Sweden's Dental and Pharmaceutical Benefits Agency (TLV) Authorizes Reimbursement of Esbriet® (pirfenidone)
STOCKHOLM, June 28, 2012 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today reported that the Swedish Dental and Pharmaceutical Benefits Agency (TLV) has included Esbriet® (pirfenidone) on Sweden's list of reimbursed drugs, making Esbriet the first medicine for the treatment of idiopathic pulmonary fibrosis (IPF) to be reimbursed in Sweden.
Magnus Skold, Professor and Consultant at the Lung and Allergy Clinic at Karolinska University Hospital, said, "Esbriet is a clear step forward. There have been a number of unsuccessful attempts to develop a drug against this serious lung disease. Currently, there is no other approved therapy with a documented positive effect on the disease, and it is therefore highly positive that we now have the first drug that slows disease progression."
This reimbursement applies for IPF patients with predicted forced vital capacity (FVC) less than 80%. The annualized list price of Esbriet in Sweden will be SEK 264,075, corresponding to more than $37,000 per patient per year.
The large majority of mild to moderate patients have a predicted FVC below 80%. Given the progressive nature of the disease, all patients can be expected to have a predicted FVC of less than 80% during the course of their disease.
IPF is a chronic, progressive and ultimately fatal lung disease with a median survival of 2-5 years from the time of diagnosis. The prevalence of the disease is estimated at 1.67 patients per 10,000 persons in the overall population, which means that about 1,500 people suffer from IPF in Sweden today. In IPF, fibrotic tissue is continuously formed in the lungs resulting in a persistent cough, recurring lung infections and shortness of breath. The majority of IPF patients become ill in their 40s to 70s and the incidence of the disease increases with age. Also, men are affected more than women.
Daniel G. Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We welcome TLV's decision to include Esbriet on the list of reimbursed medicines in Sweden. We are pleased to offer patients a reimbursed treatment that is the first therapy shown to slow progression of this relentless and devastating disease."
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan 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 for IPF anywhere in the world, is approved for marketing by InterMune in the EU as Esbriet® and is currently in a Phase 3 clinical trial to support regulatory registration in the United States. InterMune's research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and orphan 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. 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 February 29, 2012 (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; (iii) risks related to government, industry and general public pricing pressures; (iv) risks related to our ability to successfully launch and commercialize Esbriet in the EU, including successfully establishing a commercial operation in the EU and receiving favorable governmental pricing and reimbursement approvals in each EU country; and (v) 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.
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