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The European Medicines Agency Completes Validation Stage for InterMune's Marketing Authorization Application for pirfenidone
Date:3/23/2010

he other efficacy analyses and safety results the company has submitted in support of its NDA and MAA filings. Furthermore, while the FDA's PADAC voted 9 to 3 to recommend that the FDA approve pirfenidone to reduce decline in lung function in patients with IPF, because this result is not binding on the FDA and the FDA only considers such recommendation, there can be no assurance that the FDA will ultimately grant such approval upon completion of its review. 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, including in particular pirfenidone's failure to achieve statistical significance on the primary endpoint in one of the two CAPACITY trials; 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 expectations.


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SOURCE InterMune, Inc.
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