Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of June
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Bevespi
Aerosphere approved by the Japanese
19 June 2019 07:00 BST
Bevespi
Aerosphere approved by
the Japanese Ministry of Health, Labour
and Welfare for patients with chronic obstructive pulmonary
disease
First approval of a fixed-dose, long-acting dual
bronchodilator
in a pressurised metered-dose inhaler device in Japan
AstraZeneca today announced that Bevespi
Aerosphere (glycopyrronium/formoterol fumarate) has
been approved in Japan as a fixed-dose, long-acting dual
bronchodilator to relieve symptoms in patients with chronic
obstructive pulmonary disease (COPD).
This is the first approval by the Japanese Ministry of Health,
Labour and Welfare for a maintenance fixed-dose, long-acting dual
bronchodilator in a pressurised metered-dose inhaler
(pMDI), which uses the innovative Aerosphere delivery technology.
The approval was based on positive results from the Phase III
PINNACLE 4 trial,1 which
demonstrated the efficacy and safety of Bevespi
Aerosphere in 1,756
patients with moderate to very severe COPD across Asia,
Europe and the US, as well as the broader PINNACLE clinical
programme involving more than 5,000 patients.2,3,4
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "As the first medicine in its class to be
approved in a pressurised metered-dose inhaler in
Japan, Bevespi
Aerosphereoffers an important
new treatment option and choice of inhaler device for patients with
moderate to very severe chronic obstructive pulmonary
disease."
Bevespi Aerosphere is
already approved in the US, EU, Canada, Australia and other
countries as a dual bronchodilator for the maintenance treatment of
moderate to very severe COPD.
About Bevespi
Aerosphere
Bevespi Aerosphere (glycopyrronium/formoterol fumarate) is a
fixed-dose dual bronchodilator in a pMDI, combining glycopyrronium,
a long-acting muscarinic antagonist (LAMA), and formoterol
fumarate, a long-acting beta2-agonist (LABA). Pressurised
metered-dose inhalers are an important choice for COPD patients
where limited lung function, advanced age and reduced dexterity or
cognition are significant considerations for patients to achieve
therapeutic benefits from their medicines.5,6 Bevespi
Aerosphere is the only
LABA/LAMA with Aerosphere delivery technology. Results from an imaging
trial have shown that Bevespi
Aerosphere effectively
delivers medicine to both the large and small
airways.7
About the Phase III PINNACLE programme
PINNACLE 1, 2 and 4 were randomised, double-blinded, multi-centre,
placebo-controlled trials conducted over 24 weeks, which compared
the efficacy and safety of Bevespi
Aerosphereadministered twice
daily via a pMDI to its monotherapy components (glycopyrronium and
formoterol fumarate) and to placebo.1,2,3 In
PINNACLE 1, open-label tiotropium was included as an active
control.2 PINNACLE
3 was a multi-centre, randomised, double-blinded, parallel-group,
chronic-dosing, active-controlled, 28-week safety extension trial
of PINNACLE 1/2, which evaluated the long-term safety, tolerability
and efficacy of Bevespi
Aerosphere administered
twice daily via a pMDI compared to its monotherapy
components.4 All
the trials were conducted in patients with moderate to very severe
COPD.
About COPD
COPD is a progressive disease which can cause obstruction of
airflow in the lungs resulting in debilitating bouts of
breathlessness.8 It
affects an estimated 384 million people worldwide and is predicted
to be the third leading cause of death by 2020.8,9 Improving
lung function, reducing exacerbations and managing daily symptoms
such as breathlessness are important treatment goals in the
management of COPD.8
About AstraZeneca in respiratory disease
Respiratory is one of AstraZeneca's three therapy areas, and our
medicines reached more than 18 million patients as maintenance
therapy in 2018. 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 alpha),
now approved for severe, eosinophilic asthma and in development for
severe nasal polyposis and other potential indications, and
tezepelumab (anti-TSLP), which has been granted Breakthrough
Therapy Designation by the US Food and Drug Administration in
patients with severe asthma and is in Phase III trials.
AstraZeneca's research aims at addressing underlying disease
drivers by focusing on the lung epithelium, lung immunity,
lung regeneration and neuronal functions.
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 astrazeneca.com and
follow us on Twitter@AstraZeneca.
Media
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. AstraZeneca
PLC Bevespi Aerosphere demonstrates statistically significant
improvement in lung function in patients with COPD. [Online].
Available at:
https://www.astrazeneca.com/media-centre/press-releases/2017/bevespi-aerosphere-demonstrates-statistically-significant-improvement-in-lung-function-in-patients-with-copd-25092017.html
Last accessed: May 2019.
2.
Clinicaltrials.gov. Efficacy and Safety of PT003, PT005, and PT001
in Subjects With Moderate to Very Severe Chronic Obstructive
Pulmonary Disease (COPD); (PINNACLE 1). [Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT01854645. Last accessed: May
2019.
3.
Clinicaltrials.gov. Multi-Center Study to Assess the Efficacy and
Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very
Severe COPD (PINNACLE 2). [Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT01854658. Last accessed: May
2019.
4.
Clinicaltrials.gov. Extension Study to Evaluate the Safety and
Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to
Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3).
[Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT01970878. Last accessed: May
2019.
5. Usmani O, Capstick T, Chowhan
H, et
al. Inhaler choice
guideline. March 2017 [Online]. Available
at: https://www.guidelines.co.uk/respiratory/inhaler-choice-guideline/252870.article.
Last accessed: May 2019.
6. Bonini M and Usmani OS. The
importance of inhaler devices in the treatment of COPD.
COPD Res Pract. 2015; 1: 9.
7.
AstraZeneca. Aerosphere Delivery Technology - Global Core Claims
Guide.
8. GOLD.
Global Strategy for the Diagnosis, Management and Prevention of
COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD)
2018. [Online]. Available at: http://goldcopd.org. Last accessed:
May 2019.
9. Adeloye D, Chua S, Lee
C, et
al. Global Health Epidemiology
Reference Group (GHERG). Global and regional estimates of COPD
prevalence: Systematic review and
meta-analysis. J Glob
Health. 2015; 5 (2):
020415.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
19 June
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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