Healthcare Industry News: NS5A
News Release - December 17, 2010
InterMune Announces Senior Leadership Appointments to Prepare for Launch of Esbriet (Pirfenidone) in EuropeConference call and webcast today at 8:30 a.m. EST to discuss positive CHMP opinion
BRISBANE, Calif., Dec. 17, 2010 (Healthcare Sales & Marketing Network) -- InterMune, Inc. (Nasdaq:ITMN ) 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)."
EU Leadership Appointments
InterMune announced the following additions to its leadership team:
* Senior Vice President and Managing Director, Europe – Giacomo Di Nepi. Mr. Di Nepi joined InterMune in this role in November of 2009. Before Joining InterMune he was Chief Executive Officer of Takeda Pharmaceuticals Europe, where he drove the EU operations and geographic expansion. Prior to that, Mr. Di Nepi was a member of the Executive Committee of Novartis Pharma AG as Global Head for the Transplantation and Infectious Disease business unit. He previously served as Chief Executive Officer of Novartis Italy. Before entering the pharmaceutical industry, he was a partner in the healthcare practice of McKinsey & Co. Mr. Di Nepi will be based in the European headquarters in Basel, Switzerland and has worked in Switzerland, the UK, the US and Italy. The following executives will report to Mr. Di Nepi.
* Senior Vice President, EU Medical and Global Medical Advisor – Frank T. Weber, M.D.Dr. Weber has 20 years of industry experience, having served most recently as Chief Medical Officer at Merck Serono where he played a key role in the registration and reimbursement processes in Europe for Erbitux® (cetuximab). Dr. Weber previously served in various medical affairs positions at American Cyanamid/Lederle, Sythelabo and Merck KGaA. He also worked on the national reimbursement side as Medical Director with MedNet, a Munich Re/United Health Care joint venture. Dr. Weber began his career in healthcare as a surgeon and immunologist. Dr. Weber has worked in Germany, Switzerland, France, the UK and the United States. He will be based in the European headquarters in Basel, Switzerland.
* Senior Vice President and General Manager, Germany – Markus Leyck Dieken, M.D. Dr. Dieken joins InterMune from Novartis, where he was Head of the European Region for the vaccines business and Managing Director of Novartis-Behring's German operations. Prior to Novartis, he served for 10 years with Novo Nordisk Germany in various roles in Medical Affairs, Marketing and Sales, and then as General Manager of the German subsidiary and Vice President, Central Europe. He has worked in Germany and Switzerland. Dr. Leyck Dieken will be based in Berlin, Germany.
* Vice President, Sales and Marketing, Europe – Ms. Manuela Maronati. Ms. Maronati brings 15 years of sales and marketing experience, including the past seven years with Amgen where she served as an International Senior Marketing Manager on the Neupogen® (filgrastim) franchise, and where she previously launched a new medical device for use across several Amgen products. She has worked in Switzerland, the UK and Italy. Ms. Maronati will be based in the European headquarters in Basel, Switzerland.
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.
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 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 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 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.
About Esbriet (pirfenidone)
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 3 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 idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes Esbriet™ (pirfenidone) for which InterMune has completed a Phase 3 program in patients with IPF (CAPACITY). The Marketing Authorization Application (MAA) for Esbriet received a positive CHMP opinion that is now awaiting ratification by the European Commission. The hepatology portfolio includes next-generation HCV protease inhibitor and NS5A research programs. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to the anticipated receipt of marketing authorization approval from the European Commission for the use of pirfenidone for the treatment of IPF and the expected timing thereof, statements regarding commercial launch preparations and statements regarding the various anticipated durations of patent protection and marketing exclusivity. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements.
Other factors that could cause or contribute to such differences include, but are not limited to, (i) whether the European Commission approves the marketing authorization for pirfenidone for the treatment of IPF and the actual timing of the decision; (ii) risks related to unexpected regulatory actions or delays or government regulation generally; (iii) risks related to the clinical and regulatory process for pirfenidone, including having no unexpected safety, toxicology, clinical or other issues; (iv) unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; (v) government, industry and general public pricing pressures; (vi) InterMune's ability to obtain or maintain patent or other proprietary intellectual property protections; (vii) risks related to building the infrastructure required for commercial launch in various countries in the European Union, and (viii) those other factors discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 15, 2010 (the "Form 10-K"), and other periodic reports filed with the SEC. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at www.intermune.com.
Esbriet is registered trademark of InterMune, Inc.
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