Collegium Pharmaceutical Expands its Management Team to Support Continued Development of DETERx® Tamper-Resistant, Extended-Release Opioid Program
<0> Collegium Pharmaceutical, Inc.Michael Heffernan, 401-762-2000, x220President </0>
Collegium Pharmaceutical, Inc., a specialty pharmaceutical company focused on the development of innovative treatments for chronic pain, is pleased to announce the addition of three key members to its management team. Ernest A. Kopecky, PhD, MBA has joined the Company and will lead the clinical development team as Vice President, Clinical Development and Head, Neuroscience Therapeutic Area. In addition, Kathleen Findlen has joined the Company as Director of Clinical Operations and Stephen Mayock will lead the analytical team as Director of Analytical Development and Quality Control.
With the addition of these three experienced leaders, the Company continues to accelerate its lead development program, COL-003, a tamper-resistant, extended-release oxycodone product utilizing its proprietary DETERx®technology. The Company expects to file the NDA for COL-003 in 2013.
“I was attracted to join the Collegium team based upon the innovative concept of the DETERx® drug delivery technology. DETERx® allows for the effective delivery of opioid medications to chronic pain patients while conferring a safety and dosing flexibility advantage through the use of an innovative technology,” stated Ernest A. Kopecky, PhD, MBA.
"We are very pleased to be able to attract this high-caliber group of individuals,” stated Michael Heffernan, President and CEO of Collegium Pharmaceutical. “They bring a wealth of relevant experience, including development of tamper-resistant products for the treatment of chronic pain. I am confident that they will be instrumental in assisting us in the final stages of product development through FDA approval of COL-003.”
Dr. Ernest A. Kopecky previously held the position of Head of the Pain and Neuroscience Therapeutic Area and, subsequently, Head of the Pain Group at Endo Pharmaceuticals. Prior positions include Global Medical Director at Bayer HealthCare, Senior Clinical Scientist at Purdue Pharma and Manager of the Clinical Drug Development Unit at SCIREX. He holds the academic title of Research Fellow at the Hospital for Sick Children, Division of Clinical Pharmacology and Toxicology, Toronto, Canada. Dr. Kopecky’s other leadership roles include a seat on the IMMPACT Steering Committee, a seat on the FDA AAACTTION Executive Committee, Subteam Lead on the PhRMA Neonatal and Pediatric LDKITs, and Faculty at the Pharmaceutical Education Research Institute.
Kate has over 20 years of experience in global clinical development from Phase I through filing of new drug applications (NDA/BLA). Before joining Collegium, Kate managed U.S. clinical operations for a boutique CRO based in the UK. Prior to that, Kate served as the Executive Director of Clinical Operations at Syndax Pharmaceuticals, where she oversaw the creation of clinical product development plans for their lead oncology product, and ensured effective implementation and management of the plans. Kate has held management positions in emerging biotechnology companies at CombinatoRx, Biogen-Idec (formerly Biogen), and Antigenics, as well as in the CRO industry at Quintiles.
Steve brings over 25 years of industry experience to Collegium. Most recently he has worked as a consultant at both Genzyme and Millennium Research Laboratories. Prior to that, Steve worked at Rhone Poulenc Rorer (Sanofi), Roxane Laboratories, Geneva Pharmaceuticals (Sandoz, Inc.), Catalent Pharma Solutions, and Vertex Pharmaceuticals. Steve is a member of the Dissolution Discussion Group (DDG) and the American Association of Pharmaceutical Scientists (AAPS) where he has served as chair of the .
The DETERx drug delivery platform consists of a multi-particulate matrix formulation in a capsule. While developed primarily to provide tamper-resistant properties to protect against common methods of tampering such as chewing, crushing, snorting and extraction for IV injection, the multi-particulate design is expected to enable patients with difficulty swallowing to open the capsule and administer the contents on food or via a gastronomy tube, while maintaining the extended release properties of the product. DETERx® technology can be used with drugs that are commonly abused such as opioids and amphetamines, as well as drugs that have narrow therapeutic windows that would benefit from protection against misuse such as breaking, crushing, grinding or dissolving the product. The formulation platform is covered by U.S. and international patents and patent applications. COL-003 is the first of a number of product candidates using the DETERx® platform.
Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company focused on developing a portfolio of products that incorporate its patent protected DETERx® formulation platform for the treatment of chronic pain. The DETERx® oral drug delivery technology provides extended release delivery, unique tamper resistant properties, and flexible dose administration options. For more information, visit the Company’s website at .