After whipping up some upbeat analyst assessments in March with a positive late-stage efficacy study for their mu-opioid pain therapy NKTR-181, Nektar Therapeutics has now put the finishing touches to its deal package on the drug with more Phase III data to position this as a first-of-its-kind opioid that addicts can’t abuse, no matter what they do to it, while effectively combating pain.
With a big focus on oncology, Nektar $NKTR has made it clear that they don’t plan to handle this solo, looking to either licensing it out completely or working on a co-marketing pact. But CEO Howard Robin clearly wants to do this on the basis that NKTR-181 is the solution to the opioid crisis that has been grabbing headlines from coast-to-coast.
And that calls for a blockbuster deal, to hear him tell it.
“We’re going to be fairly soon taking all of our data to the FDA,” Robin tells me. “We have fast track status and there’s certainly a great desire at the agency to see our results. The regulatory authorities understand that this is potentially a solution to the opioid abuse in our country. No other molecule like this is available.”
In March the news from Nektar was that NKTR-181 beat out a placebo in reducing pain. The comparison data weren’t stellar, but it was significant. Today, Nektar wants you to know that a wide range of comparisons on likability with a range of doses in a head-to-head with oxy demonstrated that there was a consistent and significantly lower attachment to their opioid. Again, the data points didn’t hit the ball out of the park, but they came in positive — with the exception of one comparison with a 40 mg dose of oxy.
Study the endpoints, says Robin, and it’s clear that this drug takes much longer than marketed opioids to take effect. So there’s no immediate rush that addicts are looking for.
“If someone wants to abuse a drug,” he says, “they don’t want to wait 3 hours to get there. They want that 10-minute rush.”
That’s something a major marketing group could do well with in the ongoing crisis environment.
“First, you know this is pretty much a primary care market,” says Robin, and Nektar’s not in a position to market to a large primary care audience. We’re an R&D company at this stage, looking for a partner who can do this. While it is an opioid, it’s novel and different.” A deal “could range from a pure out-licensing agreement with a very significant upfront and very significant back end, or a joint venture and we keep our hand in sales and marketing.”
“This is not a formulation or a coating,” adds the CEO. “It’s taken as a tablet or liquid with the exact same effect. There’s really no way to alter its properties. Apply any chemistry you like. You can make it ineffective but you can’t separate the opioid from the overall molecule. No euphoria is associated with 181. Chop it up. Dice it up. Turn it into a liquid. Inject it… It’s a new opioid molecule that is highly efficacious and just not likeable. For me it is a major breakthrough; a critical step.”
Remarkably, ‘181 failed a Phase II study in 2013. But Jefferies’ David Steinberg noted after the efficacy data came out in March that this one was back from the dead. This pain therapy could be particularly effective dealing with chronic pain, especially lower back pain. He noted:
As such, peak sales could be in the $1B+ range and possibly much higher. Our new model assumes NDA submission in late 2019, launch in 2H20 and 30% royalty (similar to Amikacin Inhale) with a significant upfront and milestones in excess of $200M.
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