Nektar stands to earn $610 million in development, regulatory, and sales milestones.

Nektar Therapeutics will pocket $125 million up front as part of an exclusive licensing agreement with AstraZeneca for the worldwide development and commercialization of two of Nektar’s opioid therapy-related drug programs. The agreement has a potential value of $610 million in success-based fees.

The first candidate, NKTR-118, is designed to help treat opioid-related constipation and has completed Phase II trials. The drug combines Nektar’s small molecule polymer conjugate technology platform with naloxol, a derivative of the opioid-antagonist, naloxone. Nektar claims its advanced polymer conjugate technology increases the bioavailability and half-life of naloxol, enabling NKTR-118 to act selectively in the periphery, while preserving centrally mediated opioid-analgesic clinical benefits.

The second program licensed by AstraZeneca is NKTR-119, an early-stage drug development program that combines oral NKTR-118 with opioid drugs, for use in the treatment of pain without the constipation-related side effects normally associated with opioid-based therapies.

Under terms of the deal, AstraZeneca will be responsible for all development and commercialization activities for both drugs, including global manufacturing and marketing. The companies said that AstraZeneca expects to complete design of the Phase III NKTR-118 program in the near future and anticipates regulatory filing in 2013. The deal could be worth another $235 million to Nektar in regulatory milestones, plus $375 million in sales milestones, and additional double-digit royalty payments on net sales of NKTR-118.

Commenting on the agreement, Howard W. Robin, Nektar’s president and CEO, says that AstraZeneca represents “the ideal development and commercialization partner” for NKTR-118 and NKTR-119. “In addition to the promise that these potential products provide to patients, this partnership validates Nektar’s successful strategy to create novel oral small molecule drug candidates with our polymer conjugate technology platform.” 

Nektar is exploiting its polymer conjugation technologies for the development of products in a range of therapeutic fields, both in-house and in partnership with major biotech and pharma companies. The deal with AstraZeneca comes just a few days after Nektar reported topline data from a Phase II study with NKTR-118, which met the primary endpoint of increasing spontaneous bowel movements (compared with baseline) in patients with opioid-induced constipation while maintaining its analgesic effects.

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