Navigation Links
InterMune Announces Senior Leadership Appointments to Prepare for Launch of Esbriet™ (Pirfenidone) in Europe
Date:12/17/2010

BRISBANE, Calif., Dec. 17, 2010 /PRNewswire-FirstCall/ -- 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.

About InterMune

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.

Forward-Looking Statements

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.


'/>"/>
SOURCE InterMune, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. InterMune to Release Third Quarter Financial Results on October 28
2. InterMune Sells Danoprevir Rights to Roche for $175 Million
3. InterMune to Present at 2010 Citi Health Care Conference
4. InterMune Receives FDA Complete Response Letter on Esbriet(TM) (Pirfenidone) New Drug Application
5. InterMune to Release First Quarter Financial Results on April 29
6. InterMune Announces Submission of MAA for Pirfenidone for the Treatment of Patients With IPF
7. InterMune Announces Proposed Public Offering of Common Stock
8. InterMune to Release Third Quarter Financial Results on November 5
9. InterMune Announces Collaboration With National Jewish Health on NIH-Supported Genetic Research in Idiopathic Pulmonary Fibrosis
10. InterMune to Present at Canaccord Adams Conference
11. InterMune Reports Second Quarter 2009 Financial Results and Business Highlights
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ... June 23, 2016 , ... STACS DNA Inc., the ... at the Arkansas State Crime Laboratory, has joined STACS DNA as a Field Application ... team,” said Jocelyn Tremblay, President and COO of STACS DNA. “In further expanding our ...
(Date:6/23/2016)... , June 23, 2016 Apellis Pharmaceuticals, ... 1 clinical trials of its complement C3 inhibitor, ... and multiple ascending dose studies designed to assess ... of subcutaneous injection in healthy adult volunteers. ... either as a single dose (ranging from 45 ...
(Date:6/23/2016)... , June 23, 2016 ... Review, 2016;12(1):22-8 http://doi.org/10.17925/OHR.2016.12.01.22 Published ... the peer-reviewed journal from touchONCOLOGY, Andrew D ... cost of cancer care is placing an increasing ... of expensive biologic therapies. With the patents on ...
(Date:6/23/2016)... ... 23, 2016 , ... ClinCapture, the only free validated electronic ... showcase its product’s latest features from June 26 to June 30, 2016 for ... Disrupting Clinical Trials in The Cloud during the conference. DIA (Drug Information ...
Breaking Biology Technology:
(Date:6/3/2016)... 3, 2016 Das ... Nepal hat ein 44 ... geprägter Kennzeichen, einschließlich Personalisierung, Registrierung und IT-Infrastruktur, ... Produktion und Implementierung von Identitätsmanagementlösungen. Zahlreiche renommierte ... Januar teilgenommen, aber Decatur wurde als konformste ...
(Date:6/2/2016)... Perimeter Surveillance & Detection Systems, Biometrics & ... & Other Service  The latest report from ... of the global Border Security market . Visiongain ... billion in 2016. Now: In November 2015 ... and hardware technologies for advanced video surveillance. ...
(Date:5/20/2016)... May 20, 2016  VoiceIt is excited to ... VoicePass. By working together, VoiceIt and ... VoiceIt and VoicePass take slightly different approaches to ... both security and usability. ... this new partnership. "This marketing and ...
Breaking Biology News(10 mins):