InterMune Announces Presentation of Positive Pirfenidone Data at the International Conference of the American Thoracic Society (ATS)

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

 

 

BRISBANE, Calif., May 16, 2011 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that an oral presentation and a poster presentation related to the company's development program for pirfenidone in idiopathic pulmonary fibrosis (IPF) will be presented at the 2011 International Conference of the American Thoracic Society (ATS), being held in Denver May 13-18, 2011.

IPF is a chronic respiratory disease with an estimated survival rate of only 20 percent after five years, which makes it more rapidly lethal than many cancers, including breast, ovarian and colorectal. There are currently no approved medicines available for IPF patients in the U.S.

"InterMune, as the world's leader in research and development for IPF, continues to devote significant resources to investigate the benefit-risk profile of pirfenidone, and we are pleased to be able to present some of our new findings at ATS, the world's leading scientific meeting for lung disease," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "In addition to the data presented at ATS, we look forward to rapidly enrolling patients in ASCEND, a new Phase 3 trial of pirfenidone, which will commence in the U.S., Mexico, South America, Australia and New Zealand in June."

InterMune plans to share additional details about the ASCEND study at the company's Analyst Day, which is scheduled for May 26, 2011 in New York City.

The schedule of presentations at ATS is as follows:

Monday, May 16
Session: [B102]
Location: Korbel Ballroom 1A-1B (Lower Level), Colorado Convention Center
Poster Viewing and Discussion: 2:00 p.m.4:30 p.m.
The Effect of Treatment with Pirfenidone on Progression-Free Survival in Patients with Idiopathic Pulmonary Fibrosis (IPF): Exploratory Analysis of Outcomes Using Novel Criteria for Disease Progression
(Poster # 3810)  
S.A. Sahn, C. Albera, R.M. du Bois, W. Bradford, U. Costabel, T.E. King, P.W. Noble, D. Valeyre, p.A3810

Tuesday, May 17
Session: [C93] Mini Symposium: Interstitial Lung Disease Novel Insights for Diagnosis, Prognosis and Treatment
Location: Korbel Ballroom 2A-3A (Lower Level), Colorado Convention Center
Discussion: 3:15 p.m.
The Effect of Treatment with Pirfenidone on Longitudinal Change in Lung Volume in Patients with Idiopathic Pulmonary Fibrosis (IPF): A Meta-Analysis of Outcomes in Four Randomized Controlled Clinical Trials
T.E. King, C. Albera, R.M. du Bois, W. Bradford, U. Costabel, P.W. Noble, S.A. Sahn, D. Valeyre, p.A5302

Both the presentation slides and poster will be available on the investors page of InterMune's website at www.intermune.com.

About Pirfenidone

Pirfenidone is an orally active, small molecule drug that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. It also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.  

On February 28, 2011, the European Commission (EC) granted marketing authorization for Esbriet® (pirfenidone) for the treatment of adults with mild to moderate IPF.  The approval authorizes marketing of Esbriet in all 27 EU member states.  Esbriet has since been approved for marketing in Norway and Iceland.

Since 2008, pirfenidone has been marketed in Japan as Pirespa® by Shionogi & Co. Ltd.  Pirfenidone is still under investigation for the treatment of IPF in the United States and has not been approved by the U.S. Food and Drug Administration for this use.

About InterMune

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 Esbriet® (pirfenidone), which is now approved in the European Union in adults for the treatment of mild to moderate IPF, a progressive and fatal lung disease.  The hepatology portfolio includes next-generation HCV protease inhibitor and NS5A research programs.  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 commercial launch preparations, anticipated timing of commercial launch and statements regarding the various anticipated durations of patent protection and marketing exclusivity.  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.  

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 Securities and Exchange Commission (SEC) on March 9, 2011 (the "Form 10-K"), and other periodic reports filed with the SEC, including but not limited to the following: (i) risks related to the uncertain, lengthy and expensive clinical development process for the company's product candidates, including having no unexpected safety, toxicology, clinical or other issues and having no unexpected clinical trial results such as unexpected new clinical data and unexpected additional analysis of existing clinical data; (ii) risks related to the regulatory process for the company's product candidates, including the possibility that the results of the proposed new 52-week Phase 3 clinical trial (ASCEND) having an FVC endpoint may not be satisfactory to the FDA for InterMune to receive regulatory approval for pirfenidone in the United States; (iii) risks related to unexpected regulatory actions or delays or government regulation generally; (iv) risks related to the company's manufacturing strategy, which relies on third-party manufacturers and which exposes InterMune to additional risks where it may lose potential revenue; (v) government, industry and general public pricing pressures; and (vi) InterMune's ability to obtain or maintain patent or other proprietary intellectual property protections.  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.

Posted: May 2011

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