Tuesday, August 15, 2006

Sanofi-Aventis Seeks to Shut Down News Coverage by the Acomplia Report

The French pharmaceutical giant, Sanofi-Aventis, is attempting to shut down news coverage by the Acomplia Report just as it prepares to seek regulatory approval for its highly touted diet drug Acomplia (rimonabant). The Acomplia Report has for the past year been the most comprehensive independent source of news and information about rimonabant, and Sanofi's action appears designed to shut off independent news coverage at a critical stage of the approval process.

(PRWEB) May 3, 2005 -- Sanofi-Aventis, developer of the much touted diet drug Acomplia, has announced its intention to try and shut down the independent Acomplia Report, denying hundreds of thousands of obese and overweight individuals this unbiased source of news about the drug and efforts to bring it to market.

In emails to Milton R. Benjamin, chief executive of Medical Week News, Inc., publisher of the Acomplia Report, Sanofi-Aventis has claimed that use of the name Acomplia Report "is definitely confusing" to readers insofar as "Acomplia and Rimonabant are clearly associated to Sanofi-Aventis Group."

The Sanofi-Aventis legal department in Paris has demanded that Medical Week News, Inc., agree to the "transfer of AcompliaReport to Sanofi-Aventis" by May 6th. Otherwise, it said it will "lodge a legal action" to take over the independent news site.

Benjamin, in responding to Sanofi-Aventis, said it would be difficult to see how Acomplia Report could be mistaken for an official Sanofi-Aventis publication since the top of each and every page of the Acomplia Report has always contained the subhead: "Your independent source of news and reviews about the new diet drug Acomplia (rimonabant)."

He also pointed out that each and every page of the Acomplia Report has always contained the disclaimer: "This is an independent news site reporting on rimonabant, a diet drug developed by Sanofi-Synthelabo Inc., which plans to market it under the trademarked name Acomplia. Nothing on this site is intended to infringe on that trademark."

"I do not think it is any coincidence that Sanofi-Aventis is trying to shut down independent coverage of Acomplia just as they are about to submit the drug to the U.S. Food and Drug Administration and European regulators for marketing approval," Benjamin said.

"During the past year, when they were presenting results from their clinical trials, they were more than happy to have the Acomplia Report help build excitement about the way rimonabant seemed to help many participants lose weight and curb smoking.

"Sanofi-Aventis made company executives and consultants available at medical meetings to assist the Acomplia Report, and notified us of impending news. They sure weren't voicing any specious trademark concerns then.

"So why, suddenly, are they trying to curb the flow of independent news about Acomplia? Well, they are about to seek FDA approval to sell the drug, and these discussions are expected to focus on poissible side effects. It would appear that Sanofi-Aventis is anxious to shut down the leading source of independent news about Acomplia," Benjamin said.

"We are simply amazed that Sanofi-Aventis has such little respect for Freedom of Speech and Freedom of the Press that it believes it can gain by trying to shut down a legitimate news site," said Benjamin, a former editor of The Washington Post and Newsweek.

"We have absolutely no intention of being intimidated by these demands from Sanofi-Aventis and intend to do everything in our power to continue bringing all the relevant news about Acomplia to people anxious for a new diet aid -- but equally interested in knowing about all the issues that come up during the regulatory approval process," Benjamin added.

Sunday, February 19, 2006

Acomplia receives FDA Approvable Letter

The US Food and Drug Administration has issued an approvable letter on weight management recently for Acomplia (rimonabant). In this approvable letter, don't confuse with a definitive approbation, the FDA spells out the steps Sanofi-aventis needs to take to win final approval for its new diet drug. Neither the company nor the FDA revealed the specifics of the letter.

In a press release issued in Paris, the company said "Sanofi-aventis will continue to work in close collaboration with the FDA." Sanofi-aventis also said the FDA issued a non-approvable letter for the indication of smoking cessation for Acomplia.

Just this week investigators for the RIO-North America trial reported in the Journal of the American Medical Association that a year of treatment with 20 mg of Acomplia was associated with an average weight loss of almost 14 pounds and a waist reduction of 2.4 inches, versus just under four pounds and less than an inch in the placebo group (P<0.001 for both).

Moreover, patients treated with 20 mg of Acomplia and calorie reduction for a year increased HDL cholesterol by 12.6% versus a 5.4% increase in the placebo arm (P<0.001) and decreased triglycerides by 5.3% versus a 7.9% increase for patients taking placebo (P<0.001).

In year two, 40% of patients maintained on 20 mg achieved "a weight loss of 5% or greater" compared with 19% of patients in the placebo arm (P<0.001), and 17% achieved weight loss of 10% or more versus 8% in the placebo arm (P<0.001).

Moreover, after two years, patients taking 20 mg of Acomplia were able to maintain a waist measurement that was about two inches smaller than baseline measurements, compared with a reduction of just 0.87 inches for those in the placebo arm (P<0.001).

Nonetheless, a high attrition rate -- 51% dropped out after a year -- led F. Xavier Pi-Sunyer, M.D., of the obesity center at St. Luke's-Roosevelt Hospital in New York and colleagues to conclude that more study is needed to finally confirm a long-term benefit for Acomplia, which is the first cannabinoid-1 receptor blocker.