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AstraZeneca Announces Top-line Phase III Results from Naloxegol Pivotal Trials In Patients With Opioid-Induced Constipation
Date:11/12/2012

sis. All three trials were conducted in patients with non-cancer pain and documented OIC, who require daily opioid therapy.

Enrolment is complete for the open-label, randomized, 52-week long-term safety trial (KODIAC-08) and the trial is expected to be completed by Q1 2013.

Naloxegol is currently considered a Schedule II controlled substance by the US Drug Enforcement Administration (DEA) based on structural relatedness to noroxymorphone. AstraZeneca has conducted the studies necessary to evaluate the abuse potential and dependence-producing properties of naloxegol in support of obtaining decontrol. A petition for the decontrol of naloxegol was submitted to the DEA in March 2012 and subsequently accepted for review. Commercialisation and launch in the US will be subject to both FDA approval and DEA schedule determination.

Nektar to Host Conference Call with Investors and AnalystsNektar Therapeutics (Nasdaq: NKTR) will host an investor and analyst conference call today to discuss these results.  The call will begin at 8:15 a.m. Eastern Standard Time (EST)/5:15 a.m. Pacific Standard Time (PST).
A link to the live conference call webcast is accessible from the home page of the Nektar website: http://www.nektar.com.

To access the conference call live by telephone, please follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 70465377 (Nektar Therapeutics is the host)

About Naloxegol
Naloxegol is a peripherally-acting mu-opioid receptor antagonist being investigated for the treatment of constipation (opioid-induced constipation or OIC) as a side effect of prescription opioid pain medicines.

Top-line results of the Phase II study of naloxegol (formerly NKTR-118) were previously presented at the American College of Gastroenterology Annual Clinical
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SOURCE Nektar Therapeutics
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