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

s and our anti-fibrotic research programs."

Recent Business and Clinical Development Highlights

  • On July 17, 2014, InterMune reported that pirfenidone had been granted Breakthrough Therapy Designation by the FDA.  This designation is reserved for drugs that are intended to treat a serious or life threatening disease or condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.  According to the FDA Fact Sheet: "If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug."
  • InterMune today reported that the FDA has informed the company that at this time, the agency does not plan to convene an advisory committee for pirfenidone.
  • On July 10, 2014, InterMune submitted to the European Medicines Agency (EMA) a variation to the Esbriet marketing authorization.  The purpose of the variation is to update the Summary of Product Characteristics (SmPC) to include the ASCEND clinical data.  InterMune anticipates receiving a decision on the proposed variation from the EMA in early 2015. 
  • At the International Conference of the American Thoracic Society (ATS) in May 2014, data from the Phase 3 ASCEND trial of pirfenidone in IPF were presented.  The ATS presentation included data and additional supportive analyses demonstrating the treatment effect of pirfenidone on Forced Vital Capacity (FVC) change and other important clinical endpoints, including mortality.  Additionally, the data demonstrated a favorable safety and tolerability profile of pirfenidone in ASCEND that was generally consistent with observations from the previous Phase 3 CAPACITY studies, open-label extension studies and post-marketing experience.  Simultaneous with its presentation at ATS, the results of ASCEND were published in the New England Journal o
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