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March 30, 2007
Rimonabant, Slowly
Posted by Derek
Remember back when Sanofi-Aventis submitted Acomplia (rimonabant) to the FDA? Remember when the FDA told them that they needed more data before it would be approved? That's been over a year ago now - time flies - and now they're saying that another hearing with the agency is scheduled for June 13.
There was an excellent summary of the whole situation by Jeanne Whalen in the Wall Street Journal the other day, which subscribers will already have seen. Here's the article for free access in the Arizona Republic for everyone else. This will take you through the whole story, from the hype of 2004 to the. . .well, uncertainly today.
What's worth thinking about are the (in retrospect, rash) statement of Sanofi's people back then about the huge blockbuster potential of the drug, and the (in retrospect, clueless) statements of various analysts back a year ago. "A brief delay" was one phrase that turned up several times, along with predictions of approval by the middle of 2006. . .make the the end of the year. . .OK, first quarter of 2007. . .fine, fine, by the end of '07.
And what's continued to amaze me is the ability of the S-A management to give no details about what's going on with the drug. A year ago, I thought they'd be forced to talk shortly by investor pressure, but I'm clearly a bit clueless myself. . .
Comments (6)
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1. Roadnottaken on March 30, 2007 4:09 PM writes...
i wonder what the chances are that someone else will get FDA approval for their own CB1 antagonist before Sanofi? that article makes it sound like Sanofi just screwed itself with bad relations with the FDA and poorley managed clinical trials but i'm sure there are other pharmas in line with their own CB blockers. as long as they're up-front about the psych side effects (which are to be expected, really...) i don't see why they shouldn't get approved for certain indications...
Permalink to Comment2. AcompliaWatcher on March 30, 2007 10:13 PM writes...
Perhaps the most amazing thing in this saga has been the willingness of "analysts" to simply parrot what is being whispered in their ears. First, it was the "brief delays." Now, it is that the advisory panel hearing is what is needed to get a "diabetes indication." No way is that going to happen. Hard to believe anyone makes money decisions based on advise from these "analysts."
Permalink to Comment3. Chrispy on March 31, 2007 1:09 PM writes...
That WSJ article had an interesting chart which wasn't reprinted in that link. Here:
Obesity treatments under development
Pfizer CP-945598 Phase 3 CB-1 antagonist
Merck taranabant Phase 3 CB-1 inverse agonist
Alizyme cetilistat Phase 2 complete (similar to Xenical)
Of those the Merck inverse agonist looks particularly interesting. Funny, but taranabant.com is occupied by what looks to be a squatter -- I wonder what that will be worth if the drug is released?
Permalink to Comment4. dan on March 31, 2007 2:45 PM writes...
Any formulation of medication that effects (numbs-out) obsessive/compulsive behaviors such as food addiction, would naturally have opponents other than competitors in the pharmaceutical industry. Consider how much of the U.S. economy is supported by impulse buying. Consider again the wide tax revenue support from cigarettes, alcohol, gambling and junk food. Even a parcel responsive drug having temporary short term benefits, or placebo, would turn the known marketplace upside down. The lobbing efforts must be currently succeeding.
Permalink to Comment5. Will on April 2, 2007 9:33 AM writes...
I guess the impending merger with Aventis may have made the board at S-A make some strange decisions, my PhD was sponsored by them and it took 6 months to get a poster vetted at the time.
Permalink to Comment6. Dave H on April 2, 2007 3:28 PM writes...
Chrispy, shame on you. Taranabant.com ? Only the chemists will care. Marketing will come up with real humdinger of a name. Probably with a lot of killer consonants: X,Z and V are popular!
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