AstraZeneca and Nektar Ink Agreement for Constipation Drug

AstraZeneca and Nektar Therapeutics have entered into an exclusive worldwide license agreement for two drug development programmes: NKTR-118, a late stage investigational product that is being evaluated for the treatment of opioid-induced constipation, and the NKTR-119 program, an early stage program that is intended to deliver products for the treatment of pain without constipation side effects.

Both programmes were developed by the latter, utilizing their proprietary small molecule advanced polymer conjugate technology platform. Under the terms of the agreement, the former will assume the responsibility for the continued development of both the NKTR-118 and NKTR-119 programmes, including the initiation of late-stage clinical studies for NKTR-118.

AstraZeneca expects completion of the design of the phase III program in the near term, and anticipates filing the drug with regulators in 2013. It will also be responsible for global manufacturing and marketing for both programs. Under the agreement, Nektar will receive an upfront payment of US$125 million for both NKTR-118 and NKTR-119.

NKTR-118 has completed a Phase 2 clinical trial and is being developed to treat constipation caused by the use of opioid pain products. Under the agreement, for NKTR-118, Nektar is eligible to receive up to US$235 million in aggregate payments upon the achievement of certain regulatory milestones, as well as additional tiered sales milestone payments of up to US$375 million if the product achieves considerable levels of commercial success. The company will also be eligible to receive significant double-digit royalty payments on net sales of the drug worldwide.

NKTR-119 is an early stage drug development program that is intended to combine oral NKTR-118 with selected opioids, with the goal of treating pain without the side effect of constipation, that is traditionally associated with opioid therapy. AstraZeneca will continue the development of this programme, including determining the appropriate opioid combinations with NKTR-118. For NKTR-119, Nektar would receive development milestone payments as well as tiered sales milestone payments. The company will also receive significant double-digit royalty payments on NKTR-119 net sales worldwide.

The agreement is subject to review by the US government under the Hart-Scott Rodino Act and becomes effective after the expiration or earlier termination of the waiting period (or any extension thereof).