InterMune Receives European Union Approval for Esbriet® (pirfenidone)

BRISBANE, Calif., March 3, 2011 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that the European Commission (EC) has granted marketing authorization for Esbriet® (pirfenidone).  Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease.  The approval authorizes marketing of Esbriet in all 27 EU member states, and marks a significant turning point for the treatment of IPF patients in Europe.  More than 100,000 patients suffer from IPF in the 10 nations that comprise the most-populated European countries; approximately 87,000 patients in the five largest countries of Germany, France, Spain, Italy and the United Kingdom.  

"InterMune is proud to bring the first IPF medicine, Esbriet, to patients in Europe," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune.  "We are very pleased with our approved label for Esbriet and believe it will effectively support the access, pricing, reimbursement and marketing of Esbriet in Europe.  The approval of Esbriet not only marks an historic moment in the treatment of IPF patients, but also an exciting new chapter for our company as we now transition to become an international commercial organization.  Our seasoned leadership team in the EU is working very diligently to make Esbriet available to European patients as soon as possible, beginning with Germany in September of this year."  

Based on anticipated EU country reimbursement timelines, InterMune currently plans to launch Esbriet in the so-called "Top 5" EU countries as follows: Germany in September of 2011; France, Spain and Italy in the first half of 2012 and in the United Kingdom in mid-2012.  InterMune also plans to launch Esbriet in all or substantially all of the 10 most important pharmaceutical markets in the EU by approximately mid-2012.  

Roland du Bois, M.D., Professor of Respiratory Medicine, Imperial College, London, and co-chair of the Esbriet Phase 3 clinical program, said, "IPF is a chronic, progressive, respiratory disease with an estimated survival rate of only 20 percent after five years, which makes it more lethal than many cancers, and yet no therapeutic interventions have been approved for European patients suffering from this devastating disease -- until today.  The approval of this new medicine for European patients is a landmark event in IPF care, as Esbriet now offers individuals suffering from this appalling disease a novel treatment that has been shown to have a clinically meaningful effect in their disease."

Summary of Product Characteristics (SmPC)

Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).  InterMune will host a conference call today at 8:30 a.m. EST to discuss European approval of Esbriet and highlights of the SmPC, or "label" for the marketing of Esbriet in all 27 countries of the EU.  The SmPC includes the full prescribing information, including the safety and efficacy profile of Esbriet in the approved indication.  A copy of the approved SmPC, as well as a slide presentation that summarizes the key points of the SmPC and will be used during the conference call, will be available at that time on the "Investors" page of InterMune's website at www.intermune.com.  

Orphan Drug Designation and Patents

Esbriet has been granted Orphan Drug designation in Europe, which provides 10 years of marketing exclusivity lasting until 2021.  In addition, InterMune has a number of granted, allowed and pending patent applications in Europe relating to Esbriet's formulation and use in IPF patients, particularly related to the safe and efficacious usage of the product.  This collection of patents is currently expected to provide patent protection in Europe until 2030. 

One such patent has been granted by the European patent office which relates to the effect of food on the pharmacokinetics and safety of pirfenidone in IPF patients.  This patent expires in late 2026.  Two additional patents have recently been allowed in Europe, one of which relates to the safe usage of Esbriet in patients who develop elevation in liver transaminase levels, which expires in late 2029, and a second relating to the titration of the dosing of Esbriet at the initiation of therapy, which expires in late 2027.  In addition, the company has three other patents under review in Europe that if granted, are currently expected to extend exclusivity until 2030.  

Pirfenidone has also been granted Orphan Drug designation in the United States, which is expected to provide seven years of marketing exclusivity following approval in the U.S.  As in Europe, the company has implemented an extensive patent program in the U.S. concerning the safe and appropriate use of Esbriet and its formulation.  To date, six patents have been granted in the U.S.  Assuming that the approved U.S. label for Esbriet is similar to the approved European label, these patents are currently expected to extend the exclusivity period for the patented formulation and uses of pirfenidone in the U.S. to 2030.  A number of additional patents are currently under review by the U.S. Patent and Trademark Office.

Post Approval Commitments    

In connection with this approval, the company committed to conduct routine safety surveillance of spontaneous adverse drug reactions (ADRs) and to conduct a PASS (Post Authorization Safety Study) in the form of a registry to systematically collect and monitor ADRs in patients who have been prescribed Esbriet.  The PASS Registry is expected to enroll 1,000 patients over two years and to follow these patients for a similar period.

InterMune also will conduct a drug-drug interaction study to determine the impact of the antibiotic ciprofloxacin, a moderate CYP1A2 inhibitor, on the pharmacokinetics and safety of Esbriet in 25 healthy subjects.

In addition, to help ensure the safe use of Esbriet, the company will implement a risk management plan (RMP) that includes routine safety monitoring of certain adverse reactions, a patient information leaflet and a safety checklist for physicians.

Conference Call and Webcast Details

InterMune will host a conference call today at 8:30 a.m. EST to discuss European approval of Esbriet.  Interested investors and others may participate in the conference call by dialing 888-567-5125 (U.S.) or 706-643-9223 (international), conference ID# 48513924.  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.

The teleconference replay will be available for 10 business days following the call and can be accessed by dialing 800-642-1687 (U.S.) or 706-645-9291 (international), and entering the conference ID# 48513924.  

About Esbriet® (pirfenidone)

Esbriet is an orally active, small molecule 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.  

Since 2008, pirfenidone has been marketed in Japan as Pirespa® by Shionogi & Co. Ltd.  Pirfenidone is still under investigation for the treatment of IPF in the United States and has not been approved by the U.S. Food and Drug Administration for this use.  

About InterMune

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology.  InterMune has an R&D portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections.  The pulmonology portfolio includes Esbriet® (pirfenidone), which is now approved in the European Union for the treatment of adults with mild to moderate IPF, a progressive and fatal lung disease.  The hepatology portfolio includes next-generation HCV protease inhibitor and NS5A research programs.  For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.

Forward-Looking Statements

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 commercial launch preparations, anticipated timing of commercial launch and statements regarding the various anticipated durations of patent protection and marketing exclusivity.  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, (i) risks related to unexpected regulatory actions or delays or government regulation generally; (ii) risks related to the clinical and regulatory process for pirfenidone, including having no unexpected safety, toxicology, clinical or other issues; (iii) unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; (iv) government, industry and general public pricing pressures; (v) InterMune's ability to obtain or maintain patent or other proprietary intellectual property protections in various countries in the European Union and elsewhere; (vi) risks related to building the infrastructure required for commercial launch in various countries in the European Union, and (vii) those other factors 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 15, 2010 (the "Form 10-K"), and other periodic reports filed with the SEC.  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.