BRISBANE, California, December 17, 2010 /PRNewswire/ -- -- Esbriet to be the first medicine approved for IPF patients in the EU --
InterMune, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for Esbriet(TM) (pirfenidone) in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. The CHMP is the scientific body of the EMA responsible for reviewing all Marketing Authorization Applications for new medicines. A summary of the CHMP opinion will be available here: http://tinyurl.com/2am4ubc. Please select "E" to access the Esbriet summary opinion.
The committee's positive opinion will now be forwarded to the European Commission for ratification, which typically occurs within two to three months from adoption of the CHMP opinion. Ratification results in approval for marketing in all 27 member countries of the European Union.
"We are very pleased by the positive opinion adopted by the CHMP, particularly because it was achieved earlier in the regulatory process than is typical," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "We are now focusing our efforts on completing our commercial launch preparations to bring Esbriet to European patients as soon as possible."
Roland du Bois, M.D., Professor of Respiratory Medicine, National Heart & Lung Institute, Imperial College, London, and co-chair of the CAPACITY Phase 3 program, said, "IPF is among the most urgent of unmet medical needs in respiratory medicine, with no approved therapies in the EU and with survival rates as poor as many forms of cancer. Today's opinion by the CHMP represents a major milestone in the treatment of IPF and is extremely exciting news for the more than 100,000 Europeans who suffer from IPF, and for the physicians who care for them. What all patients have awaited for so long - hope and new therapy for their disease - will soon be realized."
Esbriet has been granted Orphan Drug designation in Europe, which provides 10 years of marketing exclusivity; until 2021. In addition, InterMune has a number of pending patent applications in Europe relating to Esbriet's formulation and use in IPF patients, particularly related to the safe usage of the product which, if granted, will provide patent protection in Europe for at least an additional five years, until 2026, and possibly as long as an additional nine years, until 2030. One such patent has been allowed by the European patent office which relates to the effect of food on the pharmacokinetics and safety of pirfenidone in IPF patients. The company has an extensive patent position on the Esbriet formulation and uses of Esbriet in IPF patients, and in the United States the company has already secured the grant of six new patents that extend the exclusivity period for the patented formulation and uses of pirfenidone in the U.S. to 2030. If one or more of the analogous patents are granted in Europe, the company's current expectation is that Esbriet will enjoy patent protection in both the U.S. and Europe to at least 2026 or 2030.
The company plans to hold a conference call today at 8:30 a.m. Eastern time.
Conference Call and Webcast Details
InterMune will host a conference call today at 8:30 a.m. EST to discuss Esbriet (pirfenidone) and the related Marketing Authorization Application. Interested investors and others may participate in the conference call by dialing 888-567-5125 (U.S.) or +1-706-643-9223 (international), conference ID# 33188579. 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 http://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 +1-706-645-9291 (international), and entering the conference ID# 33188579. The webcast will remain available on the company's website until the next earnings call.