Sep. 14, 2009 (PR Newswire) -- VIENNA, Sept. 14 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that the results of a comprehensive review of safety data from four clinical studies were presented at the 2009 European Respiratory Society Annual Congress in Vienna, Austria by Dr. Ulrich Costabel of the Ruhrlandklinik, Essen, Germany.

In order to assess the risk-benefit profile of pirfenidone in IPF patients, a comprehensive review of safety was conducted involving two Phase 3 trials (CAPACITY 1 and CAPACITY 2) and two open-label studies (RECAP and PIPF-002). RECAP is an on-going open-label extension study that enrolled 603 patients who completed CAPACITY. PIPF-002 is an on-going long-term, open-label study in 83 IPF patients.

The summary and conclusions from the safety analysis as presented at ERS were:

    --  A comprehensive review of safety data from four clinical studies showed
that treatment with pirfenidone was safe and generally well tolerated
--  In the CAPACITY studies:
--  The majority of adverse events (AE) were mild to moderate in nature and
relatively few patients discontinued treatment due to adverse events.
--  A similar incidence of serious adverse events (SAE) was observed in the
pirfenidone group relative to the placebo group
--  Fewer deaths were observed in the pirfenidone group relative to the
placebo group and this difference was driven by a reduction in
IPF-related deaths
--  GI and skin AE were more common in pirfenidone-treated patients and were
generally mild to moderate, transient, and rarely led to treatment
discontinuation
--  Transaminase (liver enzyme) elevations were slightly more common in the
pirfenidone group, generally low-grade and without clinical sequelae (or
secondary effect)

--  Results from the two open label studies also suggest that long-term
pirfenidone therapy is safe and generally well-tolerated

Dr. Costabel commented on the results, "Based on this comprehensive analysis of safety, pirfenidone appears to be safe and generally well tolerated in patients with IPF and for treatment periods longer than 72 weeks. These safety results, coupled with the evidence of a clinically meaningful pirfenidone treatment effect reported in three Phase 3 clinical trials and taken in the context of the urgent unmet medical need for new medicines for IPF patients, suggest that pirfenidone provides a reasonable risk-benefit profile for patients suffering from IPF. The new analysis presented today on the incidence of IPF-related deaths provides further support for the potential role of pirfenidone in the treatment of patients with this devastating disease."

In this analysis of safety, fewer treatment emergent deaths (those occurring after the first dose and within 28 days of the last dose of study treatment) were observed in the pirfenidone group relative to the placebo group, and this difference was driven by a reduction in IPF-related deaths. In this exploratory analysis of pooled results of the two CAPACITY trials, the incidence of IPF-related deaths was 3.5% in the high-dose pirfenidone arm, compared to 7.2% in the placebo arm (p=0.031; Hazard Ratio = 0.48), indicating that patients treated with pirfenidone had a 52% lower risk of IPF-related death than those treated with placebo. The incidence of treatment emergent death from any cause was 5.5% in the 2403 mg/day pirfenidone arm compared to 8.4% in the placebo arm (p=0.141; Hazard Ratio = 0.65) indicating that patients treated with pirfenidone had a 35% lower risk of death from any cause than those treated with placebo.

A similar incidence of SAEs was observed in the pirfenidone group relative to the placebo group.