France's Economic Committee (CEPS) Authorizes Reimbursement of Esbriet® (pirfenidone)
PARIS, Sept. 11, 2012 /PRNewswire/ -- InterMune, Inc. (ITMN) today reported that the Comite Economique des Produits de Sante (CEPS) has granted reimbursement for Esbriet® (pirfenidone), making it the first medicine for the treatment of idiopathic pulmonary fibrosis (IPF) to be reimbursed in France. The price of Esbriet is expected to be published in France's Journal Officiel in the fourth quarter of 2012; the final step in the reimbursement process for a new medicine in France.
Professor Vincent Cottin of the National Reference Center for Rare Pulmonary Diseases said, "IPF is a devastating disease with a mortality rate similar to many cancers. Until now, French patients with IPF had no licensed therapy available to them. Esbriet is a clear step forward in the treatment of patients suffering with mild to moderate IPF as it is the first medicine to slow the progression of this disease. I am very pleased that Esbriet will soon be available in France."
The CEPS authorized an ex-factory reimbursed price of 1.923,08¬ for a four-week treatment pack of Esbriet, corresponding to 25,000¬ per patient, per year (approximately $32,000 USD at current exchange rates). Esbriet will be reimbursed by the French National Health Insurance system for the treatment of mild to moderate forms of IPF in adults.
Esbriet will be reimbursed as a "Medicament d'Exception," which means that it will be reimbursed only for the labeled indication, defined previously by the Commission de Transparence of the French High Health Authority (CT) as IPF patients with forced vital capacity (FVC) > 50% and carbon monoxide diffusing capacity (DLco) > 35%.
In agreement with CEPS, InterMune France will collect information in the form of a patient registry regarding the use of Esbriet in clinical practice.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We are very pleased to have reached an agreement with the CEPS, allowing InterMune to soon make Esbriet® available to the 6,000 to 8,000 French citizens with mild to moderate IPF. We expect to launch Esbriet in France in December, after the publication of its price in the Journal Officiel and the recruitment and training of our field-based personnel. France is the second-largest market in Europe after Germany, where Esbriet was granted final pricing in July 2012. Esbriet is currently available in seven countries and we continue to make progress toward making Esbriet available in additional countries in the EU on the timetable that we have previously announced."
Conference Call and Webcast Details
InterMune will host a live webcast of a conference call today at 8:00 a.m. EDT to discuss the pricing and reimbursement of Esbriet in France. Interested investors and others may participate in the conference call by dialing 800-891-8257 (U.S.) or +1-212-231-2939 (international), conference ID# 21604853. A replay of the webcast and teleconference will be available approximately three hours after the call.
To access the webcast, please log on to the company's website at www.intermune.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.
A telephonic replay will be available for 10 business days following the call and can be accessed by dialing 800-633-8284 (U.S.) or +1 402-977-9140 (international), and entering conference ID# 21604853. The webcast will remain available on the company's website until the next earnings call.
About Esbriet® (pirfenidone)
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.
On February 28, 2011, the European Commission granted marketing authorization for Esbriet in adults for the treatment of mild to moderate IPF. The approval authorized marketing of Esbriet in all 27 EU member states. Esbriet has since been approved for marketing in Norway and Iceland. Esbrietis commercially available in Austria, Denmark, Germany, Iceland, Luxembourg, Norway and Sweden.
InterMune is conducting a Phase 3 study, ASCEND, to support the regulatory registration of Esbriet for the treatment of IPF in the United States and expects to complete patient enrollment of the study around the end of 2012.
Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease characterized predominantly by fibrosis (scarring) in the lungs, hindering the ability for gas exchange in the lungs. IPF is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. 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. Patients diagnosed with IPF are primarily between the ages of 40 and 80, with a median age of 63 years. The disease tends to affect slightly more men than women.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. In pulmonology, the company 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. Additional information about the study is available at www.ASCENDtrial.com. 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 the statements related to the estimated size of the patient population in France suffering with mild to moderate IPF, including that France is the second largest market in Europe after Germany, the projected timing for publication of reimbursement of Esbriet in France's Journal Officiel, the role of Esbriet in the treatment of patients with IPF and our expectation regarding the timing and nature of full enrollment in the ASCEND study and the prospects of success thereof to support regulatory registration of Esbriet for the treatment of IPF in the United States. 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"), most recent quarterly report on Form 10-Q filed with the SEC on August 8, 2012 (the "Form 10-Q") 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 the regulatory process for the company's product candidates, including the possibility that the results of the new 52-week Phase 3 clinical trial (ASCEND) having an FVC endpoint may not be satisfactory to the FDA for InterMune to receive regulatory approval for pirfenidone in the United States; (iii) risks related to unexpected regulatory actions or delays or government regulation generally; and (iv) risks related to our ability to successfully commercialize Esbriet in the EU. 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, Form 10-Q and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at www.intermune.com.
SOURCE InterMune, Inc.