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InterMune to Provide Overview of Corporate Strategy, Update on Esbriet Commercialization Plans in the EU and Details of Phase 3 ASCEND Study
Date:5/25/2011

Esbriet as follows: Germany in September of 2011; France, Spain and Italy during the first half of 2012 and the United Kingdom by mid-2012.  InterMune plans to have a focused organization in Europe of approximately 125 full-time personnel by the end of 2012, supported by expert consultants and third-party service providers.  InterMune will provide an update at the meeting and on the webcast on the company's launch preparations for Esbriet in Europe.

ASCEND: New Phase 3 Trial

During the meeting, Bill Bradford, Senior Vice President of Clinical Science and Biometrics, will provide an update on InterMune's new Phase 3 study 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.

ASCEND will be a randomized, 52-week placebo-controlled trial with a primary endpoint of change in forced vital capacity (FVC), a key measure of lung function, between baseline and Week 52. The trial will enroll approximately 500 IPF patients with mild-to-moderate impairment in lung function who will be randomly assigned to receive oral pirfenidone (2403 mg/day) or placebo. More details will be provided at the meeting and on the webcast.

Primary enrollment will take place in the U.S. with additional centers in Mexico, South America, Australia and New Zealand, across more than 140 investigational sites in total. InterMune expects to begin enrollment in ASCEND in June 2011, with all trial participants fully enrolled by the first half of 2012.  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.  

Guidance for 2011 Expenses

InterMune also will discuss at the Analyst Day its 2011 financial guidance for operating expenses.  The company today provided its forward-looking expense guidance fo
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SOURCE InterMune, Inc.
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