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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: Twitter: Dereklowe

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October 25, 2010

Lorcaserin's Complete Response

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Posted by Derek

Arena released their complete response from the FDA over the weekend, regarding the non-approval of their weight loss drug Lorcaserin. And the arguing has already started about just how bad the news is. There are several levels that this process could be tracking on, and we just don't know which one it's on yet.

And the varied regulatory paths that result give you answers to "When will the drug be approved" ranging from "Maybe in six months" through "Maybe in a year" on out to "Maybe in a few years", which at that point shades into "Never". One of the main sticking points is the carcinogenicity data from the animal studies - the FDA is worried, and they want Arena to round up some outside experts to go over the data to address their concerns. Problem is, we don't quite know what that means. It could be anything from "Have some people assure that FDA that everything's actually fine" (the Arena bull position) to "Go run a bunch more long clinical trials" (which is one of the bear positions). I think it's unlikely that the FDA will let the company go through without at least running more rodent studies; I just can't see an outside review of the data doing enough to calm them down. The agency, I believe, is in more of a "Get some people to help you design some good studies" mode.

Matthew Herper's take seems reasonable to me. As he points out, even when companies have gotten a drug through after one of these Complete Response Letters, it's taken at least seven months when the issues didn't involve the clinic. He seems to be taking flak from Arena investors who have loarcaserin penciled in for somewhere around Valentine's Day. But I don't see how that's going to happen, either. Try April Fool's - of some other year.

Comments (4) + TrackBacks (0) | Category: Diabetes and Obesity | Regulatory Affairs


1. Hap on October 25, 2010 11:52 AM writes...

Small-company pharma investments - because you get home from work too late to watch soap operas on TV and get sick on roller coasters.

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2. glinkst on October 25, 2010 9:17 PM writes...

No matter what the FDA's response is, the Arena bulls will be adamant that approval is just around the corner, and that the rest of the world are complete idiots.
It is curious that none of them are calling for the CEO's head. It is all about drinking the kool-aid.

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3. BbooooooyA on October 25, 2010 9:58 PM writes...

No smart money in arna, bunch of retail pump dumpers.

Great to be on this roller coaster if you know which way it's going

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4. DCRogers on October 26, 2010 2:32 PM writes...

Let the lawsuits begin!

My Google ad when I went to look at the stock price (brutal 3M graph, BTW -- latest news "only" knocked off 5% more equity value):

Did you lose money investing in ARNA? Legal investigation.

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