Sanofi-aventis Announces 2007 Earnings Ahead of Guidance Sharp Rise in Propose...(Cardiovascular Results from the ATHEN...),Health

Results from the ATHENA study, assessing the potential morbidity/mortality benefits of Multaq(R) /Dronedarone, will be presented to the American Heart Rate Society at San Francisco in May 2008. A submission for approval by the healthcare authorities could be filed in mid-2008.

Phase IIb is ongoing for ilepatril, a novel anti-hypertensive for uncontrolled hypertension that inhibits ACE/NEP receptors. The final results will be presented to the American Heart Association at New Orleans in November 2008. The preliminary results are being used as the basis for ongoing discussions with the healthcare authorities on the phase III program.

The TAMARIS phase III program, a 1-year evaluation of the effectiveness of NV1FGF (a highly innovative gene therapy) in reducing the number of amputations in patients with critical lower limb ischemia, is under way. Filing for approval in this indication is scheduled for 2010.

Central Nervous System

Results from the EPLILONG phase III study demonstrate that eplivanserin, a 5-HT2A antagonist, significantly reduces WASO (Wake After Sleep Onset) and the number of nocturnal wakings reported by the patient at 6 to 12 weeks, compared with placebo.

This beneficial effect on sleep has also been confirmed by polysomnography in the results from the EPOCH phase III study, which showed that eplivanserin reduces WASO at 3 weeks (significant difference) and 6 weeks and nocturnal waking (significant difference at 3 to 6 weeks), versus placebo.

In both studies, eplivanserin demonstrated a good tolerance profile versus placebo with no residual effect on waking as measured by psychometric tests, and with no rebound phenomenon or withdrawal symptoms.

The GEMS phase III study, evaluating WASO at 12 weeks as reported by the patient, is ongoing. Filing for approval of Eplivanserin is scheduled for the second half of 2008.

The decision to file for approval of amibegron, a selective be
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