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Sanofi-Aventis throws its weight behind Acomplia

Published on 05/12/05 at 12:22pm

Sanofi-Aventis is gearing up for the launch of its potential blockbuster Acomplia, a drug which the company wants to promote as a breakthrough in cardiovascular medicine.

The company has invested a great deal of time and money in preparing Acomplia (rimonabant) for market, its first major launch since the merger of Sanofi-Synthelabo and Aventis in 2004.

The drug's mechanism is truly innovative, being the first ever treatment

to block endogenous cannabinoid binding to neuronal CB1 receptors - by blocking this process the drug inhibits appetite and leads to weight loss.

The company hopes it has succeeded in demonstrating that this weight loss in turn helps patients control a range of cardiovascular factors which lead to serious conditions such as heart attacks, strokes and diabetes.

Acomplia was filed with European and US regulators in June and if approved, could be launched in the first half of 2006, with analysts anticipating peak sales in excess of $1 billion.

Since filing, Sanofi-Aventis has continued to publish new findings, with the latest RIO-LIPIDS trial data showing the drug's efficacy in lowering triglyceride levels and increasing levels of good HDL cholesterol.

The trial also found reductions in waist circumference and body weight, improved glucose tolerance and decreased blood pressure.

Sanofi-Aventis' research is at the cutting edge of cardiovascular disease, measuring a number of emerging markers influencing cardiovascular health, though their action is still not entirely understood.

One of these markers is adiponectin, a protein associated with reduced risk of diabetes and heart disease and a reduction in C-Reactive Protein (CRP), a marker for inflammation associated with cardiovascular risk.

"One of the most noteworthy findings of the trial is the evidence that rimonabant, through its effects in peripheral tissues significantly increases adiponectin levels (produced by fat cells) beyond what could be expected from weight loss alone," said Jean-Pierre Despres, director of research at the Quebec Institute and principal investigator on the RIO-LIPIDS trial.

"This provides evidence for the potential of rimonabant to improve multiple cardiometric risk factors in patients with excess abdominal adiposity and other co-morbidities such as diabetes or dyslipidaemia."

Sanofi-Aventis is positioning the drug as the first ever comprehensive management approach to cardiovascular risks such as dyslipidaemia, abdominal obesity and insulin resistance - part of the so-called metabolic syndrome observed in patients before they have more advanced symptoms of diabetes and heart disease.

Sanofi-Aventis estimates that about 50 million Americans have metabolic syndrome and looks set to communicate directly with patients in the US when the drug is launched, encouraging them to measure their waist circumference.

The measurement is a much more accurate indicator of risk from type II diabetes and heart disease than the commonly used Body Mass Index (BMI) system. The company's research shows just 1% of the population measure their waist -encouraging more to do so could boost those prescribed Acomplia in the long term.

Acomplia has attracted a great deal of media interest around the world, including the UK. In January this year, the MHRA cleared Sanofi-Aventis of promoting the drug before launch following a complaint relating to articles about the drug in a number of national newspapers.

It ruled that Sanofi-Aventis had merely provided the media with an update on its development.

The company's primary target is of course doctors, and it says it has developed 2,100 thought leaders across major markets, with an accompanying large-scale medical education programme in place.

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