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New Data Demonstrate Longer-Term Safety Profile of Esbriet®
Date:9/26/2011

AMSTERDAM, Sept. 26, 2011 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today reported that new data(1) was presented at the European Respiratory Society (ERS) Annual Congress supporting the longer-term safety and tolerability of Esbriet® (pirfenidone) in patients with idiopathic pulmonary fibrosis (IPF), a devastating lung disease.  Approximately 30,000-35,000 new IPF patients are diagnosed in Europe each year, with an estimated median survival of only two to five years. The announcement follows the recent marketing authorization of Esbriet in Europe and its first launch in Germany on 15 September.

Professor Ulrich Costabel, from the Department of Pneumology/Allergy at the Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany who presented the data, said: "These new data from the RECAP study show that the safety profile of pirfenidone remains consistent, even when pirfenidone treatment continued beyond three years, thereby adding to the growing body of evidence that supports the treatment of IPF with pirfenidone. This news should be welcomed by European clinicians who will soon have the opportunity to treat their mild to moderate IPF patients with this new medicine."

The RECAP extension study data, presented on 25 September at ERS, highlighted the positive longer-term safety and tolerability of Esbriet in patients with IPF. RECAP is an open-label extension study for patients who participated in the Phase 3 program for Esbriet, known as CAPACITY.  The CAPACITY program (studies 004 and 006) was designed to evaluate the treatment effect of Esbriet in IPF patients. In the CAPACITY studies, 779 patients were randomized to treatment with Esbriet or placebo and 626 patients completed the study. Of these, 603 (96 percent) were enrolled in RECAP.  

"IPF is a devastating condition with no proven management options other than
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SOURCE InterMune, Inc.
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