Results from Phase III Studies of Naloxegol for Treatment of Opioid-Induced Constipation Presented at Digestive Disease Week

  Results from Phase III Studies of Naloxegol for Treatment of Opioid-Induced
  Constipation Presented at Digestive Disease Week 2013

Business Wire

ORLANDO, Fla. -- May 21, 2013

AstraZeneca (NYSE: AZN) today presented the results of two pivotal Phase III
studies of naloxegol showing the 25 mg dose of the investigational drug met
its primary and secondary endpoints for efficacy and showed a safety profile
consistent with previous studies. Data was presented at the Digestive Disease
Week (DDW) meeting in Orlando, Florida. Naloxegol is a peripherally-acting
mu-opioid receptor antagonist, which has been specifically designed for the
treatment of opioid-induced constipation (OIC), a common and often
debilitating side effect of prescription opioid pain medicines.

The Phase III studies, KODIAC-04 and -05, were 12-week, multicenter,
randomized, double blind, placebo-controlled pivotal trials that evaluated
12.5 mg and 25 mg doses of naloxegol, administered once-daily. The primary
endpoint in both trials was percentage of OIC responders, versus placebo, over
12 weeks of treatment. The secondary endpoints included the 12-week response
rate in a laxative inadequate response population, the median time to first
spontaneous bowel movement (SBM) and the number of days per-week with at least
one bowel movement.

Plans for naloxegol will be finalized over the coming months, incorporating
the outcome of ongoing discussions with health authorities in the US, EU and


About Naloxegol

Naloxegol is part of the exclusive worldwide license agreement announced on 21
September 2009, between AstraZeneca and Nektar Therapeutics (NASDAQ:NKTR).
Naloxegol was developed using Nektar’s oral small molecule polymer conjugate

About Opioid-Induced Constipation

Opioids bind to specific proteins called opioid receptors. When the opioids
bind to certain opioid receptors in the gastrointestinal (GI) tract,
constipation may occur. Opioid-induced constipation is a result of increased
fluid absorption and lower GI motility due to opioid receptor binding in the
gastrointestinal tract.

Globally, approximately 40–50% (28-35 million) of patients taking opioids for
long-term pain develop constipation. About 40–50% (11-18 million) of those OIC
sufferers achieve the desired treatment outcomes with current options that
include over-the-counter and prescription laxatives.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialisation of prescription
medicines, primarily for the treatment of cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and neuroscience
diseases. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide.

For more information about AstraZeneca in the US or our AZ&Me™ Prescription
Savings programs, please visit:www.astrazeneca-us.comor call 1-800-AZandMe

2675405 5/13


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