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InterMune Reports Japanese Regulatory Approval of Pirfenidone in IPF
Date:10/16/2008

o announce top-line efficacy and safety results in January or February of 2009, and remains on track for submission of a New Drug Application (NDA) in mid-2009, pending positive data from CAPACITY. Pirfenidone has received Fast Track designation from the FDA, and if granted Priority Review status, InterMune could receive a six-month review of its NDA submission.

Mr. Welch added, "As we approach the last patient visits in our two CAPACITY studies, we are extremely pleased with the quality of the study conduct and to have exceeded our aggressive goal for having at least 95% of transplant-free, surviving patients reporting for their Week 72 Visit. We look forward to reporting top-line results of CAPACITY in January or in February of 2009."

Pirfenidone has been granted Orphan Drug and Fast Track designation in the United States and Orphan Drug designation in Europe for the treatment of IPF.

About IPF

Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal disease that affects a total of approximately 200,000 people in the United States and Europe, with approximately 30,000 new cases developing in the United States alone, each year. There are no medicines approved by the U.S. Food and Drug Administration (FDA) or European Medicines Evaluation Agency (EMEA) for the treatment of IPF. IPF is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen and causing shortness of breath (dyspnea) and cough. IPF is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The median survival time from diagnosis is two to five years.

About Pirfenidone

Prior in-vitro evidence has shown that pirfenidone inhibits collagen synthesis, down-regulates profibrotic cytokines and decreases fibroblast proliferation. Data presented from one Phase 3 study and four Phase 2 clinical trials in more than 400 patients suggest that pirfenidone may positively
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SOURCE InterMune, Inc.
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