Healthcare Industry News: pirfenidone
News Release - March 18, 2008
Statement by InterMune, Inc. Regarding Justice Department Action Against Former Employee for Past ConductBRISBANE, Calif., March 18 (HSMN NewsFeed) -- InterMune, Inc. (Nasdaq: ITMN ) issued the following statement regarding today's indictment of a former employee in connection with the promotional activities for ActimmuneŽ (interferon gamma-1b) during a period that ended in June of 2003.
"Today's indictment concerns conduct by a former employee who left the company more than four years ago.
"In 2006, InterMune settled all government claims related to that conduct, without criminal sanctions against the company. At the time, the government acknowledged that InterMune fully cooperated with its investigation and had instituted numerous and comprehensive compliance changes before the investigation even began. Today's government action does not affect the Company's settlement in any way.
"In today's action, the government is bringing charges against a former employee, not against InterMune, its current employees or its Directors.
"Since 2004, InterMune has been a transformed company with a new management team, a rigorous compliance program and a promising pipeline focused on serious pulmonary and hepatic diseases.
"We have taken great strides to put this matter behind us and have focused our resources on what we believe is a promising future for our Company and our shareholders."
The individual charged today was Scott Harkonen, formerly President, Chief Executive Officer and a Director of InterMune.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a research and development 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 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 at Roche) in Phase 1b, 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.
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. 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 http://www.intermune.com.
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