SAN DIEGO, May 17 /PRNewswire-FirstCall/ -- InterMune, Inc. today reported that results of a study assessing the relationship between various measures of clinical status and the risk of death in patients with idiopathic pulmonary fibrosis (IPF) were presented at the 2009 International Conference of the American Thoracic Society (ATS) in San Diego.
The study demonstrated that change in percent predicted forced vital capacity (FVC) over the preceding 6 months was among the strongest independent predictors of one-year mortality. Researchers found that a decline in percent predicted FVC as small as 5% over 6 months was associated with a two-fold increase in the risk of death over the subsequent 12 months compared with patients who experienced a smaller or no decline over the same period. Additional predictors of one-year mortality included age, baseline percent predicted diffusing capacity (DLCO), baseline FVC, history of respiratory hospitalization, dyspnea score (as measured by the University of California at San Diego Shortness of Breath Questionnaire) and 24-week change in patient-reported respiratory symptoms, as measured by the St. George Respiratory Questionnaire.
The results were presented by Dr. Roland M. du Bois, Professor of Medicine at National Jewish Health, Denver, Colorado. According to Dr. du Bois, "Previously, only changes of forced vital capacity of 10% or more had been considered to be of sufficiently robust magnitude to be clinically meaningful. What this study has shown convincingly is that smaller changes may predict an adverse outcome. This clearly has important implications for disease management."
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We view the results of this study as clinically important and supportive of the results from our Phase 3 CAPACITY program, in which the primary endpoint was change in percent predicted FVC."
The analysis in the du Bois study employed longitudinal data from two large prospective clinical trials in patients with IPF. A total of 1,099 well-characterized patients who participated in the GIPF-001 and GIPF-007 (INSPIRE) trials were included in the analysis. In addition to a comprehensive multivariate model that considered all potential predictors of one-year mortality, researchers developed a practical model based on widely available and reliable measures, including FVC change, that can be used in the clinical setting to assess the near-term risk of death in patients with IPF. Dr. du Bois added, "What the practicing clinician needs is an index that is simple to apply in the office and that predicts likely outcome for an individual patient over the short term. To be able to add this information into the risk/benefit equation for that individual patient will allow a more informed management strategy to be defined. This study has provided such an index."
About the CAPACITY Program
InterMune has reported the results of two concurrent, randomized, double-blind, placebo controlled, Phase 3 trials, known as CAPACITY 1 and CAPACITY 2, evaluating the safety and efficacy of pirfenidone for the treatment of patients with IPF. In CAPACITY 2, treatment with pirfenidone resulted in a statistically and clinically significant reduction in the loss of forced vital capacity (FVC) and increase in progression-free survival time. In CAPACITY 1, the difference between pirfenidone and placebo in FVC change at week 72 was not statistically significant; however, the overall results were consistent with those of CAPACITY 2, suggesting a treatment benefit. Treatment with pirfenidone was safe and generally well tolerated; consistent with previous studies, the most frequently reported side effects were gastrointestinal symptoms and rash.
An exploratory analysis of pooled data from both trials revealed that treatment with pirfenidone resulted in a 30% relative reduction in the percentage of patients who experienced an absolute decline in percent predicted FVC of at least 10%. This magnitude of decline is considered clinically meaningful as a decline in percent predicted FVC as small as 5% over a six-month period has been shown to be an independent predictor of mortality in patients with IPF, as reported in the du Bois presentation at ATS.
InterMune expects to submit a new drug application (NDA) to the FDA in the summer of 2009 and a marketing authorization application (MAA) to the European authorities around the end of 2009.
About IPF
Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal disease that affects a total of approximately 200,000 people in the United States and Europe, with approximately 30,000 new cases developing in the United States alone, each year. There are no medicines approved by the U.S. Food and Drug Administration (FDA) or European Medicines Evaluation Agency (EMEA) for the treatment of IPF. On October 16, 2008, pirfenidone was approved for marketing in Japan as Pirespa(R), the first regulatory approval of any treatment for IPF in any major market in the world. IPF is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen and causing shortness of breath (dyspnea) and cough. 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.
About Pirfenidone
Prior in-vitro evidence has shown that pirfenidone inhibits collagen synthesis, down-regulates profibrotic cytokines and decreases fibroblast proliferation. Data presented from one Phase 3 study and four Phase 2 clinical trials in more than 400 patients suggest that pirfenidone may positively affect lung function and disease progression in patients with IPF. In these clinical studies, pirfenidone was generally well tolerated with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms.
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 http://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 http://www.intermune.com/.
InterMune, Inc.
CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228,
jgoff@intermune.com
Web Site: http://www.intermune.com/
