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Aubagio® Significantly Reduced Risk Of New Clinical Relapse Or MRI Lesion In Multiple Sclerosis Study

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today positive new data from the TOPIC study of its once-daily, oral Aubagio ® (teriflunomide). These new data, presented today at the 29 th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS), include the following:

  • Aubagio 14 mg significantly reduced the risk of a new clinical relapse or MRI lesion over the two-year study period. There was a 35 percent reduction among patients who received Aubagio 14 mg compared to placebo (p=0.0003).
  • As measured by MRI over the two-year study period, there was a 5 percent increase in total lesion volume among patients treated with Aubagio 14 mg compared to a 28 percent increase among patients treated with placebo (p=0.0374). In addition, there was a 59 percent reduction in gadolinium-enhancing T1 lesions among patients treated with Aubagio 14 mg compared to placebo (p=0.0008).

Similar results were observed for the 7 mg dose, though the effects did not achieve statistical significance on some endpoints.

The TOPIC trial was designed to assess whether early initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack, i.e., conversion to clinically definite multiple sclerosis (CDMS).

As previously announced, patients receiving Aubagio 14 mg and 7 mg in the TOPIC trial were significantly less likely than placebo to develop CDMS, the primary endpoint. Compared to placebo, Aubagio 14 mg reduced the risk of conversion to CDMS by 43 percent.

“The findings presented today are encouraging, as they are in line with the body of evidence supporting the value in treating MS early,” said Dr. Aaron E. Miller, Medical Director, The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai Medical Center. “ These results demonstrate Aubagio’s consistent efficacy and safety across a spectrum of MS patients.”

The average duration of Aubagio exposure in TOPIC was approximately 16 months. Adverse events observed in the trial were consistent with previous clinical trials with Aubagio in MS. The most common types of adverse events reported more frequently in the Aubagio arms were ALT (Alanine aminotransferase) elevations, headache, hair thinning, diarrhea, paresthesia and upper respiratory tract infection. There were no deaths reported in either Aubagio group over the course of the study. There was one death due to suicide in the placebo arm. The rate of treatment discontinuation due to adverse events was similar across treatment arms (9.9 percent in placebo arm, compared to 12.1 percent in 7 mg Aubagio arm and 8.3 percent in 14 mg Aubagio arm).

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