) 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
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
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
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
INTERMUNE INC (ITMN): Free Stock Analysis
To read this article on Zacks.com click here.