Nektar Therapeutics announced the formation of Inheris Biopharma, a wholly-owned subsidiary of Nektar and a CNS-focused company. Inheris will be responsible for launch preparation and commercialization for NKTR-181, a novel, first-in-class, investigational opioid molecule. NKTR-181 is currently under review with the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target action date of August 29, 2019. Inheris will also lead development of several Nektar preclinical CNS assets.
Nektar also announced that Inheris has appointed Jay Galeota as President & Chief Executive Officer, Dr. Joe Stauffer as Chief Medical Officer and George Shiebler as Senior Vice President & General Counsel. The new company will be headquartered in northern New Jersey.
"We're excited to announce the formation of Inheris and the appointments of Jay, Joe and George, who we believe have the experience and track record to successfully launch and bring a novel, first-in-class medicine like NKTR-181 to patients," said Howard W. Robin, President and CEO of Nektar. "Inheris will lead all of the preparations for the potential commercialization of NKTR-181, as well as development of other CNS programs, enabling Nektar to remain focused on advancing our immuno-oncology and immunology development pipeline."
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
Jay Galeota brings to Inheris more than three decades of industry experience, including a 28-year tenure at Merck & Co., where he held several leadership roles including Chief Strategy & Business Development Officer and President of Emerging Businesses. Prior to that, Galeota was President of Hospital and Specialty Care at Merck. He most recently served as President of G&W Laboratories, a fully-integrated specialty pharmaceutical company, overseeing all business operations including research and development, commercial, manufacturing, business development and supply chain. Galeota holds a B.S. in Biology from Villanova University and is a graduate of Harvard Business School's Advanced Management Program.
"I'm pleased to take the helm at Inheris," said Jay Galeota, President and Chief Executive Officer of Inheris. "Launching a new company focused on bringing important CNS-focused innovations to patients in areas of high unmet medical need is a unique opportunity. I look forward to working with Joe and George as we continue to build out the Inheris team and prepare for the anticipated approval of NKTR-181. The potential for a novel advance in the treatment of chronic pain is particularly important right now given the opioid abuse crisis in our country."
Dr. Joe Stauffer has more than 25 years of combined clinical practice and clinical research experience. He completed his anesthesiology residency at the Johns Hopkins University Hospital and maintained an appointment as adjunct assistant professor in the Department of Anesthesiology & Critical Care Medicine through 2016. Before beginning his industry career, Dr. Stauffer served 10 years as a medical officer in the U.S. Navy, followed by an appointment as a medical review officer at the FDA. Prior to joining Inheris, he served as Principal and Founder of Alta Life Sciences, a pharmaceutical consulting firm. Since 2004, Dr. Stauffer has served as Chief Medical Officer at public and private companies, including: Ikaria, Alpharma, and Cara Therapeutics. He received his medical degree from the Philadelphia College of Osteopathic Medicine and his MBA from a joint program (TRIUM) between New York University, London School of Economics, and Hautes Etudes Commerciales School of Management in Paris.
George Shiebler has over 30 years of corporate counsel experience, and most recently served as General Counsel and Chief of Staff for G&W Laboratories. Prior to his work at G&W Laboratories, George spent 23 years at Merck & Co, where he served as Vice President and Assistant General Counsel. While at Merck, he led numerous significant deals, including Merck's acquisition of Schering Plough. Shiebler has significant experience in the structuring and negotiation of complex business transactions and has a deep expertise in pharmaceutical industry regulation. He holds a J.D. from the University of Georgia School of Law, where he was a member of the Law Review, and a B.S. in Finance and Management Information Systems from the University of Virginia.