InterMune Announces Senior Leadership Appointments to Prepare for Launch of Esbriet(TM) (Pirfenidone) in EuropeBy Intermune Inc., PRNE
Thursday, December 16, 2010
BRISBANE, California, December 17, 2010 - — Conference call and webcast today at 8:30 a.m. EST to discuss positive
CHMP opinion –
InterMune, Inc. (Nasdaq: ITMN) today announced additions to its senior
leadership team to prepare for the commercialization of Esbriet(TM)
(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(R) (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(R) (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 +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
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
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(R) 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(TM) (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
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.
Jim Goff of InterMune, Inc., +1-415-466-2228, jgoff at intermune.com
Tags: Brisbane, california, December 17, Intermune Inc., Western Europe