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Sanofi-Aventis investors should brace for trading volatility next week when U.S. regulators reveal their review of the company's highly anticipated weight loss drug.

The French pharmaceutical company seeks Food and Drug Administration approval of Acomplia, a drug approved in Europe for fighting obesity.

The FDA is set to release its Acomplia review ahead of a Wednesday meeting at which outside experts will vote on whether it should be approved. The agency does not have to follow the experts' vote, though it often does.

The drug is considered a potential blockbuster despite hitting several regulatory bumps that have left some on Wall Street questioning its sales prospects.

"With the initial demand for Acomplia likely to be massive, the known neuropsychiatric side effects may make it difficult for the FDA to see a positive risk-benefit ratio," wrote Citigroup analyst Kevin Wilson in a Thursday note.

In recent weeks, the FDA has been widely criticized over a lag in getting new safety data about a GlaxoSmithKline diabetes drug to the public.

Analysts say that controversy might give regulators pause at approving a new drug with potentially dangerous side effects. Studies of Acomplia have shown instances of depression, insomnia and anxiety in patients who take it.

Wilson predicts that the FDA's review of the drug will likely focus more on safety than effectiveness, driving Sanofi's stock down in the first part of the week.

Sanofi originally touted Acomplia as both an anti-obesity pill and an anti-smoking treatment because it stops cravings associated with addictive behavior.

Last February, however, the FDA rejected the company's application for the anti-smoking use and said it needed more information before approving the drug to fight obesity.

The drug gained approval in the European Union soon after, but regulators there also did not approve the smoking use and limited approval to overweight patients who suffer additional health problems, including abnormal cholesterol and diabetes.

Even so, sales there soared to $20 million in the first quarter of 2007, and Sanofi said more than 130,000 people have used the drug since its European launch.

If approved in the U.S., Sanofi said it would market the drug under the name Zimulti, because FDA reviewers felt the name Acomplia could potentially mislead consumers.

Shares of Sanofi-Aventis rose 5 cents to $45.28 Friday in midday trading.

Source: http://www.chron.com/disp/story.mpl/ap/fn/4873677.html

Sanofi-Aventis announced the launch of Acomplia (rimonabant), their new scientific drug for the treatment of abdominally obese patients with cardio metabolic risk cluster.

Acomplia has received approval from the European Medicines Evaluation Agency (EMEA) to be used in combination with diet and exercise for the treatment of abdominal obesity with cardio metabolic risk cluster, and is already sold in over 12 European countries, including Germany and the UK.

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How is it possible that mid-sized Indian pharmaceutical companies are already selling their own versions of diet drug rimonabant in India while the original developer of the drug, Sanofi-Aventis, still doesn't have Indian government approval to sell Acomplia?

Well, part of the answer may be that Sanofi was so focused on getting approval to sell the drug in Europe (where Acomplia went on sale last summer) and in the United States (where it still awaits regulatory action) that the French pharmaceutical giant was late in filing for marketing authorization in India.

While a Sanofi spokesperson said the company filed last summer with India's Central Drugs Standard Control Organization, which regulates the market authorization of new drugs as well as the standards for imported drugs, Sanofi confirmed that the Indian regulatory agency has not yet acted on Acomplia.

"It's too soon to tell what will be our strategy regarding the launch of Acomplia in India,'' a Sanofi spokesperson told Bloomberg News last week.

Given the relatively high cost of the drug -- generally somewhat more than US$100 per month -- in the dozen plus countries where Acomplia is already on sale, Sanofi may have thought the number of Indians who would be able to afford a price of this magnitude would be relatively small.

But in the meantime, Indian pharmaceutical companies that seem to have replicated Sanofi's version of the rimonabant molecule -- which apparently was never granted patent protection in India -- independently filed with the regulatory agency and received approval to sell their own versions of the drug.

With at least two companies -- Torrent Pharmaceuticals and Zydus Cadila -- already selling Rimoslim and Slimona in India for under US$6 per month, the market for rimonabant in a country that has a growing urban, middle-class obesity problem may turn out to be significantly greater than Sanofi believed.

Source: http://www.dietdrugreport.com/News/news-052707.htm

Sanofi-Aventis said that Switzerland''s regulatory body Swissmedic has approved anti-obesity drug Acomplia for sale in the country.

Sanofi-Aventis said the regulator has authorised the use of the drug for "for obese patients (Body Mass Index - BMI - greater than or equal to 30 kg/m2) or for overweight patients (BMI greater than or equal to 27 kg/m2) with at least one associated cardiovascular risk factor, after insufficient weight reduction following physical activity or alimentary adaptation.

Physicians in Switzerland may prescribe the 20 mg once-daily pill along with a light diet and physical activity for obese or overweight patients with at least one associated cardiovascular risk factor and after insufficient weight reduction following physical activity or food adaptation.

Source: http://www.businessportal24.com/

While Sanofi's diet drug Rimonabant (Acomplia / Zimulti) remains stalled at the FDA, a potential competitor currently in phase III trials, Merck's MK-0364, now has an official generic name: Taranabant.

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When Sanofi-Aventis SA reported data on a new obesity pill at a medical conference in March 2004, it generated instant buzz.

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Sanofi-Aventis said on Monday a U.S. panel of health experts would review its anti-obesity pill Acomplia in June, a move which analysts said caused new concerns over whether it would win U.S. marketing approval by the Food and Drug Administration.

Shares in the French drugmaker lost as much as 2 percent and were off 1.5 percent at 64.39 euros by 1454 GMT, while the DJ Stoxx European health sector index fell 0.5 percent.

"It (the panel meeting) indicates there are more question marks or concerns that need to be ironed out in a broader forum. It's a way for the FDA to hedge itself," Karl Heinz Koch, analyst at Vontobel said.

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Acomplia was a ground-breaking new breed of medication which targeted the body’s little understood endocannabinoid system when it was launched in the UK last June but it could soon have one or more rivals. Both Merck and Pfizer have similar drugs in Phase III clinical trials which are said to be producing very promising results. Merck has already announced that it intends to apply for regulatory approval in 2008 and it is believed that Pfizer will be aiming to seek approval at around the same time. There is another drug which works in a similar way to Acomplia under development by Bristol Myers Squibb but it is believed that the development of this product is significantly behind those of Merck and Pfizer.