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AstraZeneca: EMA Accepts Marketing Authorisation Application For Naloxegol

27th Sep 2013 06:50

LONDON (Alliance News) - AstraZeneca PLC(AZN.L, AZN), Friday said its investigational peripherally-acting mu-opioid receptor antagonist, naloxegol's Marketing Authorisation Application has been accepted by the European Medicines Agency. Naloxegol is designed to treat opioid-induced constipation for adults, including patients with inadequate response to laxatives.

The application was based on data from the Phase III KODIAC programme, designed to study the safety and efficacy of naloxegol.

Naloxegol is covered by the exclusive worldwide license agreement announced on September 21 2009 between AstraZeneca and Nektar Therapeutics. Pursutn to the terms of the recently amended license agreement, AstraZeneca will make a $25 million milestone payment to Nektar within five business days of acceptance of the application by the European Medicines Agency.

Copyright RTT News/dpa-AFX


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