Navigation Links
InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF
Date:11/4/2009

BRISBANE, Calif., Nov. 4 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that it has submitted an electronic New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe.

"IPF is a rapidly and uniformly fatal disease. Sadly, there are no medicines approved for the approximately 100,000 Americans who suffer from this terrible disease," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "InterMune has dedicated almost ten years to the development of new medicines for patients with IPF. We are very proud to have submitted the first NDA ever submitted to the FDA for a medicine to treat IPF patients."

About Pirfenidone

Preclinical and in-vitro evidence had shown that pirfenidone has both anti-fibrotic and anti-inflammatory effects. Results from three adequate and well-controlled Phase 3 studies have shown evidence of a treatment effect in IPF patients and the compound has been safe and generally well tolerated, with side effects including photosensitivity rash and gastrointestinal symptoms.

InterMune licensed pirfenidone from Marnac, Inc. and its co-licensor, KDL GmbH, in 2002 and in 2007 purchased from Marnac and KDL the rights to sell the compound in the United States, Europe and other territories except in Japan, Taiwan and South Korea where rights to the molecule were licensed by Marnac and KDL to Shionogi & Co. Ltd. of Japan. In October of 2008, pirfenidone was approved for use in IPF patients in Japan and is marketed as Pirespa® by Shionogi in that country.

About IPF

Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal disease that affects approximately 200,000 patients in the United States and Europe combined, with approximately 30,000 new cases reported per year in each of the United States and Europe.

IPF is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen and causing shortness of breath (dyspnea) and cough and is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20%. Patients diagnosed with IPF are usually between the ages of 40 and 70, with a median age of 63 years and the disease tends to affect slightly more men than women. There are no medicines approved in the United States or Europe for IPF.

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has an R&D portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes pirfenidone for which InterMune has completed a Phase 3 program in patients with IPF (CAPACITY) and has submitted a New Drug Application (NDA) to the FDA. The hepatology portfolio includes the HCV protease inhibitor compound RG7227 (ITMN-191) that entered Phase 2b in August of 2009 and a second-generation HCV protease inhibitor research program. For additional information about InterMune and its R&D pipeline, please visit 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 product development timelines, the interpretation of the CAPACITY clinical data, including certain exploratory analyses conducted by the Company with respect to such data and the likelihood of regulatory success. 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. Pirfenidone failed to achieve statistical significance on the primary endpoint in one of its two pivotal clinical trials and there can be no assurance that the regulatory authorities in either the United States or Europe will grant regulatory approval based upon these data, in combination with the other efficacy analyses and safety results the company currently intends to submit in support of its NDA and MAA filings. 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 16, 2009 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the long, expensive and uncertain clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues or delays in anticipated timing of the regulatory approval process; (ii) risks related to failure to achieve the clinical trial results required to commercialize our product candidates; and (iii) 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 Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at www.intermune.com.

SOURCE InterMune, Inc.


'/>"/>
SOURCE InterMune, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. InterMune Announces Approval of Clinical Trial Authorization for Phase 1b Trial of ITMN-191
2. InterMune Announces Start of Phase 1b Trial of ITMN-191
3. InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
4. InterMune Provides Additional Information on ITMN-191 (R7227) MAD Study Results
5. InterMune Announces Progress on Pirfenidone in IPF
6. InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA
7. InterMune Announces Start of 14-Day Triple Combination Study of ITMN-191 in Patients With Chronic Hepatitis C
8. Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C
9. InterMune to Report Top-Line Results of Triple Combination Study of ITMN-191 in January 2009
10. InterMune to Conduct Conference Call and Webcast to Discuss Results of Triple Combination Study of ITMN-191
11. InterMune to Announce Results of Phase 3 CAPACITY Program of Pirfenidone in IPF Tomorrow, February 3
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/9/2016)... , Dec. 9, 2016  Axovant Sciences ... clinical-stage biopharmaceutical company focused on the treatment of ... data from a Phase 2b trial evaluating treatment ... donepezil, compared with donepezil plus placebo in people ... the addition of intepirdine to treatment was associated ...
(Date:12/8/2016)... 2016 Australia Glaucoma Surgery Devices Market ... report, "Australia Glaucoma Surgery Devices Market Outlook to ... Glaucoma Surgery Devices market. The report provides value, ... and average prices (USD) within market segement - ... company shares and distribution shares data for each ...
(Date:12/8/2016)... , Dec. 8, 2016 KEY FINDINGS ... to grow in 2017-2023. Various reasons for growth of ... population, higher incidences of chronic diseases, high recovery cost ... aid services. Medical lifting sling refers to an ... limited mobility. These slings connect to the lift and ...
Breaking Medicine Technology:
(Date:12/9/2016)... (PRWEB) , ... December 09, 2016 , ... "I have ... "I used this old family recipe, which is meant to relieve gout and pain ... gave me a 12-hour energy boost every time. It relieved what VA doctors called ...
(Date:12/9/2016)... ... December 09, 2016 , ... An inventor from Cana, Va., wanted ... all types of amusement park rides. , The patent-pending SAFETY STRAP FOR AMPUTEES improves ... use and could be set up in a matter of minutes, or even seconds. ...
(Date:12/9/2016)... Smithsburg, Maryland (PRWEB) , ... December 09, 2016 ... ... intelligent digital whiteboard display solutions, proudly announced today that a new solution for ... package to fit in the tight space in Emergency Department examination rooms, and ...
(Date:12/8/2016)... ... 2016 , ... The West Virginia Medical Institute (WVMI) announced ... name change aligns the entire company with its existing Quality Insights branded projects ... are very proud of the achievements associated with the West Virginia Medical Institute ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... LLC, announced the first national #QuackGivesBack campaign which supported local breast cancer ... our first franchise-wide Quack Gives Back initiative, and we’re very pleased ...
Breaking Medicine News(10 mins):