INTERMUNE PROVIDES UPDATE ON PULMONOLOGY PROGRAMS

InterMune has provided an update on its two Phase III programs evaluating two separate compounds for the treatment of idiopathic pulmonary fibrosis (IPF). The update included the status of enrollment of the Phase III INSPIRE trial for Actimmune (interferon gamma-1b) and details regarding the finalized protocol design of the Phase III pirfenidone program.

The trial, a randomized, double-blind, multinational, survival trial with a 2:1 randomization to Actimmune versus placebo, has achieved very strong enrollment to date, with the 600th patient expected to enroll by the end of 2005. The INSPIRE trial is scheduled to conclude around the end of 2007. InterMune has decided to increase the trial size by an additional 200 patients to take advantage of strong enrollment trends and to increase the likelihood of observing the planned number of total events prior to the trial's completion date.

The objective of the INSPIRE trial is to determine if Actimmune decreases mortality in IPF patients. As part of the study protocol, a blinded, pre-specified sample size re-evaluation was recently conducted to determine if the observed overall mortality rate was consistent with the mortality assumptions underlying the trial design. At this early point in the trial, the overall mortality rate observed was somewhat lower than the projections used in designing the trial. To increase the likelihood of reaching the total number of events upon which the INSPIRE trial is powered by the time it is scheduled to conclude around the end of 2007, the company has decided to enroll approximately 200 additional patients in the trial.