Sanofi oral MS drug Aubagio shows strong efficacy in Ph III trial; plans massive Indian vaccine plant

French drug major Sanofi (Euronext: SAN) and its subsidiary Genzyme says that the results of a pivotal Phase III TEMSO study with investigational once-daily oral multiple sclerosis drug Aubagio (teriflunomide), published in The New England Journal of Medicine (NEJM), showed that teriflunomide at the 14mg dosage significantly reduced the annual relapse rate, reduced disability progressions and improved several magnetic resonance imaging (MRI) measures of disease activity, including new or worsening brain lesions.

Teriflunomide, for which peak annual sales in excess of $450 million have been forecast, has a well-characterized safety profile, with a similar proportion of trial participants reporting adverse events compared to placebo, the companies noted. However, assuming it gains regulatory approval, it will be a relatively late comer to the oral MS drug market, where Novartis was the first to gain approval of such a drug with its Gilenya (fingolimod), which was cleared for marketing in the USA last year (The Pharma Letter June 11) and in Europe this spring (TPL March 21).

"The TEMSO data demonstrate the effect of teriflunomide in terms of reducing relapse rates, disability progression and Magnetic Resonance Imaging (MRI) lesions," said Paul O'Connor, Director of the MS Clinic at St Michael's Hospital, Toronto, Canada and principal investigator in the TEMSO study quoted by Sanofi, adding: "These results, sustained over two years, provide clinically meaningful data for teriflunomide."