Daiichi Sankyo to Present Findings From New Subgroup Analyses of Once-Daily LIXIANA® (edoxaban) in NVAF and VTE at ACC's 65th Annual Scientific Session

Munich (ots/PRNewswire) -

- Four abstracts highlight new subgroup analyses from the global
phase 3 ENGAGE AF-TIMI 48 and Hokusai-VTE studies to be presented
in oral and poster sessions

Daiichi Sankyo Europe GmbH Group (hereafter, Daiichi Sankyo) today
announced that data from three new subgroup analyses from the phase 3
ENGAGE AF-TIMI 48 study, and one new subgroup analysis from the phase
3 Hokusai-VTE study, will be presented at the American College of
Cardiology's 65th Annual Scientific Session, April 2-4, 2016, in
Chicago, Illinois. Results will provide new insights into the safety
and efficacy profile of once-daily edoxaban compared to warfarin in
patients with non-valvular atrial fibrillation (NVAF) and venous
thromboembolism (VTE).

The subgroup analysis data on edoxaban (known by the brand name
LIXIANA®) will be presented. The complete list of presentations is
included below:

Presentation Title Presenter
Session Details
Oral Session

Outcomes in 2,824 Patients With
Giulia Renda, MD, PhD, Monday, April 4,
Valvular Heart Disease
Treated G. d'Annunzio 8:30-8:42 AM CDT
With
Edoxaban or Warfarin in the University of Location:
S405
ENGAGE AF-TIMI 48 Trial (ACC Chieti-Pescara,

Session #915-06) Chieti, Italy

Poster
Presentations

Recurrent Venous
Marjolein P.A. Sunday, April 3
Thromboembolism
Brekelmans, MD 9:45-10:30 AM CDT
in
Pulmonary Embolism Patients Department of Location:
South
With Right Ventricular Vascular Medicine,
Hall A1
Dysfunction in the Hokusai-VTE Academic Medical

Study (ACC Abstract Center, Amsterdam,

#1186-305/305) Netherlands

Sudden Cardiac Death in
21,105 Alon Eisen, MD, Sunday, April 3
Patients
With Atrial Brigham and Women's 9:45-10:30 AM CDT
Fibrillation: Insights From the Hospital, Boston, MA,
Location: South
ENGAGE AF-TIMI 48 Trial (ACC
USA Hall A1
Abstract #1188-338/338)

Moderated Poster Presentation

Edoxaban Versus
Warfarin in 841 Jonathan Monday, April 4

Patients With Atrial Fibrillation Cunningham, MD,
12:45-12:55 PM CDT
and Peripheral Arterial Disease: Brigham
and Location: South
Insights From the ENGAGE AF-TIMI
Women's Hospital, Hall A1
48 Trial (ACC Session
#1289M-03) Boston, MA, USA

About the ENGAGE AF-TIMI 48 Study

The ENGAGE AF-TIMI 48 global phase 3 study investigated once-daily
edoxaban in comparison to warfarin in 21,105 patients with NVAF. This
represented the largest and longest trial with a novel oral
anticoagulant (NOAC) in patients with atrial fibrillation (AF)
performed to date, with a median follow-up of 2.8 years. Edoxaban
demonstrated non-inferiority for stroke or systemic embolism (SE) in
comparison to warfarin. Edoxaban was also found to be superior for
the principal safety endpoint of major bleeding in comparison to
warfarin.[1]

About the Hokusai-VTE Study

The Hokusai-VTE global phase 3 study was the largest single
comparative trial of a NOAC in patients with VTE, which evaluated
once-daily edoxaban versus warfarin in 8,292 patients with either
acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE)
or both. The Hokusai-VTE study was designed to reflect clinical
practice using a flexible treatment duration of 3-12 months in a
broad spectrum of VTE patients, including initial use of parenteral
anticoagulant (heparin) for at least five days, the proven global
standard of care. Edoxaban demonstrated non-inferiority to warfarin
for the primary efficacy endpoint of recurrence of symptomatic VTE,
and was found to be superior in the primary safety endpoint of
clinically relevant bleeding compared to warfarin.[2]

About AF

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.[3]

AF is the most common type of heart rhythm disorder, and is
associated with substantial morbidity and mortality.[4] More than six
million Europeans are diagnosed with AF, and this figure is expected
to at least double over the next 50 years.[5],[6] Compared to those
without AF, people with the arrhythmia have a 3-5 times higher risk
of stroke.[7] One in five of all strokes are as a result of AF.[5]

About VTE

VTE is an umbrella term for two conditions, DVT and PE. DVT is a
disease caused by a blood clot found in deep veins, usually within
the lower leg, thigh or pelvis, although they can occur in other
parts of the body as well.[8] PE occurs when part of a clot detaches
and lodges in the pulmonary arteries, causing a potentially fatal
condition.[9]

VTE is a major cause of morbidity and mortality.[10] A 2007 study
of morbidity and mortality from VTE in six European countries
(France, Germany, Italy, Spain, Sweden and the UK) estimated a total
of approximately 762,000 VTE episodes and a further 370,000
VTE-related deaths each year.[10] There is a high rate of recurrence
after a first VTE event, which is reduced with anticoagulant
treatment. Without anticoagulant treatment, approximately half of
patients who experience an initial VTE event have recurrent VTE
within three months.[11]

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 received EU approval in June 2015 for the prevention of
stroke and SE in adult patients with NVAF with one or more risk
factors, such as congestive heart failure, hypertension, age >= 75
years, diabetes mellitus, prior stroke or transient ischaemic attack
(TIA), as well as for the treatment of deep vein thrombosis (DVT) and
pulmonary embolism (PE), and prevention of recurrent DVT and PE in
adults. Edoxaban is currently marketed in South Korea, the
Netherlands, Ireland, the UK, Germany, Switzerland, the US and Japan,
and was approved in Taiwan. In other countries, regulatory review is
ongoing.

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of
innovative pharmaceutical products to address diversified, unmet
medical needs of patients in both mature and emerging markets. With
over 100 years of scientific expertise and a presence in more than 20
countries, Daiichi Sankyo and its 17,000 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 its strong
portfolio of medicines for hypertension, dyslipidemia, bacterial
infections, and thrombotic disorders, the Group's research and
development is focused on bringing forth novel therapies in
cardiovascular-metabolic diseases, pain management, and oncology,
including biologics. For more information, please visit:
http://www.daiichisankyo.com .

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. Giugliano R, et al. Edoxaban versus warfarin in patients with
atrial fibrillation. N Engl J Med. 2013;369(22):2093-2104.
2. Büller H, et al. Edoxaban versus warfarin for the treatment of
symptomatic venous thromboembolism. N Engl J Med.
2013;369(15):1406-1415.
3. 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: March 2016].
4. Iqbal MB, et al. Recent developments in atrial fibrillation. BMJ.
2005;330(7485):238-43.
5. 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.
6. 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.
7. Ball J, et al. Atrial fibrillation: Profile and burden of an
evolving epidemic in the 21st century. Int J Card.
2013;167:1807-1824.
8. Deep Vein Thrombosis (DVT) / Pulmonary Embolism (PE) - Blood Clot
Forming in a Vein. Centers for Disease Control and Prevention.
Available at: http://www.cdc.gov/ncbddd/dvt/facts.html . [Last
accessed: March 2016].
9. Van Beek E, et al. Deep vein thrombosis and pulmonary embolism.
New York: John Wiley & Sons, 2009. Print.
10. Cohen A, et al. Venous thromboembolism (VTE) in Europe. Thromb
Haemost. 2007;98(4):756-764.
11. Kearon C. Natural history of venous thromboembolism. Circulation.
2003;107(23 suppl 1):I-22-30.

Contact

Kimberly Wix (U.S)

Daiichi Sankyo, Inc.

Senior Director,
Public Affairs

+1-973-944-2338

Lydia Worms (Europe)

Daiichi Sankyo Europe GmbH

Edoxaban
Communications & Product PR Europe

+49(89)7808751

EDX/16/0070

Date of prep: March 2016

ots Originaltext: DAIICHI SANKYO EUROPE GmbH
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