Novartis Multiple Sclerosis Pill Missed Expectations in Key Study
(Bloomberg) — Novartis AG’s experimental multiple sclerosis pill prevented fewer relapses than expected in two late-stage trials, potentially giving its cross-town competitor Roche Holding AG an advantage with a rival drug it’s developing.
Novartis’ medicine, which is already sold as Rhapsido to treat chronic hives, cut annual MS relapse rates by 35% and 31% compared with Sanofi’s Aubagio in the studies, Novartis said in a statement on Friday. That was below the roughly 50% reduction expected by analysts at BNP Paribas and weaker than the 51% and 59% reductions seen in trials of Roche’s experimental medicine, fenebrutinib.
Novartis’ American depositary receipts fell as much as 4.5% in New York trading on the news on Friday.
Reducing relapses by about one-third with Novartis’ drug is an important advance for patients with MS, said Robert Bermel, a neurologist at the Cleveland Clinic’s Mellen Center for Multiple Sclerosis, who helped lead the trials. He was particularly encouraged by the lack of any signal of liver damage in the trial.
“We are looking at something very good in both efficacy and the safety profile,” he said. The reduction in new lesions detected with advanced imaging “strengthens the evidence that the drug controls inflammatory disease activity,” he said. If approved, it could become an attractive initial treatment for patients who prefer an oral medication, he said.
The results are particularly important for Novartis after a string of clinical setbacks this fall. Rhapsido, known chemically as remibrutinib, met the main goal of the study, making it the company’s only recent positive late-stage trial readout. It didn’t significantly slow progression of the patients’ disability in the first months after treatment in the study, though there was a trend in a positive direction.
The drug is seen as a potential successor to the company’s blockbuster multiple sclerosis treatment Kesimpta, making it a key element of Novartis’ plans to handle key patent expirations early in the next decade.
Roche officials, meanwhile, were enthused about potential comparisons to its drug.
“Our efficacy is hard to beat,” Roche Chief Executive Officer Thomas Schinecker said during an earnings call on Thursday, the day before the results were released. That could create a potential opportunity for his company’s drug, Schinecker said.
(Updates throughout.)
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