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2017-09-07

AstraZeneca: 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, US 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.

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