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InterMune Reports Preliminary Fourth Quarter 2011 Esbriet® (pirfenidone) Revenue and Other Recent Business Highlights
Date:1/5/2012

patients treated with Esbriet in CAPACITY, and both were directionally higher than in patients receiving placebo in CAPACITY.

With these new analyses, this is the third InterMune study to show similar changes in lung function following slightly more than one year of Esbriet therapy. A fourth study from Japan demonstrated that pirfenidone reduces decline in lung function at one year.   

Additional details of the RECAP analyses will be presented on the conference call and webcast InterMune will host at 8:30 a.m. EST this morning.

Phase 3 ASCEND Study

InterMune today reported that patient enrollment in the Phase 3 pirfenidone study, ASCEND, in the United States and certain additional territories is expected to be fully enrolled in the second quarter of 2012.

  • ASCEND is a double-blind, placebo-controlled trial of 52 weeks duration with a primary endpoint of change in FVC between baseline and Week 52.  The trial will enroll approximately 500 IPF patients with mild-to-moderate impairment in lung function.
  • InterMune expects that results from the study will be available in mid-2013. 

 

Guidance for 2011 Expenses

The company updated its financial guidance for operating expenses in 2011:

  • R&D expense: anticipated to be in a range of approximately $75 to $80 million, previously estimated during InterMune's Third Quarter 2011 earnings call to be in the range of $85 to $95 million.
  • SG&A expense: anticipated to be in a range of approximately $85 to $90 million, previously projected during InterMune's Third Quarter 2011 earnings call to be in the range of $75 to $85 million. 
  • Total Operating Expenses (R&D and SG&A): anticipated to be in a range of approximately $160 to $170 million, compared to the previously projecte
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SOURCE InterMune, Inc.
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1. InterMune Appoints Angus C. Russell to Board of Directors
2. InterMune to Release Third Quarter Financial Results on November 3
3. InterMune Announces Launch of Esbriet® (pirfenidone) in Germany
4. InterMune to Provide Overview of Corporate Strategy, Update on Esbriet Commercialization Plans in the EU and Details of Phase 3 ASCEND Study
5. InterMune Receives European Union Approval for Esbriet® (pirfenidone)
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