BRISBANE, Calif., Oct. 16 InterMune, Inc.(Nasdaq: ITMN) today reported that on October 16, 2008, the Japanese Ministryof Health, Labor and Welfare (MHLW) approved the New Drug Application (J-NDA)submitted by Shionogi & Co. Ltd. to market pirfenidone for the treatment ofpatients with idiopathic pulmonary fibrosis (IPF) in Japan. Pirfenidone wasdeveloped in Japan for the treatment of IPF by Shionogi, which has rights topirfenidone in Japan, Taiwan and South Korea.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune,said, "We are very encouraged by the Japanese regulatory approval ofpirfenidone for IPF, making pirfenidone the first medicine approved for IPFpatients in any major market in the world."
InterMune also provided a progress report on its Phase 3 CAPACITY programof pirfenidone in IPF. CAPACITY consists of two multinational, randomized,double-blind, placebo-controlled Phase 3 studies with a total enrollment of779 IPF patients at 110 centers in the United States, Europe and Australia.The primary endpoint in CAPACITY is change in Forced Vital Capacity (FVC) frombaseline to week 72.
InterMune reported that 97% of transplant-free, surviving patients hadcompleted their Week 72 Visit, the study visit at which the primary endpointis assessed.
The CAPACITY protocol calls for a final patient visit to be completed 30days after the Week 72 Visit. This means that all patient visits for CAPACITYare expected to be completed around the end of October 2008. Based on thistimeline for study completion, InterMune expects to announce top-line efficacyand safety results in January or February of 2009, and remains on track forsubmission of a New Drug Application (NDA) in mid-2009, pending positive datafrom CAPACITY. Pirfenidone has received Fast Track designation from the FDA,and if granted Priority Review status, InterMune could receive a six-monthreview of its NDA submission.
Mr. Welch added, "As we approach the last patient visits in our twoCAPACITY studies, we are extremely pleased with the quality of the studyconduct and to have exceeded our aggressive goal for having at least 95% oftransplant-free, surviving patients reporting for their Week 72 Visit. Welook forward to reporting top-line results of CAPACITY in January or inFebruary of 2009."
Pirfenidone has been granted Orphan Drug and Fast Track designation in theUnited States and Orphan Drug designation in Europe for the treatment of IPF.
Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fataldisease that affects a total of approximately 200,000 people in the UnitedStates and Europe, with approximately 30,000 new cases developing in theUnited States alone, each year. There are no medicines approved by the U.S.Food and Drug Administration (FDA) or European Medicines Evaluation Agency(EMEA) for the treatment of IPF. IPF is characterized by inflammation andscarring (fibrosis) in the lungs, hindering the ability to process oxygen andcausing shortness of breath (dyspnea) and cough. IPF is a progressivedisease, meaning that over time, lung scarring and symptoms increase inseverity. The median survival time from diagnosis is two to five years.
Prior in-vitro evidence has shown that pirfenidone inhibits collagensynthesis, down-regulates profibrotic cytokines and decreases fibroblastproliferation. Data presented from one Phase 3 study and four Phase 2clinical trials in more than 400 patients suggest that pirfenidone maypositively affect lung function and disease progression in patients with IPF.In these clinical studies, pirfenidone was generally well tolerated with themost frequent side effects reported being photosensitivity rash andgastrointestinal symptoms.
InterMune is a biotechnology company focused on the research, developmentand 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 portfolioincludes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as apossible therapeutic candidate for the treatment of patients with IPF and aresearch program focused on small molecules for pulmonary disease. Thehepatology portfolio includes the HCV protease inhibitor compound ITMN-191(referred to as R7227 at Roche) in Phase 1b, a second-generation HCV proteaseinhibitor research program, and a research program evaluating a new target inhepatology. For additional information about InterMune and its R&D pipeline,please visit http://www.intermune.com.
This news release contains forward-looking statements within the meaningof section 21E of the Securities Exchange Act of 1934, as amended, thatreflect InterMune's judgment and involve risks and uncertainties as of thedate of this release, including without limitation the statements related toanticipated product development timelines. All forward-looking statements andother information included in this press release are based on informationavailable to InterMune as of the date hereof, and InterMune assumes noobligation to update any such forward-looking statements or information.InterMune's actual results could differ materially from those described inInterMune's forward-looking statements.
Factors that could cause or contribute to such differences include, butare not limited to, those discussed in detail under the heading "Risk Factors"in InterMune's most recent annual report on Form 10-K filed with the SEC onMarch 14, 2008 (the "Form 10-K") and other periodic reports filed with theSEC, including the following: (i) risks related to the uncertain, lengthy andexpensive clinical development and regulatory process, including having nounexpected safety, toxicology, clinical or other issues; (ii) risks related toachieving positive clinical trial results; (iii) the results of the InterMuneCAPACITY trials of pirfenidone may differ materially from those of theShionogi & Co., Ltd. Phase 3 trial of pirfenidone in Japan; (iv) thedesignation of pirfenidone for Fast Track status by the FDA does not guaranteethat the FDA will grant Priority Review of the NDA filed by InterMune inconnection with the approval of pirfenidone for the treatment of IPF in theUnited States. The risks and other factors discussed above should beconsidered only in connection with the fully discussed risks and other factorsdiscussed in detail in the Form 10-K and InterMune's other periodic reportsfiled with the SEC, all of which are available via InterMune's web site athttp://www.intermune.com.
SOURCE InterMune, Inc.