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August 23, 2005
Gritting Our Teeth
Posted by Derek
I'll tell you a company that's been watching what's happened to Merck and thinking hard about it: Sanofi. Well, OK, everyone in the industry has been looking at Merck's situation and shuddering, but I suspect the people at Sanofi(-Aventis) are especially jumpy. Why? Rimonabant.
Rimonabant, which will come to the market next year (most likely) under the name Acomplia, is one everyone's short list of potential multibillion dollar drugs. It'll be the first new drug treatment for obesity in years, and it's the first one ever with its mechanism of action (antagonism of the CB(1) receptor). It has potential for many sorts of addiction therapy as well. Although there's room to argue about just how effective it is compared to existing therapies, and there's some concern about how many HMOs will pay for it, there's little doubt that it's going to sell like crazy.
And there's the worry. There is absolutely no way that large enough clinical trials could be run on a drug like this to predict everything that might happen when millions of people start taking it. Can't be done. You can get down to a margin of safety that will get you past the FDA, but that isn't enough, now is it? No, if one person out of a hundred thousand has a nasty side effect, that's enough to bring the sky down on your head. And we can't test down to the level of one-per-hundred-thousand effects.
A fine situation, isn't it? This same argument applies to every new drug, naturally, but especially to a groundbreaking compound like rimonabant. That's just what we needed, an incentive not to be first in class with a new drug. What, exactly, are we doing to ourselves?
Comments (3)
+ TrackBacks (0) | Category: "Me Too" Drugs | Clinical Trials | Diabetes and Obesity
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1. tombartlett7 on August 24, 2005 6:21 AM writes...
Tell me about it. I work for a start-up. Management has had the devil of a time scoring VC money to keep us together in these post-".com" days. Now, the VC's can be further spooked by frivolous mega-lawsuits, like the Vioxx cases. I wouldn't completely blame them if they put their money on some kind of short time-t0-market fluff like a Google or Napster clone instead.
Permalink to Comment2. casey451 on August 24, 2005 5:48 PM writes...
A company that everybody in the industry SHOULD be watching is Elan. They pulled their very promising MS drug immediately after 2 test subjects died from a rare brain disorder. So far, no further deaths, no evidence the drug caused the disorder, and, unlike Merck, no indication Elan hid any negative test results. Elan apparently learned to be upfront about all things after their former executives were caught playing games in the accounting department. Its drug appears to be headed back to the marketplace with some warnings, an outcome that seems appropriate to me. And I own the stock, and took a very significant hit when they pulled the drug.
So far Sanofi seems to be doing things right on behalf of ITS very promising drug, Rimonabant. It's the FDA that could stomp on it by pretending it is possible to test enough people to avoid nasty side effects. After all, the FDA has to make up for Vioxx, and Rimonabant seems the perfect victim for the reasons you cite above.
Permalink to Comment3. Tom Bartlett on August 25, 2005 4:05 PM writes...
I have some ELN, too-- not tons, but some. I think their Alzheimers work has promise. I'd like to see them crawl back up to $60, but maybe I'm deluded....
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