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2007/7/27

Diet Drug Acomplia Sales Dwarfed by Initial Sales of Diet Pill alli

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@ 09:21 PM (12 months, 3 days ago)

Just how badly sales of diet drug Acomplia (rimonabant) have been set back by Sanofi's inability to bring it to the U.S. market was dramatically illustrated July 25th when GlaxoSmithKline revealed initial launch results for over-the-counter diet pill alli (low-dose Xenical).

Sales of non-prescription alli totaled a surprising $156 million in the weeks after its U.S. launch in mid-June -- a sales surge that dwarfs the monthly sales of Acomplia in all the countries where it is on the market in the European Union.

If most of the alli sales were to people initially buying a one-month supply of the over-the-counter diet pill, the sales figure would suggest that more than 1 million Americans decided to try the first FDA-approved non-prescription weight-loss product in its first weeks on the market.

By contrast, in the European Union, where Acomplia was approved for sale last summer, somewhere between 100,000 and 200,000 are believed to have tried it over the course of a year.

Sanofi had initially hoped that Acomplia -- which was to be sold in the United States as Zimulti -- would be a blockbuster drug with sales that could even exceed $5 billion worldwide.

But without the U.S. market, it appears that Sanofi will be fortunate if sales in Europe and other countries where it has been approved total one-tenth of that.

Glaxo, in announcing sales results for alli as part of its report on second-quarter earnings, said its big advertising and promotion campaign paid off with more than 2.4 billion media mentions since the FDA approved sale of the diet pill in February.

Glaxo also said that it had recorded more than 4.5 million visits to its website -- myalli.com -- making it the third-most visited website for any over-the-counter pharmaceutical product.

Acomplia is currently marketed in 13 European Union nations as well as in Argentina, Mexico and a handful of other countries.

Source: http://www.acompliareport.com/

2007/7/22

European watchdog warns about dangers of Acomplia

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@ 09:12 PM (12 months, 8 days ago)

The European Medicines Agency has warned consumers that the weight loss drug Acomplia heightens the risk of suicide among those taking anti-depressants.

The agency wants stronger warnings placed on the drug to reflect that risk but has stopped short of suspending the drug.

The agency says though the benefits of Acomplia outweigh its risks, it should not be used under any circumstances in patients with ongoing major depression or those who are taking antidepressants.

The panel has also called for a new warning on Acomplia's label to state that treatment should be stopped if a patient develops depression.

Information regarding the updated information will be sent to all doctors as the agency says it is important patients and their carers are aware of the risk of depression with the drug.

The move is in line with that of an advisory panel to the Food and Drug Administration (FDA) in the U.S. which has said the product should not be approved because it may increase suicidal thinking and depression.

The FDA decision was the result of a study which found that of 120 patients taking the drug, two had committed suicide and one was considering it, while another attempted to strangle his daughter.

Since that decision drug company Sanofi has withdrawn its application to sell Acomplia in the United States; it has been available under the brand name Zimulti in Europe since the middle of last year.

European officials are likely to allow the drug to remain on the market but with stricter warnings.

Acomplia is the first in a new class of drugs that work by switching off the same brain circuits that make people hungry when they smoke cannabis and it was forecast to become a multibillion dollar blockbuster.

More than 40,000 Britons have been treated with Acomplia since last year which was lauded as a wonder drug after trials showed it could help dieters lose up to 10 per cent of their body weight and also help smokers quit.

The Medicines and Healthcare Products Regulatory Agency in the UK says to date there have been 318 cases of patients being adversely affected by Acomplia.

Source: http://www.news-medical.net/?id=27891

2007/7/15

Safety of new weight-loss drug is questioned

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@ 10:56 PM (12 months, 15 days ago)
A new over-the-counter weight-loss drug called Alli may give people with eating disorders another tool to harm themselves, local therapists fear.

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2007/6/19

Alli hits the stores

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@ 09:34 PM (13 months, 11 days ago)

The first non-prescription diet drug ever to be approved by the FDA hit the shops this week and optimistic dieters are dashing out to buy it.

The new diet pill, Alli which is manufactured by GlaxoSmithKline (GSK) works by blocking the absorption of fat by the body which is then eliminated by way of the bowels.

The drug does have some unpleasant side-effects such as oily bowel movements, loose stools and the possibility of leakage, along with gas.

A months supply of Alli will set you back US$60 and GSK recommends the best results will be achieved when no more than 15 grams of fat per meal are eaten while taking the drug.

Alli is not recommended for people younger than 18, people with kidney disease, or people on blood thinners.

In a study, Alli taken in conjunction with a good diet, offered an additional 5% of weight loss when compared to somebody following a good diet without taking the drug.

Only 20% of people who use Alli can expect to lose 10% or more of their body weight and many will lose very little weight and possibly suffer the embarrassing gastrointestinal side effects.

Unlike other prescription weight-loss drugs Alli does not induce a feeling of fullness, reduce cravings or curb the appetite; what it does do is prevent the body from breaking down and absorbing fat.

The active ingredient in Alli, orlistat is also found in the prescription diet drug Xenical but in a higher dosage.

While Alli blocks around 25% of the fat eaten, Xenical blocks one-third of the fat ingested.

In real terms 2,000 calories a day with about 30% fat, would translate to about 150 calories a day with Alli.

A pound of weight loss equates to 3,500 calories.

Limiting fat intake to 15 grams a meal will help avoid the side-effects - .most Americans consume 80 to 100 grams of fat a day.

Glaxo officials do admit that many people would lose weight on their own with a reduction in fat intake, but say that Alli helps people lose more weight.

Doctors say most people are eating far more fat than they realize and the case with most dieters is that are unable to sustain the weight loss.

Orlistat has been widely tested and about 50% of the people who use orlistat lose at least 5% of their body weight; only one out of five people who take the drug lose at least 10% of their body weight, according to Glaxo.

Experts say even small amounts of weight loss offer health benefits.

Source: http://www.news-medical.net/?id=26566



2007/6/12

Alli weight loss drug on the U.S. market soon

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@ 09:38 PM (13 months, 18 days ago)

The new weight loss drug Alli is about to hit the U.S. market.

Alli which is produced by GlaxoSmithKline will be available to consumers in America next week following a 150 million dollar advertising campaign to promote the non-prescription drug.

Alli will be the only non-prescription drug marketed as a weight loss remedy that has the approval of the Food and Drug Administration.

The drug works by reducing the amount of fat that is absorbed by the body; the undigested fat is eliminated in bowel movements, which can cause side effects such as gas and oily discharge.

Alli is a half-dose version of the Roche prescription drug Xenical which also works by reducing the amount of fat the body absorbs from food.

It will cost between $55 and $60 for a month's supply, just over 60 cents per tablet, based on a regimen of three pills a day.

Alli is good news for GSK who are still recovering from the safety scare over it's diabetes drug Avandia.

GSK hopes the product will be available in Europe, under a different name, in 2008 and are also planning to submit Alli for regulatory approval in Canada, Latin America, China, Australia and New Zealand before the end of 2007.

Glaxo is stressing in their advertisements that Alli is no "magic bullet" and requires commitment to a low-fat diet.

It will compete with multiple OTC supplements that claim weight-loss benefits but have not been cleared by the FDA.

Source: http://www.news-medical.net/?id=26221



2007/6/10

FDA Reviewing Acomplia Drug

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@ 11:29 PM (13 months, 20 days ago)

The FDA is set to release results of their review of a weight loss pill called Acomplia which is manufactured by French drug maker Sanofi-Aventis.


The FDA is getting set to release results of their review of a new weight loss drug that is already approved for use in Europe.

Acomplia is the name of the drug which is manufactured by Sanofi-Aventis and on Wednesday of this week, an expert advisory panel is set to meet to discuss the drug.

"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.

The decision handed down by the advisory panel may have a big impact on the FDA's final decision. Although they do not have to agree with their expert advisory panels, they often do.

Studies of the Acomplia drug have reported some symptoms such as depression, insomnia and anxiety in patients who take it, thus whether or not the drug will be approved by the FDA is anybody's guess.

Last February, the FDA denied Sanofi's application for their drug to be used as an anti-smoking pill stating that they needed more information before approving it.

Source: http://www.dogflu.ca/06102007/21/fda_reviewing_acomplia_drug

2007/5/22

alli™ debuts through the alli Experience

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@ 08:39 PM (14 months, 9 days ago)
GlaxoSmithKline Consumer Healthcare [NYSE:GSK] introduces a new approach to weight loss that will debut through a public multi-media exhibit in New York City— the alliTM Experience. The alli Experience represents part of GSK Consumer Healthcare’s comprehensive educational program to prepare adults interested in losing weight with alli — the only over-the-counter weight loss product approved by the U.S. Food and Drug Administration (FDA) — before it goes on sale in pharmacies and mass retailers beginning on or about June 15. The alli Experience will be open daily beginning Tuesday May 22 through Sunday June 10, 2007, and is open Monday through Fridays from 11 a.m. until 6 p.m., Saturdays from 10 a.m.until 6 p.m.and Sundays from 11 a.m.to 5 p.m.The exhibit is located in New York City at 20 Union Square East (located at the Southeast corner of the Square).

More than two-thirds of the U.S. population is overweight or obese, resulting in increased risk for serious diseases such as heart disease, diabetes, cancer and stroke. These serious health complications require the American public to take an honest look at the realities of weight loss. “We’re here today to unveil the alli Experience and demonstrate our commitment to changing the way people think about weight loss.” says Steven L. Burton, vice president, Weight Control, GlaxoSmithKline Consumer Healthcare. “People are fed up being bombarded with hyped products and fad diets that over promise and under deliver. Unlike all the hype, alli is about straight talk and an honest voice, being real about the fact that losing weight is hard work.” Burtonadds, “We’re here to help and to partner with people who want to lose weight with a realistic approach. But we’re not the total answer. The answer is individual commitment in partnership with alli, and all the support and education the alli program offers.”

The alli Experience is designed to help overweight people revisit and engage the principles of modest, gradual weight loss. The exhibit, divided into five zones, begins with a sensory tour that leads to an interactive journey and multi-media education about weight loss realities. Each zone encourages visitors to embrace a more realistic approach to diet and exercise for improved health. Visitors receive meal planning ideas, delicious low-fat recipes and shopping lists with nutritious foods to help support a healthier lifestyle. The alli Experience will also help overweight people who want to lose weight determine if they are ready to commit to the alli program.

Zone 1: You enter a surround-sound passage of empty promises — “guaranteed, miracle pill, easy, no carbs!” Bombarded by chaos and hyperbole flashing on ceilings and walls, you’re asked, “Fed up?”

Zone 2: In contrast to Zone 1 you enter a more serene space… classic, clean, clear. To match the simplicity of the message is one lone bench. Above it you read sound advice — there are no shortcuts. Tenets of truth inscribed on the wall acknowledge and inspire — losing weight is hard but not impossible. Need help? Engage in the next Zone.

Zone 3: Enter a theater of interactive stations to ask, learn, and discover. Find out if you’re ready for a true weight loss commitment or still looking for a quick fix. Learn how alli can be a partner to help you lose 50 percent more weight than dieting alone… understand that you can’t just try alli, you have to commit to it. Test yourself to see if you’re ready to commit.

Zone 4: Feast your eyes on a larger-than-life sized dinner plate featuring projections of appetizing dishes that challenge your dietary aptitude. See carousels showcasing flavorful low-fat meals and learn how to keep temptation out of your pantry in a simulated kitchen. Encouraged? Reflect in the next Zone.

Zone 5: At interactive kiosks, embark on a personal journey to find out what’s holding you back... exercise your option to speak to a trained expert. Exit the alli Experience… and enter a new weight loss revolution. You. Your commitment.

The alli Experience is open to anyone who is 18 years or older, as alli is for overweight adults.

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2007/5/2

The Skinny on Alli

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@ 01:58 AM (15 months, 2 hours ago)

Could the first FDA-approved, over-the-counter diet pill jump start weight loss for overweight Americans?

For years, dieters across the nation have turned to drugstore aisles in search of a quick fix for their weight problems. Hundreds of bottles of supplements and diet pills line these aisles, and most use catchy advertisements and testimonials to make what many doctors say are unsubstantiated claims -- fooling dieters into believing that a bottle of pills could help them lose 10 or 20 pounds in a matter of days or weeks.

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2007/3/9

Diet drug acomplia being used to reduce the craving for alcohol

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@ 09:29 PM (16 months, 23 days ago)
Acomplia, or the generic name rimonabant, is a medication that may soon be approved by the Food and Drug Administration for the treatment of overeating and possibly even for smoking, but not for alcohol.

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