InterMune Announces Presentations on Actimmune and IPF at ATS 2005
BRISBANE, Calif., May 9 /PRNewswire-FirstCall/ — InterMune, Inc. announced today data presentations scheduled to take place during scientific sessions at ATS 2005, the annual International Conference of the American Thoracic Society (ATS), being held May 20-25 in San Diego. The presentations focus on the long-term use of Actimmune(R) (interferon gamma-1b) in treating idiopathic pulmonary fibrosis (IPF), the effect of Actimmune on mortality in patients with IPF based on a meta-analysis, the mechanism of action of interferon gamma-1b in IPF, and the use of the Composite Pulmonary Index (CPI) in predicting mortality in IPF patients. The presentations are as follows:
Sunday, May 22
8:15 a.m. – 4:15 p.m.
— Poster presentation (#G54): Long-term use of interferon gamma-1b in
patients with idiopathic pulmonary fibrosis (IPF).
— Poster presentation (#G75): Interferon-gamma 1-b inhibits
interleukein-4 (IL-4) up-regulation in activated T-cells and
IL-4-induced collagen synthesis in cellular models of lung fibrosis.
8:45 a.m.
— Oral presentation at mini-symposium on “Treatment of Sarcoidosis and
IPF” (#A14): Interferon gamma-1b therapy in IPF: A meta-analysis.
9:00 a.m.
— Oral presentation at mini-symposium on “Treatment of Sarcoidosis and
IPF,” (#A14): Association of the Composite Pulmonary Index (CPI) with
mortality in a Phase III trial of patients with idiopathic pulmonary
fibrosis (IPF).
About IPF
IPF is a disabling and ultimately fatal disease that affects approximately 80,000 people in the U.S., with an estimated 30,000 new cases developing each year. Those diagnosed with IPF are usually between the ages of 50 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. Median survival time from diagnosis is two to five years in patients with IPF. There are currently no drugs approved by the FDA for the treatment of IPF.
About Actimmune(R) (interferon gamma-1b)
Interferon gamma is a naturally occurring protein that stimulates the immune system. InterMune markets Actimmune 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 fever, headache and chills. InterMune is conducting several trials with Actimmune including: the INSPIRE Trial, a Phase III study of interferon gamma-1b in IPF; the GRACES Trial, a Phase III study of interferon gamma-1b in ovarian cancer; and a Phase II trial in hepatitis C virus (HCV) nonresponders of interferon alfacon-1 plus interferon gamma-1b. Physicians and patients can obtain additional prescribing information regarding Actimmune, including the product’s safety profile, by visiting http://www.actimmune.com/.
About InterMune
InterMune is a biopharmaceutical company focused on developing and commercializing innovative therapies in hepatology and pulmonology. In addition to the currently marketed product indicated for the treatment of chronic hepatitis C virus (HCV) infections, three-times-a-week Infergen(R), InterMune has a broad and deep late-stage product portfolio addressing HCV infections, particularly nonresponders, or those patients who do not respond to first-line therapy, and IPF. Leading the hepatology portfolio is the DIRECT Trial, a Phase III study of daily Infergen(R) (interferon alfacon-1) plus ribavirin, and a Phase IIb trial of daily Infergen plus Actimmune with and without ribavirin for the treatment of HCV patients who do not respond to first-line therapy. In addition, InterMune has an early stage small molecule program targeted at the HCV protease. The pulmonology portfolio includes pirfenidone and Actimmune. Pirfenidone is being developed for the treatment of IPF. Actimmune is being investigated in the INSPIRE Trial, a Phase III study in patients with IPF. For additional information about InterMune and its development pipeline, please visit http://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 anticipated future financial results and product development. 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 Form 10-K filed with the SEC on March 16, 2005 and other periodic reports filed with the SEC, including the following: (i) the risk that if physicians do not prescribe Actimmune for the treatment of IPF, an indication for which Actimmune has not been approved by the FDA, or if patient referral rates continue to decline, InterMune’s revenues will decline; (ii) risks related to regulation by the FDA and other agencies with respect to InterMune’s communications with physicians concerning Actimmune for the treatment of IPF; (iii) risks related to potential increases in Infergen sales; (iv) reimbursement risks associated with third-party payors; (v) risks related to whether InterMune is able to obtain, maintain and enforce patents and other intellectual property; (vi) risks related to significant regulatory, supply and competitive barriers to entry; (vii) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues; (viii) risks related to achieving positive clinical trial results; (ix) 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 10-K report and InterMune’s other periodic reports filed with the SEC.
InterMune, Inc.
CONTACT: investors, Judy Hayes of InterMune, Inc., +1-415-466-2242, orir@intermune.com; or media, Jani Bergan of WeissComm Partners,+1-415-946-1064, jbergan@weisscommpartners.com, for InterMune, Inc.
Web site: http://www.intermune.com/