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Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)
Date:5/19/2009

- Results suggest pirfenidone may provide meaningful clinical benefit in IPF patients -

- Results of new analyses of efficacy and safety reported -

- Conference Call and Webcast at 9 p.m. EDT (6 p.m. PDT) -

SAN DIEGO, May 19 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) reported that results from the two Phase 3 CAPACITY studies evaluating pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) were presented today in an oral late-breaker presentation at the International Conference of the American Thoracic Society (ATS) in San Diego. Dr. Paul Noble, co-chair of the CAPACITY program and Professor of Medicine and Chief of Pulmonary, Allergy and Critical Care Medicine at Duke University Medical Center presented details of data from CAPACITY that were previously announced by the company in a press release on February 3, 2009 as well as new information from the studies regarding the efficacy and safety of pirfenidone.

The primary endpoint of change in percent predicted Forced Vital Capacity (FVC) at Week 72 was met with statistical significance in CAPACITY 2 (p=0.001). The secondary endpoints of progression-free survival (PFS) and categorical change in FVC were also met with statistical significance. The primary endpoint was not met in CAPACITY 1 (p=0.501), but supportive evidence of a pirfenidone treatment effect was observed on a number of measures, including the primary endpoint. Pirfenidone was safe and generally well tolerated in both CAPACITY studies. InterMune is preparing a New Drug Application (NDA) expected to be submitted to the FDA in the summer of 2009, to be followed by a Marketing Authorization Application (MAA) submission to the EMEA around the end of 2009.

Dr. Noble commented on the results, "CAPACITY 2 demonstrated a statistic
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SOURCE InterMune, Inc.
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