Biogen Idec and Sanofi have presented promising data on their respective oral multiple sclerosis treatments as the race to provide competition to Novartis' pill Gilenya hots up.
First up, Biogen issued a summary of new data from the DEFINE study on BG-12 (dimethyl fumarate) released ahead of the ECTRIMS meeting in Amsterdam later this month. Investigators said BG-12 had a favourable safety and tolerability profile at two years, and patients who received two or three daily doses of the drug saw a reduced rate of relapse versus placebo.
Biogen first released details about the study in April and analysts have reacted positively to the update. Geoffrey Meacham at JPMorgan was quoted as saying that "as of right now, BG-12's overall clinical profile does appear to be shaping up nicely" as the data suggest a "fairly clean" safety profile.
ISI Group's Mark Schoenebaum said that given the absolute relapse reduction seen with BG-12, "we feel more confident about a positive outcome" in the CONFIRM study. That trial compares BG-12 with Teva's injectable blockbuster Copaxone (glatiramer acetate) and the data, expected by the end of the year, are expected to form the basis for filings in the first half of next year.
Meantime, Sanofi has announced the publication of a Phase III study of its investigational once-daily oral medication teriflunomide in the New England Journal of Medicine. The results from the TEMSO data showed that teriflunomide significantly reduced the risk of annual relapses, the primary endpoint, by 31% for 7mg and 14mg doses.
The drug also reduced disability progressions and improved several magnetic resonance imaging measures of disease activity, including new or worsening brain lesions. Sanofi noted that in the two-year study, teriflunomide has a well-characterised safety profile, "with a similar proportion of trial participants reporting adverse events compared to placebo".
Teriflunomide was filed with the US Food and Drug Administration in August this year and the European filing is expected in the first quarter of 2012. At the moment, the only MS pill on the market is Novartis' Gilenya (fingolimod).