BOSTON, July 17, 2013 /PRNewswire/ -- Intarcia Therapeutics, Inc. today announced the hiring of Dr. Eddie Li to the newly created position of Vice President and Global Head of Regulatory Affairs. Dr. Li brings more than 20 years of experience in regulatory affairs to Intarcia and he will be a member of the Executive team with the vital role of overseeing the advancement of ITCA 650 (continuous subcutaneous delivery of exenatide) towards successful registration in key markets around the world. ITCA 650 is the Company's lead diabetes drug candidate currently in global Phase 3 clinical trials – if approved, it will be the first and only once- or twice-yearly GLP-1 treatment for type 2 diabetes. Dr. Li will report directly to Intarcia's Chairman, President, and CEO Kurt Graves.
"In this industry, it is rare and exciting to find someone with Eddie's unique profile and global regulatory affairs background that reflect success on all sides of the table. He not only brings to Intarcia a wealth of valuable experience, knowledge, and long-standing global relationships from academia, but also from his time at the U.S. Food and Drug Administration (FDA), and most recently at two major global diabetes companies," said Mr. Graves. "We are fortunate and pleased to have someone with Dr. Li's track record join us at this critical time of opportunity for our company. I'm confident Eddie will help us significantly toward our goal of making ITCA 650 available around the world for patients with type 2 diabetes."
Prior to joining Intarcia, Dr. Li served as Vice President and Head of U.S. Regulatory Affairs at Novo Nordisk, where he was also a member of the Leadership Team of the U.S. Clinical, Medical, Regulatory and Safety Organization. Dr. Li led and managed all regulatory functions across therapeutic areas including diabetes, obesity, hemophilia, and inflammation. Prior to Novo Nordisk, Dr. Li worked with Sanofi, where he served in a variety of product/therapeutic team leadership and senior strategic advisory roles within Global Regulatory Affairs. He also held the positions of Director and Head of Regulatory Development at Johnson & Johnson/McNeil Consumer & Specialty Pharmaceuticals, Senior Manager, Worldwide Regulatory Affairs at AstraZeneca, and Senior Toxicologist at Warner-Lambert/Parke-Davis Pharmaceuticals. Dr. Li also worked as a staff reviewer at the U.S. FDA's Center for Drug Evaluation and Research (CDER) in the Division of Neuropharmacological Drug Products. Dr. Li attended Shanghai First Medical College and subsequently received a Ph.D. in Toxicology from the University of Arkansas for Medical Sciences. He also completed a postdoctoral fellowship at the Massachusetts Institute of Technology (MIT) in the Division of Toxicology.
About ITCA 650
ITCA 650 (a once- or twice-yearly continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia's proprietary technology platform involving a matchstick-size, miniature osmotic pump that is inserted subcutaneously to provide continuous and consistent drug therapy, and the company's proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for extended periods of time.
Data from Intarcia's ITCA 650 Phase 2 program have demonstrated significant and sustained reductions in HbA1c and body weight over 48 weeks of treatment with a marked reduction in the GI adverse events typically associated with the self-injection products in this class. ITCA 650 is an investigational new therapy and is not currently approved by any regulatory authority. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as twice-daily and once-weekly self-injection therapies for type 2 diabetes. Upon approval, ITCA 650 would represent the first injection-free GLP-1 therapy that can deliver a full year of treatment from a single placement. Intarcia's robust intellectual property portfolio protects ITCA 650 through 2031.
About Intarcia Therapeutics, Inc.
Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment outcomes by optimizing and improving the efficacy, continuous administration and tolerability of drug therapies. In addition, delivering medicines just once or twice yearly virtually ensures patient adherence and compliance, which is very poor in most chronic diseases. Intarcia's drug development expertise and competitive edge are demonstrated by its abilities to stabilize proteins and peptides at above-body temperature and to deliver them in a constant and consistent manner via Intarcia's proprietary technology platform. Intarcia is pursuing a Phase 3-stage development program for type 2 diabetes and has additional programs ongoing for weight regulation to control obesity. For more information on the Company, please visit www.intarcia.com.
Intarcia and its logo are registered trademarks of Intarcia Therapeutics, Inc.
SOURCE Intarcia Therapeutics, Inc.