European Results From Global ETNA-AF Registry Show Low Bleeding and Low Cardiovascular Event Rates in Elderly NVAF Patients on LIXIANA® (edoxaban)

- One-year outcomes of real-world edoxaban-treated European
patients from the Global ETNA-AF registry showed low rates of
potentially life-threatening bleeding and low CV events in elderly
NVAF patients1

- The Global ETNA-AF programme is currently the largest and most
comprehensive repository of routine clinical practice data on the
use, effectiveness, and safety of a single NOAC in AF patients

- Real-world Europe-specific findings demonstrate effectiveness
and safety of edoxaban in routine clinical care across Europe1

Munich (ots/PRNewswire) - -- Daiichi Sankyo Europe GmbH
(hereafter, "Daiichi Sankyo") today announced one-year follow-up
results from an analysis of 12,574 European non-valvular atrial
fibrillation (NVAF) patients, mostly elderly, treated with edoxaban
(known by the brand name LIXIANA®). One-year results from the ongoing
Global ETNA-AF (Edoxaban Treatment in routiNe clinical prActice)
registry, providing a snapshot of characteristics and outcomes from a
broad range of NVAF patients receiving edoxaban in routine clinical
care, were presented today at the Great Wall International Congress
of Cardiology (GW-ICC) 2019, in Beijing, China.

Overall, results from ETNA-AF at one year showed low rates of
bleeding (major and gastrointestinal [GI]), intracranial haemorrhage
(ICH) and ischaemic events during the first year of edoxaban
therapy.1 Per year, in the 12,574 patients from 825 sites2 in
Europe:1

- ISTH-defined major bleeding occurred in only 125 (1.05%) patients,
ICH occurred in 28 (0.23%) patients, and major GI bleeding occurred
in 47 (0.39%) patients
- Ischaemic stroke occurred in 65 (0.54%) patients, transient
ischaemic attack (TIA) occurred in 44 (0.37%) patients, and
haemorrhagic stroke occurred in 13 (0.11%) patients.

Rates of systemic embolic events (SEE) and myocardial infarction
(MI) were generally low. Per year in Europe:1

- SEE occurred in 13 (0.11%) patients
- MI occurred in 63 (0.53%) patients.

Additionally, mortality rates were low. In total, per year in
Europe:1

- All-cause mortality occurred in 425 (3.55%) patients and
cardiovascular mortality occurred in 200 (1.67%) patients.

While rates of stroke, bleeding and all-cause and cardiovascular
mortality increased with age, an age-related increase in ICH was not
apparent and rates were low in each age group.

"In routine clinical practice, the rates of major and
clinically-relevant non-major (CRNM) bleeding in elderly
edoxaban-treated patients were lower than those observed in clinical
trial settings. Additionally, rates of all other cardiovascular
events were also low in these patients," said Professor Raffaele De
Caterina, Professor of Cardiology, Institute of Cardiology at the
University of Pisa, Italy. "Atrial fibrillation is the most common
form of arrhythmia in patients over the age of 65, and its prevalence
increases with age. As such, it is critical that we understand the
safety and efficacy profile of edoxaban in elderly populations."

The wider Global ETNA-AF programme, which at present is the
largest and most comprehensive repository of routine clinical
practice data on the use, effectiveness, and safety of a single NOAC
in patients with atrial fibrillation (AF), collected data from 24,962
patients in 2,242 sites in Japan, Korea/Taiwan and Europe.

"These positive results provide great insight into the safety and
efficacy profile of edoxaban in NVAF patients, particularly in those
who are elderly and/or those with comorbidities, who are considered
at higher risk of cardiovascular events," said Wolfgang Zierhut, MD,
Executive Director Medical Affairs and Head Thrombosis and
Cardiovascular at Daiichi Sankyo Europe. "Findings from ETNA-AF
demonstrate that Phase III efficacy and safety results from the
ENGAGE AF-TIMI-48 clinical study are being confirmed in regular
routine clinical care across the region."

About ETNA-AF

ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in
patients with nonvalvular Atrial Fibrillation) is a global programme
that combines data from distinct non-interventional studies in
Europe, East Asia, and Japan in a single database. A total of more
than 28,000 patients will be included in the ETNA-AF registries and
followed for two years (patients in Europe will be followed for four
years). The primary objective of ETNA-AF is to collect information on
the use of edoxaban in routine clinical practice, including the
safety and efficacy profile in non-preselected patients with
NVAF.3,4,5,6,7

About Atrial Fibrillation

AF is a condition where the heart beats irregularly and rapidly.
When this happens, blood can pool and thicken in the chambers of the
heart causing an increased risk of blood clots. These blood clots can
break off and travel through the blood stream to the brain (or
sometimes to another part of the body), where they have the potential
to cause a stroke.8

AF is the most common type of heart rhythm disorder and is
associated with substantial morbidity and mortality.9 More than six
million Europeans are diagnosed with AF, and this figure is expected
to at least double over the next 50 years.10,11 Compared to those
without AF, people with the arrhythmia have a 3-5 times higher risk
of stroke.12 One in five of all strokes are as a result of AF.9

About Edoxaban

Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten
A") inhibitor. Factor Xa is one of the key components responsible for
blood clotting, so inhibiting this makes the blood thin and less
prone to clotting. Edoxaban is currently marketed by Daiichi Sankyo
and its partners in more than 30 countries and regions around the
world.

About the Edoxaban Clinical Research Programme

More than 10 studies, more than 100,000 patients worldwide

Daiichi Sankyo is committed to expanding scientific knowledge
about edoxaban, as demonstrated through research programmes
evaluating its use in a broad range of cardiovascular conditions,
patient types and clinical settings in atrial fibrillation (AF) and
venous thromboembolism (VTE) designed to further build on the results
of the pivotal ENGAGE-AF and Hokusai-VTE studies. More than 100,000
patients worldwide are expected to participate in the edoxaban
clinical research programme, which is comprised of more than 10 RCTs
(randomised, controlled trials), registries and non-randomised
clinical studies, including completed, ongoing and future research.
Our goal is to generate new edoxaban clinical and real-world-data
regarding its use in AF and VTE populations, providing physicians and
patients worldwide with greater treatment assurance.

The RCTs include:

- ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor xA next
GEneration in Atrial Fibrillation), in AF patients at
moderate-to-high risk of thromboembolic events

- Hokusai VTE (Edoxaban in Venous Thromboembolism), in patients
with either acute symptomatic deep vein thrombosis (DVT), pulmonary
embolism (PE) or both

- ENSURE-AF (EdoxabaN vs. warfarin in subjectS UndeRgoing
cardiovErsion of Atrial Fibrillation), in AF patients undergoing
electrical cardioversion

- ENTRUST-AF PCI (EdoxabaN TReatment versUS VKA in paTients with
AF undergoing PCI), in AF patients undergoing percutaneous coronary
intervention

- Hokusai-VTE Cancer (Edoxaban in Venous Thromboembolism
Associated with Cancer), in patients with cancer and an acute VTE
event

- ELDERCARE-AF (Edoxaban Low-Dose for EldeR CARE AF patients), in
elderly AF patients in Japan

- ELIMINATE-AF (EvaLuatIon of edoxaban coMpared with VKA IN
subjects undergoing cAThEter ablation of non-valvular Atrial
Fibrillation)

- ENVISAGE-TAVI AF (EdoxabaN Versus standard of care and theIr
effectS on clinical outcomes in pAtients havinG undergonE
Transcatheter Aortic Valve Implantation (TAVI) - Atrial Fibrillation)

- STABLED Study (STroke secondary prevention with catheter
ABLation and EDoxaban for patients with non-valvular atrial
fibrillation) in Japan

- ENRICH-AF (EdoxabaN foR IntraCranial Hemorrhage survivors with
Atrial Fibrillation, an investigator initiated phase III study)

In addition, global and regional registry and non-randomised
clinical studies provide important real-world and clinical data about
the use of edoxaban and other oral anticoagulants in everyday
practice; these include:

- ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in
patients with nonvalvular Atrial Fibrillation)

- ETNA-VTE (Edoxaban Treatment in routiNe clinical prActice in
patients with Venous ThromboEmbolism)

- EMIT-AF/VTE (Edoxaban Management In diagnostic and Therapeutic
procedures-AF/VTE)

- Prolongation PREFER in AF (PREvention oF thromboembolic events -
European Registry) in patients with AF

- ANAFIE (All Nippon AF In Elderly) Registry in Japan

- Cancer-VTE Registry in Japan

- RYOUMA (Real world ablation therapY with anti-cOagUlants in
Management of Atrial fibrillation) Registry in Japan

- KYU-RABLE (Multicenter study associated with KYU-shu to evaluate
the efficacy and safety of edoxaban in patients with non-valvulaR
Atrial fiBriLlation undergoing cathEter ablation) in Japan

- BPV-AF (Atrial Fibrillation with BioProsthetic valve) Registry
in Japan

Through the edoxaban clinical research programme, we are committed
to adding to the scientific body of knowledge around edoxaban in a
variety of AF and VTE patients, including those who are vulnerable.

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of
innovative pharmaceutical therapies to improve standards of care and
address diversified, unmet medical needs of people globally by
leveraging our world-class science and technology. With more than 100
years of scientific expertise and a presence in more than 20
countries, Daiichi Sankyo and its 15,000 employees around the world
draw upon a rich legacy of innovation and a robust pipeline of
promising new medicines to help people. In addition to a strong
portfolio of medicines for cardiovascular diseases, under the Group's
2025 Vision to become a "Global Pharma Innovator with Competitive
Advantage in Oncology," Daiichi Sankyo is primarily focused on
providing novel therapies in oncology, as well as other research
areas centered around rare diseases and immune disorders. For more
information, please visit: www.daiichisankyo.com.

Contact
Lydia Worms (Europe)
Daiichi Sankyo Europe GmbH
Edoxaban Communications & Product PR Europe
+49 (89) 7808751

Forward-looking statements

This press release contains forward-looking statements and
information about future developments in the sector, and the legal
and business conditions of DAIICHI SANKYO Co., Ltd. Such
forward-looking statements are uncertain and are subject at all times
to the risks of change, particularly to the usual risks faced by a
global pharmaceutical company, including the impact of the prices for
products and raw materials, medication safety, changes in exchange
rates, government regulations, employee relations, taxes, political
instability and terrorism as well as the results of independent
demands and governmental inquiries that affect the affairs of the
company. All forward-looking statements contained in this release
hold true as of the date of publication. They do not represent any
guarantee of future performance. Actual events and developments could
differ materially from the forward-looking statements that are
explicitly expressed or implied in these statements. DAIICHI SANKYO
Co., Ltd. assume no responsibility for the updating of such
forward-looking statements about future developments of the sector,
legal and business conditions and the company.

References

[1] De Caterina, R. et al. One-year Outcomes of Major Bleeding,
Stroke and Mortality in Approximately 25,000 AF Patients Treated with
Edoxaban in Routine Clinical Practice: Snapshot from Global
Noninterventional ETNA-AF Program. Abstract presented at GW-ICC
Congress 2019.

[2] De Caterina, R. et al. Characteristics of patients initiated
on edoxaban in Europe: baseline data from edoxaban treatment in
routine clinical practice for patients with atrial fibrillation (AF)
in Europe (ETNA-AF-Europe). BMC Cardiovasc Disord. 2019;19(1):165.

[3] Edoxaban Treatment in Routine Clinical Practice for Patients
With Non Valvular Atrial Fibrillation (ETNA-AF-EU). Available at:
https://clinicaltrials.gov/ct2/show/NCT02944019. [Last accessed:
October 2019].

[4] Edoxaban Treatment in Routine Clinical Practice for Patients
With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN).
Available at: https://clinicaltrials.gov/ct2/show/NCT02951039. [Last
accessed: October 2019].

[5] Edoxaban Treatment in Routine Clinical Practice for Patients
With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong). Available
at: https://clinicaltrials.gov/ct2/show/NCT03247582. [Last accessed:
October 2019].

[6] Edoxaban Treatment in Routine Clinical Practice for Patients
With Non-Valvular Atrial Fibrillation (NVAF). Available at:
https://clinicaltrials.gov/ct2/show/NCT03247569. [Last accessed:
October 2019].

[7] ETNA-AF-Japan. Available at: https://upload.umin.ac.jp/cgi-ope
n-bin/ctr/ctr_view.cgi?recptno=R000019728 [Last accessed: October
2019].

[8] National Heart, Lung and Blood Institute - What is Atrial
Fibrillation. Available at:
http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_diagnosis.html.
[Last accessed: October 2019].

[9] Iqbal MB, et al. Recent developments in atrial fibrillation.
BMJ. 2005;330(7485):238-43.

[10] Camm A, et al. Guidelines for the management of atrial
fibrillation: the Task Force for the Management of Atrial
Fibrillation of the European Society of Cardiology (ESC). Eur Heart
J. 2010;31(19):2369-2429.

[11] Krijthe BP, et al. Projections on the number of individuals
with atrial fibrillation in the European Union, from 2000 to 2060.
Eur Heart J. 2013;34(35):2746-2751.

[12] Ball J, et al. Atrial fibrillation: Profile and burden of an
evolving epidemic in the 21st century. Int J Card.
2013;167:1807-1824.

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