AstraZeneca, Nektar Therapeutics sign license agreement

AstraZeneca, an international healthcare company engaged in research, development and manufacturing of prescription medicines, and Nektar Therapeutics, a biopharmaceutical company headquartered at California with research and development operations in Hyderabad, have entered into an exclusive license agreement for two drug development programmes.

These are NKTR-118, a late stage product being evaluated for treatment of opioid-induced constipation, and NKTR-119, an early stage programme intended to deliver products for treatment of pain without constipation side-effects. Both the programmes were developed by Nektar.

Under the terms of the agreement, AstraZeneca would assume the responsibility for continued development of NKTR-118 and NKTR-119 programmes including late-stage clinical studies for NKTR-118. AstraZeneca expects to complete Phase III development and file the drug with regulators in 2013. AstraZeneca would be responsible for global manufacturing and marketing for both the programmes. Nektar would receive an upfront payment of $125 million (about Rs 600 crore) for both NKTR-118 and NKTR-119.

The agreement is subject to review by the United States government under the Hart-Scott Rodino Act and would become effective after expiration or earlier termination of the waiting period. Currently, there are no oral drugs approved that are indicated to treat opioid-induced constipation.

NKTR-118 has completed Phase II clinical trial and results would be presented at a plenary session of the American College of Gastroenterology 2009 in October. For NKTR-118, Nektar is eligible to receive up to $235 million (Rs 1,128 crore) in aggregate payments upon achievement of regulatory milestones as well as additional tiered sales milestone payments of up to $375 million (about Rs 1,800 crore) if the product achieved considerable levels of commercial success. Nektar would also be eligible to receive royalty on net sales of NKTR-118 worldwide, according to a release.