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:6/16/2017)... 50 years ago today, the Monterey Pop Festival opened its ... San Francisco "Summer of Love."  To celebrate the anniversary, Northern ... strategic market research portals that it will begin delivering to ... Light,s "Summer of Love (For Our Customers)."  ... Northern ...
(Date:6/14/2017)... -- In 2016, Embodied Labs took top prize ... came away with $25,000 in seed-fund investment. Embodied Labs ... "entering the life of another" and by the Journal ... medical professionals in an entirely new dimension." Building upon ... for the Department of Education,s EdSimChallenge, where they received ...
(Date:6/11/2017)... June 10, 2017  Eli Lilly and Company (NYSE: ... Phase 3 studies of galcanezumab, an investigational treatment for ... data on several key secondary endpoints for galcanezumab compared ... these studies (EVOLVE-1, EVOLVE-2 and REGAIN) will be presented ... meeting in Boston . ...
Breaking Medicine Technology:
(Date:6/20/2017)... , ... June 20, 2017 , ... Uniform Advantage ... collection featuring seven new products designed to create tailored looks and athleisure-inspired outfits. UA ... and cotton easy care stretch twill. , With trendy looks hitting the medical community, ...
(Date:6/20/2017)... ... June 20, 2017 , ... John D'Eri, CEO of ... Leader in Adult Autism Award during the Autism Society of America 's ... The Daniel Jordan Fiddle Foundation (DJFF) was founded in 2002 as the ...
(Date:6/20/2017)... ... 20, 2017 , ... International water advocate Sharon Kleyne is ... Power of Water, Global Climate Change and Your Health on VoiceAmerica sponsored by ... how it affects the human eyes. , According to Sharon Kleyne and ...
(Date:6/20/2017)... Chevy Chase, MD (PRWEB) , ... June 20, 2017 , ... ... across the nation, the Society of Professional Benefit Administrators (SPBA) has provided input to ... letter with Sens. Mitch McConnell (R - KY), Charles E. Schumer (D - ...
(Date:6/19/2017)... ... June 19, 2017 , ... Intrinsic Clinical ... the international exchange of actionable insights to improve health globally through the advancement ... make clinical trial management faster, easier, and less painful. Attendees can visit Intrinsic’s ...
Breaking Medicine News(10 mins):