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2019-11-07

AstraZeneca: Roxadustat significantly increased haemoglobin levels for chronic kidney disease patients with anaemia in Phas...

OLYMPUS demonstrated a mean increase of 1.75g/dL averaged over weeks
28 to 52, compared to 0.40g/dL with placebo

ROCKIES demonstrated a mean increase of 0.77g/dL averaged over weeks
28 to 52, compared to 0.68g/dL with epoetin alfa

AstraZeneca today presented detailed results from the Phase III
OLYMPUS and ROCKIES trials showing that roxadustat significantly
increased haemoglobin (Hb) levels in non-dialysis-dependent (NDD) and
dialysis-dependent (DD) patients with anaemia from chronic kidney
disease (CKD), respectively.

The OLYMPUS trial compared roxadustat to placebo while the ROCKIES
trial compared roxadustat to epoetin alfa. The results were presented
today during two oral sessions at the American Society of Nephrology
(ASN) Kidney Week 2019 in Washington, D.C., US.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said:
"Anaemia is a common, serious condition among patients with chronic
kidney disease. It occurs when the body has fewer healthy red blood
cells than normal and low levels of haemoglobin, which may leave
patients fatigued and short of breath. Results from OLYMPUS and
ROCKIES reinforce the potential role that roxadustat could play in
increasing haemoglobin levels and managing anaemia, which is often
underdiagnosed and undertreated."

Steven Fishbane, MD, Zucker School of Medicine at Hofstra/Northwell,
Great Neck, New York, US and primary investigator on the OLYMPUS and
ROCKIES trials, said: "These data demonstrated that roxadustat
effectively increased haemoglobin levels for patients with anaemia
from chronic kidney disease, including those who show signs of
inflammation. Patients who experience chronic inflammation are often
more difficult to treat than the overall chronic kidney disease
patient population, emphasising the need for new treatment options."

In the OLYMPUS trial, roxadustat demonstrated a statistically
significant improvement in Hb levels from baseline, with a mean
increase of 1.75g/dL averaged over weeks 28 to 52, compared to
0.40g/dL with placebo, the primary efficacy endpoint.

Roxadustat also improved Hb levels from baseline in a subgroup of
patients with elevated high-sensitivity C-reactive protein (hsCRP)
levels of greater than 5mg/L, with a statistically significant mean
increase of 1.73 g/dL, compared to 0.62g/dL with placebo, a secondary
endpoint. hsCRP is a protein in the blood that increases when
inflammation is present.

Overall safety findings are generally consistent with the NDD-CKD
patient population. For all patients, the most frequently reported
adverse events in the intent to treat analysis set were end-stage
renal disease, pneumonia, urinary tract infection and hypertension.
Additional serious adverse events reported were azotaemia, sepsis,
acute kidney injury and hyperkalaemia.

In the ROCKIES trial, roxadustat demonstrated a statistically
significant improvement in Hb levels from baseline with a mean
increase of 0.77g/dL averaged over weeks 28 to 52, compared to
0.68g/dL with epoetin alfa, the primary efficacy endpoint.

Roxadustat also improved Hb levels from baseline in a subgroup of
patients with elevated hsCRP levels of greater than 5 mg/L,
demonstrating a statistically significant improvement with a mean
increase of 0.80g/dL compared to 0.59g/dL with epoetin alfa, a
secondary endpoint. Patients treated with roxadustat used less
monthly intravenous (IV) iron (mean = 59mg) compared to those treated
with epoetin alfa (mean = 91mg) from week 36 to the end of the study.

Adverse events with roxadustat were generally similar to those seen in
patients treated with epoetin alfa and commonly found in DD-CKD
patients. In roxadustat treated patients, the most frequently
reported adverse events were diarrhoea, hypertension, pneumonia,
headache and arteriovenous fistula thrombosis. Additional serious
adverse events reported were sepsis and acute myocardial infarction.

Cardiovascular (CV) safety data from these trials will be reported as
part of the pooled efficacy and CV safety analyses of DD-CKD and
NDD-CKD patients from the global Phase III programme, which is being
presented in the oral late-breaking abstract session "High-Impact
Clinical Trials" at ASN Kidney Week on 8 November 2019.

Roxadustat is currently approved in China for the treatment of anaemia
in patients with CKD, regardless of whether they require dialysis.
Data from the Phase III OLYMPUS and ROCKIES trials, together with the
efficacy and pooled CV safety data from the global Phase III
programme, will form part of the regulatory submission in the US,
anticipated in Q4 2019.

About roxadustat

Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor
(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.
Use 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 IV iron.

About the Phase III programme

FibroGen, Inc., (FibroGen) and AstraZeneca 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 Pharma Inc. (Astellas) are
collaborating on the development and commercialisation of roxadustat
for the treatment of anaemia in patients with CKD in territories
including Japan, Europe, the Commonwealth of Independent States, the
Middle East, and South Africa.

The global Phase III programme consisted of seven trials in more than
9,000 patients and was conducted by AstraZeneca, FibroGen and
Astellas.

About OLYMPUS

OLYMPUS is a Phase III, randomised, double blind, placebo-controlled
trial designed to evaluate the efficacy and safety of roxadustat vs.
placebo for the treatment of NDD patients with anaemia from CKD
stages 3, 4 and 5 . OLYMPUS evaluated 2,781 patients with anaemia
(Hb<10.0g/dL) in NDD-CKD stages 3-5 who were randomised 1:1 to
roxadustat or placebo across 26 countries. Top-line results announced
in December 2018 showed OLYMPUS met its primary efficacy endpoint.
OLYMPUS is one of two AstraZeneca-sponsored trials that are part of
the global Phase III clinical trials programme.

About ROCKIES

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 DD-CKD.
ROCKIES evaluated 2,133 DD-CKD patients with anaemia either currently
treated with an erythropoietin analogue (Hb<12g/dL) or not currently
treated with an erythropoietin analogue (Hb<10g/dL) randomised 1:1 to
roxadustat or epoetin alfa across 18 countries. Oral iron was
allowed; IV iron was used as standard of care (SoC) in the epoetin
alfa arm and with evidence of iron deficiency in the roxadustat arm.
Top-line results announced in December 2018 showed ROCKIES met its
primary efficacy endpoint. ROCKIES is one of two
AstraZeneca-sponsored trials that are part of the global Phase III
clinical trials programme.

About anaemia from CKD

Anaemia can be a serious medical condition in which patients have
insufficient red blood cells and low levels of haemoglobin, a protein
in red blood cells that carries oxygen to cells throughout the
body.[1,2 ]Anaemia from CKD is associated with increased risk of
hospitalisation, CV complications and death,[3] also frequently
causing significant fatigue, cognitive dysfunction and decreased
quality of life.[4] 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. CKD affects
more than 200 million patients worldwide and is generally a
progressive disease characterised by gradual loss of kidney function
that may eventually lead to kidney failure.

According to the United States Renal Data System, about 80% of the
approximately 507,000 patients receiving dialysis in the US in 2016
were being treated with erythropoiesis-stimulating agents (ESA).[5]
Patients seldom receive ESA treatment until they initiate dialysis
therapy.

About AstraZeneca in CVRM

Cardiovascular, Renal & 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 co-morbidities. 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.

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, CVRM, 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 (http://www.astrazeneca.com/) and follow us on
Twitter @AstraZeneca
(https://clicktime.symantec.com/37Bg16U1oCzfevsztvEsc5x6H2?u=https%3A%2F%...).

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