With a potential approval of an opioid molecule awaiting regulatory review, Nektar Therapeuticsannounced the launch of a new subsidiary, Inheris Biopharma, Inc., which will be responsible for the launch and commercialization of the opioid.
NKTR-181 is a novel, first-in-class, investigational opioid molecule developed for the treatment of chronic low back pain in adult patients new to opioid therapy. The U.S. Food and Drug Administration has set a PDUFA date of Aug. 29. In addition to NKTR-181, Inheris will also lead the development of several Nektar preclinical CNS assets.
Nektar Chief Executive Officer Howard W. Robin said the formation of Inheris will allow the parent company to remain focused on advancing its immuno-oncology and immunology development pipeline.
The new company will be helmed by Merck veteran Jay Galeota. He will serve as president and chief executive officer. Galeota held several leadership positions at the pharma giant, including chief strategy and business development officer, as well as president of emerging business. He most recently served as President of G&W Laboratories.
“I’m pleased to take the helm at 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,” Galeota said and added the fledgling company will prepare for the anticipated launch 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.”
NKTR-181 could be a game-changing medication in the treatment of pain. Although still an opioid, NKTR-181 is a new molecular entity and it being touted as the first analgesic opioid molecule to exhibit a low incidence of specific CNS-mediated side effects, such as euphoria. When the company filed its New Drug Application with the FDA last summer, Nektar said NKTR-181 is designed to have low permeability across the blood-brain barrier, which lowers concerns of dopamine release and the associated euphoria.
Joe Stauffer, who was most recently the principal and founder of Alta Life Sciences, will serve as chief medical officer. He has held CMO roles at multiple companies, including Ikaria, Alpharma and Cara Therapeutics. Another Merck veteran, George Shiebler will serve as general counsel. Shiebler most recently worked alongside Galeota at G&W as general counsel and chief of staff. Inheris will be headquartered in New Jersey, on the opposite coast from parent company Nektar.
“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,” Robin said in a statement.
