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InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA
Date:5/19/2008

- Conference call scheduled to discuss Shionogi Phase 3 results on

pirfenidone -

BRISBANE, Calif., May 19 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that its program for the development of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA). Fast Track is a designation that the FDA reserves for a drug intended to treat a serious or life threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. The FDA takes appropriate actions to facilitate the development and expedite the review of the approval applications for fast track products.

Dan Welch, Chairman and Chief Executive Officer of InterMune, said, "There are no approved medicines to treat patients who suffer from IPF, a uniformly fatal disease characterized by scarring and inflammation of the lungs. The FDA's action in granting fast track designation is an indication of pirfenidone's potential to address this serious, unmet medical need. We look forward to reporting top-line results of our Phase 3 CAPACITY program of pirfenidone in IPF, in January of 2009."

Webcast and Conference Call on May 20, 5:00 p.m. EDT

InterMune additionally announced that it will conduct a live webcast and conference call on May 20, 2008 at 5:00 p.m. EDT to discuss its Phase 3 CAPACITY program in the context of data that will be presented by Shionogi & Co., Ltd. regarding its Phase 3 trial of pirfenidone in Japan. The Shionogi Phase 3 results are scheduled to be reported in an oral presentation at the meeting of the American Thoracic Society in Toronto at 2:15 p.m.
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SOURCE InterMune, Inc.
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