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2017-09-25

AstraZeneca: Bevespi Aerosphere demonstrates statistically significant improvement in lung function in patients with COPD

Phase III, PINNACLE 4 trial demonstrates positive top-line results
compared to its monotherapy components and placebo

Trial supports filing of new drug applications in Japan and China

AstraZeneca today announced positive top-line results of the Phase
III, PINNACLE 4 trial in which Bevespi Aerosphere* (glycopyrronium
and formoterol fumarate 14.4/9.6 µg) demonstrated a statistically
significant improvement in lung function as measured by trough forced
expiratory volume in one second (FEV1), compared to its monotherapy
components (glycopyrronium 14.4 µg and formoterol fumarate 9.6 µg)
and placebo, all administered twice daily via pressurised
metered-dose inhaler (pMDI) to patients with moderate to very severe
chronic obstructive pulmonary disease (COPD). AstraZeneca will make
regulatory filing applications for Bevespi Aerosphere in Japan and
China in 2018, based on data from PINNACLE 4, as well as previously
reported trials.

Dr. Colin Reisner, Head of Respiratory, Global Medicines Development
at AstraZeneca, said: "These positive results add to the strong
established efficacy and safety profile of Bevespi Aerosphere in the
treatment of patients with COPD. PINNACLE 4 will support our
regulatory filings in Japan and China where respiratory diseases such
as COPD remain a significant and growing public health burden with
unmet treatment needs."

The 24-week PINNACLE 4 trial was designed to provide data on the
efficacy and safety of Bevespi Aerosphere. It included 1,756 patients
across Asia, Europe and the US. Safety and tolerability data for
Bevespi Aerosphere were consistent with previous trials. Data from
PINNACLE 4 will be presented at a forthcoming medical meeting.

Bevespi Aerosphere is approved in the US for the long-term maintenance
treatment of airflow obstruction in COPD. A Marketing Authorisation
Application for Bevespi Aerosphere has been accepted for review by
the European Medicines Agency with a regulatory decision anticipated
in the second half of 2018.

- ENDS -

NOTES TO EDITORS

About COPD

Chronic obstructive pulmonary disease (COPD) 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 2020. Improving lung function,
reducing exacerbations and managing daily symptoms such as
breathlessness are important to the management of COPD.

In Japan, COPD represents a significant health, economic, social and
psychological burden. It is the tenth leading cause of death.1In
China, one in 10 adults over the age of 402lives with COPD and
prevalence is increasing.3COPD is the third largest4cause of death
among chronic diseases.

About the PINNACLE 4 Trial

The PINNACLE 4 trial is a randomised, double-blind, 24-week
chronic-dosing, placebo-controlled, parallel-group, multi-centre
trial to assess the efficacy and safety of Bevespi Aerosphere
(glycopyrronium and formoterol fumarate 14.4/9.6 µg) administered
twice daily via pressurised metered-dose inhaler (pMDI) compared to
its monotherapy components glycopyrronium, 14.4 µg twice-daily pMDI,
and formoterol fumarate, 9.6 µg twice-daily pMDI, and compared with
placebo, in patients with moderate to very severe COPD.

The primary outcome was the change from baseline in morning pre-dose
(trough) FEV1 for Bevespi Aerosphere 14.4/9.6 µg compared to
formoterol fumarate, 9.6 µg twice-daily pMDI, glycopyrronium, 14.4 µg
twice-daily pMDI, and placebo. Secondary outcomes included
assessments of dyspnoea, health-related quality of life, time to
onset and rescue medication use.

About Bevespi Aerosphere

Bevespi Aerosphere (glycopyrronium and formoterol fumarate) is a
fixed-dose dual bronchodilator combining glycopyrronium, a
long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a
long-acting beta-2 adrenergic agonist (LABA). Bevespi Aerosphere is
the first and only LAMA/LABA with Aerosphere Delivery Technology.
Aerosphere Delivery Technology is also the platform for
investigational medicines including PT010, our triple combination of
budesonide/glycopyrronium/formoterol fumarate.

The efficacy of Bevespi Aerosphere has been studied in more than 5,000
patients through the PINNACLE trial programme. In PINNACLE 1 and
PINNACLE 2 trials, Bevespi Aerosphere demonstrated
statistically-significant improvements in trough FEV1 versus
glycopyrronium, formoterol fumarate and placebo.

About AstraZeneca in Respiratory Disease

Respiratory disease is one of AstraZeneca's main therapy areas, and
the Company has a growing portfolio of medicines that reached more
than 18 million patients in 2016. AstraZeneca's aim is to transform
asthma and COPD treatment through inhaled combinations at the core of
care, biologics for the unmet needs of specific patient populations,
and scientific advancements in disease modification.

The Company is building on a 40-year heritage in respiratory disease
and AstraZeneca's capability in inhalation technology spans both
pMDIs and dry powder inhalers, as well as the innovative Aerosphere
Delivery Technology. The company's biologics include benralizumab
(anti-eosinophil, anti-IL-5r?), which has been accepted for
regulatory review in the US, EU and Japan, tralokinumab (anti-IL-13),
which is currently in Phase III trials, and tezepelumab (anti-TSLP),
which successfully achieved its Phase IIb primary and secondary
endpoints. AstraZeneca's research is focused on addressing underlying
disease drivers focusing on the lung epithelium, lung immunity and
lung regeneration.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular & Metabolic Diseases
and Respiratory. The Company also is selectively active in the areas
of autoimmunity, neuroscience and infection. 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 and follow us
on Twitter @AstraZeneca.

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*Bevespi Aerosphere is a registered trademark of AstraZeneca. The
trade name is subject to regulatory review and approval in other
countries outside of the US.

References

1. 1. Ministry of Health, Labour and Welfare. Summary of population dynamics statistics in Heisei: Number of deaths/mortality rate by rank of death factors by gender. [Online]. Available at: http://www.mhlw.go.jp/toukei/saikin/hw/jinkou/kakutei15/dl/10_h6.pdf Last accessed September 2017 (http://www.mhlw.go.jp/toukei/saikin/hw/jinkou/kakutei15/dl/10_h6.pdf%20L...).
2. 2. Chinese nutrition and chronic disease report (2015), China National Health and Family Planning Commission.
3. 3. Bao Heling, et al. Chinese Journal of Epidemiology. 2016,37 (1): 119-124.
4. 4. Yang GH, et al. Lancet. 2013;381(9882):1987-2015.

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