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InterMune Initiates Phase 3 ASCEND Study of Pirfenidone in IPF
Date:7/7/2011

BRISBANE, Calif., July 7, 2011 /PRNewswire/ -- InterMune (NASDAQ: ITMN) today announced that patient enrollment has begun in ASCEND, a new Phase 3 study of pirfenidone for patients who suffer from idiopathic pulmonary fibrosis (IPF).  ASCEND is a multinational, randomized, double-blind, placebo controlled Phase 3 trial designed to evaluate the safety and efficacy of Esbriet® (pirfenidone) in IPF patients with mild to moderate impairment in lung function.  The primary endpoint is lung function, as measured by change in forced vital capacity (FVC) from baseline to Week 52.  The trial will enroll a total of approximately 500 patients who will be randomly assigned 1 to 1 to receive oral pirfenidone (2403 mg/day) or placebo.  Patients will be enrolled at centers in the United States, Mexico, South America, Australia and New Zealand.  

Steve Porter, M.D., Ph.D., Chief Medical Officer of InterMune, said, "We are very pleased to report enrollment of the first patient in ASCEND.  This study represents our continued commitment to making Esbriet available for the more than 100,000 IPF patients in the United States who are afflicted with IPF but currently have no FDA-approved therapies available to them."  

ASCEND Phase 3 Trial

InterMune's new Phase 3 study of pirfenidone is named ASCEND (Assessment of Pirfenidone to Confirm Efficacy and Safety in IPF).  ASCEND will add to pirfenidone's body of clinical evidence and support a future submission for FDA approval.

InterMune expects the trial to be fully enrolled by the first half of 2012, and that results from the study will be available in mid-2013.  InterMune anticipates a New Drug Application (NDA) resubmission for pirfenidone in the second half of 2013 and an FDA action in the first half of 2014.  

Relative to InterMune's previous studies o
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SOURCE InterMune, Inc.
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