Posted on 08/31/2004 5:36:43 AM PDT by LittleMoe
Posted on Tue, Aug. 31, 2004
Optimism on antiobesity drug
Sanofi-Aventis said it was confident that Acomplia would be approved quickly by the FDA.
By Ben Hirschler
Reuters
MUNICH, Germany - Sanofi-Aventis is confident that U.S. health-care officials will look favorably on its new antiobesity drug Acomplia and that the drug could win fast-track approval from the Food and Drug Administration.
"The climate is more and more favorable," Michel Joly, the drugmaker's vice president of strategic marketing, said in an interview at the annual meeting of the European Society of Cardiology in Munich, where encouraging clinical data on the drug were presented.
Joly said there was no reason why Acomplia, or rimonabant, which can help people both lose weight and quit smoking, should not become a multibillion-dollar-a-year seller.
Demand for the once-a-day pill - which will be marketed to tackle two of the biggest risk factors for heart disease - is likely to be higher in the United States than in Europe, and the U.S. Medicare program was likely to pay for its reimbursement, he said.
Sanofi-Aventis employs 750 people at its Malvern drug-development campus, where scientists directed the human tests involving Acomplia.
The drug is viewed as pivotal to the newly merged company's future. Some industry analysts have suggested that annual sales could reach as much as $6 billion.
Others, however, remain concerned about side effects. About 15 percent of patients on the drug have dropped out of trials because of side effects - mainly nausea, which affected one in eight patients.
But Joly said that the effects were mild and transient and that studies being conducted by Sanofi should be adequate to demonstrate that the drug was safe and effective.
Sanofi aims to file for marketing approval of the product in the United States and Europe in the second quarter of next year, with a launch in 2006.
Joly said the FDA could give the product fast-track status - implying approval within six months - because the agency had made tackling obesity a priority.
He declined to say what Acomplia would cost, but he said the drug would be priced to ensure that it got to the many poorer people who suffered obesity. "Access is more important than price," he said.
Last month, U.S. Health and Human Services Secretary Tommy Thompson said obesity treatments might be covered under Medicare and Medicaid.
This will be a block buster- unfortunately it is developed by the FROGS
Can it be washed down with Coca-cola?
THOSE are the real questions of import.
Also, when the weight returns (and it does 90% of the time) can this medication be taken again? And again? And again?
Have "they" invented a backbone pill? This would be the pill that gets me to push away from the table and makes my head move from side to side in a "no" action. It also causes me to say the magic words, "No thank you. No more for me. I've had enough."
Finally, this pill would get my butt off the chair, out the door and for a long (That would be 1/2 hour.) brisk (That would be about three miles per hour.) walk.
When they do, let us know. I would like to order a few truckloads.
Thangkew.
A better obesity drug (not an appetite suppressant) developed in Australia is moving through testing, but is not as far along as this one. Long-term it is a better bet. You can check out the company stock on Yahoo Finance (symbol MBP.AX)
Thanks John I will
The thing is that this drug is two fold
Smoking and obesity
< A better obesity drug (not an appetite suppressant) >
There's the key: "not an appetite suppressant". My appetite can be supressed to nil but I will still eat. A lot of obese people eat just to eat (the comfort factor)...not because they are hungry. A true "obesity pill" would not be just another appetite suppressant.
What I want to know is will the Drug Store deliver it to my home so I don't have to get off the couch to go get it.
Unfortunately, it has the side-effect of making you repeat everything you say.
Looks like a typical case of marketing first, worry about side effects later.
Accomplia blocks the brain's cannabinol receptors. I think this means that while taking Accomplia, one would not be able to get the proverbial "buzz" from cannabis products shuch as hashsish and marijuana. It may have actually started out as an anti-marijuana drug that only later found its application as an obesity treatment.- not sure of this, but I have heard it referred to as an anti-marijuana drug.
It is also the reason that Accomplia causes dose-dependent nausea.
You seem to know a lot about the drug you work for a pharmaceutical company?
No. I don't work for one.
But about a year ago I decided that a real, effective obesity drug would be huge, and I started researching what was in the pipeline. After doing my research, I watched the stock of three companies (Sanofi being one), but with my focus on Metabolic Pharaceuticals (MBP.AX), developers of an obesity drug known as AOD9604.
I watched for a while, then I acted. I wound up buying as many shares in the company as I could afford. And I intend buying more as early as tomorrow morning.
The news in this article is very encouraging. Aventis' estimate of the size of the market confirms my own, and if the FDA fast tracks Sanofi-Aventis' drug, they will have to do the same for AOD9604. Optimistically, it could be approved for sale in the USA by 2007.
Good choice I am buying too
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