SAN DIEGO, May 22 /PRNewswire-FirstCall/ -- InterMune, Inc. announced today the presentation of preclinical study results involving its two Phase III drug candidates for idiopathic pulmonary fibrosis (IPF), Actimmune(R) (interferon gamma-1b) and pirfenidone, at ATS 2006, the annual International Conference of the American Thoracic Society being held in San Diego. For the first time, an in vitro study provides insight into the complementary anti-fibrotic activity of Actimmune(R) and pirfenidone and points to the therapeutic potential of treating IPF with both compounds, either alone or in combination.
“IPF is a disease characterized by fibrosis or scarring of the lungs, and our in vitro studies further expand our understanding of the potential anti- fibrotic mechanisms of our two Phase III compounds,” stated Lawrence M. Blatt, Ph.D., Chief Scientific Officer of InterMune. “It is intriguing that it appears that pirfenidone does not interfere with the anti-fibrotic activity of Actimmune(R) in our in vitro models of IPF. Further, the data suggests that co-administration of these two compounds may lead to complementary anti- fibrotic effects.”
In vitro studies conducted by InterMune researchers involved human fibroblast cells pretreated with pirfenidone that were then stimulated with Actimmune(R). Actimmune(R) stimulates the production of CXCL10 and CXCL11, two genes that have been shown to reduce pulmonary fibrosis in animal models. Pirfenidone also does not suppress activation of STAT1 nor protein accumulation of IP-10, two other downstream actions of Actimmune(R). Previously, InterMune showed that a principal mechanism of anti-fibrotic action for pirfenidone is selective inhibition of p38-gamma mitogen-activated protein kinase, a distinct pathway for fibrogenesis. These combination studies demonstrate that pirfenidone does not inhibit the anti-fibrotic activity of Actimmune(R) and that the two compounds may work through complementary pathways to reduce fibrogenesis.
About IPF
IPF is a disabling and ultimately fatal disease that affects approximately 83,000 people in the United States, with approximately 30,000 new cases developing each year. InterMune estimates there is a significant IPF population in Europe. Those diagnosed with IPF are usually between the ages of 40 and 70, and the disease tends to affect men more than women. IPF causes inflammation and scarring (fibrosis) in the lungs, hindering a person’s 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 disease is very deadly, with a median survival time from diagnosis of two to five years, and a five-year survival rate of approximately 20 percent. There are currently no drugs approved by the U.S. Food and Drug Administration or the European Medicines Evaluation Agency for the treatment of IPF.
About Actimmune(R)
Actimmune(R) is a synthesized version of interferon gamma, a naturally occurring protein believed to stimulate the immune system. InterMune markets Actimmune(R) for the treatment of two life-threatening congenital diseases: chronic granulomatous disease and severe, malignant osteopetrosis. The most common side effects are flu-like symptoms, including headache, fatigue, fever, chills, and rash. InterMune was granted two composition-of-matter patents related to interferon gamma-1b in the United States, extending its patent protection until 2022. Physicians and patients can obtain additional prescribing information regarding Actimmune(R), including the product’s safety profile, by visiting www.actimmune.com.
About Pirfenidone
Pirfenidone is an orally active, small molecule that shows a wide range of biologic activity. In vitro studies demonstrate that pirfenidone suppresses fibrogenesis through selective inhibition of the p38-gamma MAP kinase. Prior in vitro evidence has shown that pirfenidone inhibits collagen synthesis, down-regulates pro-fibrotic cytokines and decreases fibroblast proliferation. Data presented from four Phase II clinical trials in over 250 patients suggest that pirfenidone may impact 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. In 2004, the U.S. Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA) granted pirfenidone orphan drug designation for the treatment of IPF. InterMune has worldwide rights, excluding Japan, Korea and Taiwan, to develop and commercialize pirfenidone for all fibrotic diseases.
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 two Phase III programs evaluating possible therapeutic candidates for treatment of patients with IPF: the INSPIRE trial is evaluating Actimmune(R) and the CAPACITY program is evaluating pirfenidone. The hepatology portfolio includes the lead HCV protease inhibitor compound, ITMN-191, formerly referred to as ITMN B, a second-generation HCV protease inhibitor program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to the progress, future patient enrollment in and timing of our clinical trials and announcements of results thereof. 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. 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 annual report on Form 10-K filed with the SEC on March 13, 2006 (the “Form 10-K”) and updates included in the most recent Form 10-Q filed with the SEC on May 9, 2006 (the “Form 10-Q”), and other periodic reports filed with the SEC, including the following: (i) risks related to the development of our product and product candidates; (ii) risks related to timely patient enrollment and retention in clinical trials, including the use of third parties to conduct such clinical trials; (iii) risks related to achieving positive clinical trial results; (iv) risks related to our intellectual property rights; and (v) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues. 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, Inc.
CONTACT: investors, InterMune, Inc. Investor Relations Dept,+1-415-466-2242, or ir@intermune.com; or media, Pam Lord of Porter NovelliLife Sciences, +1-858-527-3494, or plord@pnlifesciences.com, for InterMune,Inc.
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