InterMune, Inc. recently presented data on Esbriet from the RECAP extension study at the 2012 Annual Congress of the European Respiratory Society (ERS). The open-label extension study, which is a roll-over study from the CAPACITY program, evaluated the long-term safety and efficacy of Esbriet in patients suffering from idiopathic pulmonary fibrosis (IPF).
The CAPACITY program was designed to evaluate the safety and efficacy of the drug in patients suffering from mild-to-moderate IPF. InterMune conducted two phase III trials in the CAPACITY program. In 2009, InterMune presented results from the CAPACITY trials, which revealed that Esbriet was safe and generally well tolerated.
Patients who successfully completed the CAPACITY trials were allowed to enroll in the RECAP extension study. The new analysis evaluated patients who were on placebo in the CAPACITY trials and were subsequently treated with Esbriet in the RECAP study.
Results from the RECAP study revealed that IPF patients with mild-to-moderate impairment in lung function, treated with Esbriet for 60 weeks, had similar Forced Vital Capacity (FVC) as patients on Esbriet in the CAPACITY program treated for the same duration.
We remind investors that, in February 2011, Esbriet was approved by the European Commission. Esbriet is presently commercialized in Austria, Denmark, Germany, Iceland, Luxembourg, Norway and Sweden. InterMune expects to conclude its discussion regarding Esbriet’s pricing and reimbursement in France, Italy, Spain, Belgium, the Netherlands and Finland by the end of this year.
InterMune is also running a phase III ASCEND trial to support its regulatory application in the US. InterMune expects to complete patient enrollment in the ASCEND study by the end of this year and results from the study should be out by the first half of 2014.
InterMune reported $5.5 million in revenues from Esbriet for the second quarter of 2012. The company expects Esbriet sales for 2012 to be in the range of $20–$25 million.
We currently have a Neutral recommendation on InterMune. The stock carries a Zacks #3 Rank (short-term ‘Hold’ rating). We expect investor focus to stay on the pricing and reimbursement process in Europe.