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 from the 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 from the 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 reimbursement procedures.
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 www.intermune.com.
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.