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It Could Receive FDA's Approval This Month.: Magic Pill? Lose Weight, Ease Illness, Quit Smoking

Posted on: Saturday, 4 February 2006, 15:00 CST

By Linda Loyd, The Philadelphia Inquirer

Feb. 4--It sounds too good to be true:

A pill that helps you lose weight, quit smoking, and reduce the cardiovascular risks for diabetes and heart disease.

Sanofi-Aventis SA's new treatment, Acomplia, also known as rimonabant, has shown promise in a half-dozen clinical trials in curbing the cravings that make people hungry and reach for a cigarette.

The experimental drug, which works differently from other weight-loss medicines, could be approved by the Food and Drug Administration as soon as this month. And industry analysts predict it could become the world's first blockbuster antiobesity treatment, with annual sales of 2 billion to 4 billion euros, or $2.4 billion to $4.8 billion.

In studies, a 20-milligram dose once a day helped patients lose 5 percent to 10 percent of their weight in a year, raise good HDL cholesterol, lower triglycerides, and improve blood sugar and blood pressure.

"There is a lot of excitement about it," said Daniel J. Rader, cholesterol expert and director of Presbyterian Medical Center's Lipid Referral Center at the University of Pennsylvania. "We haven't had a new drug for obesity come out in quite a while, and the drugs we have aren't the greatest."

Rader thinks Acomplia is "likely to be approved" and potentially could be "a very successful drug. There is such a tremendous desire and need for new approaches to help people lose weight, as well as for smoking cessation, and my understanding is the safety has been pretty good in the trials."

If Acomplia gets marketing approval from the FDA later this month, Paris-based Sanofi-Aventis, which employs 1,000 at its drug-development center in Malvern, has said it could begin selling the pill by June 30.

Rimonabant is the first in a new class of medicines that works in the body's endocannabinoid system, which has a role in appetite. The drug works by blocking cannabinoid-1 receptors in the brain, deterring the munchies and cravings for nicotine. In the liver, it blocks the rate of fatty acid synthesis, which alters triglyceride and HDL cholesterol levels, and in fat cells it blocks hormones that increase insulin.

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.

Susan Z. Yanovski, of the National Institutes of Health, said in a New England Journal of Medicine editorial in November that weight-loss medicines have a checkered history. Weight loss is rarely sustained after the drugs are stopped, she said. And there have been safety issues. The diet-drug combination known as "fen-phen" was withdrawn in 1997 after it was linked to heart-valve problems. Litigation costs and legal settlements caused Wyeth to set aside $21 billion in charges.

Yet pharmaceutical companies are still seeking a magic pill for obesity. Acomplia is a "source of great speculation for the financial community because of its novelty and unique clinical profile," Prudential Equity Group analyst Timothy Anderson said in a note.

The sales potential of Acomplia has prompted other companies, including Pfizer Inc. and Merck & Co. Inc., to pursue their own cannabinoid-receptor-blocking products. None is close to regulatory review.

The trade group Pharmaceutical Research & Manufacturers of America said there were now 21 new drugs in clinical trials for obesity.

With about 30 percent of U.S. adults obese -- more than 60 million people -- and 16 percent of children and teens overweight, according to the Centers for Disease Control and Prevention, the potential market is huge, analysts say.

No one is more eager to learn the FDA's decision on Acomplia than Sanofi-Aventis' physicians and scientists in Malvern, who worked with colleagues around the world on clinical development of the drug.

Rimonabant was discovered in Sanofi laboratories in France, and more than 200 employees in Malvern have supervised the clinical trials and worked on regulatory submissions to the FDA, said John F. Newton Jr., scientific site director at the campus in the Great Valley Corporate Center.

Company executives are in final discussions with the FDA about possible approval of Acomplia, and they have been silent about the timing of a decision and about what medical indications for the drug's label the FDA may approve.

"We're down to the wire with the FDA," said senior vice president Porter McMillian Jr., head of U.S. operations based in Malvern.

Sanofi-Aventis, the world's third-largest drugmaker, which just reported 2005 sales of 27.3 billion euros, or $32.8 billion, is looking to Acomplia to keep profit rising as several of its major products, including the antihistamine Allegra and blood-thinner Plavix, are facing, or could soon face, generic competition and dwindling sales.

"It's definitely a very different drug," said Thomas Wadden, director of the University of Pennsylvania's Weight and Eating Disorders Program, who has consulted with Sanofi-Aventis about Acomplia.

Wadden said scientists identified a part of the brain "associated with eating or overeating" -- the cannabinoid receptor -- and learned there are natural substances in the body that turn the receptor on. "The drug they've developed blocks this receptor, so in essence it prevents you from feeling hungry."

Acomplia's average 8 percent weight loss is "not a whole lot different" from other weight-loss medicines, said Wadden, president of NAASO, a North American scientific society that studies obesity. The drug's cardiovascular benefits are the big difference, he said.

Acomplia also doubled the quit rate of smokers, and they did not gain weight after they stopped, research showed. Those who kicked the habit while taking rimonabant gained only about a pound, compared with a six-pound weight gain in smokers who stopped on placebo.

Currently, there are two main obesity medicines on the market: Roche Holding AG's, Xenical, which works by limiting fat absorption, and Abbott Laboratories Inc.'s Meridia, which suppresses appetite.

Both have unfavorable side effects. Xenical can cause oily stools, excess gas, and abdominal cramping, while Meridia can increase blood pressure. As a result, sales of both drugs have been limited -- $102 million and $72.8 million, respectively, in 2004, according to IMS Health.

Financial analysts predict multibillion-dollar sales eventually for Acomplia. Some, including Gbola Amusa of Sanford Bernstein & Co., see Acomplia as the most promising new drug of the year, and Amusa predicts sales of 4.4 billion euros, or $5.3 billion, eventually.

"Cardiologists say there are nine things patients should do to live longer. Acomplia works on six of them," Amusa said. "It causes weight loss, improves diet, helps you quit smoking, improves good cholesterol, reduces triglycerides, and works for diabetes about as well as the best available oral therapies on the market today."

Amusa said company-sponsored studies show about half the improvement in HDL cholesterol and triglycerides was caused by the drug "independent of weight loss."

How successful Acomplia will be depends on the medical conditions of use that the FDA agrees to. The company hopes to persuade regulators that Acomplia reduces cardiovascular risk factors since an obesity label alone may not be enough to get reimbursement from insurers.

A major hurdle for weight-loss medicines has been lack of reimbursement by health plans. "Obesity medications get no respect," said Penn's Wadden. "There would be a lot more people on the medications if they were reimbursed -- $100 a month out-of-pocket forces some people to choose between their car payment or their weight-loss drug."

Contact staff writer Linda Loyd at 215-854-2831 or lloyd@phillynews.com.

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Source: The Philadelphia Inquirer

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