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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: derekb.lowe@gmail.com Twitter: Dereklowe

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February 24, 2006

What's French for "Trust Us"?

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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


COMMENTS

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

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