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InterMune Higher on Superior Lung Drug Data, FDA Resubmission Next

By: Adam Feuerstein | 05/19/14 - 10:39 AM EDT

InterMune  (ITMN) shares are up 13% $38.66 Monday following last night's idiopathic pulmonary fibrosis (IPF) showdown with rival Boehringer Ingelheim.

I went full clinical data geek with my comparison of the respective phase III studies of InterMune's pirfenidone and Boehringer's nintedanib. I won't rehash all the details here -- for that, please read the article -- but bottom line: InterMune emerged the winner. Both drugs are approvable and will likely be used by doctors treating their IPF patients, but Intermune's pirfenidone should slot No. 1 ahead of Boehringer's nintedanib. That's my read of the data presented Sunday.

Next step: Regulatory filings. InterMune will resubmit pirfenidone to the FDA early in the third quarter. Remember, FDA rejected pirfenidone in 2010 (stupid move) so the new data qualifies as a resubmission and will be reviewed by the agency in six months. If we assume a June resubmission, FDA approval of pirfenidone would happen December. If you want to be more conservative, it's safe to bet on a U.S. approval of pirfenidone in early 2015. 

Figuring out Boehringer's regulatory timetable is much trickier. As a private company, Boehringer doesn't have to say anything publicly. I asked the company Friday if nintedanib had been filed with the FDA yet but received a polite "No comment." Boehringer has had the nintedanib data from the two phase III studies in house for six months, give or take, so you'd think the company would have filed by now, or be close to filing. 

Once Boehringer does file nintedanib with the FDA, the review clock is eight months long.

Here's a year-to-date chart of InterMune plotted against the iShares Nasdaq Biotechnology ETF (IBB). The February spike to $37.80 per share was InterMune's announcement about the positive results from the pirfenidone phase III study. Today's move represents a new high for InterMune shares. 


ITMN Chart
ITMN data by YCharts

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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