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 May
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
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United
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AstraZeneca PLC
INDEX
TO EXHIBITS
1. Update on TERRANOVA PIII trial for Fasenra in
COPD
30 May 2018 07:00 BST
Update on TERRANOVA Phase III trial for Fasenra
in chronic obstructive pulmonary disease
TERRANOVA trial did not meet the primary endpoint of a
statistically-significant reduction of exacerbations in patients
with chronic obstructive
pulmonary disease
AstraZeneca
and MedImmune, its global biologics research and development arm,
today announced top-line results from TERRANOVA, the second of two
pivotal Phase III trials for Fasenra (benralizumab) in patients with
moderate to very severe chronic obstructive pulmonary disease
(COPD). The trial did not meet the primary endpoint of a
statistically-significant reduction of exacerbations. This news
follows the announcement earlier this month that the first pivotal
Phase III trial, GALATHEA, did not meet its primary
endpoint.
Dr.
Sean Bohen, Executive Vice President, Global Medicines Development
and Chief Medical Officer, said: "These results are disappointing
because uncontrolled COPD patients already on dual or triple
inhaled therapy need new treatment options. We will now analyse the
complete data sets from the GALATHEA and TERRANOVA trials to
further understand these results."
The
pivotal Phase III trials GALATHEA and TERRANOVA were randomised,
double-blinded, 56-week placebo-controlled, multicentre trials
assessing the safety and efficacy of Fasenra as an add-on to dual or triple
inhaled therapy compared to placebo in patients with moderate to
very severe COPD with a history of exacerbations across a range of
baseline blood eosinophils.1,2
The safety and tolerability findings in TERRANOVA were consistent
with those observed in previous trials with Fasenra. A full evaluation of the data is ongoing, and
the results will be submitted for presentation at a forthcoming
medical meeting. The Company does not currently intend to make a
regulatory submission.
Fasenra is AstraZeneca's first respiratory biologic and is
currently approved as an add-on treatment for severe eosinophilic
asthma in the US, EU, Japan and several other countries. The
results of the GALATHEA and TERRANOVA trials do not impact the
approved indication in severe eosinophilic asthma.
About COPD
COPD is a progressive disease which can cause obstruction of
airflow in the lungs resulting in debilitating bouts of
breathlessness.3 It
affects an estimated 384 million people worldwide and is
predicted to be the third-leading cause of death by
2020.3,4 At
initial diagnosis, approximately one-third of COPD patients have
severe or very severe forms of this disease.5
Improving lung function, reducing
exacerbations and managing daily symptoms such as breathlessness
are important to the management of COPD.3
About 30-40% of moderate to severe COPD patients on triple inhaled
therapy (ICS/LAMA/LABA) remain uncontrolled and continue to
experience exacerbations.6,7
COPD exacerbations significantly
impair quality of life and are linked to disease progression,
accelerated decline in lung function, and increased
hospitalisations and mortality.8,9,10
About Fasenra
Fasenra (benralizumab) is a monoclonal antibody that
recruits natural killer cells to induce rapid and near-complete
depletion of eosinophils, a type of white blood cell that are a
normal part of the body's immune system.11,12 Depletion of
circulating eosinophils is rapid, with an onset of action within 24
hours as confirmed in Phase I/II severe asthma trials.11,12,13
Fasenra is AstraZeneca's first respiratory biologic, now
approved in severe eosinophilic asthma in the US, EU, Japan, Canada
and Australia and under regulatory review in several other
jurisdictions. Fasenra is also being tested in severe nasal
polyposis.
Fasenra was developed by AstraZeneca with MedImmune, the
company's global biologics research and development arm and is
in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa
Hakko Kirin Co., Ltd., Japan.
About the VOYAGER Programme
VOYAGER is AstraZeneca's Phase III Fasenra clinical trial programme in COPD and, with close
to 4,000 patients, it is currently the largest COPD biologics
development programme in the world.14
The VOYAGER programme includes two
trials, GALATHEA and TERRANOVA, evaluating Fasenra in patients with moderate to very severe COPD with
a history of exacerbations across a range of baseline blood
eosinophils.14
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),
now approved for severe eosinophilic asthma and in development for
severe nasal polyposis, and tezepelumab (anti-TSLP), which achieved
its Phase IIb primary and secondary endpoints and is continuing
development in the Phase III PATHFINDER clinical trial programme.
AstraZeneca's research is focused on addressing underlying disease
drivers focusing on the lung epithelium, lung immunity and lung
regeneration.
About MedImmune
MedImmune
is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
small molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Oncology, Respiratory, Cardiovascular & Metabolic Diseases, and
Infection and Vaccines. The MedImmune headquarters is located in
Gaithersburg, Md., one of AstraZeneca's three global R&D
centres, with additional sites in Cambridge, UK and Mountain View,
Calif. For more information, please visit www.medimmune.com
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 also is 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 www.astrazeneca.com
and follow us on Twitter
@AstraZeneca.
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. U.S.
National Institutes of Health. "Efficacy and Safety of Benralizumab
in Moderate to Very Severe Chronic Obstructive Pulmonary Disease
(COPD) With Exacerbation History (TERRANOVA)." NCT02155660. 2018.
Last Accessed May 2018.
https://clinicaltrials.gov/ct2/show/NCT02155660?term=TERRANOVA&rank=1.
2. U.S.
National Institutes of Health. "Benralizumab Efficacy in Moderate
to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With
Exacerbation History (GALATHEA)." NCT02138916. 2018. Last Accessed
May 2018.
https://clinicaltrials.gov/ct2/show/NCT02138916?term=GALATHEA&rank=1.
3.
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 2018.
4.
Bereza BG, Nielsen AT, Valgardsson S et al. Patient preferences in
severe COPD and asthma: a comprehensive literature review.
Int J Chron Obstruct Pulmon
Dis. 2015: 10: 739-744.
5.
Mapel DW, Anand AD, Blanchette CM et al. Severity of COPD at
initial spirometry-confirmed diagnosis: data from medical charts
and administrative claims. Int J
Chron Obstruct Pulmon Dis. 2011;6:573-81. doi:
10.2147/COPD.S16975.
6.
Vestbo J, Papi A, Corradi M, et al. Single inhaler extrafine triple
therapy versus long-acting muscarinic antagonist therapy for
chronic obstructive pulmonary disease (TRINITY): a double-blind,
parallel group, randomised controlled trial. Lancet 2017; 389: 1919-29.
7.
Mullerova H, Maskell J, Meeraus WH, Galkin D, Albers FC, Gait C.
Characterization of COPD patients treated with inhaled triple
therapy containing inhaled corticosteroids [ICS], long-acting
beta2- agonists [LABA], and long-acting muscarinic antagonists
[LAMA] in the UK. Am J Respir Crit
Care Med 2017; 195: A4986. abstract.
8.
Hurst JR, Vestbo J, Anzueto A, et al. Evaluation of COPD
Longitudinally to Identify Predictive Surrogate Endpoints(ECLIPSE)
Investigators. Susceptibility to exacerbation in chronic
obstructive pulmonary disease. N
Engl J Med. 2010 Sep 16;363(12):1128-38.
9.
Lange P, Halpin DM, O'Donnell DE, MacNee W. Diagnosis, assessment,
and phenotyping of COPD: beyond FEV₁. Int J Chron Obstruct Pulmon Dis. 2016
Feb 19;11 Spec Iss:3-12.
10.
Soler-Cataluna JJ et al. Severe acute exacerbations and mortality
in patients with chronic obstructive pulmonary disease.
Thorax. 2005 Nov; 60:
925-31.
11. Kolbeck
R, Kozhich A, Koike M, et al. MEDI-563, a humanized anti-IL-5
receptor a mAb with enhanced antibody-dependent cell-mediated
cytotoxicity function. J Allergy
Clin Immunol. 2010 Jun;125(6):1344-1353.e2.
12. Pham TH,
Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers
by benralizumab in patients with asthma. Respir Med. 2016;
111:21-29.
13.
Laviolette M, Gossage DL, Gauvreau G, et al. Effects of
benralizumab on airway eosinophils in asthmatic patients with
sputum eosinophilia. J Allergy
Clin Immunol. 2013 Nov; 132(5): 1086 - 1096.e5.
14.
AstraZeneca. Clinical Trials Appendix
Full-Year and Q4 2017 Results Update. Available at
https://www.astrazeneca.com/content/dam/az/PDF/2017/Full-Year/Full-Year%202017%20Results%20Clinical%20trials%20appendix.pdf.
Last Accessed May 2018.
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:
30 May
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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