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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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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

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March 11, 2010

Intermune's Rise

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Posted by Derek

If you want to know why people continue to speculate in biotech stocks, just take a look at the stairsteppy last few days of trading in Intermune (ITMN). Last Thursday it was at $15; now it's at $38. And all you have to do to cash in on these moves is read the FDA's mind!

That's not a money-making proposition, in case anyone thinks I'm advocating it. There are just too many surprises. But Intermune's good fortune started last week, when the FDA briefing documents came out on the application on the company's pirfenidone for idiopathic pulmonary fibrosis and were characterized as "not as bad as they could have been". (The company's history of overzealous PR wasn't helping it at this point). And if you still don't think that the moves in the stock have been surprising, consider that two ITMN executives sold shares on after the first jump, missing out on the second one completely when the FDA advisory panel gave the drug a favorable recommendation.

Pirfenidone, by the way, is another structure entry in the so-simple-I-can't-believe-it drug sweepstakes. If approved, it would be the first specific therapy for IPF, which can be a nasty disease. I certainly hope it helps out the patients involved (a few hundred thousand in the US), but that small patient population means that the drug isn't going to be cheap. Intermune's investors certainly don't think so.

But as has been clear for some time, we're in a rather tricky environment for expensive health care options. If pirfenidone makes it, I'd guess that it will be picked up widely, but cautiously, by health insurance. No one knows how it'll perform in the real world, and if little benefit is seen, it'll be hard to justify reimbursing for it. (It made one Phase III trial's endpoint, but missed another one, so there's room to wonder). The more cost-conscious European regulatory agencies will be a good place to watch this argument play out. One correspondent of mine refers to the drug as the next Iressa. That's not a compliment.

Comments (5) + TrackBacks (0) | Category: Business and Markets | Clinical Trials | Regulatory Affairs


COMMENTS

1. milkshake on March 11, 2010 9:45 AM writes...

This looks just like something from antipyrine family - very old anti-inflammatory drugs. if the mechanism of action is the same, would it be possible for a doc to prescribe old disused generics antipyrine off-label for these patients?

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2. Cellbio on March 11, 2010 10:14 AM writes...

Wow, so simple even a biologist can't believe it.

Milkshake, I did a quick search and found a news article with Intermune claims that this is a specific p38gamma inhibitor. Is that possible? I would think it too small to have any true specificity. Maybe it hits gamma at a concentration right below the concentration that crashes it out of solution? I'll look for the original reference.

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3. milkshake on March 11, 2010 10:38 AM writes...

there are N-aryl 2-pyridone p38 mixed alpha + beta inhibotors from Pharmazia, and they are very potent - but this particular molecule lacks several substituents that are essential for potency. It has been a while since I was on p38 project, in those timese the actual role of various isoforms was mysterious.

Who knows how it works - just because the molecule hits a know target it does not mean that it is the actual mechanism of action

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4. Edmundo on March 16, 2010 10:19 AM writes...

Intermune -- is that where Michael Bolton, Samir Nagheenanajar and Bill Lumbergh now work?

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5. Tasia Stmary on January 7, 2013 4:23 PM writes...

I relish, result in I discovered just what I was taking a look for. You have ended my four day long hunt! God Bless you man. Have a nice day. Bye

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