Nektar Therapeutics (NKTR)

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6:52AM Nektar Therapeutics reported that partner AstraZeneca (AZN) announced European Medicines Agency acceptance of Marketing Authorisation Application for Naloxegol (NKTR) 10.54 : Co reported that AstraZeneca (AZN) announced that the European Medicines Agency has accepted the Marketing Authorisation Application for Naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist, which has been specifically designed for the treatment of opioid-induced constipation for adult patients 18 years and older, including patients with inadequate response to laxatives. The MAA filing was based on comprehensive data from the core Phase III KODIAC programme, comprised of four clinical trials designed to investigate the safety and efficacy of naloxegol for the treatment of OIC.

Naloxegol is part of the exclusive worldwide license agreement announced on 21 Sep 2009, between AstraZeneca and Nektar Therapeutics. Under the terms of the recently amended License Agreement, AstraZeneca will pay Nektar a $25 mln milestone within five business days of acceptance of the MAA by the EMA.