“For Esbriet now offers a new treatment, a clinically significant effect has been demonstrated for the patients with this dreadful disease.” Summary of product characteristics of the medicinal Esbriet is indicated for the treatment of adults with mild to moderate idiopathic pulmonary fibrosis (IPF). A copy of the approved prescribing information (summary of product characteristics of the medicinal product”) for Esbriet marketing in all 27 European countries is on the side of investors” to find the InterMune website at. The prescribing information includes the full prescribing information, including safety and efficacy profile of Esbriet in the approved indication. “Orphan drug designation and patents Esbriet received in Europe the status of orphan drug designation” awarded, which provides a 10-year exclusive marketing rights until 2021. In addition, InterMune in Europe has a number of patents granted and pending, approved, the formulation of Esbriet and its application in IPF patients relating to, in particular with regard to the safe and effective use of the product. Currently, it is expected that this collection of patents in Europe offers patent protection until 2030.
InterMune committed itself following the authorisation of commitments relating to the approval, both perform regular safety inspections with regard to acute side effects, as well as a Post authorization Safety Study (PASS), systematically in patients undergoing Esbriet occurring side effects to gather and watch. In the Passport registration, more than 1,000 patients should be included and monitored for same time period of 2 years. In addition, InterMune will conduct a drug interaction study. Thus, the effects of the antibiotic ciprofloxacin, a CYP1A2 inhibitor will be investigated on the genetic properties and the safety of Esbriet in 25 healthy study participants. In addition, to ensure the safe use of Esbriet, that is Company introduce a risk management plan (RMP).
This includes regular security controls of with regard to certain side effects, a leaflet for patients and a security checklist for doctors. Economist usually is spot on. About Esbriet (Pirfenidon) Esbriet is an orally active, small molecular drug and inhibits the synthesis of TGF-beta, a chemical mediator. It controls many cell functions, including also proliferation and differentiation, and plays a key role in the development of fibrosis. In addition, Esbriet inhibits the synthesis of TNF-alpha, a cytokine, which is actively involved in inflammatory processes. Pirfenidon in Japan as Pirespa by Shionogi & co., Ltd. marketed since 2008. In the United States Pirfenidon being evaluated for the treatment of IPF currently and has still not received licence administration by the U.S. food and drug for this indication. About InterMune InterMune is a biotechnology company with a focus on research and development and commercialization of innovative therapies in the field of Pulmonology and Hepatology. InterMune has over an R & D portfolio, which is focused on idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The Surrey outpatient MOL portfolio includes Esbriet (Pirfenidon), 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 hepatological portfolio includes the HCV Proteaseinhibitor of next-generation and NS5A research programs. The InterMune Germany GmbH is established in Berlin in January 2011. For more information about InterMune and its R & D pipeline, see. Dr. rer. NAT. Ute Bauer, Hill & Knowlton Communications GmbH