BRISBANE, Calif., Aug. 27, 2012 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced that an oral presentation and three poster presentations related to the company's research programs in idiopathic pulmonary fibrosis (IPF) will be presented at the Annual Congress of the European Respiratory Society (ERS) being held in Vienna, Austria, September 1-5.
New analyses of FVC change and Survival from the RECAP extension study of Esbriet® (pirfenidone) will be delivered in an oral presentation. Additionally, new data on the long-term clinical safety of Esbriet in IPF patients who have received treatment for up to 7.7 years will be presented as part of a scientific poster discussion.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "These data demonstrate that the safety profile of Esbriet in IPF patients treated for several years is generally consistent with the well characterized safety profile from previous clinical studies. Importantly, Esbriet is the first and only agent to demonstrate long-term clinical safety in a prospective well-designed study in patients with IPF."
Two additional scientific posters, including an analysis of safety outcomes in IPF patients treated with Esbriet and commonly used concomitant medications and the results of analyses that confirm the threshold defining clinically significant changes in the 6-minute walk test in patients with IPF will also be presented.
The schedule of presentations regarding Esbriet and/or IPF at ERS is as follows (all times CET):
Sunday, September 2, 2012
Thematic Poster Presentation
Dr. Carlo Albera: "Safety and Tolerability of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis Receiving Commonly Used Concomitant Medications"
Location: Hall A11/P718
Monday, September 3, 2012
14:45 - 16:45 h
Dr. Ulrich Costabel: "Analysis of Lung Function and Survival in RECAP: An Open-label Extension Study of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis"
Location: Oral Presentation OP2820/Hall A3
Tuesday, September 4, 2012
08:30 - 10:30 h
Dr. Dominique Valeyre: "The Long-term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis: Integrated Analysis of Safety from Four Clinical Trials"
Location: Hall A5/P3159
12:50 - 14:40 h
Dr. Steve Nathan: "6-Minute Walk Test in Patients with Idiopathic Pulmonary Fibrosis: Confirmation of the Minimal Clinically Important Difference"
Location: Hall A13/P3656
RECAP is an open-label extension study for patients who participated in the Phase 3 program for Esbriet, known as CAPACITY. The CAPACITY program (studies 004 and 006) was designed to evaluate the safety and efficacy of Esbriet in IPF patients with mild to moderate impairment in lung function. In the CAPACITY studies, 779 patients were randomized to treatment with Esbriet or placebo and 626 patients completed the study. Of these, 603 (96 percent) were enrolled in RECAP.
Long-term safety results from RECAP were initially presented at the Annual Congress of the European Respiratory Society (ERS) in September 2011. These results demonstrated that long-term treatment with Esbriet was safe and generally well-tolerated, with a long-term safety profile similar to that observed in CAPACITY.
About Esbriet® (pirfenidone)
Esbriet is an orally active 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 granted marketing authorization for Esbriet in adults for the treatment of 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. Esbriet is commercially available in Austria, Denmark, Germany, Iceland, Luxembourg, Norway and Sweden.
InterMune is conducting a Phase 3 study, ASCEND, to support the regulatory registration of Esbriet for the treatment of IPF in the United States.
Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease characterized predominantly by fibrosis (scarring) in the lungs, hindering the ability for gas exchange in the lungs. IPF 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 20-40 percent, which makes IPF more rapidly lethal than many cancers, including breast, ovarian and colorectal. Patients diagnosed with IPF are primarily between the ages of 40 and 80, with a median age of 63 years. The disease tends to affect slightly more men than women.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. In pulmonology, the company is focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. Pirfenidone, the only medicine approved for IPF anywhere in the world, is approved for marketing by InterMune in the EU as Esbriet® and is currently in a Phase 3 clinical trial to support regulatory registration in the United States. Additional information about the study is available at www.ASCENDtrial.com. InterMune's research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases. 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 InterMune's judgment and involve risks and uncertainties as of the date of this release. 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 February 29, 2012 (the "Form 10-K"), most recent quarterly report on Form 10-Q filed with the SEC on August 8, 2012 (the "Form 10-Q") and other periodic reports filed with the SEC, including but not limited to the following: (i) the 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 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; and (iii) risks related to our ability to successfully launch and commercialize Esbriet in the EU. 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, Form 10-Q 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.