InterMune (ticker: ITMN, exchange: NASDAQ) News Release - 2/4/03
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InterMune Provides Update on IPF Development Programs at Merrill Lynch Conference
BRISBANE, Calif., Feb 4, 2003 /PRNewswire-FirstCall via COMTEX/ -- InterMune, Inc. (Nasdaq: ITMN) announced today that it will provide an update on its development programs for idiopathic pulmonary fibrosis (IPF), a debilitating and fatal lung disease, at the Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Device Conference.
Company President and CEO Scott Harkonen will update investors about how InterMune's early stage pirfenidone development program is advancing. He will also discuss results of an additional exploratory survival analysis from the Company's randomized, controlled Phase III clinical trial of Actimmune(R) (interferon gamma 1-b) in the pre-specified cohort of IPF patients who were compliant with their therapy during the study.
"We are fully committed to developing these promising therapies for the broad population of patients who suffer with this difficult disease," said Harkonen. "In addition, a recently completed exploratory analysis of the Phase III Actimmune IPF trial suggests a relationship between compliance and survival. We plan to make these data part of the scientific manuscript and may present them at the next appropriate medical/scientific forum."
Phase III Clinical Trial Compliance Data Analysis
A total of 330 patients were randomized into the Company's Phase III clinical trial evaluating Actimmune for the treatment of IPF, which was conducted at 58 centers in North America, Europe and South Africa. The study enrolled an extremely well-defined cohort of IPF patients, and treatment groups were well balanced by baseline characteristics. Patients received either placebo or 200 micrograms of Actimmune injected subcutaneously three times per week.
Final results of the pre-specified analysis from the Phase III clinical trial were presented last year at two international scientific conferences after the 306th patient received 48 weeks of treatment (representing a 60 week median observation period as of June 26th, 2002). These data showed that Actimmune did not demonstrate statistically significant efficacy with respect to the primary or secondary endpoints. However, the overall analysis of survival, a secondary endpoint in this trial, suggested that Actimmune may provide a survival benefit for patients with mild to moderate impairment in lung function.
Researchers recently conducted an exploratory analysis of survival in the pre-specified cohort of patients who received greater than or equal to 80% of their scheduled doses at the earliest time of death, or by June 26. Among these patients, which constituted over 80% of randomized patients in the Phase III study, there were 6/126 deaths in the Actimmune treated group (4.8%) compared to 20/143 deaths in the placebo group (14.0%), representing a 66% relative reduction in mortality in favor of Actimmune (p = 0.017; log-rank test for survival time).
In the Phase III study, Actimmune was generally well tolerated with few discontinuations due to adverse events, though there were a greater number of non-fatal pneumonias in the Actimmune treated group versus placebo.
Pirfenidone Update
In March 2002, InterMune licensed worldwide rights, excluding Japan, Korea and Taiwan, to develop and commercialize pirfenidone for all fibrotic diseases, including renal, liver and pulmonary fibrosis.
Currently, InterMune is evaluating pirfenidone's safety and preliminary efficacy in six ongoing clinical trials in a variety of indications, including IPF. The Company is in the process of completing, ahead of schedule, a 55-patient proof-of-concept Phase II clinical trial of pirfenidone in IPF, to collect preliminary safety and efficacy data and to accelerate the design and implementation of a larger-scale registrational program. These data should be available by the second half of this year. At that time, based on the initial safety and efficacy of pirfenidone, the Company will finalize its plans for a larger scale registrational trial and consider the appropriateness and possibility of initiating an expanded access program.
"I am very pleased that InterMune is demonstrating the same kind of dedication and commitment to pirfenidone as it has with Actimmune," said Ganesh Raghu, M.D., Professor of Medicine, University of Washington in Seattle, and lead principal investigator of the Phase III Actimmune IPF study.
Having pioneered and published the first clinical study of pirfenidone in patients with advanced IPF, Dr. Raghu cautioned in extrapolating these results as the study was open label and did not have a control arm. "While pirfenidone appears to be a promising new anti-fibrotic agent, it deserves a carefully designed multi-center clinical trial to test its potential effects. I look forward to working further with InterMune on the pirfenidone program to gain a fuller understanding about its safety and efficacy before it is used more widely in IPF patients. I believe that together with Actimmune, it represents an exciting new era of realistic hope in IPF treatment, and I look forward with great enthusiasm to participating in its continued development with InterMune."
About Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is the most common form of idiopathic interstitial pneumonia. Once symptoms appear, there is a relentless deterioration of pulmonary function and median survival of 2.8 years after diagnosis. There are currently no drugs approved by the FDA for the treatment of IPF.
About Actimmune
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. InterMune is also conducting a Phase III study of Actimmune in ovarian cancer and a Phase II study of Actimmune for the treatment of severe liver fibrosis, or cirrhosis, caused by hepatitis C virus (HCV).
About Pirfenidone
Pirfenidone is an orally active small molecule drug that appears to inhibit collagen synthesis, down regulate production of multiple cytokines and block fibroblast proliferation and stimulation in response to cytokines. Pirfenidone, which has demonstrated activity in multiple fibrotic indications, is currently in Phase II clinical development for fibrotic diseases of the lung, kidney and liver.
Webcast Details
The presentation will begin at 2:10 p.m. (EDT), Tuesday, February 4, 2003. To access the live audio webcast, log on to the investor relations page of the company's website at www.intermune.com. We recommend logging on 15 minutes early in order to register or download any necessary software.
About InterMune
InterMune is a commercially driven biopharmaceutical company focused on the marketing, development and applied research of life-saving therapies for pulmonary disease, infectious disease and hepatology. For additional information about InterMune, please visit www.intermune.com. |
