Jim Goff, InterMune, Inc., 415-466-2228, firstname.lastname@example.org
INTERMUNE ANNOUNCES SUBMISSION OF NDA FOR PIRFENIDONE
TREATMENT OF PATIENTS WITH IPF
Brisbane, Calif., November 4, 2009 InterMune, Inc. (Nasdaq: ITMN) today announced that it has submitted an electronic New Drug Application (NDA) with the U.S. Food and Drug
Administration (FDA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug
status in Europe.
IPF is a rapidly and uniformly fatal disease. Sadly, there are no medicines approved for the approximately 100,000
Americans who suffer from this terrible disease, said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. InterMune has dedicated almost ten years to the development of new medicines for patients with IPF. We are
very proud to have submitted the first NDA ever submitted to the FDA for a medicine to treat IPF patients.
Preclinical and in-vitro evidence had shown that pirfenidone has both anti-fibrotic and anti-inflammatory effects. Results from three
adequate and well-controlled Phase 3 studies have shown evidence of a treatment effect in IPF patients and the compound has been safe and generally well tolerated, with side effects including photosensitivity rash and gastrointestinal symptoms.
InterMune licensed pirfenidone from Marnac, Inc. and its co-licensor, KDL GmbH, in 2002 and in 2007 purchased from Marnac
and KDL the rights to sell the compound in the United States, Europe and other territories except in Japan, Taiwan and South Korea where rights to the molecule were licensed by Marnac and KDL to Shionogi & Co. Ltd. of Japan. In October of
2008, pirfenidone was approved for use in IPF patients in Japan and is marketed as Pirespa® by Shionogi in that
Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal disease that affects approximately 200,000 patients in the United States and Europe combined, with approximately 30,000 new cases reported per year in each of the
United States and Europe.
IPF is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen
and causing shortness of breath (dyspnea) and cough and is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The median survival time from diagnosis is two to five years, with a five-year survival rate
of approximately 20%. Patients diagnosed with IPF are usually between the ages of 40 and 70, with a median age of 63 years and the disease tends to affect slightly more men than women. There are no medicines approved in the United States or Europe
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has an R&D portfolio addressing idiopathic pulmonary fibrosis (IPF) and
hepatitis C virus (HCV) infections. The pulmonology portfolio includes pirfenidone for which InterMune has completed a Phase 3 program in patients with IPF (CAPACITY) and has submitted a New Drug Application (NDA) to the FDA. The hepatology
portfolio includes the HCV protease inhibitor compound RG7227 (ITMN-191) that entered Phase 2b in August of 2009 and a second-generation HCV protease inhibitor research program. For additional information about InterMune and its R&D pipeline,
please visit 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 InterMunes judgment and involve risks and
uncertainties as of the date of this release, including without limitation the statements related to anticipated product development timelines, the interpretation of the CAPACITY clinical data, including certain exploratory analyses conducted by the
Company with respect to such data and the likelihood of regulatory success. 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. InterMunes actual results could differ materially from those described in InterMunes 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 currently intends to submit 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 InterMunes most recent annual report on Form 10-K filed with the SEC on March 16, 2009 (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 InterMunes other periodic reports filed with the SEC, all of which are available
via InterMunes web site at www.intermune.com.
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