Sanofi-aventis Announces 2007 Earnings Ahead of Guidance Sharp Rise in Propose...(g interaction. AVE5530 hasthe potential ...),Health

Date:2/12/2008

g interaction. AVE5530 has the potential to be used as monotherapy or in combination with statins. A phase III program comprising a number of trials, including an evaluation over a 12- month treatment period, will start in the second half of 2008. Filing for approval is scheduled for the second half of 2010, both as monotherapy and in fixed combination with a statin.

After consultation with the healthcare authorities, the phase III program for the GLP-1 agonist AVE0010 will begin in the first quarter of 2008. The program will include over 3,000 diabetic patients and will evaluate a once-a- day injection of AVE0010 in combination with the principal existing treatments (metformin, sulfonylurea insulin), as well as a comparison with exenatide and a monotherapy study. Filing for approval is expected in 2010. A prolonged release formulation is currently being evaluated in phase I.

Results from phase IIb trials of AVE2268, a new renal SGLT2 inhibitor, are due in the first half of 2008, with phase III scheduled to start in the second half of 2008. This product has a novel action, and is expected to improve glycemic control at all stages of diabetes.

The program to develop rimonabant in diabetes already includes 3,400 out of the planned total of 5,700 patients. Results of the ARPEGGIO study, evaluating rimonabant in combination with insulin, will be presented to the American Diabetes Association in June 2008. Filing for approval in type II diabetes is expected in 2009, followed by filing for a fixed rimonabant/metformin combination in 2010.

Results from the STRADIVARIUS study, evaluating rimonabant in atherosclerosis, will be presented to the American College of Cardiology in March 2008, and the results of the ADAGIO trial, evaluating rimonabant in patients with dyslipidemia, will be presented to the European Atherosclerosis Society in April 2008..

Enrolment of patients to the CRESCENDO morbidity/mortality study is ongoing. Over 14,000 out
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