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Phase III Study of Consensus IFN Fully Enrolled
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"InterMune Completes Enrollment of the Phase III DIRECT Trial Evaluating Daily Infergen Plus Ribavirin in PEG-Nonresponders"
Intermune releases this press announcement
Monday July 11, 5:30 am ET
Important Clinical Enrollment Milestone Achieved Ahead of Schedule
BRISBANE, Calif., July 11 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) announced today the completion of patient enrollment in its Phase III clinical trial of daily Infergen (interferon alfacon-1) in combination with ribavirin for the treatment of patients chronically infected with hepatitis C virus (HCV) who have failed to respond to a previous course of therapy with pegylated interferon alfa-2 plus ribavirin. These patients are referred to as PEG-nonresponders.
"Results from independent investigator studies of daily Infergen plus ribavirin in the U.S. and in Europe suggest sustained virologic response (SVR) rates that are substantially higher than alternative treatments for PEG- nonresponders. We hope to confirm these promising findings in this large, multi-center Phase III study," said Bruce R. Bacon, M.D. of the Saint Louis University School of Medicine and Steering Committee Chair and Co-Protocol Chair of the study. "As per the protocol, study participants will be monitored during 48 weeks of therapy and 24 weeks of follow-up; therefore, we expect to announce results from the trial in the first half of 2007."
This randomized, open-label study known as the DIRECT (Daily-dose consensus Interferon and Ribavirin: Effect of Combination Therapy) trial has enrolled 514 PEG-nonresponders at 40 leading medical centers in the U.S. The trial is designed to compare the safety and efficacy of daily Infergen plus ribavirin to observation without treatment, the most frequently adopted approach to treating PEG-nonresponders. The primary endpoint is the proportion of patients with SVR, defined as the absence of detectable HCV RNA in serum 72 weeks after the initiation of treatment. To date, the Data Monitoring Committee has noted no safety concerns.
"Over the past 18 months we significantly strengthened our clinical development team at InterMune and this new team is delivering, as evidenced by the enrollment of the DIRECT trial one full quarter ahead of schedule," stated Dan Welch, President and CEO of InterMune. "Completion of enrollment in the DIRECT trial marks an important milestone both for InterMune and for PEG- nonresponders, and we thank the many physicians, health care workers and patients involved in this trial."
InterMune expects to meet with the Food and Drug Administration (FDA) later this year to discuss its proposed plan to complete the additional clinical work it believes would satisfy the requirements for the registration of daily Infergen. The Company will provide more details when it receives feedback from the FDA.
Growing Unmet Medical Need in Chronic Hepatitis C
According to the Centers for Disease Control and Prevention, an estimated 3.9 million Americans (1.8%) have been infected with HCV, of whom 2.7 million are chronically infected. HCV causes an estimated 10,000 to 12,000 deaths annually in the U.S. and is the leading indication for liver transplant. The prevalence of chronic HCV is increasing. First-line treatment for patients chronically infected with HCV is pegylated interferon alfa-2 plus ribavirin. Approximately half of all patients treated do not respond. There are currently approximately 200,000 PEG-nonresponders in the U.S. and the number is growing by an estimated 50,000 each year.
About Infergen (interferon alfacon-1)
Infergen is a bio-optimized type 1 interferon alpha indicated for treatment of adult patients with chronic HCV infections with compensated liver disease and is dosed three times-per-week. Infergen is the only interferon alpha with data in the label regarding use in patients following relapse or non-response to certain previous treatments. The most common side effects are flu-like symptoms (i.e., headache, fatigue, fever, myalgia, and rigors). Physicians and patients can obtain additional prescribing information regarding Infergen, including the product's safety profile and the black box warning for all interferon alphas regarding neuropsychiatric, autoimmune, ischemic and infectious disorders, by visiting www.infergen.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 (interferon alfacon-1), 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 idiopathic pulmonary fibrosis (IPF). Leading the hepatology portfolio is the DIRECT Trial, a Phase III study of daily Infergen plus ribavirin, and a Phase IIb trial of daily Infergen plus Actimmune (interferon gamma-1b) 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 evaluated in the INSPIRE Trial, a Phase III study in patients with IPF. For additional information about InterMune and its development 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 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-Q filed with the SEC on May 10, 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-Q report and InterMune's other periodic reports filed with the SEC.
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