J&J hands off non-opioid painkiller to an upstart in the race for next-gen analgesics
Still facing billions in potential liability for its alleged role in the opioid epidemic, J&J announced a global out-licensing deal for one of its non-opioid painkiller candidates and a suite of backup compounds.
The NJ-based giant signed the deal with the Palo Alto biotech upstart Neumentum. No figures were given.
The drug, JNJ-10450232, is an oral non-opioid analgesic that recently saw mixed results from a Phase IIa clinical trial on dental patients. That trial tested two doses of the drug against acetaminophen and a placebo on 269 patients suffering tooth removal pain. The higher dose performed comparably, if slightly worse than acetaminophen.
The news came a day after Oklahoma announced it was appealing a federal judge’s August ruling in its lawsuit against J&J. The judge ordered J&J to pay $572 million, a large number on its face but a small fraction of the $17 billion Oklahoma sought, citing the cost of addiction treatment, drug courts and other services over the next 20 years.
J&J also settled earlier this month with two Ohio counties for $20.4 million.
J&J noted in both cases they accounted for only 1% of all opioid sales, but the Oklahoma attorney general’s office argued that in addition to the sales of its branded drugs, J&J persuaded doctors to prescribe opioids in volume and delivered the raw material to many of the larger players in the crisis, including Purdue Pharma, refining poppy seeds from a contracted producer in Tasmania and ultimately supplying 60% of the opiate ingredients used to create drugs like Oxycodone.
The deal is an example of how quickly a full slate of biopharmas is trying to produce replacements for opioids – and the hurdles they’ve faced in that effort.
In April, Eli Lilly and Pfizer revealed mixed results from a Phase III trial on tanezumab, a new painkiller targeting nerve growth factor, that also showed safety issues. A month later, they licensed a non-opioid from Centrexion for $47 million upfront and $950 million in potential milestones and royalties.
In March, J&J partner Pacira acquired MyoScience to add their pain-mitigating ioveraaº system to its flagship Exparel treatment. They were acting in advance of an expected FDA approval for Heron Therapeutics’ non-opioid painkiller (the FDA ultimately rejected it over manufacturing concerns, but that’s expected to only be a temporary setback).
Last December, SpecGX – the Mallinckrodt generics subsidiary that held a large chunk of the opioid market at the epidemic’s height (as measured by total pills) – saw its “abuse-deterrent” opioid rejected by the FDA.