NKTR-181 is currently under review with the FDA, with a Prescription Drug User Fee Act (PDUFA) target action expected in August 2019.
Nektar Therapeutics today announced the formation of Inheris Biopharma, Inc. A CNS-focused company, Inheris is a wholly-owned subsidiary of Nektar.1
Inheris will be responsible for launch preparation and commercialization for NKTR-181, a novel, first-in-class, investigational opioid molecule.1 Indicated for the treatment of moderate to severe chronic low back pain, the drug is designed to provide potent pain relief without high levels of euphoria that can lead to abuse and addiction.2
“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," said Jay Galeota, the new company’s President and Chief Executive Officer, in a prepared statement1.
NKTR-181 is currently under review with the FDA, with Prescription Drug User Fee Act target action expected in August 2019.1
"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," said Howard W. Robin, President and CEO of Nektar, in a prepared statement.1
In addition to Galeota’s appointment, Nektar announced Dr Joe Stauffer as Chief Medical Officer of Inheris, and George Shiebler as the new company’s Senior Vice President & General Counsel. Inheris will be headquartered in northern New Jersey.1