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2020-01-13

AstraZeneca: Update on Phase III STRENGTH trial for Epanova in mixed dyslipidaemia

Independent Data Monitoring Committee has recommended to discontinuen
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
(http://www.astrazeneca.com/) and follow the Company on Twitter
@AstraZeneca (https://twitter.com/AstraZeneca).

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