis funded the trials, which enrolled 2,007 adults at 407 centers in 46 countries.
Reuters reported that analysts had expected relapse reductions of 45% to 60%. CNBC separately reported that Barclays lowered its peak-sales estimate after the detailed trial results, but did not give the revised figure. Novartis’ Oct. 23 investor presentation put potential peak sales above $4 billion for relapsing MS, with possible additional potential in nonrelapsing secondary progressive MS. The drug is not approved for MS; Novartis said it plans to seek regulatory approval worldwide.
Roche reported a 55% reduction in annualized relapse rates for its drug fenebrutinib in pooled Phase 3 results against teriflunomide. The drugs were tested in separate trials, so the figures do not establish which is more effective.
Entresto sales fell 38% year over year to $1.165 billion in the third quarter ended Sept. 30. Novartis cited generic competition, mainly in the United States. Kisqali sales rose 37% to $1.821 billion and Kesimpta sales increased 22% to $1.484 billion, both on a constant-currency basis.
Novartis’ 2025 filing says its U.S. combination patent for Entresto has expired. It lists EU regulatory data protection expiring in 2026 and a combination patent and supplementary protection certificate expiring in 2028. For Kisqali and Kesimpta, the filing lists U.S. patent-related dates in 2031 and a 2032 date for Kisqali in the EU. The company cautions that the dates do not establish when generic competition will begin and that competition could start earlier.
Companywide third-quarter sales rose 4% to $14.522 billion, and core operating income increased 11% to $6.036 billion. Reported operating income fell 59% and net income fell 70%; Novartis cited a $1.9 billion partial impairment charge for del-desiran among the reasons. It also said Phase 3 studies of del-desiran and pelacarsen missed their primary endpoints.
Novartis’ Meet Novartis Management event is scheduled for Nov. 18-19 in London. The company says it will discuss 2026-2031 midterm guidance and updated peak-sales potential for key growth drivers.
