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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 December
2019
Commission
File Number: 001-11960
AstraZeneca PLC
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AstraZeneca's triple-combination therapy
approved in China for patients with COPD
23 December 2019 07:00 GMT
AstraZeneca's triple-combination therapy
approved in China for patients with COPD
First fixed-dose triple-combination therapy in a
pressurised metered-dose inhaler device in China
Budesonide/glycopyrronium/formoterol fumarate is known
as
PT010 outside of China and
as Breztri
Aerosphere in
Japan
AstraZeneca today announced
that budesonide/glycopyrronium/formoterol fumarate has been
approved in China for the maintenance treatment of chronic
obstructive pulmonary disease (COPD).
This is the first approval by the National Medical Products
Administration for a triple-combination therapy in a
pressurised metered-dose inhaler (pMDI), which uses the
innovative Aerosphere delivery technology.
The approval follows a priority review and is based on results from
the Phase III KRONOS trial in which PT010 demonstrated a
statistically significant improvement in trough forced expiratory
volume in one second (FEV1), the primary endpoint for China,
compared with dual-combination therapies Bevespi
Aerosphere (glycopyrronium/formoterol fumarate) and
PT009 (budesonide/formoterol fumarate).
The safety and tolerability of PT010 were consistent with the known
profiles of the dual comparators. Data from the KRONOS trial were
published in The
Lancet Respiratory Medicine in October 2018.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Chronic obstructive pulmonary disease affects
almost 100 million people in China, and is a leading cause of
morbidity and mortality. With this approval, we are now able to
provide a powerful new triple-combination therapy to patients for
whom new treatments are critically needed. Our
triple-combination therapy is administered in a
pressurised metered-dose inhaler, an important device option for
clinicians and patients in China."
Professor Wang Chen, Director of China National Clinical Research
Centre for Respiratory Diseases, Director of the Centre for
Respiratory Disease at China-Japan Friendship Hospital, and China
National Lead Investigator of the KRONOS trial, said: "Addressing
the burden of chronic obstructive pulmonary disease in China is a
public health priority and triple-combination therapy will play an
important role in helping patients manage their disease. In the
KRONOS trial, budesonide/glycopyrronium/formoterol
fumarate provided rapid and sustained lung function
improvements in patients with moderate-to-very-severe
disease."
Budesonide/glycopyrronium/formoterol fumarate was approved in
Japan in June 2019
as Breztri
Aerosphere, a
triple-combination therapy to relieve symptoms of COPD. The
medicine is also under regulatory review in the US and EU,
under the name PT010.
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 approximately
100 million people in China.2,3 COPD
is predicted to be the third leading cause of death globally by
2020.1 Improving
lung function, reducing exacerbations and managing daily symptoms
such as breathlessness are important treatment goals in the
management of COPD.1
About ATHENA
ATHENA is AstraZeneca's Phase III global clinical trial
programme for PT010, including 11 completed trials with more than
15,500 patients.4,5,6,7 The
four key trials are ETHOS, KRONOS, TELOS and
SOPHOS.4,5,6,7 The
ETHOS and KRONOS trials assessed the efficacy and safety of
PT010.4,5 The
TELOS and SOPHOS trials characterised PT009 and substantiated it as
an active comparator in the PT010 clinical trial
programme.6,7
In the KRONOS Phase III randomised, double-blinded, parallel-group,
24-week, chronic-dosing, multi-centre trial, PT010 met
six of seven lung function primary endpoints versus
dual-combination therapies Bevespi
Aerosphere, Symbicort
Turbuhaler (budesonide/formoterol fumarate) and PT009
in patients with moderate-to-very-severe COPD, in a patient
population without a requirement for an exacerbation in the
previous year.5 PT009
also met two non-inferiority endpoints to support its qualification
as an active comparator. As published in The
Lancet Respiratory Medicine, in
a key secondary endpoint, PT010 showed a statistically
significant 52% reduction in the rate of moderate or severe COPD
exacerbations compared with Bevespi
Aerosphere.5
In the ETHOS Phase III randomised, double-blinded,
multi-centre, parallel-group, 52-week trial,
PT010 demonstrated a statistically significant reduction in
the rate of moderate or severe exacerbations compared
with dual-combination therapies Bevespi
Aerosphere and
PT009 in patients with moderate-to-very-severe COPD and a
history of exacerbation(s) in the previous year.4 Full
trial design details are published in Respiratory
Medicine.8 AstraZeneca announced results
from the Phase III ETHOS trial in August 2019.9
Bevespi Aerosphere 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). Symbicort
Turbuhaler is a single
inhaler containing budesonide, an inhaled corticosteroid
(ICS), and formoterol, a LABA. PT009 is a single inhaler,
fixed-dose dual-combination therapy of budesonide, an ICS, and
formoterol fumarate, a LABA.
About PT010
PT010 is a single-inhaler, fixed-dose triple-combination of
budesonide, an ICS, with glycopyrronium, a LAMA, and formoterol
fumarate, a LABA. The China approval for PT010 follows a priority
review designated for treatments that utilise advanced dosage
technology, innovative treatment measures or clinical treatment
advantage.
Under the terms of the agreement to acquire Pearl Therapeutics
Inc., AstraZeneca anticipates making a $150m milestone payment upon
US regulatory approval of PT010 for COPD. This payment would be the
final development and regulatory milestone under that
agreement.
About AstraZeneca in respiratory diseases
Respiratory is one of AstraZeneca's main 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), 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 (LSE/STO/NYSE: AZN) 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 and Metabolism, and Respiratory.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. Please
visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
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References
1. GOLD.
Global Strategy for the Diagnosis, Management and Prevention of
COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD)
2020. [Online]. Available at: http://goldcopd.org. [Last accessed:
December 2019].
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. Wang C, Xu J, Yang L, Xu Y,
Zhang X, Bai C, et al. Prevalence and risk factors of chronic
obstructive pulmonary disease in China (the China Pulmonary Health
[CPH] study): a national cross-sectional
study. Lancet. 2018;391:1706-1717.
4.
Clinicaltrials.gov. Study to Assess the Efficacy and Safety of
PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very
Severe COPD (ETHOS). [Online]. Available
at: https://clinicaltrials.gov/ct2/show/NCT02465567. [Last
accessed: December 2019].
5. Ferguson GT, Rabe KF, Martinez
FJ, et
al. Triple combination of
budesonide/glycopyrrolate /formoterol fumarate using co-suspension
delivery technology versus dual therapies in chronic obstructive
pulmonary disease (KRONOS): a double-blind, parallel-group,
randomised controlled trial. Lancet Respir
Med.
2018;6(10):747-758.
6. Clinicaltrials.gov. Study to Assess
Efficacy and Safety of PT009 Compared to PT005, PT008,
and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects
With Moderate to Very Severe COPD (TELOS). [Online]. Available
at: https://clinicaltrials.gov/ct2/show/NCT02766608. [Last
accessed: December 2019].
7.
Clinicaltrials.gov. A Study to Assess the Efficacy and Safety of
PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period
in Subjects With Moderate to Very Severe COPD (SOPHOS). [Online].
Available at: https://clinicaltrials.gov/ct2/show/NCT02727660.
[Last accessed: December 2019].
8. Rabe K, Martinez F, Ferguson
G, et
al. A Phase III study of
triple therapy with budesonide/glycopyrrolate/formoterol fumarate
metered dose inhaler 320/18/9.6µg and 160/18/9.6µg using
co-suspension delivery technology in moderate-to-severe COPD: The
ETHOS study protocol. Respir Med. 2019;158: 59-66.
9. AstraZeneca
PLC. Breztri
Aerosphere Phase III ETHOS
trial met its primary endpoint in chronic obstructive pulmonary
disease. [Online]. Available
at: https://www.astrazeneca.com/media-centre/press-releases/2019/breztri-aerosphere-phase-iii-ethos-trial-met-its-primary-endpoint-in-chronic-obstructive-pulmonary-disease-28082019.html. [Last
accessed: December 2019].
Adrian Kemp
Company Secretary
AstraZeneca PLC
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:
23 December
2019
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
|
|
Title:
Company Secretary
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