BRISBANE, Calif., Feb. 19 /PRNewswire-FirstCall/ -- InterMune, Inc. today announced the issuance of U.S. Patent Number 7,491,794, a composition of matter patent which covers the ITMN-191 (R7227) compound. The nominal 20-year patent term extends to October 13, 2024. ITMN-191 is an inhibitor of the hepatitis C virus (HCV) NS3/4A protease.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, “We are pleased to announce that this new patent, which is the foundation of our intellectual property coverage of ITMN-191, has issued. We look forward to continued progress in developing ITMN-191 with our partner, Roche, as we anticipate the start of our Phase 2b program in the second quarter of 2009.”
About ITMN-191 (R7227)
ITMN-191 is being developed with InterMune’s collaborative partner, Roche, for the treatment of patients chronically infected with HCV. On January 12, 2009, InterMune announced top-line results from a 14-day study of ITMN-191 in combination with Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin). InterMune reported that after 14 days of triple combination therapy, the median change in HCV RNA from baseline exceeded 5 log10 in five of the six dosage cohorts in the study, and was -5.4 log10 and -5.7 log10 in the best performing q12h and q8h cohorts, respectively. Reductions in HCV RNA occurred rapidly and there was no evidence of viral rebound during ITMN-191 treatment in any cohort. ITMN-191 was generally safe and well tolerated in the study. There were no serious adverse events or Grade 4 adverse events (AEs) during treatment with ITMN-191. AEs reported during study treatment (ITMN-191 or placebo) were predominantly mild to moderate in severity, typically consistent with the AE profile of standard of care (SOC), and none led to treatment discontinuation.
In November 2008, InterMune, Roche and Pharmasset, Inc. initiated the first all-oral combination study of direct anti-virals in the absence of interferon or ribavirin, known as the INFORM-1 study. That study has completed the first dose cohort. Results of INFORM-1 are expected to be reported at a major medical conference in the second quarter of 2009.
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, RECAP, an open-label extension study from CAPACITY and a research program focused on small molecules for the treatment of pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in Phase 1b, a second-generation HCV protease inhibitor research program, and a research program evaluating new targets in hepatology. For additional information about InterMune and its R&D pipeline, please visit 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 and the likelihood of regulatory success. 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 14, 2008 (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 www.intermune.com.
Pegasys(R) and Copegus(R) are registered trademarks of Roche
CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228, jgoff@intermune.com
Web site: http://www.intermune.com/
