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InterMune Reports Third Quarter 2010 Financial Results
Date:10/28/2010

rities 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 projected cash balances and the likelihood of regulatory success for the use of pirfenidone for the treatment of IPF.  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.  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 and safety results the company has submitted in support of its New Drug Application (NDA) and MAA filings. Furthermore, while the Pulmonary-Allergy Drugs Advisory Committee (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 intend to continue to work diligently with the FDA to determine a regulatory path forward with respect to pirfenidone in the United States, we do not know whether 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 trial as requested by the FDA in the Complete Response letter.  

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SOURCE InterMune, Inc.
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