Results From Phase 3 CAPACITY Program of Pirfenidone in IPF and Study of Predictors of Mortality in IPF to be Presented at ATS

Update: Esbriet (pirfenidone) Now FDA Approved - October 15, 2014

- Phase 3 CAPACITY results poster presentation Sunday, May 17, 8:15 a.m. PDT -

- Phase 3 CAPACITY results oral presentation, Tuesday, May 19, 3:35 p.m. PDT -

- Conference call and webcast Tuesday, May 19, 6 p.m. PDT -

BRISBANE, Calif., May 14 /PRNewswire-FirstCall/ -- InterMune, Inc. (NASDAQ:ITMN) today announced that an oral late-breaker presentation and two poster discussion presentations related to the company's pulmonology programs will be presented at the 2009 International Conference of the American Thoracic Society (ATS) in San Diego. In addition, the company will conduct a conference call and webcast to discuss the results of its Phase 3 CAPACITY program on Tuesday, May 19 at 6:00 p.m. PDT (9:00 p.m. EDT).
 

Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We are very pleased that our Phase 3 CAPACITY program will be the subject of two significant sessions at this year's ATS meeting. Details of the CAPACITY results will be presented in a poster discussion session on the morning of Sunday, May 17. A more in-depth presentation of the efficacy and safety data from the two CAPACITY studies will be the subject of an oral late-breaker presentation on Tuesday, May 19. In addition, the results of a large study examining the predictors of mortality in patients with idiopathic pulmonary fibrosis (IPF) will be presented in a poster discussion session on Sunday, May 17. Among the independent predictors of mortality identified in the study was change in percent predicted forced vital capacity (FVC), the primary endpoint and a component of important secondary endpoints in our CAPACITY program."
 

The schedule of presentations at ATS related to InterMune's efforts in the research and development of new medicines for IPF are as follows:
 

  SUNDAY, MAY 17
  POSTERS: (A23) INTERSTITIAL LUNG DISEASE: OUTCOMES AND SELECTED CLINICAL
  ISSUES

       Room: 6 F (Upper Level)

       Session time: 8:15 a.m. - 10:45 a.m.  (Poster Viewing: 8:15 a.m. -
       9:15 a.m.  Discussion 9:15 a.m. - 10:45 a.m.)

       POSTER 201: R. du Bois:  PREDICTORS OF MORTALITY IN PATIENTS WITH
       IDIOPATHIC PULMONARY FIBROSIS (IPF)

       POSTER 216: P.W. Noble:  THE CAPACITY (CAP) TRIALS:
       RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III TRIALS OF
       PIRFENIDONE (PFD) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS
       (IPF)

  TUESDAY, MAY 19
  LATE BREAKING CLINICAL TRIALS (C98)

       Room 7 A-B (Upper Level)

       3:35 p.m. - P.W. Noble:  PIRFENIDONE IN THE TREATMENT OF
       IDIOPATHIC PULMONARY FIBROSIS: RESULTS OF TWO RANDOMIZED, DOUBLE-
       BLIND, PLACEBO-CONTROLLED, PHASE III TRIALS (THE CAPACITY TRIALS)

  Webcast Details

InterMune will host a teleconference and webcast on Tuesday, May 19 at 6:00 p.m. PDT (9:00 p.m. EDT), in which Dr. Paul Noble, co-chair of the CAPACITY program and Professor of Medicine and Chief of Pulmonary, Allergy and Critical Care Medicine at Duke University Medical Center, will present his oral presentation of the CAPACITY results and accompanying slides. Dr. Roland du Bois, Professor of Medicine at National Jewish Health, Denver, Colo., and CAPACITY co-chair, will also participate in the webcast.
 

To access the live teleconference, dial 888-799-0528 (U.S.) or 973-200-3372 (international), conference ID# 97738057. To access the live audio webcast of the conference call, please log on to the investor relations page of the company's website at www.intermune.com. The company recommends logging on to the site 15 minutes prior to the start of the presentation in order to register or download any necessary software.
 

A replay of the webcast and teleconference will be available approximately three hours after the call. The teleconference replay will be available for 10 business days following the call and can be accessed by dialing 800-642-1687 (U.S.) or 706-645-9291 (international), and entering the conference ID# 97738057.
 

About InterMune
 

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as a possible therapeutic candidate for the treatment of patients with IPF, RECAP, an open-label extension study from CAPACITY and a research program focused on small molecules for the treatment of pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche, its development partner) in Phase 1b, a second-generation HCV protease inhibitor research program, and a research program evaluating new targets in hepatology. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
 

Forward-Looking Statements
 

This news release contains forward-looking statements within the meaning of section 21E of the Securities 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 anticipated product development timelines 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. 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 currently intends to submit in support of its NDA and MAA filings. Further analyses of the CAPACITY results will be conducted in the future and additional observations may be made which may lead to material change in the company's current regulatory strategy for pirfenidone, including a decision by the company not to proceed with either or both of its regulatory submissions in the United States and Europe. These analyses and observations will be included in one or more scientific publications. 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") 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, all of which are available via InterMune's web site at www.intermune.com.
 

Source: InterMune, Inc.

CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228,
jgoff@intermune.com
 

Web Site: http://www.intermune.com/
 

Posted: May 2009

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