About this Author
DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

Chemistry and Drug Data: Drugbank
Chempedia Lab
Synthetic Pages
Organic Chemistry Portal
Not Voodoo

Chemistry and Pharma Blogs:
Org Prep Daily
The Haystack
A New Merck, Reviewed
Liberal Arts Chemistry
Electron Pusher
All Things Metathesis
C&E News Blogs
Chemiotics II
Chemical Space
Noel O'Blog
In Vivo Blog
Terra Sigilatta
BBSRC/Douglas Kell
Realizations in Biostatistics
ChemSpider Blog
Organic Chem - Education & Industry
Pharma Strategy Blog
No Name No Slogan
Practical Fragments
The Curious Wavefunction
Natural Product Man
Fragment Literature
Chemistry World Blog
Synthetic Nature
Chemistry Blog
Synthesizing Ideas
Eye on FDA
Chemical Forums
Symyx Blog
Sceptical Chymist
Lamentations on Chemistry
Computational Organic Chemistry
Mining Drugs
Henry Rzepa

Science Blogs and News:
Bad Science
The Loom
Uncertain Principles
Fierce Biotech
Blogs for Industry
Omics! Omics!
Young Female Scientist
Notional Slurry
Nobel Intent
SciTech Daily
Science Blog
Gene Expression (I)
Gene Expression (II)
Adventures in Ethics and Science
Transterrestrial Musings
Slashdot Science
Cosmic Variance
Biology News Net

Medical Blogs
DB's Medical Rants
Science-Based Medicine
Respectful Insolence
Diabetes Mine

Economics and Business
Marginal Revolution
The Volokh Conspiracy
Knowledge Problem

Politics / Current Events
Virginia Postrel
Belmont Club
Mickey Kaus

Belles Lettres
Uncouth Reflections
Arts and Letters Daily
In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« Blogroll Revamp | Main | Tied to the Mast »

February 24, 2006

What's French for "Trust Us"?

Email This Entry

Posted by Derek

Well, Sanofi-Aventis has held their meeting with analysts and taken questions, and there's still not much to say about the Acomplia (rimonabant) situation. They still say that they plan to launch the drug later this year, and that they plan to talk with the FDA in March. A Bloomberg story says that they hope to resolve the issues "within months", which they'd better do if they're planning on 2006.

As far as I can determine, they still haven't come out and said just what the FDA's concerns are. And that, to me, has to be a bad sign. If the problems were inarguably small, the company would surely be motivated to tell everyone about them. But it looks more like: "We think we can launch this year. But if we told about you all the FDA's concerns, you might not think so yourselves. So we're not going to tell you."

If more details come out, I'll revise my opinion. But failing that, can anyone think of a reason why this isn't the right way to interpret this?

Comments (12) + TrackBacks (0) | Category: Diabetes and Obesity


1. Jack Friday on February 24, 2006 9:04 AM writes...

Quite so.

I too get the feeling that this is all being very carefully managed....if not spun.

By the way, type "French military victories" into Google and see what turns up.

Permalink to Comment

4. peej on February 24, 2006 9:26 AM writes...

Has anyone noticed that this approvable letter came WITHOUT the drug having been reviewed by an FDA advisory board meeting? That cant be good news - right? Does the FDA ever approve drugs without going through an advisory board?

Usually, advisory boards are where the drugs dirty laundry tends to get aired... but its silence on rimonobant. I dont get it - can anyone explain?

Permalink to Comment

5. John Johnson on February 24, 2006 9:30 AM writes...

Ok, I find this completely bizarre. According to pharmagossip, they company claims that the FDA does not require any further studies. Yet they are being very tight-lipped on what the FDA does require.

Did somebody screw up the NDA submission? Did the safety report not come out on time, or was it incompatible with the rest of the submission? Inquiring minds want to know!

Permalink to Comment

6. John Johnson on February 24, 2006 9:39 AM writes...

Perhaps also this could be as benign as the FDA wanting the endocrinology advisory committee to discuss it, though I would expect if that were the reason the company would just come out and say it. But PR people can be pretty weird about things like that, too.

Permalink to Comment

7. CJ Croy on February 27, 2006 9:04 PM writes...

After some consultation with colleagues, "Faites-nous confiance" has emerged as French for "Trust us", but "Nous-rendons" should also work.

Permalink to Comment

8. Petros on February 28, 2006 9:29 AM writes...

I've just listened to the Q&A and thought that they seemed very touchy about rimonabant, and were evasive in even answering how they would communicate the ouctomes of the meeting they will be having with the FDA.

They did indicate that an additional study has not been required for the obesity indication, but has been indicated to be necessary for the smoking cessation indication.

Permalink to Comment

9. Brian on March 4, 2006 10:49 AM writes...

I can tell you that the drug will not be called Accomplia. The FDA has rejected that name. The HQ in Paris has not even released the Approvable letter to any employee in the US. Therefore even the US affliate has no idea what the issues are. What I find more interesting, is that the NDA contained 5 indications, yet the press release only talks about two of them (weight mgmt and smoking cessation)....

Permalink to Comment

10. Milt on March 6, 2006 6:18 PM writes...

What were the other indications in the original NDA? I also hear that the latest name they are cosidering is Celnec, but I don't understand what the problem is with Acomplia, since they have had it trademarked in the U.S. for almost a year.

Permalink to Comment

11. Brian on March 7, 2006 8:00 PM writes...

The other indications are cardiometabolic risk, Diabetes and cholesterol improvement. If this is to be a multi-billion dollar drug, it is essential to have these indications. If they only get weight loss, Managed Care wont reimburse it and the potential of the drug will drop way down. With respect to the name, the trademark has nothing to do with it. The FDA can reject any name if they feel it is too similiar to another drug. In the case of Accomplia, I suspect they dont like the implied claim in the name (Accomplish). They frown upon that.

Permalink to Comment

12. dana smith on August 14, 2006 12:18 AM writes...

Could it be that the release of Acomplia will "step on some toes" of the multi-billion dollar diet industry???? Germany and Britain are both ready to dispense it, so what's the REAL problem with the U.S./FDA (or whomever or whatever)?? Seems to me that someone doesn't want to see its' release here in the U.S. Same thing with phen-fen. I took it for a year with no ill effects. All medications carry risk. Phen-fen was just too much competition for the diet industry.

Permalink to Comment


Remember Me?


Email this entry to:

Your email address:

Message (optional):

The Last Post
The GSK Layoffs Continue, By Proxy
The Move is Nigh
Another Alzheimer's IPO
Cutbacks at C&E News
Sanofi Pays to Get Back Into Oncology
An Irresponsible Statement About Curing Cancer
Oliver Sacks on Turning Back to Chemistry