InterMune Announces Publication of Pricing and Reimbursement Conditions for
Esbriet® (pirfenidone) in Italy
-- First approved therapy for IPF patients in Italy will be reimbursed from
June 29 --
BRISBANE, Calif., June 14, 2013
BRISBANE, Calif., June 14, 2013 /PRNewswire/ --InterMune, Inc. (NASDAQ: ITMN)
today announced that the Board of the Italian Drug Agency (AIFA) has approved
the pricing and reimbursement conditions for Esbriet^® (pirfenidone), and that
the agreement has been published in the Official Gazette, the official journal
of the government of Italy. Esbriet is InterMune's product for the treatment
of adult patients with mild to moderate idiopathic pulmonary fibrosis (IPF).
The availability of Esbriet will mark the first time an approved therapy for
IPF has been commercially available to the approximately 6,000 to 9,000
mild-to-moderate patients estimated to be living with IPF in Italy. Esbriet
will be reimbursed beginning 15 days fromthe publication date on the Italian
Official Gazette, or June 29.
The gross ex-factory price of Esbriet in Italy will be €32,994, or
approximately $44,000 per patient, per year. In addition, pharmaceutical
products in Italy are subject to the mandatory national discount of 9.75%.
Reimbursement for Esbriet will be provided under a risk-sharing arrangement,
similar to the "Payment for Performance" system already in place for many
specialty medicines in Italy.
Prof. Alberto Pesci, Head of the Pulmonary Clinic at San Gerardo Hospital in
Monza (Milan) and Coordinator of the Interstitial Lung Diseases working group
at the Italian Society of Respiratory Medicine, said, "IPF is a devastating
disease with a mortality rate similar to many cancers and until now, no
treatment options were available. This represents a clear step forward in the
management of IPF and I wish to express, on behalf of all patients and the
Italian scientific community, my sincere appreciation for the upcoming
availability of Esbriet in our country."
Giacomo Di Nepi, Executive Vice President and Managing Director, Europe for
InterMune, said, "We are very pleased to see the publication of our pricing
and reimbursement agreement, which allows us to make Esbriet available very
soon to Italian patients with mild to moderate IPF. Our entire organization
is prepared to launch Esbriet in Italy and our Italian team is excited and
fully committed to making Esbriet available to all appropriate IPF patients as
rapidly as possible."
Publication in the Official Gazette means that Esbriet will be nationally
reimbursed beginning 15 days fromthe publication date on the Italian Official
Gazette, or June 29. This will provide access to a number of patients in
Italy; however, full access to patients will require up to three quarters, the
time that is currently needed after launch in Italy to address all regional
InterMune currently has an organization in Italy of 31 people, including 19
field-based personnel and 12 office-based personnel in the areas of
management, medical, regulatory, finance, commercial and administration.
The agreement with AIFA specifies that Esbriet may be prescribed by
pulmonologists. Esbriet will be reimbursed as a Hospital Product, Class H,
and will be distributed, similarly to other specialty products, by the
pharmacies of the hospitals designated by the Regions and Autonomous
Provinces. Patients treated with Esbriet therapy will be recorded in a
registry designed and maintained by AIFA to collect patient data and to ensure
appropriate patient selection to fit the approved label. Most medicines
marketed to specialists in Italy are monitored via a similar registry.
As previously announced, reimbursement for Esbriet will be provided under a
risk-sharing arrangement. Patients' forced vital capacity (FVC) will be
measured at six months post initiation of Esbriet therapy. Patients whose FVC
declines, in absolute terms, by 10 percent or more during the first six-month
treatment period will not be eligible for reimbursement and their cost of
therapy during their treatment period will be credited to the National Health
Care System. InterMune estimates that approximately 15 percent of patients
that initiate therapy will have such an FVC decline.
About Esbriet^® (pirfenidone)
Esbriet 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. It also inhibits the synthesis of TNF-alpha, a cytokine
that is known to have an active role in inflammation.
Idiopathic pulmonary fibrosis (IPF) is an irreversible, unpredictable and
ultimately fatal disease characterized by scarring (fibrosis) in the lungs,
hindering the ability to process oxygen. 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.
InterMune is a biotechnology company focused on the research, development and
commercialization of innovative therapies in pulmonology and fibrotic
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 worldwide for IPF, 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
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
its anticipated timing of when Esbriet will be reimbursed and commercially
available in Italy; concluding regional reimbursement procedures for Esbriet;
the estimated size of the patient population in Italy suffering from IPF; and
InterMune's expectations with respect to the percentage of patients who will
suffer a 10% or greater decline in FVC. 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) risks related to unexpected regulatory actions or delays or
government regulation generally; (ii) risks related to the company's
manufacturing strategy, which relies on third-party manufacturers and which
exposes InterMune to additional risks where it may lose potential revenue; and
(iii) government, industry and general public pricing pressures. 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, including its
Quarterly Report on Form 10-Q for the three months ended March 31, 2013, 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.
Contact: Jim Goff, InterMune, Inc., 415-466-2228, email@example.com
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