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Important Data Presented on Independent Predictors of Mortality in Patients With Idiopathic Pulmonary Fibrosis
Date:5/17/2009

consistent with previous studies, the most frequently reported side effects were gastrointestinal symptoms and rash.

An exploratory analysis of pooled data from both trials revealed that treatment with pirfenidone resulted in a 30% relative reduction in the percentage of patients who experienced an absolute decline in percent predicted FVC of at least 10%. This magnitude of decline is considered clinically meaningful as a decline in percent predicted FVC as small as 5% over a six-month period has been shown to be an independent predictor of mortality in patients with IPF, as reported in the du Bois presentation at ATS.

InterMune expects to submit a new drug application (NDA) to the FDA in the summer of 2009 and a marketing authorization application (MAA) to the European authorities around the end of 2009.

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. On October 16, 2008, pirfenidone was approved for marketing in Japan as Pirespa(R), the first regulatory approval of any treatment for IPF in any major market in the world. 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 decreas
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SOURCE InterMune, Inc.
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