FDA's Acomplia Review Delayed Until July 27

http://www.forbes.com/
"Sanofi-Aventis said the US Food and Drug Administration has extended its review of anti-obesity drug Acomplia by three months to July 27.
In December, Sanofi had said it expected the FDA's decision by April 26."
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France Recommends Acomplia Reimbursement

http://www.forbes.com/
"Sanofi-Aventis said its Acomplia drug has received a 'favourable recommendation' from the independent Transparency Committee in France for reimbursement by health insurance companies and state social security plans when prescribed for diabetic, obese patients.

The next stage is for the government to decide if it will follow this recommendation and then the proportion of the cost to be refunded."


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Australian Acomplia Study

http://www.thewest.com.au/
"Perth researchers will test a new anti-obesity pill on West Australians in the hope it will not only help them lose weight but reduce their risk of heart disease by boosting levels of HDL, or “good” cholesterol.

The Royal Perth Hospital study, part of an international trial, could prove the weight-loss pill rimonabant, sold as Acomplia, can help ward off the condition known as metabolic syndrome, a particularly highrisk form of obesity which entails problems controlling blood pressure, cholesterol and insulin.

RPH professor of medicine Gerald Watts, who specialises in metabolic disorders, said the drug was expected to be approved for Australia within a few months and the hospital aimed to recruit 15 to 20 patients as part of the 80 being studied worldwide.

“We’re interested in the mechanism of how this drug works and the role it could play in obese people who have several risk factors for heart disease, one of which is low HDL cholesterol, or metabolic syndrome,” he said. "
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Sanofi To Challenge Acomplia Decision By German Court

http://www.pharmatimes.com/
"Sanofi-Aventis says that it intends to challenge in the courts the decision made by the German Ministry of Health which states that the firm's anti-obesity drug Acomplia will not be reimbursed.

The Ministry of Health has upheld a recommendation from the German Federal Joint Committee, the G-BA, which said in October that it believes funding treatment with Acomplia (rimonabant) is inappropriate because it is a 'lifestyle' drug, a viewpoint which Sanofi disagrees with vigorously.

The French drugmaker has argued that Acomplia should be covered because it helps lower the risk of developing diabetes and cardiovascular disease, in addition to aiding weight loss. Indeed, Sanofi recently presented data from a Phase III trial of Acomplia which shows that treatment-naive patients with type 2 diabetes who received the drug experienced significant improvements in blood glucose control and weight loss, compared to those who took placebo."
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Will Rimonabant Be Used To Treat Drug Addiction?

http://www.rivistaonline.com/
"Proven that testing is working, the pill won't treat marijuana lighter users. Mr Lucchini points out the Federsed is intended to make use of it in order to treat "troublesome addictions". The drug is not aimed just to marijuana but also to hard cocaine and heroine addicts. Furthermore, the Sanofi Aventis, the Rimonabant International Company producer, shall be also available to allow a change in the drug public image, passing from a fat treatment to a drugs treatment pill. A multibillionaire contract offered by the state is always attracting; the Sanofi, however, may decide not to get involved with drugs and be satisfied with the 5 billion dollars it is certain to gain through the obesity treatment pill selling within 2010. Nevertheless, a question remains unanswered: is it reasonable to treat drugs addicts with a pill? On one side, there are the supporters of medical treatment considered as the only way-out for drug users, in constant search for a pharmacologic solution to pains and troubles of social order. On the other, the drugs-as-choice and result-of-discontent supporters. But society who produces discontent can hardly be treated with drugs. Federsed promised to explain his reasons on a press conference due to be arranged in near future: the conference will be coupled with a left-leaning manoeuvre by the ruling government aimed to a progressive reassessment of the national drugs law. We wait for what is next .
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How Rimonabant Can Help You Lose Weight

http://www.newswise.com/

"Blocking cannabinoid receptors may dampen an overactive EC system, reining in appetite, reducing weight, and improving obesity-related risk factors for heart disease and type 2 diabetes.

A drug that blocks cannabinoid receptors, rimonabant (Acomplia), is being considered by the U.S. Food and Drug Administration (FDA) to treat people with type 2 diabetes. Four similar drugs are also in the pipeline. “We’ve seen that blocking these receptors results not only in reduction of food intake, but also a reduction in triglycerides and glucose, and even an increase in ‘good’ HDL cholesterol. And that’s above and beyond any reduction in weight,” says Dr. Aronne.

A recent review of four placebo- controlled clinical trials of rimonabant found it produces only moderate weight loss. But even the average 5 percent weight loss seen in the trials after one year of using 5 mg of rimonabant reduced risk factors for type 2 diabetes and cardiovascular disease, according to the October 17, 2006 edition of The Cochrane Library.

A higher dose (20 mg) produced a larger weight loss, almost 11 pounds, as well as a reduction in waist circumference, triglycerides, blood pressure, and raised low HDL cholesterol. These are all risk factors for metabolic syndrome, notes Dr. Aronne.

“In the clinical trial conducted in North America, there was a 39 percent reduction in metabolic syndrome prevalence in the rimonabant group versus 8 percent in the placebo group.” However, the higher dose also produced more side effects such as dizziness, nausea, headache, and depressed mood."

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FDA Will Review Acomplia April 26

http://www.fool.com/
"On Friday, Sanofi announced that the FDA has set April 26 as the new date to review Acomplia and give Sanofi a thumbs-up or -down on marketing it in the U.S. Back in February, the drug received an approvable letter for its weight-loss indication and was deemed non-approvable as a treatment to help people stop smoking.

Acomplia was approved in the European Union back in late June, but the U.S. is where the big money is, especially now that France and Germany have been enacting new measures such as higher taxes on drug sales and rules to encourage doctors to prescribe cheaper prescriptions or generic drugs.

Since the limited launch of the drug in the EU in the third quarter, Acomplia sales have been roughly $15 million. But sales should increase much faster as Sanofi gets the word out about Acomplia via marketing and other measures."

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Another Rimonabant Article

http://www.cbc.ca/
"Rimonabant works by blocking cannabinoid receptors in the brain that cause cravings. It also affects other organs such as the liver and pancreas that control blood fats and insulin levels.

It works differently than other anti-obesity drugs but seems to have many of the same side-effects, such as nausea and diarrhea. People taking rimonabant also have a tendency to get anxious and depressed."

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FDA To Rule On Acomplia In Spring 2007

http://www.norml.org/
"US regulatory authorities have announced that they will decide this spring on whether to approve the prescription use of the cannabinoid receptor antagonist SR 141716A, to be marketed by Sanofi-Aventis Pharmaceuticals as a diabetes treatment and anti-obesity drug under the trade name Acomplia (Rimonabant). In July, the selective cannabinoid blocking agent received regulatory approval in a handful of European nations as a dietary aid. Acomplia is the first cannabinoid antagonist ever to be approved for human consumption.

The US Food and Drug Administration (FDA) will review newly published clinical data indicating that Acomplia significantly lowers blood sugar levels in humans compared to placebo. The FDA had previously denied Sanofi permission to market Acomplia in the United States."

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FDA To Rule On Acomplia In Spring 2007

http://www.norml.org/
"US regulatory authorities have announced that they will decide this spring on whether to approve the prescription use of the cannabinoid receptor antagonist SR 141716A, to be marketed by Sanofi-Aventis Pharmaceuticals as a diabetes treatment and anti-obesity drug under the trade name Acomplia (Rimonabant). In July, the selective cannabinoid blocking agent received regulatory approval in a handful of European nations as a dietary aid. Acomplia is the first cannabinoid antagonist ever to be approved for human consumption.

The US Food and Drug Administration (FDA) will review newly published clinical data indicating that Acomplia significantly lowers blood sugar levels in humans compared to placebo. The FDA had previously denied Sanofi permission to market Acomplia in the United States."

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Acomplia Before Obesity Surgery

http://www.bloomberg.com/
"Obese people should receive drugs such as Sanofi-Aventis SA's Acomplia and surgery only as a last resort, a U.K. government panel that assesses the cost effectiveness of therapies said today.

Surgery shouldn't be considered for most morbidly obese adults, the National Institute for Health and Clinical Excellence, which advises the National Health Service of England and Wales, said in its new treatment guidelines. Drugs are recommended only if the patient has complicating factors such as sleep apnea or a psychological condition"

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Sanofi Completes Class 2 Response For Acomplia

http://www.earthtimes.org
"Sanofi-aventis announces that concerning the New Drug Application for rimonabant in the United States, the Food and Drug Administration has considered its October 26, 2006 resubmission to be a complete, class 2 response to the FDA February 17, 2006 action letter."

The user fee goal date is April 26, 2007. About Rimonabant
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Data Findings of Rimonabant Serenade Trial

http://biz.yahoo.com/
"In the SERENADE study, treatment-naive type 2 diabetes patients receiving rimonabant 20mg per day for a duration of six months significantly lowered their HbA1c levels by 0.8% from a baseline value of 7.9 as compared to a reduction of 0.3% in the placebo group (p=0.002). In addition, patients with an HbA1c level greater than or equal to 8.5% at baseline, significantly reduced their HbA1c by 1.9% with rimonabant as compared to 0.7% with placebo (p<0.0009). acomplia
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The Acomplia Serenade Trial

http://www.forbes.com/
"The trial, known as SERENADE, found Acomplia -- a CB-1 agonist -- reduced HbA1c and triglyceride levels and increased HDL levels in type 2 diabetes patients who took it as a monotherapy for six months. The study results were presented Tuesday at the World Diabetes Congress in Cape Town, South Africa.

Bank of America analyst Chris Schott said he thinks the results of the study could aid in winning reimbursement for Acomplia. Although the treatment has been approved for marketing in Europe, Germany recently declined reimbursement for the drug.

'We believe data from SERENADE as well as RIO-Diabetes could support broader reimbursement for Acomplia, especially as its efficacy appears in line with other oral diabetes agents,' Schott stated in a research report Tuesday."

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More On The Rimonabant Serenade Trial

http://www.medicalnewstoday.com/
"The trial achieved not only significant reduction in blood sugar levels but also in patient body weight - 6.7 kg compared to 2.7 kg in the placebo group. Results also showed improvements in (good) HDL cholesterol and triglicerides. This is unlike many currently approved diabetes treatments, where weight gain is a common and unwelcome side effect.

"This study suggests that rimonabant can achieve improvement in blood glucose with the added benefit of significant weight loss and improvement in other risk factors" said trial investigator Julio Rosenstock, MD, Director of the Dallas Diabetes and Endocrine Center at Medical City and Clinical Professor of Medicine at the University of Texas Southwestern Medical School, Dallas.

Nearly 300 patients throughout the US and six other countries took part in the SERENADE trial. The drug rimonabant is not currently available in the US although it has been approved in Europe."
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Acomplia: The Serenade Study

http://www.forbes.com/
"The Serenade study evaluated Acomplia for diabetes treatment, with the drug lowering blood sugar levels while also reducing a patient's weight. Other Sanofi studies had looked primarily at the drug's ability to promote weight loss.

Green declined to comment on when Acomplia might be approved in the US. Sanofi had hoped for approval by the end of this year, but the US Food and Drug Administration recently asked for more information, which many analysts expect to push back approval by several months.

Acomplia is slated to become a new blockbuster drug for Sanofi, with over 1 bln eur of annual sales. Investors hope it will help shore up a product portfolio that has a number of drugs facing generic competition over the coming years."

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Acomplia Update

http://www.businessweek.com/
"As if all that weren't enough, FDA approval for the company's long-awaited anti-obesity treatment, Acomplia, has been delayed until next spring. "It's just the latest setback for a volatile company that's struggling with a lot of issues," says Navid Malik, a pharmaceutical analyst with London-based brokerage Collins Stewart.

With troubles mounting, Sanofi is under intense pressure to get Acomplia onto the U.S. market—fast. Hailed by analysts as a potential multibillion-dollar blockbuster, Acomplia is critical to the company's future growth. Also known as rimonobant, the drug is the first in a new class of medicines that curtail cravings by blocking receptors known as cannabinoid type 1 (CB1) found in the brain and in fat tissue. CB1 receptors influence hunger and addictions, such as to nicotine.

Clinical trials indicate that Acomplia not only could help people lose weight but also shrink abdominal fat and help them stop smoking. Even more remarkably, it can also improve cholesterol levels and blood-sugar control. That means Acomplia might also someday be used in treating diabetes, though approval for that application remains years off, pending results of tests now under way. "

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Rimonabant-Acomplia Press Release

http://www.prweb.com/
"Rimonabant-Acomplia (discovered and developed by Sanofi-Aventis) is a CB1 endocannabinoid receptor antagonist. CB1 blockers act on the endocannabinoid system, a system controlling energy and nicotine dependence, reducing the overstimulation thought to lead to obesity and nicotine addiction. In a recent study, 1,036 overweight or obese patients with blood lipid disorders were randomly placed in one of three groups (placebo vs. 5 mg or 20 mg per day of Rimonabant-Acomplia). After one year of treatment, patients receiving 20 mg per day of Rimonabant-Acomplia lost an average of 20 pounds, compared to only 5 pounds for patients on placebo. Further comparisons between the placebo and 20 mg per day Rimonabant-Acomplia group showed that the latter patients enjoyed significant improvements in waist circumference and HDL-C and triglyceride levels, all important factors in maintaining heart health. The drug was said to be well tolerated, with only mild and transient side effects like dizziness and gastrointestinal distress. The drug is currently only approved for sale in Europe, with a date for U.S. availability still uncertain."

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Acomplia To Be Reimbursed In Sweden

http://www.pharmalive.com/
"Sanofi-aventis announced today that Acomplia™ (rimonabant) recently approved in the 25 countries of the European Union was granted reimbursement by the Pharmaceutical Benefits Board (PBB) of Sweden for treatment of obese patients with BMI over 35 kg/m2 or overweight patients with BMI over 28 kg/m2 and type-2 diabetes or dyslipideamia. Acomplia™ is available for patients in Sweden as of today

Swedish reimbursement of Acomplia™, the first-in-class medicine that targets multiple cardiometabolic risk factors, is the third reimbursement obtained in Europe in a month and completes the reimbursements obtained in Denmark and Ireland "

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Acomplia Approved In Mexico

http://www.euro2day.gr/
"Sanofi-Aventis said Mexico''s health ministry has approved the obesity treatment Acomplia for commercial sale, the first North American country to do so.
The move comes after concerns arose that the US Food and Drug Administration (FDA) could take several months longer than planned with its decision on Acomplia.
Sanofi-Aventis recently declined to comment on the FDA''s timetable."
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More Acomplia Data

http://www.itp.net/
"Sanofi-aventis’ drug rimonabant (Acomplia) may aid in controlling blood sugar levels in type-2 diabetes, offering a new avenue in diabetes management, reports a new study.

Results from the year-long RIO-Diabetes trial, published in The Lancet, found that rimonabant 20 mg once daily significantly improved several cardiometabolic risk factors in patients whose diabetes was uncontrolled by metformin or
sulfonylurea. Improvements were recorded in weight, HbA1c, HDL- cholesterol, triglycerides, systolic blood pressure and waist circumference.

50% of the improvements in HbA1c and HDL-cholesterol levels were independent of the weight loss achieved, indicating a direct effect of rimonabant on these parameters, say authors."
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Acomplia Now Available In Ireland

http://media.netpr.pl/
"Sanofi-aventis Ireland Ltd. announced today, that ACOMPLIA(R) (rimonabant 20mg/day), is available from today, 1st November 2006.

ACOMPLIA(R) is the first in a new class of drugs that target cardiometabolic risk factors such as abdominal obesity, insulin resistance, cholesterol and elevated triglycerides(i). It is licensed for use as an adjunct to diet and exercise for the treatment of obese patients (BMI greater than or equal to 30kg/m2), or overweight patients (BMI >27kg/m2) with associated risk factors, such as type 2 diabetes or dyslipidaemia(1).

Ireland is the third country in the world to have launched ACOMPLIA(R) and the treatment has been welcomed by physicians across the country.

"Rimonabant (Acomplia) addresses the multiple cardiometabolic risk factors that put patients at risk for cardiovascular disease and type 2 diabetes" said Dr. Seamus Sreenan, Consultant Endocrinologist, Connolly Hospital, Blanchardstown, Dublin 15. He continued "ACOMPLIA(R) is an important advancement which will offer benefits beyond current treatments for individual risk factors such as blood pressure, cholesterol and diabetes and I applaud the foresight of early access to this valuable medicine for patients in Ireland".

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Sanofi Sponsors Two Year Acomplia Study In East Texas

http://www.zwire.com/

The pharmaceutical firm Sanofi-Aventis is sponsoring the two-year trial of the drug, rimonabant. Dr. David Shafer, director of UTHCT's Center for Diabetes Care, is the principal investigator of the study at UTHCT.

The study seeks to enroll 6,000 people who are at high risk of diabetes and live in Texas, Louisiana or California. The health center - the only East Texas institution participating in the study - hopes to recruit at least 30 of those patients, Shafer said.

Individuals enrolled in this double-blind study will be followed for two years to determine whether the drug helps prevent diabetes, information from the health center stated. "

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New Rimonabant Study Results

http://www.forbes.com/
"After a year, Scheen's team found that patients taking rimonabant lost significantly more weight than those taking the placebo. Patients on placebo lost an average of 1.4 kilograms, compared with 2.3 kilograms for those given 5 milligrams per day and 5.3 kilograms in patients taking 20 milligrams per day. (For conversion, one kilogram is equal to just over 2 pounds.)
In addition, patients taking rimonabant had greater improvement in waist size, blood sugar control, cholesterol, and better appetite control, compared with patients receiving placebo, the researchers report.
"These findings support the use of 20 mg per day of rimonabant, in addition to diet and exercise, as a new approach to reduce body weight and improve blood glucose control as well as several other cardiovascular risk factors in overweight or obese patients with type 2 diabetes that was inadequately controlled by standard treatment," the researchers concluded."
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Acomplia Needs More Tests To See If It Helps Diabetes

http://www.bloomberg.com/apps/news?pid=20601085&sid=apyjYwLX4kfI&refer=europe

"Sanofi-Aventis SA, Europe's second- largest drugmaker, needs more tests on weight-loss drug Acomplia to prove the company's claim that the medicine helps obese diabetics control blood sugar levels, researchers said.

A study in today's Lancet that suggests the drug may offer a new approach in diabetes treatment isn't conclusive, Naveed Sattar, a professor at the University of Glasgow, wrote in an accompanying comment. He said the improvement in blood sugar levels may have been caused by factors other than the drug. Sattar wasn't involved in the Sanofi-sponsored study of 1,047 overweight or obese people with type 2 diabetes.

``The results are encouraging, but they leave a number of key questions unanswered,'' Sattar said in a telephone interview. ``More studies are needed to assess the drug's true position in the treatment of diabetes.'' "


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Germany State Won't Pay For Acomplia

http://www.forbes.com/
"German authorities have decided that the state health-care system shouldn't pay for Acomplia, a new obesity drug viewed as a potential blockbuster for Sanofi-Aventis SA.

The Federal Joint Committee of doctors and health-insurance funds said it has classified Acomplia a 'lifestyle' drug and therefore ineligible for a price subsidy, the Wall Street Journal reported.

The committee did not accept Sanofi's argument that Acomplia should be covered because it helps lower a person's risk for developing diabetes and heart disease, in addition to helping with weight loss. "


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Rimonabant Offers Modest Weight Loss

http://www.innovations-report.de/

"Rimonabant is a selective cannabinoid-1 receptor antagonist that is currently undergoing phase III trials to investigate whether it can help obese people lose weight. A review of the early research shows that it can produce a 5% reduction in weight after one year.
The increasing worldwide prevalence of obesity is creating a growing demand for effective treatments. One possible option is rimonabant. Cochrane Review Authors analysed data from four randomized controlled studies in which people were either given 20 mg rimonabant, 5 mg rimonabant or a placebo. At the same time they all followed a low calorie diet. Each of the trials ran for 1 year.


Over the year, people taking 20 mg rimonabant lost 4.9 kg more than those given the placebo. Those taking 5 mg only lost 1.3 kg more when compared with placebo.

Taking the higher dose of 20 mg rimonabant did, however, cause significantly more adverse effects, which may account for the fact that 40% of people overall dropped out of the trials early.

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Strong UK Demand For Acomplia

http://www.tradearabia.com/
"Sanofi-Aventis has seen strong demand for new obesity pill Acomplia since its launch in Britain in late June, the managing director of the group's UK business said.

Nigel Brooksby said that although NICE, which assesses the cost effectiveness of new drugs, was unlikely to give a verdict on Acomplia before the first half of 2008, many doctors were already eager to prescribe it.

'We're very pleased. The UK launch has certainly met our expectations,' he said in a telephone interview. 'The qualitative information we are receiving is that it is getting a very good reception.'"

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Acomplia: BMI Limits

http://www.theaustralian.news.com.au/
"Acomplia, however, appears to be more effective because of its wider effect through the body. It has been tested on 6600 people in nine countries, more than 1000 of them in Britain.

The drug trials not only promoted weight loss in at least a quarter of those taking it, but also produced lowering of cholesterol and blood fat levels far greater than would be achieved by diet alone. It is these benefits that are supporting hopes that the drug could cut the taxpayer bill for treating obesity.

Acomplia's initial UK licence will limit its use to people who have a body mass index (BMI) of at least 30. Someone is considered to be obese if they have a BMI of 30 or higher.

But the licence will also allow it to be prescribed for patients with slightly lower BMIs, of 27, if these patients also have other risk factors such as diabetes and high blood pressure.

BMI is a formula based on weight-to-height ratio, and no one weighing under at least 160kg will initially be eligible. "

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Similarities Between Acomplia & Marijuana?

http://www.timesonline.co.uk/
"Acomplia is a close relation of the cannabinoids, the active ingredients in marijuana. But while hash can give users the “munchies” — a powerful desire for food — Acomplia is designed to do the opposite. Both work by affecting a chemical called anandamide, which has effects both in the brain and in other organs as well.

A study of the effects of marijuana, this time among mice, showed that it can disturb the anandamide balance and cause a lot of complications in pregnancy, including ectopic pregnancies, when the foetus is implanted in the wrong place.

The research did not show that the same was true for Acomplia but it suggested it might be. No drug that has yet been invented has effects but no side-effects, so we must be especially careful that the anti-obesity drugs really do more good than harm. "

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Acomplia Might Be Available in US By End of 2006

http://today.reuters.com/
"Sanofi-Aventis still expects it can launch its anti-obesity pill Acomplia in the United States before the end of this year, the French drugmaker said on Wednesday.

"We are still hopeful and confident we can launch Acomplia before the end of 2006 in the U.S.," Hanspeter Spek, head of pharmaceutical operations, said during a conference call."


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Rimonabant Might Be Bad For Future Moms

http://news.monstersandcritics.com/
"U.S. scientists say they`ve determined some weight-loss drugs might present a danger to women of childbearing age.

The study conducted at the Vanderbilt University Medical Center in Nashville, Tenn., suggests a key chemical affected by the drug rimonabant is needed for embryos to implant normally in the womb, The Times of London reported Wednesday.

Rimonabant apparently affects the level of anandamide, which governs the development and implantation of the embryo. Researchers said even a small variation in the level of anandamide might have disastrous consequences."


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Acomplia Update

http://www.dailyreckoning.co.uk/
"The latest front-runner is Acomplia® by Sanofi-Aventis. The drug blocks the cannabinoid receptor that reportedly gives marijuana smokers the "munchies," thereby decreasing food cravings and over-eating. Acomplia was once hailed as the next wonder drug, with possible uses in smoking cessation, diabetes, cholesterol, alcoholism, and obesity.

Acomplia received regulatory approval in Europe for obesity treatment, and is now in the midst of its first commercial launch. FDA approval was delayed, but is likely to come sometime this year. It is estimated that worldwide sales could be $5 billion, while others question the side-effect profile for the drug, citing nausea, depression, and high dropout numbers from the clinical trials. We’ll all be closely watching for early sales numbers from Acomplia’s launch to gauge prescribing habits for doctors treating obesity and related disorders. "
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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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Acomplia / Rimonabant Coming To New Zealand?

http://www.stuff.co.nz/
"Medsafe is considering an application to put Rimonabant on the market here. It recently went on sale in the UK and throughout continental Europe and is also before Australian authorities for approval.

Those who endorse it describe it as a miracle drug because it works by blocking receptors in the brain responsible for food cravings. They are known as "cannabinoid 1 receptors" because they are the ones that stimulate the "munchies" in cannabis users.

There is even evidence that Rimonabant may help curb nicotine cravings in smokers and control cholesterol levels.

But it may be too good to be true. Professor of neuro-pharmacology at Otago University's School of Medicine, Paul Smith, said that while reputable clinical trials overseas had shown Rimonabant was effective for weight loss, not enough was known about its long-term effects. "

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More Acomplia Information

http://www.enjoyfrance.com
"A monthly supply will cost £55.20 but is only available on prescription for people who are overweight and suffer from type 2 diabetes or cholesterol problems.


This drug, which is sold under the brand name Acomplia, controls appetite by targeting the endocannabinoid system, the part of the brain that regulates the body's energy and metabolism and clinical trials have shown that it can reduce weight by up to 10 percent and has important effects on glucose, cholesterol and triglyceride blood fat levels, thus reducing the risk of heart disease and diabetes considerably.

Before it becomes readily available on the NHS to others, studies must be carried out by the National Institute for Health and Clinical Excellence as to it's cost-effectiveness. Sanofi Aventis claim that the cost will be lower than the estimated £7 billion per year currently spent on dealing with weight problems.

An initial trial suggested that Acomplia also suppresses cigarette cravings and could therefore help smokers quit their habit. However, consequent tests have failed to prove the same and therefore it is being promoted solely as a weight-control measure."
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How Much Will Acomplia Cost

http://health.dailynewscentral.com/
"Britain is the first country to have the drug after a license was granted throughout the European Union. But the drug must still gain approval from Britain's National Institute for Health and Clinical Excellence.

At a cost of about $100 per patient per month, or about $3.50 per tablet, treatment could cost Britain's National Health Service billions of dollars, Sky News noted.

However the drug's manufacturer, Sanofi Aventis, says that must be compared with the nearly $13 billion annual cost of treating problems connected with obesity. "

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Sanofi To Fight To Get Rimonabant Approved Across Europe

http://today.reuters.com/
"But Sanofi now faces a country-by-country fight to get Acomplia accepted and reimbursed within individual national health services.


Even in Britain, widespread prescription use is unlikely until the National Institute for Health and Clinical Excellence recommends it as a cost-effective treatment.

Sanofi also hopes to launch Acomplia before the end of this year in Germany, Denmark, Ireland, Finland and Norway.

It has yet to give a date for launch in France, however, where the world's third biggest drugmaker first needs to agree a price with the government."

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Will Rimonabant Come To New Zealand?

http://www.nzherald.co.nz/
"Health authorities are evaluating a new weight-loss drug hailed as a potential breakthrough in treating obesity.

The application to market the drug rimonabant in New Zealand comes as the pill becomes available on prescription in Britain.

Clinical trials have shown that 40 per cent of overweight or obese people who take rimonabant lose 10 per cent of their body weight."

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England Is First Country To Receive Rimonabant

http://www.timesonline.co.uk/
"Britain is the first country to receive Rimonabant, after the decision by drug regulators last week to grant it a licence throughout the European Union. Experts say that 20 per cent of Britain’s population could be eligible for treatment.

However, the drug is unlikely to be widely available until it is approved by the National Institute for Health and Clinical Excellence.

The institute, which advises on NHS best practice, is not expected to issue guidance on Rimonabant for two years.

At a cost of £55.20 per patient per month, or £1.97 per tablet, even treating a fraction of the group eligible could cost the NHS billions."

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Acomplia: 1 Pound 97 Per Day

http://today.reuters.com/
"Sanofi-Aventis priced its new anti-obesity drug Acomplia at 1.97 pounds ($3.59) per tablet on Wednesday in Britain, the first country where it has become available.

The world's third largest drugmaker last week won European Union clearance to sell Acomplia -- for which it has forecast annual global sales of more than $3 billion -- to tackle obesity and related health risks that can cause cardiovascular diseases. "

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Rimonabant Could Cost England

http://www.24dash.com/
"A new drug that promises to revolutionise the treatment of obesity and diabetes was launched in the UK today.

Rimonabant is the first drug to target a natural body system that governs a host of factors controlling appetite, weight, metabolism and energy use.

As an added bonus, it is said to combat a smoker's craving for nicotine.

But widespread use of the medicine would land the NHS with a fat bill.

Experts say that potentially 20% of Britain's population could be eligible for treatment with rimonabant."

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The Importantce Of European Acomplia / Rimonabant Approval

http://www.newswire.ca/
""The approval of ACOMPLIA(R) 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. "Through our discovery, development and
now this approval of ACOMPLIA(R), sanofi-aventis has once again demonstrated
our expertise and commitment to making first-in-class treatments available to
patients and physicians alike."
ACOMPLIA(R) 20 mg is targeted at improving multiple cardiometabolic risk
factors in obese and overweight patients. Those likely to gain most benefit
will be patients presenting with abdominal obesity (a large waist
circumference) who also have diabetes and/or dyslipidemia. Almost half the
adult population with a large waist circumference (defined as 102 cm/40 inches
in men and 88cm/35 inches in women) present with at least 3 additional risk
factors, all contributing to increased cardiometabolic risk.
Global cardiometabolic risk represents the overall risk of developing
type 2 diabetes and/or cardiovascular disease and is due to a cluster of
modifiable risk factors. Cardiometabolic risk factors include classical risk
factors such as high LDL-cholesterol levels, hypertension and hyperglycaemia
and emerging risk factors closely related to abdominal obesity (especially
intra-abdominal adiposity), such as insulin resistance, low HDL-cholesterol,
high triglyceride levels, and inflammatory markers such as adiponectin and
CRP (C-reactive protein)."

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More On The European Rimonabant Approval

http://www.pharmaceutical-business-review.com/
"Results from the RIO program demonstrated that one Acomplia 20mg 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% of the observed improvements in HbA1c, HDL-cholesterol and triglycerides were beyond that expected from weight loss alone.

"Rimonabant (Acomplia) is an important advance to treat the multiple risk factors which contribute to the global risk for diabetes and cardiovascular disease, which will offer benefits beyond current treatments for individual risk factors such as blood pressure, cholesterol and diabetes," said Dr Luc Van Gaal, professor of diabetology, metabolism and clinical nutrition, Antwerp University Hospital, and principle investigator in the RIO Europe trial."
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Sanofi Gets EU Approval To Sell Acomplia

http://www.forbes.com/
"French pharmaceutical group Sanofi-Aventis SA said it has won approval from the European Commission to begin selling its anti-obesity drug Acomplia.

A 20-mg per day version has been authorized for all 25 EU member states, with the first launch set for the UK in July. Launches in Denmark, Ireland, Germany, Finland and Norway will occur by the end of this year, Sanofi said in a statement."
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More Acomplia Findings

http://www.foxnews.com/
"Acomplia, an experimental weight loss drug, helps obese people with type 2 diabetes lose weight, reduce waist size, and even control blood sugar and blood fats.

Surprisingly, Acomplia's beneficial effect on blood sugars and fats went 57 percent beyond the benefit that would have been expected from weight loss alone. The drug, which affects the body's cannabinoid system, appears to reduce interrelated risks for heart and metabolic diseases.

The benefits seen were in addition to the benefits of standard, ongoing treatment with Glucophage or the family of diabetes drugs called sulfonylureas. Researcher André Scheen, MD, PhD, head of diabetes at the University of Liège in Belgium, reported the findings at this week's annual meeting of the American Diabetes Association, held June 9-13 in Washington."

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More Acomplia Benefits

http://www.webmd.com/
"Acomplia, an experimental weight lossweight loss drug, helps obese people with type 2 diabetesdiabetes lose weight, reduce waist size, and even control blood sugar and blood fats.

Surprisingly, Acomplia's beneficial effect on blood sugars and fats went 57% beyond the benefit that would have been expected from weight loss alone. The drug, which affects the body's cannabinoid system, appears to reduce interrelated risks for heart and metabolic diseases.

The benefits seen were in addition to the benefits of standard, ongoing treatment with Glucophage or the family of diabetes drugs called sulfonylureas. Researcher André Scheen, MD, PhD, head of diabetes at the University of Liège in Belgium, reported the findings at this week's annual meeting of the American Diabetes Association, held June 9-13 in Washington. "

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Sanofi Target Raised

http://www.newratings.com/
"Sanford Bernstein raises Sanofi-Aventis's (SNY) target price to EUR100 from EUR94 on the basis of the group's 1Q results and its recently improved risk profile. Increases '06 EPS forecast to EUR5.52 from EUR5.25 and '07 EPS to EUR6.14 from EUR5.72. "

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Rimonabant: A History

http://www.nature.com/
"Appetite control can be achieved through the use of agonists for appetite suppressing pathways or antagonists for appetite-stimulating pathways. Much anticipation has surrounded rimonabant (Acomplia; Sanofi-Aventis), a first-in-class selective cannabinoid type 1 (CB1) receptor antagonist for obesity/metabolic syndrome and smoking cessation. Over-stimulation of the CB1 receptor is associated with excessive food intake, fat accumulation and nicotine dependence. In clinical studies, rimonabant produced moderate weight loss (5% body mass). However, rimonabant use was associated with a high dropout rate (40–50%) partly due to psychiatric side effects, such as depression, anxiety and aggression3. This is of concern, especially for a drug intended for broad and chronic use and with high potential for recreational abuse.

In February 2006, the FDA issued an approvable letter for rimonabant for weight loss and a non-approvable one for smoking cessation. Sanofi-Aventis says it will launch this drug for weight loss by the second half of 2006, but experts suggest that approval could be delayed by a safety-conscious FDA, which might require additional studies. Even if approved, rimonabant is likely to have a rather narrow label, potentially limiting its prospects for third-party reimbursement."

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Rimonabant Recommended By EU

http://www.businessweek.com/

"The European Medicines Agency has recommended an innovative new weight-loss pill for approval, the drug's maker, Sanofi-Aventis SA, announced Friday.

Sanofi shares rose 2.7 percent to euro75.55 (US$94.72) in Paris after the agency's human medicines committee backed the new drug, Acomplia. The U.S. Food and Drug Administration issued an "approvable letter" for Acomplia in February, a step toward its approval for weight control."

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Acomplia - The Hyped Drug

http://www.itp.net/
"Considerable excitement surrounds rimonabant (Acomplia), a type of weight-loss drug that works by blocking the same receptors in the brain that cause ‘munchies’ in marijuana users. Rimonabant reduces weight, quiets food
cravings, and improves cholesterol and other risk factors for heart disease, including waist circumference.

We certainly need new weight-loss solutions. Two-thirds of adults in the United States are overweight or obese and at risk for several major medical conditions, as well as premature death. Even modest weight loss can reduce these risks. But as most of us know, losing weight can be extremely difficult, and keeping it off even more so. Most people who shed pounds regain them within five years. Little wonder that there’s intense interest in drugs to boost weight-loss efforts."
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Fake Rimonabant Being Sold Online

http://europa.eu.int/
"The European Commission has issued a warning that fakes of the medicine rimonabant are currently being sold via several websites. Rimonabant has been developed to treat obesity and related risk factors and smoking cessation[1]. The medicine is still under evaluation by the European Medicines Agency (EMEA). The product will only receive marketing authorisation by the European Commission once its quality, safety and efficacy have been satisfactorily established by the EMEA scientific committee, and this approval is still pending. Once approved, the company intends to market rimonabant under the name AcompliaTM. Patients who buy unlicensed and counterfeit or illicit copies of rimonabant may be putting their health at risk. This latest example underlines European Commission concern that criminals are taking advantage of the anonymity of the internet to sell fake, adulterated and unlicensed medicines to an unsuspecting public, putting lives at risk as well as undermining the pharmaceutical industry. "
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Rimonabant / Acomplia Effects

http://www.rctimes.com/
"RIMONABANT (BRAND NAME ACOMPLIA)

• FDA approval status: The FDA is currently reviewing rimonabant for approval as a prescription drug. The drug's maker anticipates approval this year.

• How it works: While other drugs work as appetite suppressants or fat absorption blockers, this one works as a behavioral drug by affecting receptors in the brain that play a role in compulsive behaviors such as overeating and smoking.

• The benefits: A study published last month found that people who took the drug lost 4.5% of their body weight. The study also found that people who stopped taking the drug regained the weight they lost.

• The side effects: Nausea, anxiety and depressed mood.

• The bottom line: "The results are not all that different from what's already out there," Spaw says."

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Rimonabant / Acomplia Featured In Time Magazine

http://www.time.com/
" In half a dozen clinical trials, the compound helped 6,000 patients lose up to 10% of their body weight over a year and maintain that loss for another year. And because rimonabant works in liver and fat cells as well, it also improved the patients' cholesterol profiles, boosting "good" HDL levels and lowering amounts of dangerous triglyceride fats in the blood."

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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.