FDAnews Drug Daily Bulletin

InterMune has received fast-track designation from the FDA for idiopathic pulmonary fibrosis (IPF) treatment pirfenidone.

Currently, there are no approved medications for IPF, a fatal disease characterized by lung scarring and inflammation, InterMune Chairman and CEO Dan Welch said.

InterMune was to hold a webcast Tuesday to discuss its Phase III CAPACITY program for pirfenidone, including data from a trial of the drug in Japan by Shionogi & Co., which holds a license for the drug in Japan, Korea and Taiwan.

InterMune had said it would begin an open-label, rollover study this August to evaluate the long-term safety of pirfenidone in IPF patients who complete one of the two concurrent Phase III CAPACITY studies.

In 2007, InterMune purchased pirfenidone patent rights previously licensed from Marnac and KDL GmbH. That agreement did not affect the rights to pirfenidone in Japan, Korea and Taiwan, which are licensed to Shionogi.

InterMune’s previous president, Scott Harkonen, was indicted March 18 for alleged illegal marketing of Actimmune for IPF. The court has set a Sept. 15 date in USA v. Harkonen for review of discovery.