BRISBANE, Calif., May 13 InterMune, Inc. (Nasdaq: ITMN) today announced that an oral presentation and six posters related to the company's pulmonology programs will be presented at the 2010 International Conference of the American Thoracic Society (ATS) in New Orleans.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We are very pleased to present the results of our on-going research on pirfenidone and idiopathic pulmonary fibrosis (IPF) at this year's ATS meeting. Of particular interest, a meta-analysis of the effect of pirfenidone on lung function and progression-free survival, including more than 1,000 patients from three Phase 3 studies in IPF - the two CAPACITY studies and Shionogi's Phase 3 study in Japan - will be presented as a poster on the morning of Sunday, May 16. In addition, the results of a large study examining the individual risk of mortality in patients with IPF will be presented in an oral session on Monday, May 17."
The schedule of presentations at ATS related to InterMune's efforts in the research and development of new medicines for IPF is as follows:
In February 2009, InterMune announced the results of the company's two global Phase 3 clinical trials evaluating pirfenidone for the treatment of IPF, known as the CAPACITY trials. Prior to the CAPACITY results, a Phase 3 study in IPF patients was conducted in Japan by Shionogi & Co. Ltd. which led to the marketing approval of pirfenidone in Japan in October of 2008. In these clinical studies, pirfenidone was safe and generally well tolerated with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms.
InterMune submitted a New Drug Application (NDA) for pirfenidone to the U.S. Food and Drug Administration (FDA) on November 4, 2009, which was granted "Priority Review" designation on January 4, 2010. On March 9, 2010, the Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 9-3 to recommend approval of pirfenidone for the treatment of IPF to reduce decline in lung function. However, on May 4, 2010, the FDA issued to InterMune a complete response letter for InterMune's NDA which requested an additional clinical trial to support the efficacy of pirfenidone for IPF patients. The company plans to meet with the FDA as soon as possible to address the points raised by the Agency and to discuss pathways to approval.
Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease that affects approximately 200,000 people in Europe and the United States combined, with approximately 30,000 new cases reported per year in each region.
IPF is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen 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 Europe and the United States for the treatment of IPF.
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). A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA). The hepatology portfolio includes the HCV protease inhibitor compound danoprevir (also known as RG7227 or ITMN-191, partnered by Roche) that entered Phase 2b in August 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, which reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to anticipated regulatory 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 analyses and safety results the company has submitted in support of its New Drug Application (NDA) and MAA filings. Notably, on May 4, 2010 the U.S. Food and Drug Administration (FDA) issued to InterMune a complete response letter for InterMune's NDA which requested an additional clinical trial to support the efficacy of pirfenidone for IPF patients. 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 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; 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.
Sunday, May 16 Session: [A23] Idiopathic Pulmonary Fibrosis: Epidemiology, Biomarkers and Outcomes Location: Room 225-227 (Second Level), Morial Convention Center Discussion: 9:15 a.m. - 10:45 a.m. -- 6-Minute Walk Test is a Reliable, Valid and Responsive Outcome that Predicts Mortality in Patients with IPF (Poster #103) R du Bois, C Albera, W Bradford, U Costabel, A Kartashov, T King, Jr., P Noble, S Sahn, M Thomeer, J Szwarcberg, D Valeyre, D Weycker -- Effect of Pirfenidone on Lung Function and Progression- free Survival in Patients with IPF: A Meta-analysis of Three Phase 3 Studies (Poster #220) P Noble, C Albera, W Bradford, U Costabel, R du Bois, T King, Jr., S Sahn, J Szwarcberg, D Valeyre Monday, May 17 Session: [B14] Translational Research in Interstitial Lung Disease (Mini Symposium/Oral Presentation) Location: Room 260-262 (Second Level), Morial Convention Center Discussion: 8:15 a.m. - 10:30 a.m. -- Ascertainment of Individual Risk of Mortality for Patients with Idiopathic Pulmonary Fibrosis R du Bois, C Albera, W Bradford, U Costabel, A Kartashov, T King, Jr., P Noble, G Raghu, S Sahn, M Thomeer, J Szwarcberg, D Valeyre, D Weycker Session: [B40] Interstitial Lung Disease: Epidemiology and Outcomes Location: Area C, Hall G (First Level), Morial Convention Center Discussion: 10:45 a.m. - 12:30 p.m. -- Prognostic Significance of Surgical Lung Biopsy in a Well- characterized Cohort of Patients with Idiopathic Pulmonary Fibrosis (Poster C45) C Albera, W Bradford, U Costabel, R du Bois, T King, Jr., P Noble, S Sahn, J Szwarcberg, D Valeyre Wednesday, May 19 Session: [D48] Idiopathic Pulmonary Fibrosis: Epidemiology, Biomarkers, and Outcomes Location: Area F, Hall G (First Level), Morial Convention Center Discussion: 10:45 a.m. - 12:30 p.m. -- Global Assessment of Pirfenidone Treatment Outcomes Over Time in the CAPACITY Studies in Patients with IPF (Poster F115) U Costabel, C Albera, W Bradford, R du Bois, T King, Jr., P Noble, S Sahn, J Szwarcberg, D Valeyre -- Clinical Outcomes with Pirfenidone Therapy in Treatment- adherent Patients with Idiopathic Pulmonary Fibrosis (Poster F117) S Sahn, C Albera, W Bradford, U Costabel, R du Bois, T King, Jr., P Noble, J Szwarcberg, D Valeyre -- 6-Minute Walk Distance and Forced Vital Capacity in Patients with IPF: Similar Pattern of Pirfenidone Treatment Response (Poster F118) D Valeyre, C Albera, W Bradford, U Costabel, R du Bois, T King, Jr., P Noble, J Szwarcberg, S Sahn
SOURCE InterMune, Inc.