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InterMune Bullish On Pirfenidone NDA Despite Mixed Study Results

This article was originally published in The Pink Sheet Daily

Executive Summary

Differences in patient populations may explain conflicting results from Phase III pulmonary fibrosis trials.

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InterMune Files NDA For IPF Drug Despite Mixed Pivotal Trial Results

With IPF currently an unmet medical need in the U.S.; company seeks priority review; drug marketed in Japan by partner Shionogi.

InterMune Files NDA For IPF Drug Despite Mixed Pivotal Trial Results

With IPF currently an unmet medical need in the U.S.; company seeks priority review; drug marketed in Japan by partner Shionogi.

InterMune files NDA for IPF drug despite mixed pivotal trial results

InterMune submitted the first NDA for a drug to treat the orphan condition idiopathic pulmonary fibrosis on Nov. 4, despite mixed results from its two Phase III CAPACITY trials. Pirfenidone, which has anti-inflammatory and anti-fibrotic activity, met the primary efficacy endpoint - change in predicted forced vital capacity at week 72 - in the CAPACITY 2 trial, but missed statistical significance in the CAPACITY 1 study (1"The Pink Sheet" DAILY, Feb. 4, 2009). InterMune requested priority review for pirfenidone, which already has fast track and orphan drug status, since IPF is an unmet medical need. The company notes that IPF has a high mortality rate, with a five-year survival rate of approximately 20 percent, and that pirfenidone has a strong tolerance and safety profile. In addition to the CAPACITY 1 and 2 trials, the NDA includes data from two ongoing open-label trials. Results from the pivotal trial conducted by pirfenidone Japanese licensee Shionogi are also included, but not as part of the pivotal study database; pirfenidone was approved in Japan in October 2008 as Pirespa

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