Navigation Links
InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA
Date:5/19/2008

- Conference call scheduled to discuss Shionogi Phase 3 results on

pirfenidone -

BRISBANE, Calif., May 19 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that its program for the development of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA). Fast Track is a designation that the FDA reserves for a drug intended to treat a serious or life threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. The FDA takes appropriate actions to facilitate the development and expedite the review of the approval applications for fast track products.

Dan Welch, Chairman and Chief Executive Officer of InterMune, said, "There are no approved medicines to treat patients who suffer from IPF, a uniformly fatal disease characterized by scarring and inflammation of the lungs. The FDA's action in granting fast track designation is an indication of pirfenidone's potential to address this serious, unmet medical need. We look forward to reporting top-line results of our Phase 3 CAPACITY program of pirfenidone in IPF, in January of 2009."

Webcast and Conference Call on May 20, 5:00 p.m. EDT

InterMune additionally announced that it will conduct a live webcast and conference call on May 20, 2008 at 5:00 p.m. EDT to discuss its Phase 3 CAPACITY program in the context of data that will be presented by Shionogi & Co., Ltd. regarding its Phase 3 trial of pirfenidone in Japan. The Shionogi Phase 3 results are scheduled to be reported in an oral presentation at the meeting of the American Thoracic Society in Toronto at 2:15 p.m. EDT on May 20.

Interested investors and others may participate in the InterMune conference call by dialing 888-799-0528 (U.S.) or 706-634-0154 (international), conference ID# 48122233. A replay of the webcast and teleconference will be available approximately three hours after the call.

The teleconference replay will be available for 10 business days following the call and can be accessed by dialing 800-642-1687 (U.S.) or 706-645-9291 (international), and entering the conference ID# 48122233.

To access a live audio webcast of the conference call, investors and other interested parties may log on to the investor relations page of InterMune's corporate website at http://www.intermune.com. The company recommends logging on to the site 15 minutes prior to the start of the presentation in order to register or download any necessary software.

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a research and development portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in Phase 1b, a second-generation HCV protease inhibitor research program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, 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 most recent annual report on Form 10-K filed with the SEC on March 14, 2008 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues; (ii) risks related to achieving positive clinical trial results; (iii) the results of the InterMune CAPACITY trials of pirfenidone may differ materially from those of the Shionogi & Co., Ltd. Phase 3 trial of pirfenidone in Japan; (iv) the designation of pirfenidone for Fast Track status by the FDA does not guarantee that the FDA will grant Priority Review of the NDA filed by InterMune in connection with the approval of pirfenidone for the treatment of IPF in the United States. 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 Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at http://www.intermune.com.


'/>"/>
SOURCE InterMune, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. InterMune Announces Progress on Pirfenidone in IPF
2. InterMune Provides Additional Information on ITMN-191 (R7227) MAD Study Results
3. InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
4. InterMune Announces Start of Phase 1b Trial of ITMN-191
5. InterMune Announces Approval of Clinical Trial Authorization for Phase 1b Trial of ITMN-191
6. Ipsogen Announces Three Studies at the American Society of Clinical Oncology (ASCO) Meeting Extending the Utility of the Genomic Grade Index for Predicting Response to Chemotherapy in Breast Cancer
7. TAP Pharmaceutical Products Inc. Announces Phase 3 TAK-390MR Data Demonstrating Higher Overall Healing Versus Lansoprazole in Patients with Erosive Esophagitis
8. Pulmo BioTech Announces Details of the Methodology for its Phase I Human Trials
9. GSK Announces Results of First Phase III Trial Evaluating Tykerb(R) (Lapatinib) Plus Herceptin(R) (Trastuzumab)
10. ADVENTRX Announces ANX-530 Safety Data From Registrational Bioequivalence Clinical Study
11. Medivation Announces Presentation of MDV3100 Clinical Data in Patients With Castration-Resistant Prostate Cancer at 44th American Society of Clinical Oncology Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... Inc ., a digital health company focused on modernizing and ... $25 million in Series B funding led by Qiming US ... Seattle that is part of a broader family ... included participation from SR One , who led ZappRx,s ... Google Ventures). As part of the financing, Mark McDade ...
(Date:4/20/2017)... Research and Markets has announced the ... Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies ... ... was valued at US$ 7,167.6 Mn in 2015, and is ... a CAGR of 5.6% from 2016 to 2024. ...
(Date:4/20/2017)... 20, 2017 NeuroVive Pharmaceutical AB (Nasdaq ... positive preclinical results demonstrating anti-fibrotic effects with ... steatohepatitis (NASH), in an additional well-validated experimental ... has previously shown similar anti-fibrotic effects in ... scientists present novel data demonstrating anti-fibrotic effects ...
Breaking Medicine Technology:
(Date:4/24/2017)... ... April 24, 2017 , ... ... opioid overdose deaths now claim the lives of 62 Americans each day.(1) Yet ... against drug manufacturers, distributors, pharmacies and prescribers by more than half.(2) Novus ...
(Date:4/24/2017)... ANGELES, CA (PRWEB) , ... April 24, 2017 , ... ... picture is worth a thousand words. The good news for single women is that ... for Attraction," which is available on April 25th. Joan's insight, personal experiences and sparkling ...
(Date:4/24/2017)... ... ... “Reflections of God’s Work”: an enlightening collection of life lessons leading each ... published author, Jerri Broglin, a survivor of great loss who gained insight on how ... for those searching for answers, as we are finding the answers that are so ...
(Date:4/24/2017)... NC and Seattle, WA (PRWEB) , ... April ... ... utilized by 75+ leading lifestyle brands, work wear distributors and International relief organizations ... they can carry. The company also offers lifestyle and work wear collections via ...
(Date:4/22/2017)... ... April 22, 2017 , ... Ecommerce sales have grown every year since ... $394.9 billion. The consequences of rapid innovation and growth are often neglected in ... it is every business and individual’s job to give something back to the planet ...
Breaking Medicine News(10 mins):