Acomplia Receives EU Marketing Authorization

http://www.expresspharmaonline.com/

"Sanofi-Aventis announced that the European Commission has granted marketing authorisation for Acomplia (rimonabant, 20 milligram per day) in all 25 European member states. Acomplia, discovered and developed by Sanofi-Aventis, is the first in a new class of drugs called CB1 blockers. Acomplia is indicated as an adjunct to diet and exercise for the treatment of obese patients, or overweight patients with associated risk factors, such as Type 2 diabetes or dyslipidaemia.

The marketing authorisation was based on the review of comprehensive efficacy and safety data, including data from the RIO clinical trial programme which involved more than 6,600 patients worldwide, of which over 4, 500 were studied for up to two years. Results from the RIO programme demonstrated that one Acomplia 20 milligram tablet taken every day significantly decreased weight and waist circumference, HbA1c, and triglycerides and increased HDL-cholesterol levels. Importantly, the label granted by the European Commission states that an estimated 50 percent of the observed improvements in HbA1c, HDL-cholesterol and triglycerides were beyond that expected from weight loss alone.

"The approval of Acomplia in the European Union is important news for obese and overweight patients with additional cardiometabolic risk factors such as Type 2 diabetes or dyslipidaemia, who will now have access to an innovative treatment option," said Jean-François Dehecq, Chairman and Chief Executive Officer of Sanofi-Aventis. "


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Sanofi To Regroup Around Acomplia

http://www.marketwatch.com/
"But Friday, Sanofi-Aventis said it hopes to start marketing the drug as a weight-loss treatment in the U.S. in the second half of 2006.

"It's possible that the product will be launched before the end of 2006," Sanofi-Aventis' director for research Gerard le Fur told reporters.

Gbola Amusa, an analyst with Sanford C. Bernstein in London, said "Acomplia represents a paradigm shift in the way weight and cardiovascular risks are managed - it's the first weight-loss drug where the disease pathway is mechanistically clear, and the drug has been developed to address the underlying pathology in the body."

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Accomplia Might Be Significantly Delayed

http://www.pharmaceutical-business-review.com/
"Sanofi-Aventis had hoped to launch Accomplia (rimonabant) in the second quarter of 2006, but this could now be significantly delayed. The extent of the hold-up is unclear as the company has not yet been revealed what information the FDA has requested. It could take as little as a few weeks to provide the data necessary for approval, or the drug could not reach the market for years.

Acomplia was hailed as one of Sanofi-Aventis' most promising pipeline candidates. Benefiting from strong efficacy data from long-term obesity trials, suggesting superiority to currently marketed weight-loss treatments, it was expected to prove highly successful. However, the potential development of hyperalgesia had already been identified by Datamonitor as a concern that would require further investigation. Although this could be behind the FDA's decision, the cause of the delay has yet to be confirmed.

The weight-loss indication would also have benefited the drug's use in smoking cessation, as giving up tobacco is often associated with weight gain. However, this revenue stream has now been lost as the FDA has refused Sanofi-Aventis' application in this indication completely. "

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Acomplia: The Markets React

http://www.businessweek.com/

"Investment firm Citigroup reacted and downgraded Sanofi-Aventis to "Sell" from "Hold," while Prudential Equity Group held its "Neutral Weight" rating, calling the outcome a likely one.
Citigroup analyst Amit Roy downgraded the drug maker, citing a delayed release of the drug and a possible FDA advisory panel meeting to address safety concerns. Also, the delay and possible speed bumps to approval better position competition from generic versions of blood thinners made by Sanofi-Aventis' and Bristol-Myers Squibb Co. that are believed to encourage weight loss, Roy said.

In a research note, Prudential analyst Tim Anderson said indications the drug may be launched in the second half of the year came as a surprise, as he had forecast a second-quarter launch for weight loss."
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Possible Reasons For Rimonabant Delay

http://pipeline.corante.com/
"You see, the problem is, I did the first half of my career in CNS drug discovery. Drugs that act on central nervous system receptors can do all kinds of odd stuff, and we most definitely do not know enough about brain chemistry to predict what those interesting surprises might be. The endocannabinoid receptor that rimonabant targets is very much an evolving story - it's even less worked out than the other brain targets. The thought of a CNS drug whose target is relatively less well understood than the others should be enough to make anyone gaze thoughtfully out the window for a bit.

The field has other brisk and tangy qualities. For example, the patient population tends to have an alarmingly heterogeneous response to CNS drugs, as a look at the antipsychotic and antidepressant markets will show you. Drugs that work fine for one person do nothing for another, and we don't yet know why. I can see no reason why rimonabant should be any different."

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Sanofi Shares Fall 4.5% After Acomplia Ruling

http://www.bloomberg.com/
"Sanofi-Aventis SA shares fell as much as 4.5 percent after U.S. regulators delayed a final decision on whether to clear the French drugmaker's Acomplia drug for weight loss and rejected it to help smokers quit.

The stock fell 3.9 percent to 71 euros as of 9:11 a.m. in Paris trading, the sharpest drop in eight months. The U.S. Food and Drug Administration issued a so-called approvable letter, which outlines conditions to be met before Acomplia can be cleared for sale as a diet drug, the Paris-based company said on Friday. Sanofi said it will continue work with the FDA, which also issued a rejection letter for the anti-smoking indication. "


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The FDA Approval Letter For Acomplia / Rimonabant

http://www.medpagetoday.com/
"The FDA issued an approvable letter on weight management today for Acomplia (rimonabant), spelling out the steps Sanofi-aventis needs to take to win final approval for its much-heralded 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"

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Test From The Sanofi / Rimonabant Press Release

http://www.prnewswire.com/=
"Sanofi-aventis announced today
that it has received from the U.S. Food and Drug Administration (FDA),
Division of Metabolism and Endocrinology Products an approvable letter for
rimonabant for weight management, and from the Division of Anesthesia,
Analgesia and Rheumathology Products a non approvable letter for smoking
cessation.
Sanofi-aventis will continue to work in close collaboration with the FDA.
Rimonabant is the first in a new class of therapeutic agents called CB(1)
blockers."

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Acomplia / Rimonabant Turned Down For Smoking Cessation

http://www.philly.com/
"In studies, Acomplia doubled the quit rate of smokers. And those who kicked the habit while taking rimonabant gained only about a pound, compared with six pounds gained by smokers who stopped while on a placebo, research showed.
Acomplia's most common side effects are nausea, dizziness and diarrhea. The drug also can affect mood. Depression and anxiety, while not common, did occur at higher rates than on a placebo in tests."

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Acomplia Press Release

http://www.onlypunjab.com/

Mentions that patients lost about 10% of body weight with Acomplia and 11.6% of study participants had to drop out.

Acomplia

Acomplia: You Can Lose Weight and Stop Smoking (or both) with 1 Miracle Drug!!!

The word is out around the world about the newest miracle drug Acomplia. Developed by French Drug Maker Sanofi-Synthelabo, Acomplia has also been called the anti-Marijuana, because where Marijuana gives folks the "munchies", Acomplia blocks the ability to receive these "munchy" signals. By blocking the body's ability to receive the signals telling it that it needs to eat or smoke, Acomplia (Rimonabant) allows people to lose their cravings either to overeat or to smoke (or both simultaneously). Both smokers and overweight people have overstimulated Endocannabinoid Systems. The Endocanabinoid System is a natural physiological system that believed to play a role in maintaining energy balance through the regulation of food intake and energy expenditure. Acomplia selectively blocks some of the receptors in the Endocannabinoid System which puts the system in proper balance.

This drug will be available in America as early as February 2006. In America, the drug will be sold under the name "Acomplia", not Rimonabant.

It is clear that Acomplia will be one of the most significant drugs ever created that will address critical needs of the public. Viagra (followed by Levitra and Cialis) revolutionized treatment for male sexual dysfunction. Phentermine is the most popular diet drug worldwide. Soon, Acomplia will revolutionize how the world treats two
significant health issues - stopping smoking and losing weight.

http://www.attheplace.com/
is be the #1 website for Acomplia information. Check this site often for updates concerning Acomplia the soon to be available 2 in 1 Wonder Drug.