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 September
2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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82-_____________
7 September 2017 07:00 BST
DUAKLIR SIGNIFICANTLY IMPROVES LUNG FUNCTION IN COPD
PATIENTS
Phase III AMPLIFY trial demonstrated a statistically- significant
improvement in lung function in patients with COPD
Study achieved the primary endpoints to support a New Drug
Application (NDA) submission
AstraZeneca
today announced positive top-line results from the Phase III
AMPLIFY trial for Duaklir* (aclidinium bromide/formoterol
400µg/12µg twice-daily), which met its primary endpoints,
demonstrating a statistically-significant improvement in lung
function in patients with moderate to very severe stable chronic
obstructive pulmonary disease (COPD) compared to each individual
component (either aclidinium bromide or formoterol). In addition,
aclidinium bromide achieved its primary bronchodilation endpoint of
demonstrating non-inferiority to tiotropium bromide 18µg
once-daily.
Dr.
Sanjay Sethi, Professor and Chief, Pulmonary, Critical Care and
Sleep Medicine at University at Buffalo, The State University of
New York, USA and the lead investigator of the trial, said: "These
results demonstrate the improvement in lung function achieved by
the combination of aclidinium and formoterol compared to single
LAMA bronchodilators tiotropium and aclidinium, with comparable
safety."
The
efficacy, safety and tolerability profiles for aclidinium bromide
and formoterol were consistent with current experience. A full
evaluation of the AMPLIFY data is ongoing and further results will
be presented at a forthcoming medical meeting. AstraZeneca is
expected to submit an NDA during H1 2018 to the US Food and Drug
Administration (FDA) for Duaklir, based on the AMPLIFY
data.
Steve
Lewington, Global Medicine Leader, Respiratory, AstraZeneca said:
"The AMPLIFY study top-line results provide further clinical
evidence of Duaklir's efficacy and support making this LAMA/LABA
combination treatment option available to COPD patients in the
US."
In
April 2017 AstraZeneca entered a strategic collaboration with
Circassia Pharmaceuticals plc (Circassia) for the development and
commercialisation of Tudorza and Duaklir in the US. Under the terms
of the collaboration, Circassia was granted the rights to Duaklir
in the US. Circassia is also leading the promotion of Tudorza in
the US and was conferred an option to gain full commercial rights
in the future.
- 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.
About AMPLIFY
AMPLIFY
is a 24-week treatment, multicentre, randomised, double-blind,
double dummy, parallel-group trial to assess the efficacy and
safety of aclidinium bromide/formoterol 400µg/12µg
twice-daily compared to its component parts (aclidinium bromide
400µg twice-daily or formoterol fumarate 12µg
twice-daily) and once-daily tiotropium 18µg in moderate to
very severe stable COPD patients.
The
primary outcome measures were to demonstrate;
●
a change from
base-line morning pre-dose (trough) FEV1 for aclidinium
bromide/formoterol 400µg/12µg versus formoterol 12µg
at week 24
●
a change from
base-line in morning one-hour post-dose FEV1 for aclidinium
bromide/formoterol 400µg/12µg versus aclidinium bromide
400µg at week 24
●
a change from
baseline in morning pre-dose (trough) FEV1 at week 24 comparing
aclidinium bromide 400µg versus tiotropium 18µg to
demonstrate non-inferiority
Other
objectives were to assess the safety of aclidinium
bromide/formoterol fumarate 400µg/12µg, as well as to
further characterise the effect of the combination on
bronchodilation and health related quality of life.
About Duaklir
Duaklir
(aclidinium bromide/formoterol fumarate 400µg/12µg
twice-daily) is an approved fixed-dose LAMA/LABA combination of two
long-acting bronchodilators - aclidinium bromide is a long-acting
muscarinic antagonist (LAMA) and formoterol fumarate is a
long-acting beta-agonist (LABA). The fixed-dose combination was
approved by the European Medicines Agency (EMA) in November 2014 as
a maintenance bronchodilator treatment to relieve symptoms in adult
patients with COPD.
About Pressair
The
Pressair is an easy-to-use, multi-dose, breath-activated inhaler
with a unique patient feedback mechanism that is approved in the US
for delivering Tudorza (aclidinium bromide). The Pressair inhaler
is being used for the development of Duaklir in the US. Outside of
the US the Pressair inhaler is marketed as Genuair.
About Circassia
In
April 2017 AstraZeneca entered a strategic collaboration with
Circassia Pharmaceuticals plc, for the development and
commercialisation of Tudorza and Duaklir in the US. Under the terms
of the collaboration Circassia was granted the rights to Duaklir in
the US. Circassia is also leading the promotion of Tudorza in the
US and was granted an option to gain the full commercial rights in
the future. AstraZeneca has received a minority equity stake in
Circassia. AstraZeneca will complete ongoing development activities
and continue to manufacture and supply both medicines. AstraZeneca
will receive $100 million at the approval of Duaklir in the US, or
30 June 2019, whichever is earliest, and Circassia will pay
AstraZeneca tiered percentage royalties on potential future US
sales of Duaklir.
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 is also 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 http://www.astrazeneca.com/
and follow us on Twitter @AstraZeneca
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*Duaklir,
Pressair, Genuair and Tudorza are all registered trademarks of
AstraZeneca. Duaklir is a registered trademark in Europe and other
markets. The US trademark is subject to review and approval by the
FDA.
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:
7th
September 2017
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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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