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Key dates and milestones

Summary of the key dates and milestones in the development of ACOMPLIA® (rimonabant).

1994

Characterization of rimonabant (SR141716) by sanofi-aventis researchers.

1999

Phase II clinical studies initiated.

2001-2005

Enrolment in the RIO (Rimonabant In Obesity) program begins. The program was established to assess the safety and efficacy of ACOMPLIA® in more than 6,600 patients across four phase III studies: RIO-Diabetes, RIO-Lipids, RIO-North America and RIO-Europe.

Q2 2005

1-year results from the RIO-Europe study published in The Lancet(1)

Q2 2005

Results from the RIO-Diabetes study are presented at the 65th Annual Scientific Sessions of the American Diabetes Association(2)

Q2 2005

ACOMPLIA® (rimonabant) filed with FDA and EMEA.

Q4 2005

Results from the RIO-Lipids study are published in The New England Journal of Medicine

Q1 2006

Results from the RIO-North America study are published in The Journal of the American Medical Association(4)

Q3 2006

European Commission grants marketing authorization in the European Union for ACOMPLIA® as an adjunct to diet and exercise for the treatment of obese patients (BMI = 30 kg/m2), or overweight patients (BMI = 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia.

References:

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(1)Van Gaal et al. Effects of the cannabinoid-1 receptor blocker rimonabant on weight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet. 2005 Apr 16-22;365(9468):1389-97.

(2)Data presented at the American Diabetes Association's 65th Annual Scientific Sessions on June 12, 2005

(3)Després, J.P. et al. Effect of Rimonabant on Body Weight and the Metabolic Syndrome in Overweight Patients. New England Journal of Medicine, November, 16, 2005.

(4)Pi-Sunyer, F. X. et al. Effect of Rimonabant, a Cannabinoid-1 Receptor Blocker, on Weight and Cardiometabolic Risk Factors in Overweight or Obese Patients RIO-North America: A Randomized Controlled Trial. Journal of the American Medical Association, February 15, 2005