InterMune, Inc. 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 (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.
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, MD, Professor of Respiratory Medicine, National Heart & Lung Institute, Imperial College, London, and co-chair of the Capacity phase III 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 US 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 US and Europe to at least 2026 or 2030.
InterMune submitted a Marketing Authorization Application (MAA) seeking approval of Esbriet for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults, which was validated by the EMA effective March 24, 2010.
Preclinical and in-vitro evidence has shown that Esbriet has both anti-fibrotic and anti-inflammatory effects. In February 2009, InterMune announced the results of the company's two pivotal phase III clinical trials evaluating Esbriet for the treatment of IPF, known as the Capacity trials. In clinical studies, Esbriet was safe and generally well-tolerated with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms. Since 2008, pirfenidone has been marketed in Japan as Pirespa by Shionogi & Co. Ltd.
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 IPF and Hepatitis C Virus (HCV) infections.