InterMune's MAA for Esbriet receives positive CHMP opinion

InterMune, Inc. today announced additions to its senior leadership team to prepare for the commercialization of Esbriet™ (pirfenidone) in Europe. InterMune's Marketing Authorization Application (MAA) for Esbriet received a positive CHMP opinion that is now awaiting ratification by the European Commission.

Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We are very pleased by the high quality of candidates who are interested in joining our European organization which will be headquartered in Basel, Switzerland.  The individuals announced today are very accomplished and seasoned pharmaceutical executives who will be the part of our team that will prepare our organization to successfully launch Esbriet in Europe.  We will continue to move quickly to prepare to launch the first approved therapy in Europe in adults for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF)."

  • InterMune also announced that the headquarters of its European operations will be Basel, Switzerland and that the company has now established subsidiaries in Germany, Italy and the United Kingdom that are licensed to conduct business and is in the process of finalizing the establishment of subsidiaries in France and Spain.  InterMune plans to have a focused organization in Europe of approximately 125 full-time personnel by the end of 2012, supported by expert consultants and third-party service providers.  Active recruitment is now underway for the countries that will first launch Esbriet, Germany and France, and InterMune expects to begin to recruit additional personnel starting in January 2011 for the Top 10 EU countries.  Additional hiring will continue in a rolling fashion based on the timing of reimbursement and pricing reviews in those countries.

    Comments

    The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
    Post a new comment
    Post

    While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

    Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

    Please do not ask questions that use sensitive or confidential information.

    Read the full Terms & Conditions.