INFORM-1 Interim Results Accepted For Late-Breaker Presentation At The 44th Annual Meeting Of The European Association For The Study Of The Liver

Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials;  Conferences;  Pharma Industry / Biotech Industry
Article Date: 19 Mar 2009 - 3:00 PDT

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InterMune, Inc. (Nasdaq: ITMN) announced that an abstract from the clinical study of ITMN-191 (R7227) in combination with polymerase inhibitor R7128 (Roche/Pharmasset), referred to as the INFORM-1 study, has been accepted for oral presentation in the late-breaker session at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL). The late-breaker session is scheduled to be conducted from 4:00 p.m. to 6:00 p.m. on Saturday, April 25 in Copenhagen, Denmark. The abstract is under embargo until after the late-breaker session on April 25; accordingly, no details of the abstract may be shared before then.

An abstract of the results of the first low dose cohorts of the INFORM-1 study, Cohorts A and B are expected to be available at http://www.easl.ch. The abstract is entitled, "First-in-man Demonstration of Potent Antiviral Activity with a Nucleoside Polymerase Inhibitor (R7128) and Protease (R7227/ITMN-191) Inhibitor Combination in HCV: Safety, Pharmacokinetics and Virologic Results from INFORM-1." Information on the INFORM-1 study design and dosing is available on http://www.clinicaltrials.gov.

Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We and our collaborators, Roche and Pharmasset, are very pleased that our abstract regarding the first low-dose cohorts of our ground-breaking study, INFORM-1, has been accepted for presentation at EASL." Mr. Welch continued, "Considering that the daily dose of ITMN-191 used in the first cohorts is only one-sixth of the highest daily dose we've explored in the clinic to date and the dose of R7128 is only one-half the dose currently being studied in the clinic, we look forward to presenting the results of subsequent higher dose cohorts of INFORM-1."

INFORM-1 Study Design

The following information regarding the INFORM-1 study is available on http://www.clinicaltrials.gov:

-- Patients in Cohort A are dosed in two groups, Group A and Group B. Patients in Group A receive 500mg BID of R7128 as monotherapy for three days followed by four days of combination therapy comprised of the same dose of R7128 plus 100mg q8h of ITMN-191. Patients in Group B receive 100mg q8h of ITMN-191 as monotherapy for three days followed by four days of combination therapy comprised of the same dose of ITMN-191 plus 500mg BID of R7128.

-- Patients in Cohort B receive the same doses of R7128 and ITMN-191 as patients in both groups of Cohort A, but for a full 14 days in combination. Cohort B is referred to as Group C in the EASL abstract.

-- Patients in Cohort C are dosed in two groups, Group D and Group E. Patients in Group D receive 1000 mg BID of R7128 and 100mg q8h of ITMN-191 for 14 days. Patients in Group E receive 500 mg BID of R7128 and 200 mg q8h of ITMN-191 for 14 days.

-- Patients in Cohort D are dosed in one Group (Group F) and receive 1000 mg BID of R7128 and 200 mg of ITMN-191 q8h for 14 days.

About EASL

The European Association for the Study of the Liver (EASL) is the leading European association in the field of liver research. EASL brings together clinicians and scientists interested in the liver, providing an outlet for networking and learning. The EASL Annual Meeting attracts more than 7,000 participants annually.

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has an R&D portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes pirfenidone for which a Phase 3 program in patients with IPF (CAPACITY) has been completed and the compound is currently in the pre-registration stage. The company also has a research program focused on a pirfenidone analog named ITMN-520. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) expected to enter Phase 2b in the summer of 2009 and a second-generation HCV protease inhibitor research program. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com.

Forward Looking Statements

This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to anticipated product development timelines. 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 most recent annual report on Form 10-K filed with the SEC on March 16, 2009 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the long, expensive and uncertain clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues or delays in anticipated timing of the regulatory approval process; (ii) risks related to failure to achieve the clinical trial results required to commercialize our product candidates; and (iii) risks related to timely patient enrollment and retention in clinical trials. 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, all of which are available via InterMune's web site at http://www.intermune.com.

InterMune, Inc.
http://www.intermune.com

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