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/

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

Alli is the most recent diet pill to hit the market. Made by the same manufacturer of the prescription diet drug Xenical, Alli is a lower dosage version and can be purchased over-the-counter.

Just like Xenical, Alli is promoted as a weight-loss enhancer by preventing the absorption of fat from foods we eat. And just like its predecessor, Alli does increase the risk of becoming deficient of fat soluble vitamins. Therefore, taking a daily multi-vitamin at a different time than taking Alli is a must.

Alli's manufacturer recommends using the pill in conjunction with making lifestyle changes. These changes include exercising and eating a low-calorie, fat-controlled diet. Since Alli is a fat blocker, the manufacturer recommends eating no more than 15 grams of fat at each meal, or a consumer runs the risk of having negative symptoms (i.e.: gas, loose stools, diarrhea, and more frequent and/or hard to control bowel movements).

Fifteen grams of fat per meal equates to eating 25 percent of one's daily calories from fat when following an 1,800 calorie meal plan (or three meals with 15 grams of fat and one snack with 5 grams of fat). Fat should provide 20 to 35 percent of our daily calories, according to the 2005 U.S. Department of Agriculture dietary guidelines.

Does it work?

Weight loss may occur, but not necessarily in the amount you are hoping. According to Dr. Donald Hensrud, of the Mayo Clinic in Rochester, Minn., although some studies have been done on Alli, most of the weight loss projections are based upon the results of studies done with Xenical. With Xenical creating an average weight loss of only 6 pounds each year above weight loss from diet and exercise, he concludes at "half the strength, Alli could conceivably result in an average of 3 pounds lost in a year."

In the end, I feel the potential positives associated with the use of Alli are heavily outweighed by the negatives. Therefore, I recommend customers save their money and not use this diet aid.

Source: http://www.masslive.com/

That hasn't stopped thousands of people from flocking to pharmacies to buy Alli, the first FDA-approved nonprescription diet drug. For the past week, pharmacy employees have stocked and restocked their shelves with the pills.

"We can't keep up with it," said Hisham Ghali, executive assistant manager of a Walgreens in River Oaks.

The store had sold out of the largest available bottle of Alli on Thursday, but he expected another shipment within a few days.

Alli, pronounced "AL-eye" and manufactured by GlaxoSmithKline, prevents the body from absorbing fat by blocking enzymes in the digestive system. Made using orlistat, which has been available for several years in a higher-dose prescription form called Xenical, Alli blocks about a quarter of the fat eaten during a meal when users pop a pill beforehand. It can be taken up to three times daily.

Users of Alli can lose about 50 percent more weight than they would through dieting alone, according to GlaxoSmithKline. For example, someone who loses 10 pounds through dieting could lose 15 pounds with Alli, the company says.

The drug can cause nasty side effects, however, particularly for dieters whose fat intake per meal is higher than the recommended 15 grams. (A fast-food hamburger can contain 30 grams.) GlaxoSmithKline warns of the potential for "gas with oily spotting, loose stools or more frequent stools that may be hard to control." The company suggests not taking the pill before meals with high fat content.

Users attest to this on Alli's online message board through posts called "accident support group." Some complain of the bowel changes and leaks consistent with GlaxoSmithKline's warnings, while others say they have constipation or cramping. Meanwhile, dieters considering using the drug ask questions such as, "adult diapers mandatory during first week?"

For at least one Alli dieter, the unpleasant side effects are part of the drug's appeal.

"It forces me to diet and exercise to avoid any bad side effects," a dieter who signed in as Sheree wrote on Alli's message boards. "Trust me, on my own I would have already cheated!"

Low-fat diet is crucial

"For the person who's committed to eating right and exercising and doing the right things, then staying on Alli will serve them well over time," said Dr. Tom Lux, assistant professor of internal medicine at the University of Texas Medical School at Houston, who has prescribed Xenical for weight-loss patients. "For a person who likes to eat a lot of steak and heavy food and fried food, it's not going to be a good choice."

After a Walgreens in the Memorial area got its first shipment on June 14, buyers bought all 36 packs of 90 pills, at a price of $59.99, that day. The store got a shipment of 60- and 120-pill packs the following day and quickly sold those, too, said store manager Bill Coligan.

"It was a little busy," he said. "Every couple of minutes, we were over here unlocking the case."

'Not a magic pill'

The drug also is selling well at other local pharmacies, including CVS and Kroger.

Rebecca Reeves, a dietician and assistant professor at Baylor College of Medicine who has conducted research on orlistat, said having the drug available over the counter provides a great opportunity for people looking to lose weight.

"It's not a magic pill," she said. "It will help you along when you are involved in a good, healthy lifestyle."

Source: http://www.chron.com/disp/story.mpl/front/4914080.html

The central tenet of the experience--and of the drug, which goes on sale mid-June--is gradual weight loss and a "don't expect miracles" approach embodied by the tag, "Your will. Our power."

The compound, an attenuated version of prescription drug Xenical (Orlistat 120mg), works by inhibiting the function of intestinal enzymes that facilitate the body's absorption of fat. The company says it blocks the absorption of about a quarter of the fat one consumes. GSK will sell Alli in product packets that include a 30-day supply and a series of books including calorie counters, diets and recipes, lifestyle tips, and a diary.

Since the compound--intended to be taken three times daily--is being pitched as a companion to dieting rather than a replacement for it, the company's marketing and the exhibit attack fad and crash diets and repeat, in different forms, the mantra that dieting is a commitment that takes time, pill or no pill.

The first area of the exhibit is a passage flanked by video screens playing clips of miracle diet ads and stories debunking them, while speakers play a cacophonous loop of quick-diet pitches.

The next space is a bench next to a wall of sayings like "there are no shortcuts." There's an interactive section featuring tables with Mac computers letting one view content on how Alli works, on dieting, etc., and there are areas featuring examples of various dishes and snacks--some healthier than others--with big turntables showing real food under glass and their respective caloric and fat content.

A dietitian and pharmacist are also on hand. Visitors leave with a shopping bag of brochures, games, surveys and a book, Are you Losing It? The book is for sale in pharmacies and bookstores for $5.99, the proceeds going to child obesity charities.

Joe Cadle, Marketing Director/Weight Control of GSK Consumer Healthcare, says that although GSK positions the treatment in contradistinction to compounds claiming to "melt off the pounds," the competition is not miracle drugs--because, he says, people who reach for quick and easy solutions to weight problems won't be interested in Alli. "People who tend to buy miracle drugs are looking for a quick fix, so we aren't competing with them. Our efforts are positioned against those selling to consumers committed to doing the hard work."

Says Cadle: "When you take a look at the messages out right now, a lot of products are being marketed as miracle fixes: 'Lose 20 pounds in two weeks!' Alli is about changes toward a healthy lifestyle that require a commitment."

Cadle says the marketing group realized, through consumer research, that consumers have no clue what the difference is between an FDA-approved compound and any number of so-called diet drugs lining shelves and being promoted in ads. "People intuitively don't trust these things any more--they hear these claims, and know they are not true. We want to be an honest voice in a category known for hype. The truth is, losing weight is hard ... and that resonates." He explained that Alli is intended to offer a kind of bonus for the work of dieting via extra "bonus" weight lost. "One woman in a focus group says those extra five pounds would be priceless."

Debbie Weis, GSK Consumer Healthcare senior brand manager, says that, depending on the response to the Alli Experience in New York, which ended last week, the company plans to have additional programs in other markets.

One of the staff pharmacists says as many as 1,300 people have come through on a given day, with many of them asking questions about the effect of Alli on diabetes and cholesterol-lowering drugs. Cadle says GSK is doing targeted efforts via sales teams and targeted communications to physicians on specific health issues.

Overall, per Weis, about 5,000 people have come through the exhibit since the opening. "They are spending around 10 minutes in the space, on average. That's more than we expected."

The company began running a "drive-to-web" 30-second TV spot earlier this month, and Cadle says that the Alli Web site, myAlli.com, has garnered 1 million unique visitors since launch.

Per Cadle, this month GSK will launch a 60-second TV commercial and will ramp up Internet efforts. Print efforts will include 15 million four-page inserts in July and August issues of women's magazines with an "accordion-fold" pull-out.

"From a marketing perspective, we are developing content that can travel, content you can carry--we want to educate consumers at every possible touch point [about] where they can find Alli," he says.

Display kiosks at pharmacies and stores selling Alli will be focused less on product pitch than education and self-inquiry about will power, Cadle says--with brochures on lifestyle and diet choices, assessment tests, even a telephone at some retail points that have audio challenging consumers to think about whether they are willing to make the commitment. The company is also running video content on YouTube.

Consumers can purchase the Alli starter kit for $49.25 for a 60 capsule-count starter pack and for $62.99 for a 90-capsule starter pack, per a GSK spokesperson. However, the retail cost of the product in stores may vary a little based on the individual retailer promotional plans.

Source: http://publications.mediapost.com/

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.

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 has applied for a patent protection for Acomplia here.

Since a patent holder cannot block the generics already available in the market, experts opine that Sanofi-Aventis can ask for a royalty from the generic companies once it is granted patent for rimonabant. However, Indian firms are of the view that since Rimonabant is a pre-1995 molecule, they are not entitled to pay royalty to Sanofi-Aventis.

In May, Torrent and Cadila launched the generic versions of Acomplia in India, named Remoslim and Slimona respectively. Sun Pharma has also launched two drugs, Riocity and Riobec.

Ruchir Modi, VP, marketing, Torrent said, “Rimonabant was discovered by Sanofi before 1995, thus Sanofi is not entitled to obtain product patent as per the patents laws of India. Hence, the question of paying royalty to Sanofi does not arise.” Torrent Pharma is aiming to clock Rs 10 crore in sales in the first year of its launch.

Source: http://www.financialexpress.com/fe_full_story.php?content_id=166520

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

The marketers of alli, a GlaxoSmithKline manufactured drug, will provide consumers with the first Food and Drug Administration (FDA)-approved over-the-counter weight loss product without a prescription as it hits store shelves this summer (2007).

However, first they are debuting the "diet pill" with an exhibit in New York City to educate the public about their product, which is being touted as a safe and effective drug that won FDA approval in February.

This product is for any adult who is overweight. However, the manufacturer and its marketing company are taking a different approach than that of the drug, Xenical, which has twice the potency of alli.

First, the educational promotions are being forthright with information, such as the facts that there is no "magic" diet pill, and that people who use alli must also make a concerted effort to eat a reduced-calorie, low-fat diet, and exercise regularly.

If these efforts are made while using the drug that manufacturer's claim only affects the gastrointestinal system, then results will be seen.

The FDA noted that people using alli lost an additional two to three pounds for every five pounds that were lost by dieting and exercising.

According to the manufacturer, "alli helps people lose 50 percent more weight than with diet alone."

When alli is taken along with meals, the effective process blocks absorption of nearly one-quarter of the fats consumed (approximately 150 to 200 calories), which are then passed right out of the body.

However, this affect can result in loose bowels. Nearly 50 percent of trial study participants experienced gastrointestinal side effects (including bowel leakage and oily discharges) with the use of alli.

In fact, these unpleasant side effects are why the company is stating how important it is to use the drug properly and count fat gram intake.

In addition, the educational literature even recommends that users of the product should really start the program in conjunction with time off from work.

The drug includes a "starter kit," a food journal, a healthy eating guide, a fat and calorie reference guide, and 60 capsules of alli. The recommended dosage is one to three pills per day. A total of 60 capsules will cost about $50, whereas 90 capsules will cost about $60.

Since the late 1980s, adult obesity has steadily increased in this country, according to the FDA that began to formulate a plan to tackle the problem.

Currently, two out of every three people in the U.S. are considered overweight or obese, according to an AP report

Source: http://www.allheadlinenews.com/articles/7007429094

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.

While the pricing of the drug has not been officially announced, a starter pack that includes 60 alli capsules (enough for three weeks assuming that you take one before each meal), the alli Shuttle (a carrying case for your pills), and several booklets including a calorie and fat counter and a daily journal is expected to cost between $50 and $60.

An alli starter pack that includes 90 alli capsules (enough for a month assuming that you take one before each meal) is expected to cost between $65 and $70.

An alli refill package -- consisting solely of 120 alli capsules (enough for 40 days) -- is expected to cost between $75 and $85.

Glaxo, meanwhile, has released the first two television commercials of what is ultimately expected to be a $100 million plus first-year blitz for the first FDA-approved over-the-counter diet drug.

Both of the first two commercials can be viewed by those who have missed them on television via the video sharing website YouTube.

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.

For the first time, however, medical experts at the Food and Drug Administration have stamped their seal of approval on an over-the-counter weight-loss pill. The drug, Alli (pronounced AL-eye), which will be available in stores in June, lends a helping hand to dieters looking to gradually lose weight, according to manufacturer GlaxoSmithKline.



AN ALLY FOR OVERWEIGHT AMERICANS?



Alli can help overweight Americans shed extra pounds, but should not be considered a miracle drug, said Malesia Dunn, a GlaxoSmithKline spokesperson. Consumers will also have to follow a reduced-calorie diet and commit to regular exercise to see results, she said.

"Now, instead of [losing] 10 pounds, by including Alli in that program, you will potentially lose up to 15 pounds," Dunn said. "And for a lot of people that becomes very meaningful."

The drug's active ingredient decreases the body's absorption of fat by about 25 percent per meal -- meaning that dieters do not absorb those fat calories. The undigested fat passes through the body and can cause unpleasant side effects, including gas, oily spotting and loose stools. The FDA recommends that users follow a low-fat diet to reduce these side effects.

"If you eat a lot of fattening, high-fat products, you're still going to have a lot of that in your body," Dunn said. "The product only blocks a percentage."

Source: http://media.www.dailyfreepress.com/media/storage/paper87/news/2007/05/01/Science/The-Skinny.On.Alli-2889960.shtml

The pill has been tested i mice thus far. The pill allowed the mice to eat a very high-fat diet without gaining an ounce. This would be a major break-through as it would allow more freedom in the diets of fast-paced peopel around the world.

The pill works by triggering the same type of fat-burning processes which occur when you go to the gym or go for a run. This exercise can be doubled by taking the pill. When they are not active, the mice continued to burn fat.

Dr. Ronald Evans stated “Too few people get an ideal amount of exercise. Having access to an exercise pill would improve the quality of muscles, and increase the burning of energy or excess fat lowering the risks of heart disease and diabetes.”

The rule of thumb is as long as more calories are burned than taken in, you will lose weight.

Source: http://www.ecanadanow.com/