Sanofi's Genzyme unit announced Friday top-line data from a Phase III trial demonstrating that patients with relapsing forms of multiple sclerosis who received Aubagio (teriflunomide) achieved significant reductions in annualised relapse rates when compared to placebo. Genzyme CEO David Meeker said the findings "are consistent with the results on relapse rate and disability that were observed in the TEMSO study," which were released in 2010.
In the TOWER study, 1169 patients aged 18 to 55 years with relapsing forms of MS received treatment with one of two doses of Aubagio once-daily or placebo. Results of the trial showed that patients who took the higher dose of the oral drug had a 36.3 percent reduction in annualised relapse rate, the main goal of the study, compared to placebo. For the secondary endpoint of the risk of 12-week sustained accumulation of disability, a 31.5 percent reduction was seen for patients given the higher dose of Aubagio, versus placebo.
Genzyme noted that for the lower dose, a 22.3 percent reduction in annualised relapse rate was observed compared to placebo, while there was no significant difference between the oral drug and placebo for the risk of 12-week sustained accumulation of disability. The company indicated that full data from the study will be presented at a future medical meeting.
Cheuvreux analyst Marcel Brand said the results were positive and consistent with earlier data, "which is reassuring." Regulatory submissions for Aubagio as a treatment for relapsing forms of MS are currently under review, with the FDA expected to make a decision by July and the European Medicines Agency scheduled to provide feedback in the first quarter of 2013. If approved, Brand expects the therapy to generate peak sales of $1.8 billion in 2018.
According to JPMorgan analysts, the market for oral therapies for MS could grow to $14 billion in 2015, dominated by Novartis' Gilenya (fingolimod), which was approved in the US in 2010 and in Europe last year, and Biogen Idec's experimental agent BG-12 (dimethyl fumarate). Analysts suggest Aubagio could find a niche among newly diagnosed patients with MS.
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