October 15, 2010
MS drug candidate meets final phase clinical trial goals
***********************************************************MS drug candidate meets final phase clinical trial goals
* MS drug cuts annualised relapse rate by 31 pct vs placebo
* 7 mg and 14 mg doses of teriflunomide well tolerated
(Adds detail from statement)
By Caroline Jacobs
PARIS, Oct 15 (Reuters) - Sanofi-Aventis (SASY.PA), locked in a battle to buy U.S. biotech Genzyme (GENZ.O), said its multiple sclerosis candidate drug teriflunomide significantly cut relapses in patients who took the once-daily oral treatment.
The outcome of the final phase clinical trial showed that two different doses of the drug cut the annualised relapse rate of the chronic disease by 31 percent against placebo and that patients tolerated both doses well, the French drugmaker said on Friday.
Sanofi's two-year trial data follows those of Genzyme, a rare disease specialist, showing in five-year clinical results that its MS experimental drug alemtuzumab or Campath continued to show strong efficacy with no new or worsening side effects. [ID:nN13242220]
Sanofi's so-called TEMSO trial also demonstrated that the risk of progression in disability fell 30 percent in patients who were given 14 mg of teriflunomide and was down 24 percent for those on half the dose.
Teriflunomide had no major safety concerns, according to Sanofi, which cited diarrhea and nausea in patients on the higher dose as well as alanine transferase increases that were mainly mild.
The study involved 1,088 patients who were either on 7 mg or 14 mg doses of teriflunomide or on a placebo.
"We are very pleased with the successful results of the TEMSO study which are an important step forward in multiple sclerosis clinical research," Sanofi's head of research Marc Cluzel said in a statement.
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