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FDA Advisory Committee Recommends Approval of InterMune's Esbriet(R) (pirfenidone) for Idiopathic Pulmonary Fibrosis
Date:3/9/2010

or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements. Pirfenidone failed to achieve statistical significance on the primary endpoint in one of its two pivotal clinical trials and there can be no assurance that the regulatory authorities in either the United States or Europe will grant regulatory approval based upon these data, in combination with the other efficacy analyses and safety results the company has submitted in support of its NDA and MAA filings. 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"), those additional risks and uncertainties relating InterMune and its business found in the risk factors attached as Exhibit 99.3 to InterMune's Form 8-K filed with the SEC on January 20, 2010, and in the Prospectus Supplement filed with the SEC on January 21, 2010, 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, the Form 8-K, the Prospectus Supplement and InterMune's other periodic reports filed wit
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SOURCE InterMune, Inc.
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