Based upon positive results, Nektar Therapeutics (NKTR) expects to begin a licensing deal with a established leader in pain drugs, asserts biotech expert John McCamant, editor of The Medical Technology Stock Letter.

The SUMMIT-07 trial met its primary endpoint demonstrating highly significant improved chronic back pain relief with NKTR-181 compared to placebo.

Moreover, the safety and tolerability of ‘181 in SUMMIT supports its breakthrough profile for moderate-to-severe pain relief without the abuse and addiction that has caused the opioid epidemic of today.

With the global efforts to combine opioid abuse/dependence, Nektar expects to be able to meet with the FDA with the current study and the positive HAL trials — possibly gaining an accelerated approval path.

NKTR-181 has received Fast Track Designation from the FDA. The SUMMIT trial is yet another positive Phase III study for biotech and Nektar in particular.

The study also demonstrated that NKTR-181 had a favorable safety profile and was well tolerated. Patients reported better overall quality of sleep with less sleep problems on NKTR-181 versus placebo.

The drug has low abuse potential. NKTR-181 is the first time an opioid pain medication cannot be broken by kitchen or laboratory chemistry.

Earlier this month, results from a separate human abuse potential trial of NKTR-181 were published in the American Academy of Pain Medicine's journal of Pain Medicine. 

The opioid epidemic is global, horrific and gaining momentum. Moderate/severe pain sufferers need a holy grail that is not an opioid, and NTKR-181 fills the very valuable void.

NKTR-181 has a novel chemical structure that allows for significant pain relief that does not lead to abuse and/or addiction.

NKTR-181 is the first long-acting, selective mu-opioid agonist designed to provide potent pain relief without the inherent high levels of euphoria which lead to abuse and addiction with standard opioids. It is a breakthrough that should not be taken lightly.

In our view, the SUMMIT trial represents a best case scenario for NKTR. As a result, we are raising our buy limit from $20 to $25. Our target price is $35.

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