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2018-08-23

AstraZeneca: AstraZeneca provides update on AERISTO Phase IIIb trial for Bevespi Aerosphere in chronic obstructive pulmonar...

AstraZeneca today announced top-line results from the AERISTO Phase
IIIb trial for Bevespi Aerosphere (glycopyrronium/formoterol
fumarate) in patients with moderate to very severe chronic
obstructive pulmonary disease (COPD). In the trial, Bevespi
Aerosphere demonstrated non-inferiority to umeclidinium/vilanterol on
peak forced expiratory volume in one second (FEV1) but did not
demonstrate superiority on peak FEV1 or non-inferiority on trough
FEV1.

Dr Colin Reisner, Head of Respiratory, Global Medicines Development,
said: "The efficacy and safety of Bevespi Aerosphere has been
established by the Phase III PINNACLE trial programme involving more
than 5,000 patients. The performance of Bevespi Aerosphere in AERISTO
is inconsistent with previous data. A full analysis is underway to
understand and characterise these findings and will be presented at a
forthcoming medical meeting."

The 24-week AERISTO Phase IIIb trial was a randomised, double-blinded,
double-dummy, multicentre, parallel-group trial designed to assess
the efficacy and safety of Bevespi Aerosphere compared with
umeclidinium/vilanterol. The primary endpoints were peak change from
baseline in FEV1 where non-inferiority and superiority were measured
and change from baseline in trough FEV1 where non-inferiority was
measured. In the trial, 1,119 patients were randomised to receive
either two inhalations twice a day of Bevespi Aerosphere
(glycopyrronium/formoterol fumarate 7.2/4.8µg) via pressurised
metered-dose inhaler or one inhalation once a day of
umeclidinium/vilanterol 62.5/25µg via dry powder inhaler. Safety and
tolerability data for Bevespi Aerosphere were consistent with the
known profile of the medicine.

Bevespi Aerosphere is approved in the US and Canada for the long-term
maintenance treatment of airflow obstruction in COPD. Bevespi
Aerosphere is currently under review by the European Medicines Agency
with a regulatory decision anticipated in the second half of 2018.

About COPD

COPD is a progressive disease which can cause obstruction of airflow
in the lungs resulting in debilitating bouts of breathlessness.1 It
affects an estimated 384 million people worldwide and is predicted to
be the third leading cause of death by 2020.1,2 At initial diagnosis,
approximately one-third of COPD patients have severe or very severe
forms of the disease.3 Improving lung function, reducing
exacerbations and managing daily symptoms such as breathlessness are
important to the management of COPD.1 Moderate to severe COPD is
typically managed through long-acting bronchodilator therapy. Despite
the availability of effective long-acting bronchodilator
monotherapies, many patients remain symptomatic and may require dual
long-acting bronchodilator therapy.1,4

About Bevespi Aerosphere

Bevespi Aerosphere is a fixed-dose dual bronchodilator combining
glycopyrronium, a long-acting muscarinic agonist (LAMA), and
formoterol fumarate, a long-acting beta2-agonist (LABA). Bevespi
Aerosphere is the first and only LAMA/LABA with Aerosphere Delivery
Technology. Results from an imaging trial have shown that Bevespi
Aerosphere effectively delivers medicine to both the large and small
airways.5 Aerosphere Delivery Technology is also the platform for
potential new medicines including PT010, AstraZeneca's triple
combination of budesonide/glycopyrronium/formoterol fumarate.

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 2017. 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
pressurised metered-dose inhalers and dry powder inhalers, as well as
the Aerosphere Delivery Technology. The company also has a growing
portfolio of respiratory biologics, including Fasenra
(anti-eosinophil, anti-IL-5r?), now approved for severe eosinophilic
asthma and in development for severe nasal polyposis, and tezepelumab
(anti-TSLP), which achieved its Phase IIb primary and secondary
endpoints and is continuing development in the Phase III PATHFINDER
clinical trial programme. 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, Renal & Metabolism
and Respiratory. 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.

Media Relations
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Matt Kent UK/Global +44 203 749 5906
Gonzalo Viña UK/Global +44 203 749 5916
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677

Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Josie Afolabi +44 203 749 5631
Craig Marks Finance; Fixed Income +44 7881 615 764
Henry Wheeler Oncology +44 203 749 5797
Mitchell Chan Oncology; Other +1 240 477 3771
Christer Gruvris Cardiovascular; Metabolism +44 203 749 5711
Nick Stone Respiratory; Renal +44 203 749 5716
Jennifer Kretzmann Retail Investors +44 203 749 5824
US toll-free +1 866 381 7277

References

1. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018. Available from: http://goldcopd.org. Last accessed June 2018.

2. Mapel DW, Anand AD, Blanchette CM et al. Severity of COPD at initial spirometry-confirmed diagnosis: data from medical charts and administrative claims. Int J Chron Obstruct Pulmon Dis. 2011;6:573-81. doi: 10.2147/COPD.S16975.

3. Cazzola et al. The scientific rationale for combining long-acting beta2-agonists and muscarinic antagonists in COPD. Pulm Pharmacol Ther. 2010: 23(4):257-67

4. Pedersen S et al. Influence of inspiratory flow rate upon the effect of a Turbuhaler. Arch Dis Child. 1990;65:308-10

5. AstraZeneca. Aerosphere Delivery Technology - Global Core Claims Guide.

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