BRISBANE, Calif., Sept. 13 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that four oral presentations related to the company's development program for pirfenidone and idiopathic pulmonary fibrosis (IPF) will be presented at the Annual Congress of the European Respiratory Society (ERS), to be held September 18-22 in Barcelona, Spain.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We are very pleased that our pirfenidone program will be the subject of three oral presentations at this year's ERS meeting. A fourth oral presentation will focus on Percent Predicted Forced Vital Capacity (FVC), a measure of clinical status in patients with IPF and the primary endpoint in our Phase 3 CAPACITY studies. We look forward to the presentation of these results and analyses at ERS."
The schedule of presentations at ERS related to InterMune's efforts in the development of new medicines for IPF is as follows:
Sunday, September 19, 10:45 a.m. – 12:45 p.m. (New Insights in the Treatment of IPF)
Geneva Room (Hall 1)
Tuesday, September 21, 8:30 - 10:30 a.m. (Clinical Issues in IPF)
Florence Room (Hall 1)
InterMune has submitted a Marketing Authorization Application (MAA) seeking approval of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) in adults, which was validated by the European Medicines Agency (EMA) effective March 24, 2010. Validation of the MAA by the EMA indicates that the application is complete and that the review process has begun.
IPF is a rare and fatal lung disease that affects approximately 200,000 people in the United States and Europe combined. If approved by the EMA, pirfenidone would be the first medication to be made available to IPF patients in the European Union. Pirfenidone has been granted Orphan Drug designation in Europe.
Preclinical and in-vitro evidence has shown that pirfenidone has both anti-fibrotic and anti-inflammatory effects. 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, Shionogi & Co. Ltd (Shionogi) had presented data from a Phase 3 study conducted in Japan which demonstrated that pirfenidone reduced the decline in lung function and improved progression-free survival in patients with IPF. In this clinical study, pirfenidone was safe and generally well-tolerated, with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms. In October of 2008, pirfenidone was approved for use in IPF patients in Japan and is marketed as Pirespa® by Shionogi in that country.
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 the Phase 3 CAPACITY program in patients with IPF. A Marketing Authorization Application (MAA) for pirfenidone is under review by the European Medicines Agency (EMA). The hepatology portfolio includes the HCV protease inhibitor compound danoprevir (also known as RG7227 and ITMN-191) 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 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 will work diligently with the FDA to determine a path forward with respect to pirfenidone in the United States, we do not currently know where that path will lead and there can be no assurance that 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 study as requested by the FDA in the Complete Response letter.
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.
|SOURCE InterMune, Inc.|
Copyright©2010 PR Newswire.
All rights reserved