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InterMune Reports First Quarter 2011 Financial Results and Business Highlights
Date:4/28/2011

nd Upcoming Milestones  Esbriet® (pirfenidone):  

  • In advance of its May 26 Analyst Day, InterMune provided a high-level summary of the design of the ASCEND study as follows:  
  • ASCEND will be a 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.
  • Relative to the CAPACITY program, the ASCEND study population will be enriched for patients more likely to experience FVC decline and disease progression during the study. 
  • InterMune currently expects to begin enrollment in ASCEND in June 2011. 
  • The study will be primarily enrolled in the United States but will also include sites in Mexico, South America, Australia and New Zealand.
  • InterMune announced on March 3, 2011, that the European Commission (EC) had granted marketing authorization for Esbriet® (pirfenidone).  Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease.  The approval authorizes marketing of Esbriet in all 27 EU member states.  
  • Additionally, Esbriet has now received marketing authorization in Norway and Iceland.  These countries recognize EU approvals of new medicines.
  • Based on anticipated EU country reimbursement timelines, InterMune currently plans to launch Esbriet as follows: Germany in September of 2011; France, Spain and Italy during the first half of 2012 and the United Kingdom around the middle of 2012.  InterMune also plans to launch Esbriet in all or substantially all of the next five largest pharmaceutical markets in the EU during 2012.  
  • Pre-launch efforts in the areas of Key Opinion Leader development, pricing, reimbursement, market research and staffing continue on schedule with the above t
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  • SOURCE InterMune, Inc.
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