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Sanofi-aventis: Encouraging First-Quarter 2008 Results Further Positive Phase III Results for Eplivanserin
Date:4/30/2008

-time awakenings reported by the patient at 6 and 12 weeks, versus placebo and improves the quality of sleep.

The results of the GEMS study also confirm the product's good tolerance profile versus placebo, with no residual effect on waking and with no rebound phenomenon nor withdrawal symptoms after treatment cessation, as already demonstrated in EPLILONG and EPOCH.

Sanofi-aventis also announces the results of the first phase III study (NOCTURNE) conducted with volinanserin (second 5-HT2A antagonist developed for the treatment of insomnia characterized by sleep maintenance difficulties / night-time awakenings) which showed that volinanserin significantly reduces WASO and the number of night-time awakenings (measured by polysomnography) at 3 and 6 weeks of treatment, versus placebo. The results also demonstrate the good safety profile of volinanserin versus placebo. Two other Phase III studies versus placebo are currently on-going.

Saredutant : the INDIGO study (EFC5574 in elderly) results on saredutant are also released today. The study did not reach significance versus placebo (same for the comparator).

It is notable that the effect size obtained in INDIGO is in the same range than that of the non-elderly population. The pooled analysis of all saredutant studies demonstrates a positive short term benefit on patients suffering from MDD as measured by the HAM-D score.

Results of the maintenance trial will be available in the second half of 2008. Trials associating saredutant with an SSRI are on-going.

As expected by its new MoA, saredutant lacks side effects frequently observed with current antidepressants. This was confirmed in the INDIGO elderly study.

Multaq(R) : the results of the ATHENA study, evaluating the potential benefits of Multaq(R) on morbidity and mortality, are due to be presented to the American Heart Rate Society in San Francisco on May 15, 2008 at 10.30 hours local time (19.30 hours CET).

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