AstraZeneca PLC Announces Bevespi Aerosphere(TM) Approved by the US FDA for Patients With COPD

Demonstrated superior improvement in lung function versus mono-components and
placebo

Only long-acting dual bronchodilator delivered through a pressurised metered
-dose inhaler (pMDI) and first product to use AstraZeneca's patented Co
-Suspension(TM) Technology
AstraZeneca (http://www.astrazeneca.com/) has announced that the US Food and
Drug Administration has approved Bevespi Aerosphere (glycopyrrolate and
formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance
treatment of airflow obstruction in patients with chronic obstructive pulmonary
disease (COPD), including chronic bronchitis and/or emphysema.

Sean Bohen, Executive Vice-President, Global Medicines Development and Chief
Medical Officer, said: "With the approval of Bevespi Aerosphere we are pleased
to provide patients with the first LAMA/LABA in a pressurised metered-dose
inhaler, delivered using our unique formulation technology. LAMA/LABAs are
emerging as a preferred treatment option for many COPD patients. This class aims
to provide maximum bronchodilation, which enables patients to breathe better and
may help them be more active."

Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator combining
glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol
fumarate, a long-acting beta-2 agonist (LABA). The FDA approval is based on the
PINNACLE trial programme, which demonstrated that Bevespi Aerosphere achieved
statistically significant improvement in morning pre-dose forced expiratory
volume in 1 second (FEV1) at 24 weeks (p<0.001) versus its mono-components and
placebo.

Bevespi Aerosphere is the first product approved using AstraZeneca's Co
-Suspension Technology. This technology enables consistent delivery of one or
more different medicines from a single pMDI. The technology is being applied to
a range of AstraZeneca respiratory inhaled combination therapies currently in
clinical development, such as the fixed-dose triple combination of
LAMA/LABA/Inhaled corticosteroid (PT010).

About COPD

COPD (chronic obstructive pulmonary disease) is a progressive disease associated
mainly with tobacco smoking, air pollution or occupational exposure, which can
cause obstruction of airflow in the lungs resulting in debilitating bouts of
breathlessness. It affects an estimated 329 million people worldwide and is
predicted to be the third leading cause of death by 2030. Improving lung
function and managing daily symptoms such as breathlessness are important to the
management of COPD. It is estimated that eight out of 10 patients suffer
symptoms at night, such as an irritative cough and difficulty breathing,
frequent nocturnal awakenings, which leads to insomnia, worry and anxiety.

About AstraZeneca's Co-Suspension Technology

The Co-Suspension Technology uses porous, low-density phospholipid particles,
which are designed to form a uniform suspension inside a pressurised metered
-dose inhaler (pMDI) and distribution of drug crystals throughout the lungs for
release at their sites of deposition.

In addition, Co-Suspension Technology addresses issues often seen when multiple
drugs are combined in a pMDI. This technology provides a stable, homogeneous
suspension designed to prevent sedimentation of drug crystals over time and to
prevent drug crystals from interacting with one another, thus allowing for
consistent dosing of one or more different drugs from a single pMDI.

About the PINNACLE studies

The FDA approval of Bevespi Aerosphere is based on data from the PINNACLE 1,
PINNACLE 2, and a safety extension study, PINNACLE 3. Overall the Phase III
pivotal programme enrolled over 3,700 patients with moderate to very severe
COPD.

Bevespi Aerosphere demonstrated statistically significant improvements in lung
function as measured by change from baseline in morning pre-dose trough forced
expiratory volume in 1 second (FEV1) at 24 weeks (p<0.001) versus its individual
components (glycopyrrolate 9 mcg and formoterol fumarate 4.8 mcg) and placebo,
all dosed twice daily.

Bevespi Aerosphere demonstrated a significant improvement versus placebo on
secondary endpoints of peak FEV1 within 2 hours post-dose, and rescue medication
usage.

There were no unexpected safety findings with adverse events consistent with
previous results from the development program. The most common adverse reactions
with Bevespi Aerosphere, (with a ≥ 2% incidence and more common than with
placebo) were urinary tract infection (2.6% vs 2.3% with placebo) and cough
(4.0% vs 2.7% with placebo).

About Respiratory, Inflammation and Autoimmunity Diseases

Respiratory, Inflammation and Autoimmunity (RIA), one of AstraZeneca's main
therapy areas, has five potential medicines in pivotal trials or under
registration. In respiratory disease, our aim is to transform asthma and COPD
treatment through: Inhaled combinations at the core of care, precision biologics
for the unmet needs of specific patient populations, and scientific advancements
in disease modification. We are building on a 40-year heritage in respiratory
disease, and our capability in inhalation technology spans both pressurised
metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), as well as our
unique Co-Suspension Technology.

In Inflammation and Autoimmunity, our aim is to develop innovative therapies for
the treatment of autoimmune and rheumatoid diseases, with a lead programme in
systemic lupus erythematosus. Across respiratory, inflammation and autoimmune
diseases, our research is focused on four key treatable traits: eosinophilic
disease, Th2-driven disease, epithelial-driven pathobiology, and autoimmunity.

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 diseases in three main therapy areas -
respiratory, inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology - as well as in infection and
neuroscience. 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
Neil Burrows         UK/Global            +44 20 7604 8032
Vanessa Rhodes       UK/Global            +44 20 7604 8037
Karen Birmingham     UK/Global            +44 20 7604 8120
Jacob Lund           Sweden               +46 8 553 260 20
Michele Meixell      US                   +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen                       +44 7818 524185
Eugenia Litz         RIA                  +44 7884 735627
Nick Stone           CVMD                 +44 7717 618834
Craig Marks          Finance              +44 7881 615764
Christer Gruvris     Consensus Forecasts  +44 7827 836825
US
Lindsey Trickett     Oncology, ING        +1 240 543 7970
Mitch Chan           Oncology             +1 240 477 3771
Dial / Toll-Free                          +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and
Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

26 April 2016

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