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For Sale: Nektar Therapeutics (NKTR) Plans to License Hot New Opioid Drug

3/20/2017 5:54:50 AM

For Sale: Nektar Therapeutics Plans to License Hot New Opioid Drug March 20, 2017
By Mark Terry, Breaking News Staff

Nektar Therapeutics (NKTR), headquartered in San Francisco, announced positive results from its Phase III trial of NKTR-181, a first-in-class opioid analgesic.

NKTR-181 is a new chemical entity (NCE). It is the first full mu-opioid agonist that is designed to relieve pain without the euphoria associated with abuse and addiction. The U.S. Food and Drug Administration (FDA) gave the drug Fast Track designation.

The trial compared twice-daily doses of NKTR-181 tablets to placebo in more than 600 patients with moderate to severe chronic low back pain who had no previous opioid therapy. The trial met the primary efficacy endpoint of significantly improved chronic back pain relief. Secondary endpoints were also met.

“The data from this efficacy study are extremely important because they demonstrate that NKTR-181 produces strong analgesia in patients suffering from chronic pain while NKTR-181 has also demonstrated significantly lower abuse potential than oxycodone in a human abuse potential study,” said Martin Hale, a clinical investigator and medical director of Gold Coast Research, in a statement. “While standards opioid analgesics, including abuse-deterrent formulations, have been the most effective way to treat chronic pain, they are associated with serious safety concerns and many opioid-naïve patients fear taking them because of the potential for abuse and addiction. The data for NKTR-181 suggest that it is a transformational pain medicine that could fundamentally change how we treat patients with chronic pain conditions.”

In a meeting with analysts several weeks ago, Howard Robin, the company’s chief executive officer, said, “Assuming positive Phase III efficacy results from the current SUMMIT-07 trial, we plan to out-license NKTR-181 to a company that has a strong presence and long-term commitment in the pain market.”

It’s a strategy that’s worked well for the company in the past. The drug then was Movantik (naloxegol), which Nektar licensed to AstraZeneca (AZN).
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“As a new molecule, NKTR-181 has a highly differentiated profile with the potential to be one of the most important advancements in pain medicine,” Robin said in a statement. “Given the seriousness of the current opioid epidemic in the U.S. and the significant number of people battling chronic pain, we are committed to bringing this new molecule to patients and physicians as quickly as possible.”

Nektar seems much more focused on licensing NKTR-181 and using the money to concentrate on NKTR-214, a clinical biologic that it is developing for immuno-oncology. In September 2016, it signed a collaboration deal with Bristol-Myers Squibb (BMY) to evaluate how NKTR-181 works as a combination with Opdivo.

At that time, John Carroll, writing for Endpoints News, said, “This is not your average collaboration story. There are no big biobucks involved. Everybody is hanging on to their rights. No one is planning to conquer blockbuster markets quite yet. But it is the kind of 50/50 venture that Nektar likes for its first foray into the clinic. And it puts them at the same table as some of the best in the checkpoint business.”

Investors clearly liked the news of the Phase III trial. Nektar stock traded on Friday, March 17 for $15.50, but jumped to a current share price of $20.74 today.

Although it shows a lot of promise, there are questions still to be answered. David Juurlink, an expert on opioids and drug safety with the University of Toronto, who was not involved in the study, told TheStreet, “These findings are interesting but they’re also no home run. I’d be very interested to see how NKTR-181 compares in a more generalizable setting versus something other than a placebo. That should help clarify whether the compound is more of a meaningful advance or just another gimmick like tamper-resistant opioids.”

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