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InterMune Announces Four Oral Presentations on Pirfenidone and IPF at the Annual Congress of the European Respiratory Society (ERS)
Date:9/13/2010

ttee (PADAC) voted 9 to 3 to recommend that the U.S. Food and Drug Administration (FDA) approve pirfenidone to reduce decline in lung function in patients with IPF, this result was not binding on the FDA and the FDA subsequently issued a Complete Response letter requesting an additional clinical trial to support the efficacy of pirfenidone in IPF. While we will work diligently with the FDA to determine a path forward with respect to pirfenidone in the United States, we do not currently know where that path will lead and there can be no assurance that the FDA will ultimately grant InterMune approval for the use of pirfenidone for the treatment of IPF irrespective of whether InterMune conducts an additional clinical study as requested by the FDA in the Complete Response letter.

Other 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 15, 2010 (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. InterMune undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in InterMune's expecta
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SOURCE InterMune, Inc.
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