DUAKLIR GENUAIR APPROVED IN THE EU FOR COPD

DUAKLIR® GENUAIR® approved in the EUROPEAN union FOR CHRONIC OBSTRUCTIVE
PULMONARY DISEASE

AstraZeneca today announced that Duaklir® Genuair® (aclidinium
bromide/formoterol fumarate 340/12 mcg) has been granted Marketing Authorisation
by the European Commission (EC) to be used as a maintenance bronchodilator
treatment to relieve symptoms in adult patients with chronic obstructive
pulmonary disease (COPD).

Approximately 300 million people1 around the world live with COPD, a progressive
and chronic disease where people find breathing difficult due to limited
airflow. Improving the lung function and managing daily symptoms such as
breathlessness are important to the management of COPD.

Duaklir is a fixed-dose combination of already-approved Eklira® (aclidinium
bromide), a long-acting muscarinic-antagonist (LAMA), with the long-acting beta
-agonist (LABA) formoterol. The twice-daily therapy is the only LAMA/LABA
combination to show statistically significant improvement in breathlessness
compared to individual therapies and is administered by the Genuair® dry powder
inhaler device.

AstraZeneca owns the rights to develop and commercialise Duaklir Genuair in the
European Union (EU) following the strategic business combination of Almirall's
respiratory portfolio, which was
completed (http://www.astrazeneca.com/Media/Press-releases/Article/20140311-
-astrazeneca-completes-strategic-transaction) last month. The EU approval of
Duaklir Genuair marks an important further step in AstraZeneca's inhaled therapy
strategy of providing physicians and patients a choice of products uniquely
available in both dry powder and pressurised metered dose devices.

"We are pleased to receive European regulatory approval for Duaklir Genuair as
an innovative treatment for patients with COPD. Patients need treatments that
can help to improve their lung function and allow them to better manage the
daily and debilitating symptoms of their condition, in turn improving their
overall quality of life." said Briggs Morrison, Executive Vice President, Global
Medicines Development and Chief Medical Officer at AstraZeneca.

The EU approval of Duaklir Genuair was based on efficacy and safety data from
more than 2,000 patients in 11 clinical studies, conducted in 29 countries
worldwide. Results showed that Duaklir Genuair demonstrated statistically
significant and sustained improvement in the lung function compared to
monotherapy, providing a favourable benefit-to-risk profile.

The EC marketing authorisation applies to all member states of the EU and the
European Economic Area. Aclidinium bromide/formoterol fumarate will be marketed
in Europe by AstraZeneca under the trade name Duaklir® Genuair®.

About Duaklir® Genuair®
Duaklir Genuair (aclidinium bromide/formoterol fumarate 340/12 mcg) is a fixed
dose combination of two approved long-acting bronchodilators with different
mechanisms of action and similar pharmocodynamic profiles. Aclidinium bromide is
an anticholinergic or long acting muscarinic antagonist (LAMA) that produces
bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth
muscle. Formoterol fumarate is a long-acting beta-agonist (LABA) that stimulates
the β2-receptors in the bronchial smooth muscle resulting in bronchodilation.
Both aclidinium bromide (Eklira®) and formoterol fumarate are separately
approved for the maintenance treatment of COPD in the United States and Europe.

AstraZeneca owns the rights for the development and commercialisation of
Almirall's proprietary respiratory business as well as its pipeline of
investigational novel therapies.

About Genuair®
Genuair is a multi-dose, pre-loaded dry powder inhaler with a unique combination
of optical and acoustic signals to reassure patients that the dose has been
taken correctly. The inhaler's safety features ensure high levels of reliability
while its easy-to-use features and design minimise the potential for misuse and
are expected to increase patient acceptance and compliance.

About Phase III Studies AUGMENT and ACLIFORM
The Phase III clinical development programme included approximately 4,000
patients with a clinical diagnosis of COPD. The programme comprised of two 6
-month randomised, control- and active-controlled studies, ACLIFORM-COPD (LAC
30) - (ACLIdinium/FORMoterol fumarate combination for Investigative use in the
treatment of moderate to severe COPD) and AUGMENT (LAC 31) -
(Aclidinium/formoterol FUmurate Combination for InvestiGative use in the
TreatMENT of Moderate to Severe COPD); a 6-month extension of the AUGMENT study
(LAC 36); and a further long-term 12-month randomised controlled study comparing
aclidinium/formoterol 340/12 to formoterol (LAC 32).

About COPD
Chronic obstructive pulmonary disease (COPD) is a progressive and chronic
disease which encompasses a number of lung conditions, including chronic
bronchitis, emphysema and chronic obstructive airways disease. People with COPD
have difficulty breathing due to persistent airflow limitation.

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

1  Decision Resources 2013 for G7 prevalence:
http://www.decisionresources.com/Products-and-Services/Report?r=dbasim0213.

Buist SA, McBurnie MA, et al. International variation in the prevalence of COPD
(The BOLD Study), a population-based prevalence study; The Lancet (2007):
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(07)61377
-4/abstract,

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24 November 2014

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