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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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« For Immediate Rewording. Uh, Release. | Main | Changes in Papers »

February 25, 2014

InterMune Comes Through

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Posted by Derek

Back in 2010, I wrote about InterMune's drug for idiopathic pulmonary fibrosis, pirfenidone. The company's stock shot up on hopes that the compound would make it through the FDA, and then went straight back down when those proved ill-founded. The agency asked them for more data, and I wondered at the time if they'd be able to raise enough cash to generate it.

Well, they did, and the effort appears to have been worth it: the company says it met all its endpoints in Phase III, and is headed back to the FDA with what appears to be a solid story. Note that this press release, as opposed to the Pfizer one that I was mentioning earlier today, is full of data.

The company's stock has shot up, once again. If you've been an InterMune investor over the last few years, your fingernails are probably in bad shape and your combover is no longer plausible. The stock has had wild moves on rumors of takeovers (or lack of same) and anticipation of these clinical results. But good for them: they stuck with their compound, and it looks like it's paid off. And, just as a side note, good for people with fibrosis, too, eh?

Comments (4) + TrackBacks (0) | Category: Business and Markets | Clinical Trials


1. Ted on February 25, 2014 11:42 AM writes...

It's too bad most of that crowd has already dispersed.

Still, I hope this paves the way for the follow-on compound, which provided me with some surprisingly interesting chemistry.


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2. anon the II on February 25, 2014 11:50 AM writes...

I think it should be Pirfenidone with an "i" not an "e"

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3. sympa on February 25, 2014 3:53 PM writes...

According to Wikipedia, it already is in use for quite a while in other countries. Could that play a role in getting approval?

Also: nice small molecule!

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4. Lucas on March 2, 2014 9:12 AM writes...

Hooray for InterMune, and hooray for IPF patients!

I gotta say, as someone who spends his days analyzing data and writing CSRs for early-phase trials, I initially found the rates of discontinuation due to AEs and the incidence of SAEs (14.4% and 19.8%) horrifying, and I had to remind myself that the population of IPF patients is very different from the healthy subjects I am used to looking at, as evidenced by the small difference in both measures between the placebo and treated groups.

I only mention this because I think it highlights one of the (many, unfortunately) areas in which communication between the industry as a whole and the general public breaks down. If a clinical scientist has to do a double-take to get the numbers in perspective, what will Joe Schmoe think on hearing that a fifth of the patients experienced a serious adverse event? Part of the problem is lack of clarity in the way AEs are classified (AEs, SAEs, TEAEs, IMP-related TEAEs...), and part is that most people simply aren't equipped to (or motivated to) deal with the statistics.

Anyway, rants aside, this is a great result - let's hope the FDA agrees!

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