Biogen, Sanofi ($SNY) and Novartis ($NVS) are all trumpeting new data showing long-term benefits for their respective meds at this year's European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting--and with tough new competition on the way, they may need it.
In the case of Biogen ($BIIB), its latest analysis of Phase III data for oral treatment Tecfidera revealed that the reduction in MS relapses and delay in disability progression in early-stage patients were sustained over 6 years of follow-up. Tecfidera is also more likely to keep patients free of inflammatory disease activity than top-selling MS treatment Copaxone from Teva, new data showed.
Sanofi had similar news to report, announcing on Thursday that 5-year investigational data from an extension study of Lemtrada had shown favorable results. The positive effects observed in its two-year trials--including low yearly relapse rates and a slowing of brain volume loss--continued through the study's additional three years, its rare-disease unit, Genzyme, said in a statement.
Meanwhile, Biogen's rival pillmaker Novartis announced its own new analysis on Gilenya, taking a look at the proportion of Gilenya patients hitting the "no evidence of disease activity" mark every year over 7 years. In the first year of Gilenya treatment, 27.1% of patients hit that target, compared with 9.1% on placebo. Switching from placebo to Novartis' treatment after year two doubled the proportion of patients who reached the threshold, and of those taking Gilenya the whole way through, 31.2% to 44.8% reached the milestone in years three through 7.
MS drugmakers, already competing in a crowded landscape, will need all the positive data they can get as they prepare to take on new arrivals. Roche's ($RHHBY) candidate med, ocrelizumab, has already impressed in Phase III, and its two-administrations-a-year dosing regimen has helped earn it a reputation as a better version of Biogen standby Tysabri, Bernstein analyst Tim Anderson wrote to clients in September. If its safety and efficacy data match that of Tecfidera and Gilenya, "why can't it compete as a first-line therapy?" he asked.
And as of last week, the field could be facing generic oral competition sooner than it anticipated, too. The U.S. Patent Trial and Appeal Board nixed a patent on Gilenya, increasing the chances that the med will go generic in 2019 "with multiple entrants," Bernstein analyst Ronny Gal predicted.
- read Biogen's release
- read Sanofi's release
- read Novartis' release
Special Report: The top 10 best-selling multiple sclerosis drugs of 2013 - Gilenya - Tecfidera