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
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Update on US
regulatory review of PT010 in COPD
This announcement contains inside information
01 October 2019 07:00 BST
Update on US regulatory review of PT010 in COPD
AstraZeneca today announced that the US Food and Drug
Administration (FDA) has issued a complete response letter
regarding the New Drug Application (NDA) for PT010
(budesonide/glycopyrronium/formoterol fumarate), an inhaled
triple-combination therapy and potential new medicine for patients
with chronic obstructive pulmonary disease
(COPD).
The NDA submitted to the FDA by AstraZeneca included data from the
Phase III trial KRONOS. The Company will now work closely with the
FDA regarding next steps, including submitting for review recent
results from the second positive Phase III trial, ETHOS, which was
not completed at the time the NDA was submitted.
PT010 was approved in
Japan in June 2019
as Breztri
Aerosphere, a
triple-combination therapy to relieve symptoms of COPD. PT010 is
under regulatory review in China where it has been granted priority
review by the National Medical Products Administration, and is also
under regulatory review in the EU.
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 treatment goals in the
management of COPD.1
About ATHENA
ATHENA is PT010's global clinical trial programme, including 11
completed Phase III trials with more than 15,500
patients.3,4,5,6 The
four key trials are ETHOS, KRONOS, TELOS and
SOPHOS.3,4,5,6 The
ETHOS and KRONOS trials assessed the efficacy and safety of
PT010.3,4 The
TELOS and SOPHOS trials characterised PT009 and substantiated it as
an active comparator in the PT010 clinical trial
programme.5,6
In the Phase III ETHOS trial, PT010 demonstrated a
statistically-significant reduction in the rate of
moderate or severe exacerbations compared with
dual-combination therapies Bevespi
Aerosphere(glycopyrronium/formoterol fumarate) and PT009
(budesonide/formoterol fumarate). The safety and tolerability
of PT010 in the trial were consistent with the known profiles of
the dual comparators.7
About PT010
PT010 is a fixed-dose triple-combination of budesonide, an inhaled
corticosteroid with glycopyrronium, a long-acting muscarinic
agonist, and formoterol fumarate, a long-acting beta2-agonist,
delivered in a pressurised metered-dose inhaler.
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 three 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-IL5 receptor alpha),
now approved for severe eosinophilic asthma and in development for
severe nasal polyposis and COPD and a number of other potential
indications, 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 and
Metabolism (CVRM) 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 us on Twitter @AstraZeneca.
Media Relations
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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) 2019. [Online]. Available at: http://goldcopd.org. Last
accessed: September 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. Clinicaltrials.gov. A
Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing,
Multi-Center Study to Assess the Efficacy and Safety of PT010,
PT003, and PT009 Compared With Symbicort®Turbuhaler® (Kronos)
(KRONOS). [Online]. Available
at: https://clinicaltrials.gov/ct2/show/NCT02497001.
Last accessed: September 2019.
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: September 2019.
5. 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: September 2019.
6. 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: September 2019.
7. Rabe
KF et
al. A phase III study of
triple therapy with budesonide/glycopyrrolate/formoterol fumarate
metered dose inhaler 320/18/9.6 lg and 160/18/9.6 lg
using co-suspension delivery technology in moderate-to-very severe
COPD: The ETHOS study protocol. Respir Med. 2019 Aug 22; DOI:
10.1016/j.rmed.2019.08.010.
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:
01 October
2019
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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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