Positive CHMP Opinion for MOVENTIG (naloxegol)

Moventig® (naloxegol) receives positive CHMP opinion in

the EU for the treatment of adults with opioid-induced constipation

AstraZeneca today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion
recommending approval of MOVENTIG® (naloxegol), an investigational, peripherally
-acting mu-opioid receptor antagonist (PAMORA), for the treatment of opioid
-induced constipation (OIC) in adult patients who have had an inadequate
response to laxative(s).

OIC is a condition caused by prescription opioid pain medicines. Opioids work by
binding to mu-receptors in the central nervous system, but they also bind to mu
-receptors in the gastrointestinal tract, which can result in patients suffering
from OIC.

The positive opinion was reached after a review of comprehensive data from the
KODIAC clinical programme comprised of four studies assessing the safety and
efficacy of MOVENTIG.

The CHMP's positive opinion on MOVENTIG will be reviewed by the European
Commission (EC), which has the authority to approve medicines for the European
Union. The final decision will be applicable to all 28 European Union member
countries plus Iceland and Norway. Should the EC approve MOVENTIG, it will be
the first once-daily, oral PAMORA available in these markets for the treatment
of OIC in adult patients who have had an inadequate response to laxative(s).

Today's announcement follows the
approval (http://www.astrazeneca.com/Media/Press-releases/Article/20140916--fda
-approves-movantik-tablets) on 16 September 2014 of MOVANTIKTM (naloxegol)
tablets by the US Food and Drug Administration, as the first once-daily PAMORA
for the treatment of OIC in adult patients with chronic non-cancer pain.

About MOVENTIG® (naloxegol)

MOVENTIG is an investigational peripherally-acting mu-opioid receptor antagonist
(PAMORA) specifically designed for the treatment of opioid-induced constipation
(OIC) in adult patients on prescription opioid pain medicines. In Phase III
clinical studies, MOVENTIG was administered as a once-daily tablet and was
designed to block the binding of opioids to opioid receptors in tissues such as
the gastrointestinal (GI) tract.

The KODIAC clinical programme was comprised of four studies: KODIAC-4, -5, -7
and -8. KODIAC-4 and -5 were identically designed, placebo controlled, double
-blind, 12 week studies assessing safety and efficacy, while KODIAC-7 was a 12
week safety extension to KODIAC-4, and KODIAC-8 was a 52 week long-term safety
study.

MOVENTIG is part of the exclusive worldwide licence agreement announced on 21
September 2009 between AstraZeneca and Nektar Therapeutics. MOVENTIG was
developed using Nektar's oral small molecule polymer conjugate technology.

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
please visit: www.astrazeneca.com

CONTACTS

Media Enquiries

Esra Erkal-Paler    +44 20 7604 8030 (UK/Global)
Vanessa Rhodes   +44 20 7604 8037 (UK/Global)
Ayesha Bharmal    +44 20 7604 8034 (UK/Global)
Jacob Lund            +46 8 553 260 20 (Sweden)

Investor Enquiries

Karl Hård                                    +44 20 7604 8123  mob: +44 7789
654364

Jens Lindberg                                                               mob:
+44 7557 319729

Anthony Brown                            +44 20 7604 8067    mob: +44 7585
404943

Eugenia Litz                                +44 20 7604 8233    mob: +44 7884
735627

26 September 2014

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