InterMune Announces Four Oral Presentations on Pirfenidone and IPF at the Annual Congress of the European Respiratory Society (ERS)
BRISBANE, Calif., Sept. 13 /PRNewswire-FirstCall/ -- InterMune,
Inc. (NASDAQ:ITMN) today announced that four oral
presentations related to the company's development program for
pirfenidone and idiopathic pulmonary fibrosis (IPF) will be
presented at the Annual Congress of the European Respiratory
Society (ERS), to be held September 18-22 in Barcelona,
Spain.
Dan Welch, Chairman, Chief Executive Officer and President of
InterMune, said, "We are very pleased that our pirfenidone program
will be the subject of three oral presentations at this year's ERS
meeting. A fourth oral presentation will focus on Percent Predicted
Forced Vital Capacity (FVC), a measure of clinical status in
patients with IPF and the primary endpoint in our Phase 3 CAPACITY
studies. We look forward to the presentation of these results and
analyses at ERS."
The schedule of presentations at ERS related to InterMune's
efforts in the development of new medicines for IPF is as
follows:
Sunday, September 19, 10:45 a.m. - 12:45 p.m. (New Insights in
the Treatment of IPF)
Geneva Room (Hall 1)
-- 11:00 a.m. -- Pirfenidone dose-response in patients with idiopathic
pulmonary fibrosis: A comprehensive analysis of outcomes in CAPACITY 2
(Ulrich Costabel, M.D.)
-- 11:15 a.m. -- The magnitude of pirfenidone treatment effect in
patients with idiopathic pulmonary fibrosis: A pooled analysis of
outcomes in the CAPACITY trials (Carlo Albera, M.D.)
-- 11:45 a.m. -- The effect of treatment with pirfenidone on death or
lung transplantation in patients with idiopathic pulmonary fibrosis:
Analysis of outcomes in the CAPACITY trials (Dominique Valeyre, M.D.)
Tuesday, September 21, 8:30 - 10:30 a.m. (Clinical Issues in IPF)
Florence Room (Hall 1)
-- 10:00 a.m. -- Percent predicted forced vital capacity is a reliable,
valid, and responsive measure of clinical status in patients with
idiopathic pulmonary fibrosis (Ron du Bois, M.D.)
About Pirfenidone
InterMune has submitted a Marketing Authorization Application
(MAA) seeking approval of pirfenidone for the treatment of
idiopathic pulmonary fibrosis (IPF) in adults, which was validated
by the European Medicines Agency (EMA) effective March 24, 2010.
Validation of the MAA by the EMA indicates that the application is
complete and that the review process has begun.
IPF is a rare and fatal lung disease that affects approximately
200,000 people in the United States and Europe combined. If
approved by the EMA, pirfenidone would be the first medication to
be made available to IPF patients in the European Union.
Pirfenidone has been granted Orphan Drug designation in
Europe.
Preclinical and in-vitro evidence has shown that pirfenidone has
both anti-fibrotic and anti-inflammatory effects. In February 2009,
InterMune announced the results of the company's two global Phase 3
clinical trials evaluating pirfenidone for the treatment of IPF,
known as the CAPACITY trials. Prior to the CAPACITY results,
Shionogi & Co. Ltd (Shionogi) had presented data from a Phase 3
study conducted in Japan which demonstrated that pirfenidone
reduced the decline in lung function and improved progression-free
survival in patients with IPF. In this clinical study, pirfenidone
was safe and generally well-tolerated, with the most frequent side
effects reported being photosensitivity rash and gastrointestinal
symptoms. 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 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 the Phase 3 CAPACITY
program in patients with IPF. A Marketing Authorization Application
(MAA) for pirfenidone is under review by the European Medicines
Agency (EMA). The hepatology portfolio includes the HCV protease
inhibitor compound danoprevir (also known as RG7227 and ITMN-191)
that entered Phase 2b in August 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, which reflect InterMune's judgment and involve risks and
uncertainties as of the date of this release, including without
limitation the statements related to anticipated regulatory
timelines 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 and safety results the company has
submitted in support of its New Drug Application (NDA) and MAA
filings. Furthermore, while the Pulmonary-Allergy Drugs Advisory
Committee (PADAC) voted 9 to 3 to recommend that the U.S. Food and
Drug Administration (FDA) approve pirfenidone to reduce decline in
lung function in patients with IPF, this result was not binding on
the FDA and the FDA subsequently issued a Complete Response letter
requesting an additional clinical trial to support the efficacy of
pirfenidone in IPF. While we will work diligently with the FDA to
determine a path forward with respect to pirfenidone in the United
States, we do not currently know where that path will lead and
there can be no assurance that the FDA will ultimately grant
InterMune approval for the use of pirfenidone for the treatment of
IPF irrespective of whether InterMune conducts an additional
clinical study as requested by the FDA in the Complete Response
letter.
Other 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 15, 2010 (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. InterMune undertakes no
duty or obligation to update any forward-looking statements
contained in this release as a result of new information, future
events or changes in InterMune's expectations.
Source: InterMune, Inc.
CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228,
jgoff@intermune.com
Web Site: http://www.intermune.com/
Posted: September 2010
