Saturday, June 30, 2007


Acomplia is the European trade name of Rimanobant as sold by Sanofi (NYSE:SNY). It was approved for sale in by the European Medicine Agency in June 2006, for the treatment of obesity and metabolic syndrome. This approval followed multiple international studies, to show that it was very effective in lowering cardiovascular risk factors, especially in patients with obesity. It was supposedly cardio-protective. Sanofi Aventis was so pleased with the early results that they were touting it as another blockbuster drug almost as profitable as plavix. They must have spent millions on it with clinical trials and promotions.

When Rimanobant was first presented to me back in 2004, I did some research. It came under the group of drugs we know as CB1 or "cannabinoid receptor antagonist type 1". I reasoned that although Rimanobant may be very effective in CVS protection, I was concerned about the potential side effects. As we all know, "cannabis" (which we know as "ganja") makes the user high as a bird. If you block the cannabis receptor, the user is abruptly brought down to earth with bang. My concern at the time was the possibility of depression with a resultant increase in suicide rates (the anti-cannabis effects). The manufacturers repeatedly assured me that it was a safe drug, and when they had received EU approval. At that point, I thought that I was wrong.

Well, my worse fears were realised when in early June, the American FDA Endocrinologic and Metabolic Drug Advisory Committee (EMDAC) voted unanimously (all 14 members) not to approve the drug for use in USA. The notes tell us that at 20mg (along with diet) we can get a 5% increase in weight reduction but at the cost of a DOUBLING in suicidal thoughts and other psychiatric problems. Immediately the stock market reacted with a vengeance. Sanofi stock plunged 8% wiping out USD $9Billion.

On 29th June Sanofi announced that their application for approval was withdrawn, realizing that much more work needs to be done. A lot of money has already been put into this effort so no one is going to pack up and leave the playing field easily. There is still the Tobacco/Marijuana cessation angle being studied but that's a very small market for so much R&D cost.

So another another "block-buster" drug bites the dust. One wonders what the Europeans are going to do. I undertsnad that Germany, probably the biggest European market for Acomplia in Europe is re-considering approval, or may insist on tighter blackbox labelling.

Sanofi is in a tight spot. It's other block buster Ambien (sleeping pill) and Oxaliplatin(Chemotherapy) are going off patent. Other drugs which are just out of the lab such as Ketek (antibiotic) are under intense scrutiny.

As physicians, our greatest concern is that when block-busters fail to live up to expectations, money is lost and pharmas, in trying to re-coup their profits, will have to increase the cost of drugs, or go bankrupt, both of which are bad for the patient.

1 comment:

hannah said...

I purchased Acomplia from WWW.MEDSHEAVEN.COM , I lost 20 lbs in two week, without any workouts! if i worked out while taking this im sure I would have lost a lot more!