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AstraZeneca submits naloxegol NDA

September 18, 2013 1:01 AM UTC

Nektar Therapeutics (NASDAQ:NKTR) disclosed in an SEC filing that partner AstraZeneca plc (LSE:AZN; NYSE:AZN) submitted an NDA to FDA for naloxegol to treat opioid-induced constipation (OIC). Nektar is eligible for a $70 million milestone payment from AstraZeneca upon FDA acceptance under an amended 2009 deal that granted the pharma exclusive, worldwide rights to the product. Late last month, AstraZeneca submitted an MAA to EMA and an NDS to Health Canada for naloxegol. Nektar is eligible for a $25 million milestone payment upon EMA acceptance of the application. Naloxegol is a PEGylated form of naloxol, a peripheral mu opioid receptor ( OPRM1; MOR) antagonist. ...