InterMune, Inc. reported that new data was presented at the European Respiratory Society (ERS) Annual Congress supporting the longer-term safety and tolerability of Esbriet (pirfenidone) in patients with idiopathic pulmonary fibrosis (IPF), a devastating lung disease. Approximately 30,000-35,000 new IPF patients are diagnosed in Europe each year, with an estimated median survival of only two to five years. The announcement follows the recent marketing authorization of Esbriet in Europe and its first launch in Germany on 15 September.

Professor Ulrich Costabel, from the Department of Pneumology/Allergy at the Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany who presented the data, said: “These new data from the RECAP study show that the safety profile of pirfenidone remains consistent, even when pirfenidone treatment continued beyond three years, thereby adding to the growing body of evidence that supports the treatment of IPF with pirfenidone. This news should be welcomed by European clinicians who will soon have the opportunity to treat their mild to moderate IPF patients with this new medicine.”

The RECAP extension study data, presented on 25 September at ERS, highlighted the positive longer-term safety and tolerability of Esbriet in patients with IPF.RECAP is an open-label extension study for patients who participated in the phase III programme for Esbriet, known as CAPACITY. The CAPACITY program (studies 004 and 006) was designed to evaluate the treatment effect of Esbriet in IPF patients. In the CAPACITY studies, 779 patients were randomized to treatment with Esbriet or placebo and 626 patients completed the study. Of these, 603 (96 percent) were enrolled in RECAP.

“IPF is a devastating condition with no proven management options other than lung transplantation, so we hope that this new longer-term safety data will reinforce the known safety and importance of Esbriet as the future standard of care for patients living with IPF,” said Giacomo Di Nepi, InterMune's senior vice president and managing director, Europe. “Germany is the first country in Europe where Esbriet is now available to patients, and we are glad to be able to offer now this new treatment opportunity to patients with mild to moderate IPF.”

At Week 72 in RECAP, mean exposure to pirfenidone 2403 mg/d across both studies was 2.9 years (range, 1-4); 114 patients had received Esbriet 2403 mg/d for at least three years. The favourable safety and tolerability profile observed in CAPACITY and other prior clinical trials was confirmed in RECAP.

In RECAP, treatment-emergent adverse events (TEAE) and common adverse events (AEs) were very similar to those reported in CAPACITY: 98 per cent of RECAP patients reported at least one TEAE compared to 99 per cent in the treatment arm and 98 per cent in the placebo arm of the CAPACITY programme. In RECAP, 33 per cent of patients had a serious TEAE compared to 33 per cent in the treatment arm and 31 per cent in the placebo arm during CAPACITY.

The incidence of common AEs in RECAP was very similar to that observed in CAPACITY and these AEs were generally mild to moderate in severity. The type and frequency of adverse events were generally consistent with observations from the phase III clinical trials; no new safety signals or trends were observed.

The overall incidence of photosensitivity or rash was lower in RECAP than in CAPACITY (20 percent of patients vs. 44 percent). Rash and photosensitivity reactions were more common among patients newly initiating treatment with pirfenidone compared with those who were continuing treatment (28 percent vs. 12 percent); however, the incidence was similar to that observed among pirfenidone-treated patients in the CAPACITY studies.

The CAPACITY programme was comprised of two multinational, double-blind, placebo-controlled phase III studies (Study 004 and Study 006) that were conducted simultaneously with 779 IPF patients (aged 40-80 years) across 110 centres in Australia, Europe and North America. Patients were randomly assigned to receive oral Esbriet (1197 or 2403 mg/day) or placebo for a minimum of 72 weeks to evaluate the impact of Esbriet in reducing lung function deterioration in IPF patients.

CAPACITY results demonstrated that treatment with Esbriet: positively impacted key measures of lung function in IPF patients, including a significant reduction in the decline of Forced Vital Capacity (FVC). Led to a significant reduction in the decline of Six-Minute Walk Test (6MWT) distance, an indication of improved pulmonary function. In addition, an independent meta-analysis of progression free survival suggested a 30 percent lower risk of death or disease progression.

Esbriet (pirfenidone) is an orally active drug that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. It also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.

On February 28, 2011, the European Commission (EC) granted marketing authorization for Esbrietin adults for the treatment of mild to moderate IPF. The approval authorizes marketing of Esbriet in all 27 EU member states. Esbriet has since been approved for marketing in Norway and Iceland. It is now available in Germany and is scheduled to be available in France, Italy and Spain during the first half of 2012 and in the United Kingdom during the third quarter of 2012.

Since 2008, pirfenidone has been marketed in Japan as Pirespa by Shionogi & Co. Ltd.

Pirfenidone is still under investigation for the treatment of IPF in the United States and has not been approved by the U.S. Food and Drug Administration for this use.

Idiopathic Pulmonary Fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease characterized predominantly by fibrosis (scarring) in the lungs, hindering the ability for gas exchange in the lungs. IPF is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20-40 percent, which makes IPF more rapidly lethal than many cancers, including breast, ovarian and colorectal.

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and fibrotic diseases. In pulmonology, we are focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease.