- Nektar Therapeutics on Wednesday launched a wholly owned subsidiary tasked with selling its experimental opioid for chronic low back pain, a move the company says is aimed at keeping Nektar focused on the oncology research for which it is better known.
- A decision from the Food and Drug Administration on approval of the opioid, known as NKTR-181, could come by late August. Nektar designed the drug to have limited permeability across the blood-brain barrier in hopes of reducing its abuse potential.
- If approved, NKTR-181 would be commercialized by Nektar's new subsidiary, dubbed Inheris Biopharma. Nektar previously indicated it would create a company to house NKTR-181, and has said it hopes to secure funding for "one or more potential capital partners" to help support a launch.
Launching an opioid drug for pain amid a national crisis of opioid abuse presents a significant commercial challenge. Nektar, which has partnered with Bristol-Myers Squibb and Pfizer in cancer, appears to think its a task best suited for a more focused organization.
"We believe a launch to be done efficiently with a specialized medical liaison team and a small sales force," said Nektar CEO Howard Rubin on a recent earnings call.
Nektar doesn't appear to have secured the support of any partners to fund Inheris, an objective Rubin has previously laid out.
"We are seeking equity partners for this," Rubin said in May. "We expect to have capital coming in to fund the subsidiary that we have created."
Inheris will be led by Jay Galeota, a long-time employee at Merck & Co. and most recently the president of G&W Laboratories. The company will be headquartered in New Jersey.
An approval decision from the FDA on NKTR-181 was originally set for May, but the agency extended its review by three months to examine two preclinical abuse liability studies Nektar submitted in January. The new action date is August 29.
Nektar expects the FDA to convene an advisory committee meeting to discuss NKTR-181's risk/benefit profile, but no date has been scheduled.
While Nektar has set out to prove the abuse potential of NKTR-181 is low, its safety will be a likely focus given ongoing concerns over opioids as well as criticism the FDA received for recently approving an extremely potent synthetic opioid called Dsuvia (sufentanil).
Nektar says NKTR-181's design weakens the dopamine release behind the euphoira opioid users can experience. Data from a human abuse potential study showed NKTR-181 to have lower drug liking scores than oxycodone, although the treatment rated higher than placebo.
"This is not your average opioid, it's a very different molecule," said Rubin on the May conference call.
Shares in Nektar rose by nearly 2% Friday morning on the news.