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InterMune Reports Third Quarter 2012 Financial Results And Business Highlights
Date:11/7/2012

luded and various authorizations are secured.
  • Spain – Considering a Royal Decree introduced in 2012 affecting health care expenditures and pharmaceuticals, and the continuing economic challenges of the country, forecasting of the timing of pricing and reimbursement decisions has become more challenging for all manufacturers.  As a result, InterMune currently believes that it is more likely that a decision regarding pricing and reimbursement of Esbriet in Spain will occur in the first half of 2013 than in the fourth quarter of this year.
  • The UK – InterMune today confirmed its previous guidance that the appraisal by the National Institute for Health and Clinical Excellence (NICE) is expected to be completed in March of 2013.  If NICE provides a positive appraisal for Esbriet, the company expects to launch Esbriet as soon as possible thereafter.
  • Mid-Sized Countries (MSC) – In addition to the seven MSC for which Esbriet pricing has been secured, the company expects to conclude pricing and reimbursement processes in the remaining three MSC of Netherlands, Finland and Ireland in the first half of 2013 and launch as soon as possible thereafter, assuming that acceptable pricing and reimbursement conditions are negotiated in these countries.
  • InterMune confirmed its earlier guidance that it expects to have launched Esbriet in all top 5 markets and 10 mid-sized markets in Europe, comprising 75 percent of the EU population and 80-85 percent of the European pharmaceutical market, in the second quarter of 2013, assuming acceptable pricing and reimbursement is secured. 
  • Enrollment of InterMune's Phase 3 pirfenidone study, ASCEND, in the United States and certain additional territories continues to proceed according to plans.  The company expects the study to be fully enrolled around the end of 2012, and that results from the study will be available in the first half of 2014.  AS
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  • SOURCE InterMune, Inc.
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