InterMune, Inc. Submits Clinical Trial Authorization Application For ITMN-191 For Hepatitis C Infections

BRISBANE, Calif., Sept. 26 /PRNewswire-FirstCall/ -- InterMune, Inc. announced today that it has submitted an electronic Clinical Trial Authorization (CTA) application to the French Medicinal and Biological Products Evaluation Directorate (AFSSAPS) for ITMN-191, an orally available hepatitis C virus (HCV) protease inhibitor, developed in a collaboration between InterMune research scientists and Array BioPharma, Inc. Upon successful review by the Directorate and local Ethics Committee, InterMune will initiate the Phase I clinical program of ITMN-191.

InterMune has successfully completed preclinical toxicology and pharmacokinetic studies in multiple species in support of initiating Phase I clinical studies of ITMN-191. The CTA includes results of 28-day preclinical toxicology studies utilizing doses many-fold higher than those expected to be given to humans. These studies demonstrate a favorable safety and toxicology profile, allowing ITMN-191 to be studied in clinical trials over a range of doses predicted to have antiviral efficacy. ITMN-191 has also demonstrated high in vitro potency and specificity in biochemical assays and in assays utilizing the HCV replicon system. Moreover, ITMN-191 displays a favorable cross-resistance profile, including significant potency against variants of the NS3/4A protease that are resistant to other HCV protease inhibitors currently in development. The preclinical pharmacokinetic results reported in the CTA support the exploration of twice-daily dosing in the treatment of chronic hepatitis C.

The CTA also describes the successful GMP manufacture of multiple lots of ITMN-191 drug substance and development of an ITMN-191 drug product formulation, which is intended to be used in the Phase I clinical development program.

"We are very pleased to have submitted the CTA for ITMN-191 on the schedule we set last January," said Dan Welch, President and CEO of InterMune. "This is the first time InterMune has advanced a compound from early discovery to the submission of an electronic CTA, a notable achievement. We look forward to securing the authorization to proceed with our first clinical trial of ITMN-191, which we anticipate to begin before the end of this year."

About HCV and HCV Protease Inhibitors

According to the Centers for Disease Control and Prevention, an estimated 3.9 million Americans (1.8%) have been infected with HCV, of whom 2.7 million are chronically infected, and the prevalence of chronic HCV is increasing. Currently available therapies are insufficient, creating a need for the development of novel therapeutic approaches. HCV protease inhibitors represent a promising class of drugs for HCV, and the HCV NS3/4A protease is an attractive drug target because of its involvement in viral replication and suppressive effects on host response to viral invasion.

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and HCV infections. The pulmonology portfolio includes two Phase III programs evaluating possible therapeutic candidates for treatment of patients with IPF. The INSPIRE trial is evaluating Actimmune(R) (interferon gamma-1b) and the CAPACITY program is evaluating pirfenidone. The hepatology portfolio includes the lead HCV protease inhibitor compound ITMN-191, a second- generation HCV protease inhibitor program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.

Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to the progress, future patient enrollment in and timing of our clinical trials and announcements of results thereof. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward- looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading 'Risk Factors' in InterMune's annual report on Form 10-K filed with the SEC on March 13, 2006 (the "Form 10-K") and updates included in the most recent Form 10-Q filed with the SEC on August 8, 2006 (the "Form 10-Q"), and other periodic reports filed with the SEC, including the following: (i) risks related to the development of our product and product candidates; (ii) risks related to timely patient enrollment and retention in clinical trials, including the use of third parties to conduct such clinical trials; (iii) risks related to achieving positive clinical trial results; (iv) risks related to our intellectual property rights; and (v) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC.

InterMune, Inc.

CONTACT: InterMune, Inc. Investor Relations Dept, +1-415-466-2242, orir@intermune.com, or media, Pam Lord of Porter Novelli Life Sciences,+1-619-849-6003, or plord@pnlifesciences.com, for InterMune, Inc.

Back to news