BRISBANE, Calif., July 24 /PRNewswire-FirstCall/ -- InterMune, Inc. and its partner Roche today announced that on Monday, July 23rd, they submitted an amended Clinical Trial Authorization (CTA) with the relevant European regulatory authority, the final step before initiating a Phase 1b study of Hepatitis C Virus (HCV) protease inhibitor ITMN-191 in chronic hepatitis C patients. The CTA amendment takes into consideration new competitor information, preclinical and in-vitro data on ITMN-191 and pharmacokinetic observations from a Phase 1a study which was completed in May of 2007. InterMune also announced that it had earned a $10 million development milestone from Roche as part of the ongoing corporate collaboration.
Assuming a timely approval of the CTA amendment by the European regulatory authority and the Ethics Committee for the clinical trial sites, InterMune expects to initiate the Phase 1b multiple ascending dose (MAD) study late in the current quarter, or in the beginning of the next quarter. Given the anticipated timing of the initiation of the Phase 1b MAD trial, InterMune now expects to announce initial top-line viral kinetic and safety results from the MAD study in the first quarter of 2008.
Dan Welch, President and Chief Executive Officer of InterMune, said, “InterMune and Roche are pleased to announce that we have successfully finalized and submitted this CTA amendment to the European regulatory authority. While this new timeline represents a relatively modest delay in the steps leading to the start of the Phase 1b study, we believe that we now have the most appropriate and robust clinical study design to efficiently advance the development program.”
The Phase 1b study is designed to assess the effect on viral kinetics, viral resistance, pharmacokinetics and safety and tolerability of multiple ascending doses of ITMN-191 given as a monotherapy. InterMune plans to administer ITMN-191 for a period of 14 days to three ascending dose cohorts of treatment-naive chronic Hepatitis C patients infected with HCV genotype 1. Twice per day (BID) and three-times per day (TID) dosage regimens will be studied. The study can be extended to additional cohorts of treatment-naive patients, based on results from the first three planned cohorts. In addition, a single cohort of non-responder patients will be studied.
Second Quarter Conference Call and Webcast
InterMune will release its financial results for the second quarter and six months ended June 30, 2007 on Thursday, August 2, 2007 at 4:00 p.m. EDT. InterMune will host a live conference call and webcast at 4:30 p.m. EDT that same day.
To access the live teleconference, dial 888-799-0528 (U.S.) or 706-634-0154 (international), conference ID# 10972528. To access the webcast, please log on to the company’s website at http://www.intermune.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.
A replay of the webcast and teleconference will be available approximately three hours after the call. The teleconference replay will be available for 10 business days following the call and can be accessed by dialing 800-642-1687 (U.S.) or 706-645-9291 (international), and entering the conference ID# 10972528.
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 hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as a possible therapeutic candidate for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 within the Roche research and development programs) in Phase 1a, a second-generation HCV protease inhibitor research program, and a research program evaluating a new target in hepatology. 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 30, 2007 (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.
CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228, jgoff@intermune.com
Web site: http://www.intermune.com/
