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InterMune Reports Second Quarter 2014 Financial Results and Business Highlights
Date:8/6/2014

f Medicine.
  • Enrollment was completed on schedule for InterMune's Phase 2, four-month LOTUSS trial to evaluate the safety and tolerability of pirfenidone in 63 patients with systemic sclerosis-related interstitial lung disease (SSc-ILD).  SSc-ILD is an orphan disease with prevalence comparable to that of IPF and with no approved therapies.  In November 2013, pirfenidone was granted orphan drug status for the treatment of SSc-ILD in the United States.  The trial will conclude in the fourth quarter of 2014 and InterMune currently expects to report results at a medical meeting in 2015.
  • Effective April 1, 2014, the Ministry of Health, Welfare and Sport of the Netherlands approved Esbriet for inclusion on the Dutch list of reimbursed drugs, making Esbriet the first registered and reimbursed medicine for the treatment of IPF in the Netherlands.  Esbriet is reimbursed for patients with mild to moderate IPF with FVC of more than 50% of predicted.  The Ministry set a public price corresponding to €31,157 (~$43,000) per patient per year.
  • Regarding Spain, the only country of the company's original 15 top-priority European countries for which Esbriet reimbursement and product launch have not occurred, InterMune expects to provide an update on the Esbriet pricing and reimbursement discussions in Spain later in the second half of this year.
  • InterMune today reported that 123 patients have been enrolled in the PANORAMA trial, a randomized, double-blind, placebo controlled trial to evaluate the safety and tolerability of N-acetylcysteine (NAC) added to Esbriet therapy in patients with mild to moderate IPF.  InterMune announced that as a result of the outcome of the NIH PANTHER study, which demonstrated that NAC provided no benefit to IPF patients, no additional patients will be enrolled in PANORAMA.  Patients already enrolled will be followed according to the study protocol to provide a safety analys
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