Pirfenidone Shows Favorable Effects in Idiopathic Pulmonary Fibrosis
May 4, 2005 - 10:28:00 AM
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"This study suggests that treatment with pirfenidone may prevent acute exacerbation of IPF and reduce the rate of decline in vital capacity. We are encouraged by these promising results and are moving forward with our discussions with the U.S. Food and Drug Administration and the European Medicines Agency regarding the design of a Phase III development program for pirfenidone in IPF, which we expect to initiate in the first half of 2006."
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By InterMune, Inc.,
[RxPG] InterMune, Inc. today announced that the American Journal of Respiratory and Critical Care Medicine (AJRCCM) published results from a double-blind, randomized, placebo-controlled Phase II trial evaluating pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
This 107- patient study with a planned 12-month treatment period was conducted in Japan by Shionogi & Co., LTD and was terminated after only nine months based on the recommendation of the Data Safety Monitoring Board following an interim analysis. This analysis suggested favorable effects of pirfenidone on acute exacerbations and other efficacy parameters, prompting the decision to stop the trial.
In the 9-months of treatment, acute exacerbations had occurred in 14% and 0% of placebo and pirfenidone patients, respectively (p=0.0031). All of these patients required hospitalization and one patient died.
The analysis of the primary endpoint, change from baseline in the lowest oxygen saturation during a 6-minute exercise test, revealed a trend in the overall population (p=0.072) with a more pronounced treatment effect in a pre-specified subgroup of patients with milder disease (p=0.0305). Pirfenidone had a favorable effect on vital capacity, analyzed as both a change from baseline (p=0.0366) and a categorical assessment of the proportion of patients who improved, were stable, or declined (p=0.0028).
Changes in total lung capacity, carbon monoxide diffusing capacity, resting partial pressure of arterial oxygen, dyspnea, and quality of life were not statistically significant after nine months of treatment.
Gastrointestinal symptoms, photosensitivity and fatigue occurred more frequently in the pirfenidone group, although rates of treatment adherence were similar between the two groups. The main cause for patients discontinuing from study treatment was photosensitivity in the pirfenidone group (6.8% vs. 0%) and acute exacerbation (0% vs. 14%) in the placebo group.
"This study suggests that treatment with pirfenidone may prevent acute exacerbation of IPF and reduce the rate of decline in vital capacity," said Dan Welch, InterMune's President and CEO. "We are encouraged by these promising results and are moving forward with our discussions with the U.S. Food and Drug Administration and the European Medicines Agency regarding the design of a Phase III development program for pirfenidone in IPF, which we expect to initiate in the first half of 2006."
InterMune acquired an exclusive license relating to the manufacture, use and sale of pirfenidone for antifibrotic use worldwide, excluding Japan, Korea, and Taiwan, where rights are held by Shionogi & Co., LTD.
About IPF
IPF is a disabling and ultimately fatal disease that affects approximately 83,000 people in the United States, 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.
Publication:
American Journal of Respiratory and Critical Care Medicine (AJRCCM)
On the web:
www.intermune.com/ 
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Additional information about the news article
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About InterMune
InterMune is a biopharmaceutical company focused on developing and commercializing innovative therapies in hepatology and pulmonology. The Company has a broad and deep late-stage product portfolio addressing hepatitis C virus (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(R) (interferon gamma-1b) with and without ribavirin for the treatment of HCV nonresponders. 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.
CONTACT: investors, Judy Hayes of InterMune, Inc., +1-415-466-2242, or; or media, Carolyn Bumgardner Wang of WeissComm Partners,Inc., +1-415-946-1065, or , for InterMune, Inc. [email protected] [email protected]
Web site: http://www.intermune.com/
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