Nov. 5, 2009 (PR Newswire) -- BRISBANE, Calif., Nov. 5 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced additions to its senior leadership team to prepare for the potential commercialization of pirfenidone in the United States and Europe.
The company announced yesterday that it had submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of IPF. The company expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) in the first quarter of 2010. Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "Today's announcement underscores our commitment to be prepared to bring pirfenidone to patients, should our NDA and/or MAA be granted approval by the regulatory authorities in the United States and Europe, respectively. We are very pleased to have recruited such a high quality team of senior level commercial professionals. Further expansion of our commercial infrastructure will be driven by the outcome of key regulatory events expected in 2010."
US and EU Commercial Leadership Appointments
InterMune announced the following additions to its leadership team:
-- Vice President, Sales - Ms. Terri Shoemaker has held senior commercial
leadership positions at Du Pont Pharmaceuticals, Bristol-Myers Squibb,
Pharmion and Celgene. Most recently at Pharmion (acquired by Celgene),
Ms. Shoemaker was responsible for creating the commercial organization
and the successful launch of Vidaza®, a chemotherapeutic agent for
treating myelodysplastic syndrome and some types of leukemia. She later
was promoted to Executive Director, Strategic Commercial Operations at
Celgene.
-- Vice President, Marketing - Mr. Erik Harris has held senior positions in
marketing and sales management at Bristol-Myers Squibb, Genentech and
Elan. At Genentech, he held sales and marketing management positions,
notably as Group Brand Manager for Rituxan® and Tarceva®. Most
recently at Elan, he was a Senior Director of Marketing and Sales in
Gastroenterology prior to becoming Senior Director of Strategic Brand
Management for Gastroenterology and Neurology. Mr. Harris will assume
his responsibilities with InterMune on November 16, 2009.
-- Vice President, Managed Care and Access - Mr. Darren Cline has held
senior sales, marketing and managed care roles at Schering-Plough,
Amgen, InterMune and most recently, Alexion. At Alexion, he served as
Executive Director of Sales and played an integral role in the
successful launch of Soliris®. While at Amgen, Mr.
