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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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May 5, 2010

Intermune: Right Back Down Again

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Posted by Derek

Back in March, Intermune's stock saw a sudden jump on news that an FDA advisory committee treated their drug pirfenidone more positively than expected. But the agency is in no way committed to following these recommendations, and yesterday they turned down the drug, sending Intermune stock right back down into the basement again.

Pirfenidone was, even after the advisory committee, an iffy proposition. It made it through one Phase III trial, but missed its endpoints on another. And even though there's no current treatment for idiopathic pulmonary fibrosis, there's no use in telling people that there is one (and asking their insurance companies to pay for it) if there really isn't. The company isn't saying much, but all indications are the the FDA is concerned about efficacy: they aren't convinced that the drug really works, and will want fresh clinical trial data before reconsidering approval.

Whether Intermune can raise the cash to do that is in doubt. If they can't convince the FDA that they have something worthwhile, they'll likely have trouble persuading investors.

Comments (3) + TrackBacks (0) | Category: Business and Markets | Regulatory Affairs


COMMENTS

1. Hap on May 5, 2010 11:41 AM writes...

How about GSK? Alternatively, perhaps they can get some money from Generex's investor base - on the other hand, this has been through significant trials, so maybe there's too much data.

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2. Industry Guy on May 5, 2010 12:50 PM writes...

I wonder if any of the advisory committee set up a short sale after they made their initial decision?

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3. ER on May 6, 2010 4:23 AM writes...

The worry is what this will do to their current discovery programs/employees - i.e. when mamagement decide to apply the entire company's resources towards a 3rd phase 3 trial, and stop everything (layoff everyone) else.

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