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Genzyme Study Shows Teriflunomide Lowers Annualized Relapse Rate In MS

Biotechnology firm Genzyme, a unit of French drugmaker Sanofi (SNY,SNYNF.PK), Friday reported positive top-line results from a study assessing the efficacy and safety of once-daily, oral teriflunomide in patients with relapsing forms of multiple sclerosis or MS.

In the phase III study, dubbed TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis), patients receiving teriflunomide 14 mg had a statistically significant reduction in annualized relapse rate and risk of sustained accumulation of disability.

The double-blind, multi-center trial enrolled 1,169 patients and compared once-daily treatment with 7 mg or 14 mg oral teriflunomide against placebo.

A 36.3 percent reduction in annualized relapse rate, the primary endpoint of the trial, was observed in patients who received teriflunomide compared to placebo.

Further, a 31.5 percent reduction in the risk of 12-week sustained accumulation of disability, which was the main secondary endpoint, was observed with teriflunomide compared to placebo.

A 22.3 percent reduction in annualized relapse rate was observed in patients treated with teriflunomide 7 mg compared to placebo. There was no statistically significant difference between teriflunomide 7 mg and placebo for the risk of 12-week sustained accumulation of disability.

The trial participants were followed for 48 to 173 weeks. The average duration of teriflunomide exposure in TOWER was 18 months.

Adverse events observed in the trial were consistent with previous clinical trials with teriflunomide in MS and included headache, Alanine transaminase elevations, hair thinning, diarrhea, nausea and neutropenia.

There was one death from a respiratory infection in the placebo arm and three deaths in the teriflunomide arms from a motor vehicle accident, suicide and sepsis.

Teriflunomide, with the proposed name AUBAGIO, is under FDA review as a potential treatment for relapsing forms of MS. Marketing applications for this investigational MS agent have also been accepted by the European Medicines Agency and other regulatory authorities.

Analysis of the full TOWER data is ongoing and results will be presented at a forthcoming scientific meeting.

Sanofi closed in Paris on Thursday higher by 0.92 percent at 55 euros on 7.78 million shares.

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