InterMune, Inc. 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, MD, Professor of Respiratory Medicine, Imperial College, London, and co-chair of the Esbriet phase III clinical programme, 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.”
Esbriet is indicated in adults for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF).
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 US. As in Europe, the company has implemented an extensive patent program in the US concerning the safe and appropriate use of Esbriet and its formulation.
To date, six patents have been granted in the US assuming that the approved US 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 US to 2030. A number of additional patents are currently under review by the US Patent and Trademark Office.
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.
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 US Food and Drug Administration for this use.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology.