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 January
2020
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 Phase III
STRENGTH trial for Epanova
in mixed dyslipidaemia
13 January 2020 07:00 GMT
Update on Phase III STRENGTH trial
for Epanova in mixed dyslipidaemia
Independent Data Monitoring Committee has recommended to
discontinue
the trial as Epanova is unlikely to demonstrate a benefit to
patients
Following the recommendation from an independent Data Monitoring
Committee, AstraZeneca has decided to close the Phase III STRENGTH
trial for Epanova (omega-3 carboxylic acids) due to its low
likelihood of demonstrating a benefit to patients with mixed
dyslipidaemia (MDL) who are at increased risk of cardiovascular
(CV) disease.
STRENGTH is a large-scale, global CV outcomes trial designed to
evaluate the safety and efficacy of Epanova compared to placebo, both in combination
with standard-of-care statin medicines.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "It was
important to assess the potential benefit
of Epanova in mixed dyslipidaemia. We are disappointed
by these results, but we remain committed to addressing the needs
of patients in the cardiovascular space where we have an extensive
pipeline."
Steven E. Nissen MD, Study Chair for the STRENGTH trial and Chief
Academic Officer for the Heart and Vascular Institute, Cleveland
Clinic, US, said: "The academic leadership of the STRENGTH trial is
obviously disappointed in this result, but we are very proud to
have had the opportunity to answer this important scientific
question. We are also grateful for the opportunity to conduct the
STRENGTH trial as an exemplary collaboration between academic
physicians and industry."
This trial will now be closed in an orderly fashion, and full data
will be presented at a forthcoming medical meeting.
Financial considerations
A review is being undertaken of the ongoing value of the
$533m Epanova intangible
asset. Any impairment will be treated as a non-Core item in the
fourth quarter of 2019. A write down of up to $100m relating to
inventories is also anticipated to impact the Core earnings in the
fourth quarter of 2019.
STRENGTH
STRENGTH is a large-scale CV outcomes trial evaluating the effect
of Epanova 4g daily compared to placebo (corn oil) on
reducing the risk of major adverse cardiovascular events (MACE) in
patients on optimal statin therapy with mixed dyslipidaemia and at
high risk for CV disease. A total of 13,086
patients were enrolled at 675 sites in 22
countries.
Mixed dyslipidaemia
MDL includes patients with raised triglyceride levels (moderate
hypertriglyceridemia) between 175-499mg/dL mg/dL, and low HDL
cholesterol. Elevated triglycerides affect a growing number of
patients and is often worsened by other factors such as diabetes or
obesity. Lifestyle changes and potentially treating the underlying
cause is likely to at least partly improve the condition and reduce
cardiovascular risk.
Epanova
Epanova is a fish
oil-derived mixture of free fatty acids primarily composed of EPA
and DHA. It is approved in the US and indicated as an adjunct to
diet to reduce triglyceride levels in adult patients with severe
(≥500 mg/dL) hypertriglyceridaemia, and this indication is
not impacted by the data from the STRENGTH
trial.
AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM) together forms one of
AstraZeneca's three therapy areas and is a key growth driver for
the Company. By following the science to understand more clearly
the underlying links between the heart, kidneys and pancreas,
AstraZeneca is investing in a portfolio of medicines to protect
organs and improve outcomes by slowing disease progression,
reducing risks and tackling comorbidities. The Company's ambition
is to modify or halt the natural course of CVRM diseases and
potentially regenerate organs and restore function, by continuing
to deliver transformative science that improves treatment practices
and cardiovascular health for millions of patients
worldwide.
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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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:
13 January 2020
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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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