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InterMune IPF drug enters Phase III

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

InterMune commences enrollment of Phase III CAPACITY program evaluating pirfenidone for treatment of idiopathic pulmonary fibrosis (IPF), the firm says April 27. The dual-trial program "will advance relatively quickly and conclude toward the end of 2007," CEO Dan Welch states. Top-line data are expected in early 2009. InterMune finalized the studies' designs with FDA last fall; the company has pointed to CAPACITY as the first IPF program to utilize lung function as the primary endpoint (1Pharmaceutical Approvals Monthly November 2005, p. 6). Pirfenidone is a small molecule p38-gamma inhibitor. Other firms developing IPF treatments include Actelion, CoTherix and Novartis...

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