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InterMune Reports First Quarter 2013 Financial Results and Business Highlights
Date:4/24/2013

cts an estimated 3,500 to 5,000 Canadians.  Approximately one-third of IPF patients in Canada are covered by private insurance and up to six months are needed to secure coverage for new medicines from the major private insurance companies in Canada.  Public (provincial) drug reimbursement plans cover approximately two-thirds of IPF patients in Canada and, on average, about 18 months are needed to secure reimbursement from all 10 provincial governments.
  • On January 9, 2013, enrollment was completed in the confirmatory Phase 3 pirfenidone study, ASCEND, designed to support marketing approval in the United States.  ASCEND is a double-blind, placebo-controlled trial of 52 weeks duration, followed by an approximate five-week safety follow up, with a primary endpoint of change in Forced Vital Capacity (FVC) between baseline and Week 52.  The trial enrolled 555 IPF patients with mild-to-moderate impairment in lung function.  InterMune expects that top-line results from the study will be available in the second quarter of 2014.
  • On February 19, 2013, InterMune reported that the company and Shionogi & Co., Ltd had reached an agreement regarding the material terms of a settlement of the complaint filed by Shionogi against InterMune.  Effective January 1, 2013, InterMune agrees to pay Shionogi a royalty of 4.25% on net sales of Esbriet in the European Union through the remaining period of Orphan Drug exclusivity ending in February 2021.  Shionogi waives any claim against InterMune to royalties on Esbriet sales in Canada or in the United States.
  • On March 4, 2013, InterMune announced that the Pricing Commission (CPR) of the Italian Drug Agency (AIFA) had agreed to pricing and reimbursement conditions for Esbriet.  InterMune anticipates that the launch of Esbriet in Italy will begin following formal approval of the agreement by the Agency Board and publication in the Official Gazette, which is expected in
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