Zimulti Acomplia News About Rimonabant Sales of Acomplia Lag, But Sanofi Still Has High Hopes for Rimonabant
With sales of Acomplia (rimonabant) lagging in the several dozen countries where it is on the market, Sanofi-Aventis executives had little to say about their pioneering obesity treatment in a report to analysts on Feb. 12th. But that hardly means they have given up on the CB-1 receptor antagonist.
Instead, Sanofi unveiled plans to make at least three presentations at major U.S. and European medical meetings during 2008 on the results of clinical trials of Acomplia (rimonabant) as a treatment for heart disease and diabetes.
And as a strong indication that the results Sanofi is seeing from the diabetes trials continue to look positive, the French pharmaceutical company reiterated that it plans to once again seek FDA approval of rimonabant (to be called Zimulti in the United States), this time for treatment of diabetes, in 2009.
So where do things stand on the hopes of millions of obese and overweight men and women that Acomplia (rimonabant) would become the next blockbuster drug for treatment of obesity?
Well, Sanofi reported that fourth quarter sales of Acomplia worldwide totaled 21 million Euros (approximately US $30.6 million) — unchanged from the 21 million Euros in sales that Sanofi reported for the third quarter of 2007.
Since that performance did not get Acomplia (rimonabant) even close to Sanofi’s list of its 15 best-selling drugs, the company’s executives blasted past it without any comment on the fact that sales of the diet pill are not growing.
But Marc Cluzel, Sanofi Senior Vice President Science and Medical Affairs, was far more upbeat about the future of the drug even though he managed during his presentation to never once mention the word “;obesity” or the other phrase Sanofi used to favor in talking about Acomplia (rimonabant), “metabolic syndrome.”
Cluzel said Sanofi would be making a presentation on its STRADIVARIUS study, evaluating rimonabant in atherosclerosis, at the American College of Cardiology’s scientific meeting in March 2008.
Atherosclerosis, commonly referred to as “hardening” of the arteries, often leads if left untreated to a heart attack or sudden cardiac death.
Cluzel said Sanofi would also be making a presentation in April 2008 to the European Atherosclerosis Society on its ADAGIO trial, evaluating rimonabant in patients with dyslipidemia. Dyslipidemia is elevation of plasma cholesterol or a low HDL level that contributes to development of atherosclerosis.
He said results of the ARPEGGIO study, evaluating rimonabant in combination with insulin for treatment of diabetes, will be presented to the American Diabetes Association at its annual meeting in June 2008.
Cluzel also said Sanofi is awaiting further recommendations from the FDA on the tracking during clinical trials of depressive side-effects associated with rimonabant — the problem that led in mid-2007 to Sanofi’s withdrawal of its application to have Zimulti approved for sale as an obesity drug in the U.S.
“ As for side effects, we are in conformity with FDA recommendations particularly when it comes to psychiatric effects, suicidal ideas are very much in the limelight, and of course, this applies for the whole class of CB1s as well as for antiepileptic drugs and antidepressives as a class,” Cluzel said.
“ So we are waiting to see what the FDA recommendations will be,” he added.
Метки:acomplia news, clinical, diet pill, drug, Europe, fda, obese, obesity, obesity drug, report, results, sales, side effects, study, weight, Zimulti
Посмотрите также
If you enjoyed this post, please consider to leave a comment or subscribe to the feed and get future articles delivered to your feed reader.
Comments
Еще нет комментариев.
Извините, комментирование на данный момент закрыто.