Esbriet® (pirfenidone) Receives Positive Final Appraisal Determination from NICE for Idiopathic Pulmonary Fibrosis (IPF) -- Also Announces Reimbursement of Esbriet in Finland --
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.
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.
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.
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 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 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.