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 December
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
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Biomedical Campus
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Phase
III ROCKIES and OLYMPUS roxadustat trials
This announcement contains inside information
20
December 2018 07:00 GMT
Phase III OLYMPUS and ROCKIES trials for roxadustat met
their
primary endpoints in chronic kidney disease patients with
anaemia
OLYMPUS demonstrated a statistically-significant and
clinically-meaningful improvement in haemoglobin vs. placebo in
non-dialysis-dependent patients
ROCKIES demonstrated a statistically-significant improvement
in haemoglobin vs. epoetin alfa in dialysis-dependent
patients
AstraZeneca today announced that the Phase III OLYMPUS and ROCKIES
trials for roxadustat each met their primary efficacy endpoints for
the treatment of patients with anaemia in chronic kidney disease
(CKD) that are either non-dialysis-dependent or dialysis-dependent,
respectively. Roxadustat is a hypoxia-inducible factor prolyl
hydroxylase inhibitor (HIF-PHI) and a potential first-in-class new
medicine to treat anaemia in CKD being jointly
developed and commercialised by AstraZeneca and FibroGen,
Inc.
OLYMPUS is a Phase III, randomised, double-blinded,
placebo-controlled trial designed to evaluate the efficacy and
safety of roxadustat vs. placebo for the treatment of patients with
anaemia in CKD stages 3, 4 and 5 whose disease progression is
moderate to severe and who are non-dialysis
dependent.1 The
trial met its primary efficacy endpoint by demonstrating a
statistically-significant and clinically-meaningful improvement
in mean change from baseline in haemoglobin (Hb) levels
averaged over weeks 28 to 52 vs. placebo.1 The
trial evaluated 2,781 patients in 26 countries.
ROCKIES is a Phase III, randomised, open-label, active-controlled
trial designed to assess the efficacy and safety of roxadustat vs.
epoetin alfa, for the treatment of patients with anaemia in CKD who
are dialysis dependent.2 The
trial met its primary efficacy endpoint by demonstrating a
statistically-significant improvement in mean change from
baseline in Hb levels averaged over weeks 28 to 52 vs. epoetin
alfa.2 The
trial evaluated 2,133 patients in 18 countries.
The global Phase III programme consists of more than 9,000 patients
in trials conducted by AstraZeneca, FibroGen and Astellas. In
September 2018, Astellas announced high-level results from the
Phase III ALPS trial. FibroGen and Astellas anticipate reporting
high-level results from their remaining trials in due course. These
trials will contribute to the combined pooled safety analysis,
including major adverse cardiovascular event (MACE) outcomes,
anticipated during H1 2019.
Sean Bohen, Executive Vice-President, Global Medicines Development
and Chief Medical Officer, said: "These results add to the growing
body of evidence for roxadustat, which is part of the largest
clinical programme worldwide in evaluating the novel class of
HIF-PHI. This is a significant milestone in the role roxadustat can
play to help address a high unmet need in anaemia associated with
chronic kidney disease, which today is under diagnosed and in many
cases under treated."
Data from the Phase III OLYMPUS and ROCKIES trials, together with
the efficacy and pooled safety data from the global Phase III
programme, will be part of the regulatory submission package in the
US and other major countries. Results from these trials will be
presented at forthcoming medical meetings.
About roxadustat
Roxadustat is a first-in-class, orally-administered small-molecule
medicine recently approved in China for the treatment of patients
with anaemia from CKD on dialysis. Roxadustat is a HIF-PHI that
promotes erythropoiesis by increasing endogenous production of
erythropoietin and improving iron regulation and overcoming the
negative impact of inflammation on haemoglobin synthesis and red
blood cell production by downregulating hepcidin. Administration of
roxadustat has been shown to induce coordinated erythropoiesis,
increasing red blood cell count while maintaining plasma
erythropoietin levels within or near normal physiologic range, in
multiple subpopulations of CKD patients, including in the presence
of inflammation and without a need for supplemental intravenous
(IV) iron.
AstraZeneca and FibroGen, Inc. are collaborating on the development
and commercialisation of roxadustat for the treatment of anaemia in
patients with CKD in the US, China, and other global markets.
FibroGen and Astellas are collaborating on the development and
commercialisation of roxadustat for the treatment of anaemia in
patients with CKD in Japan, Europe, the Commonwealth of Independent
States, the Middle East, and South Africa.
About anaemia in CKD
Anaemia can be a serious medical condition in which patients have
insufficient red blood cells and low levels of Hb, a protein in red
blood cells that carries oxygen to cells throughout the
body.3,4Anaemia
in CKD is associated with increased risk of hospitalisation,
cardiovascular complications and death,5 also
frequently causing significant fatigue, cognitive dysfunction and
decreased quality of life.6 Severe
anaemia is common in patients with CKD, cancer, myelodysplastic
syndrome, inflammatory diseases, and other serious
illnesses.
Anaemia is particularly prevalent in patients with CKD, which
affects more than 200 million people worldwide and is generally a
progressive disease characterised by gradual loss of kidney
function that may eventually lead to kidney failure.
In the US, according to the United States Renal Data System
(USRDS), a majority of dialysis-eligible CKD patients are currently
on dialysis. Of the approximately 507,000 patients receiving
dialysis in the US as of 2016, approximately 80% were being treated
with ESAs for anaemia.7Patients
seldom receive ESA treatment until they initiate dialysis
therapy.
About FibroGen
FibroGen, Inc., headquartered in San Francisco, California, with
subsidiary offices in Beijing and Shanghai, People's Republic of
China, is a leading biopharmaceutical company discovering and
developing a pipeline of first-in-class therapeutics. The
company applies its pioneering expertise in hypoxia-inducible
factor (HIF), connective tissue growth factor (CTGF) biology, and
clinical development to advance innovative medicines for the
treatment of anemia, fibrotic disease, and cancer. Roxadustat, the
company's most advanced product candidate, is an oral small
molecule inhibitor of HIF prolyl hydroxylase activity, completing
worldwide Phase 3 clinical development for the treatment of anemia
in chronic kidney disease (CKD), with a New Drug Application (NDA)
now approved by the National Medical Products Administration (NMPA)
in China. FibroGen's partner Astellas submitted an NDA for the
treatment of anemia in CKD patients on dialysis in Japan in
September 2018, currently under review by the Pharmaceuticals and
Medical Devices Agency (PMDA). Roxadustat is in Phase 3 clinical
development in the U.S. and Europe and in Phase 2/3 development in
China for anemia associated with myelodysplastic syndromes
(MDS). Pamrevlumab, an anti-CTGF human monoclonal antibody, is
advancing towards Phase 3 clinical development for the treatment of
idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is
currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD).
FibroGen is also developing a biosynthetic cornea in China. For
more information, please visit www.fibrogen.com.
About AstraZeneca in Cardiovascular, Renal & Metabolism
(CVRM)
Cardiovascular, renal and metabolism together form one of
AstraZeneca's main therapy areas and 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 co-morbidities. Our 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.
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 &
Metabolism and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. For more information, please
visit astrazeneca.com and
follow us on Twitter@AstraZeneca.
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Adrian Kemp
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AstraZeneca PLC
References
1.
Clinicaltrials.gov. Safety and Efficacy Study of Roxadustat to
Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on
Dialysis. [Online]. Available at:
https://clinicaltrials.gov/ct2/show/record/NCT02174627.
Last accessed: September 2018.
2.
Clinicaltrials.gov. Safety and Efficacy Study of Roxadustat to
Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.
[Online].
Available
at: https://clinicaltrials.gov/ct2/show/record/NCT02174731.
Last accessed: September 2018.
3.
National Kidney Foundation. "Managing Anaemia When You Have Kidney
Disease or Kidney Failure." 2014.
4.
National Institute of Diabetes and Digestive and Kidney Diseases.
"Anaemia in Chronic Kidney Disease." 2014.
5.
Babitt JL, Lin HY. Mechanisms of Anemia in CKD. J Am Soc Nephrol
(2012); 23:1631-1634
6. KDOQI
Clinial Practice Guidelines and Clinical Practice Recommendations
for Anaemia in Chronic Kidney Disease. Am J Kidney Dis. 2006
May;47(5):S1-S132
7. United States Renal Data System.
"Annual Data Report." 2017.
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:
20 December
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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