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 October 2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
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Cambridge
Biomedical Campus
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United
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
CHMP
positive opinion Bevespi Aerosphere
19 October 2018 13:00 BST
CHMP issues a positive opinion
for Bevespi
Aerosphere
for the treatment of chronic obstructive pulmonary
disease
AstraZeneca today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency has
adopted a positive opinion, recommending the marketing
authorisation for Bevespi
Aerosphere (glycopyrronium/formoterol fumarate) in a
pressurised metered-dose inhaler
(pMDI) as a maintenance dual bronchodilator
treatment to relieve symptoms in adult patients with chronic
obstructive pulmonary disease (COPD).
The CHMP recommendation is based on the Phase III PINNACLE
programme, which demonstrated the efficacy and safety
of Bevespi
Aerosphere and involved
more than 5,000 patients with moderate to very severe
COPD.
Dr Colin Reisner, Head of Respiratory, Global Medicines
Development, said: "Bevespi
Aerosphere is the only
fixed-dose long-acting muscarinic antagonist/long-acting
beta2-agonist that is delivered in a pressurised metered-dose
inhaler. Today's positive CHMP opinion means COPD patients in
Europe are one step closer to having this new dual bronchodilator
treatment available to them."
Bevespi Aerosphere is
approved in the US, Canada and Australia as a dual bronchodilator
for the long-term maintenance treatment of
COPD.
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 Improving
lung function, reducing exacerbations and managing daily symptoms
such as breathlessness are important to the management of
COPD.1
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, compared to its monotherapy components
(glycopyrronium and formoterol fumarate) and to
placebo.3,4,5 In
PINNACLE 1, open-label tiotropium was included as an active
control.3 PINNACLE
3 was a multi-centre, randomised, double-blinded, parallel-group,
chronic-dosing, active-controlled, 28-week safety extension trial
of PINNACLE 1 and 2, which evaluated the long-term safety,
tolerability, and efficacy of Bevespi
Aerosphere administered
twice daily via a pMDI compared to its monotherapy
components.6 All
the trials were conducted in patients with moderate to very severe
COPD.
About Bevespi
Aerosphere
Bevespi Aerosphere is a
fixed-dose dual bronchodilator combining glycopyrronium, a
long-acting muscarinic antagonist (LAMA), and formoterol fumarate,
a long-acting beta2-agonist (LABA). Bevespi
Aerosphere is the 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.7Aerosphere Delivery
Technology is also the platform for other 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-5rɑ),
approved for severe eosinophilic asthma and in development for
severe nasal polyposis, 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 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 http://www.astrazeneca.com/ and
follow us on Twitter @AstraZeneca.
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Media Relations
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Karen Birmingham
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UK/Global
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Rob Skelding
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UK/Global
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Matt Kent
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UK/Global
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Gonzalo Viña
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UK/Global
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Jennifer Hursit
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Jacob Lund
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Sweden
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US
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. 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:
October 2018.
2. 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.
3.
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:
October 2018.
4.
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:
October 2018.
5. 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: October 2018
6.
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:
October 2018.
7.
AstraZeneca. Aerosphere Delivery Technology - Global Core Claims
Guide.
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
October
2018
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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