InterMune Announces Submission of NDA for Pirfenidone for the Treatment of
Patients with IPF
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.
Jim Goff of InterMune, Inc., +1-415-466-2228, jgoff@intermune.com
