Esbriet® (pirfenidone) Receives Positive Final Appraisal Determination from NICE for Idiopathic Pulmonary Fibrosis (IPF)

 Esbriet® (pirfenidone) Receives Positive Final Appraisal Determination from
                 NICE for Idiopathic Pulmonary Fibrosis (IPF)

-- Also Announces Reimbursement of Esbriet in Finland --

PR Newswire

BRISBANE, Calif., March 20, 2013

BRISBANE, Calif., March 20, 2013  /PRNewswire/ -- InterMune, Inc. (NASDAQ:
ITMN) today reported that the National Institute for Health and Clinical
Excellence (NICE), the health technology appraisal body in England and Wales,
has issued its Final Appraisal Determination (FAD) recommending Esbriet^®
(pirfenidone) for the treatment of mild to moderate idiopathic pulmonary
fibrosis (IPF). The company estimates that approximately 6,100 to 9,500
mild-to-moderate IPF patients are living with IPF in England and Wales.

(Logo: http://photos.prnewswire.com/prnh/20120827/SF62570LOGO)

Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said,
"The positive recommendation by NICE means that patients in England and Wales
and their families living with IPF will now have access to the only approved
treatment for this unpredictable and fatal lung disease. This is an important
step forward for patients, clinicians and the IPF community in England and
Wales and we look forward to beginning the launch of Esbriet there this
summer."

The NICE Appraisal Committee recommended pirfenidone as an option for treating
IPF patients whose predicted forced vital capacity (FVC) is between 50 percent
and 80 percent at the initiation of therapy. Treatment with pirfenidone for
these patients should be discontinued if there is evidence of disease
progression (as defined by a decline in percent predicted FVC of 10 percent or
more within any 12-month period). Based on the clinical study experience with
Esbriet, the company expects that between 10 and 15 percent of patients could
meet this definition of disease progression in a given 12-month period.

The FAD further recommends the prescription of Esbriet for as long as
InterMune makes the Patient Access Scheme (PAS) available. The PAS is a
confidential pricing and access agreement with the UK's Department of Health.
The NHS list price for Esbriet is £26,100 per full year of treatment. At
current rates of exchange this is equivalent to roughly €30,140 and $39,350
per patient per year.

The FAD forms the basis of the final guidance to the NHS in England and Wales
and is expected to be published in April of 2013. Once the final guidance is
published, the NHS must fully implement it within 90 days. The company
expects to begin its launch of Esbriet in England and Wales by the end of
June, when its field-based personnel will be hired and trained and the FAD is
largely implemented.

Mike Bray from Pulmonary Fibrosis UK said, "IPF is a progressive and fatal
lung disease with a very poor outcome. We see the outcome from NICE to
approve the use of pirfenidone for IPF as a huge step forward for patients
with this debilitating lung disease."

Dr. Toby Maher, Consultant Respiratory Physician at the Royal Brompton
Hospital, London, said, "IPF is a progressive and fatal lung disease with a
five-year survival rate which is worse than several types of cancer. The
decision by NICE is a huge step forward in ensuring access to an innovative
and effective therapy for patients who currently have no treatment options."

Finland Approves Pricing and Reimbursement for Esbriet
InterMune also reported that health authorities of the Pharmaceutical Pricing
Board of Finland (HILA) have agreed to pricing and reimbursement for Esbriet
in that country, effective June 1, 2013. Esbriet will be reimbursed for IPF
patients whose predicted FVC is between 50 percent and 80 percent at the
initiation of therapy.

The pharmacy purchase price of Esbriet in Finland will be equivalent to
approximately €26,900 per patient, per year, while the net ex-factory price
realized by InterMune will be approximately €26,000, or about $33,900 per
patient, per year at current exchange rates.

An estimated 500 to 800 patients are estimated to be living with mild to
moderate IPF in Finland.

About Esbriet^® (pirfenidone)
Esbriet (pirfenidone) is a novel anti-fibrotic agent, proven to slow disease
progression in patients with IPF. The efficacy and safety of pirfenidone in
IPF are particularly well characterized based on three large, Phase 3 trials,
with efficacy results out to 1.5 years and two ongoing extension studies that
provide safety data for up to eight years. In clinical studies, Esbriet
reduced the rate of disease progression by approximately 30 percent,
comparable to or exceeding the effectiveness of treatments for similarly
lethal diseases, such as lung cancer. Esbriet is an orally active drug that
inhibits the synthesis of TGF-beta, a chemical mediator that controls many
cell functions including proliferation and differentiation, and plays a key
role in fibrosis. Esbriet's primary anti-fibrotic activity is supplemented by
additional anti-inflammatory properties.

About IPF
Idiopathic pulmonary fibrosis (IPF) is a progressive, irreversible,
unpredictable and ultimately fatal disease characterized by scarring
(fibrosis) in the lungs. IPF inevitably leads to worsening lung function and
exercise tolerance, and shortness of breath. Every IPF patient follows a
different and unpredictable course and it is not possible to predict if a
patient will progress slowly or rapidly, or when the rate of decline may
change. Periods of transient clinical stability in IPF, should they occur,
inevitably give way to continued disease progression. The median survival
time from diagnosis is two to five years, with a five-year survival rate of
approximately 20-40 percent, which makes IPF more rapidly lethal than many
cancers, including breast, ovarian and colorectal. IPF typically occurs in
patients over the age of 50, and is more common in men than in women.

About InterMune
InterMune is a biotechnology company focused on the research, development and
commercialization of innovative therapies in pulmonology and orphanfibrotic
diseases. In pulmonology, InterMune is focused on therapies for the treatment
of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease.
Pirfenidone, the only medicine approved for IPF anywhere in the world, is
approved for marketing by InterMune in the EU and Canada as Esbriet^® and is
currently in a Phase 3 clinical trial in the United States. Pirfenidone is
also approved in multiple countries in Asia and Latin America. InterMune's
research programs are focused on the discovery of targeted, small-molecule
therapeutics and biomarkers to treat and monitor serious pulmonary and
fibrotic diseases. 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 InterMune's expectation regarding
anticipated timing of the publication of NICE's final guidance to the NHS and
related timing for implementation, the percentage of IPF patients for whom
treatment with pirfenidone could be discontinued, and the timing of
InterMune's initiation of a commercial launch in England and Wales. 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.

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
Securities and Exchange Commission (SEC) on March 1, 2013 (the "Form 10-K")
and other periodic reports filed with the SEC, including but not limited to
the following: (i) the risks related to the uncertain, lengthy and expensive
clinical development process for the company's product candidates, including
having no unexpected safety, toxicology, clinical or other issues and having
no unexpected clinical trial results such as unexpected new clinical data and
unexpected additional analysis of existing clinical data; (ii) risks related
to unexpected regulatory actions or delays or government regulation generally;
(iii) risks related to our ability to successfully launch and commercialize
Esbriet in Europe, including successfully establishing a commercial operation
in Europe; and (iv) InterMune's ability to obtain or maintain patent or other
proprietary intellectual property protections. 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.

Esbriet^® is a registered trademark of InterMune, Inc.

SOURCE InterMune, Inc.

Website: http://www.intermune.com
Contact: Jim Goff, InterMune, Inc., 415-466-2228, jgoff@intermune.com
 
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