Idiopathic pulmonary fibrosis (IPF) is a serious condition that has no cure. Many people live only about three to five years after diagnosis. The most common cause of death related to IPF is respiratory failure. However, the European Union (EU) has renewed the fight against IPF by clearing the first medicine to treat this condition to patients. The drug is named Esbriet. The approval authorizes marketing of Esbriet (pirfenidone) in all 27 EU member states, and marks 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.

Dan Welch, Chairman, Chief Executive Officer and President of InterMune, Esbriet manufacturer said:

“InterMune is proud to bring the first IPF medicine, Esbriet, to patients in Europe. 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.”

Here is who will get this new prescription first: Germany in September of 2011, France, Spain and Italy in the first half of 2012, 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 the middle of 2012.

IPF is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen and causing shortness of breath (dyspnea) and cough and 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%. Patients diagnosed with IPF are usually between the ages of 40 and 70, with a median age of 63 years and the disease tends to affect slightly more men than women.

Roland du Bois, M.D., Professor of Respiratory Medicine, Imperial College, London continues:

“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 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.

Pirfenidone has also been granted Orphan Drug designation in the United States, which is expected to provide seven years of marketing exclusivity following approval. 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 as well.

Source: InterMune News Release

Written by Sy Kraft, B.A.