Edoxaban - next generation oral anticoagulant under investigation to help prevent stroke in patients with atrial fibrillation

Barcelona (ots) -

New treatment could offer further option in addition to current
standard of care in thromboembolic disease

Edoxaban, an oral factor Xa inhibitor, is currently being
investigated in the pivotal phase III study ENGAGE AF-TIMI 48
(Effective aNticoaGulation with factor xA next GEneration in Atrial
Fibrillation) as a potential new treatment for stroke prevention in
patients with atrial fibrillation (AF). The new drug, developed
solely by DAIICHI SANKYO, could offer improvements in the management
of thromboembolic disease.

In Europe, approximately 4.5 million people suffer from AF.
"Without anticoagulation treatment these patients have a considerably
high risk of having a stroke, approximately five times higher than
that of the average population" said John Camm, Professor of Clinical
Cardiology, St. George's University of London, UK, during a press
conference organised by DAIICHI SANKYO EUROPE.

Anticoagulants interfere with the coagulation system resulting in
a decreased tendency for the formation of blood clots, and are used
to treat and prevent thromboembolic events. Existing anticoagulants,
like heparin and vitamin K antagonists have been shown to be
effective.1 However the use of these treatments, particularly vitamin
K antagonists, is limited by the requirement for close monitoring,
drug-to-drug and food-to-drug interactions, as well as a considerable
risk of bleeding.(1)

"There is a definite need for new and improved oral anticoagulants
for stroke prevention in patients with atrial fibrillation",
commented Jeffrey I. Weitz, MD, FACP, FRCP, Professor of Medicine and
Biochemistry, McMaster University and Director of the Henderson
Research Centre, Ontario, Canada. "Edoxaban could offer significant
improvements in the management of these patients."

A comprehensive phase I and phase II study programme for edoxaban
has already indicated dose-dependent anticoagulation over a range of
doses, with no significant dose-related increase in bleeding:

- Edoxaban has a safety and tolerability profile similar to that
of warfarin in patients with non-valvular atrial fibrillation.(2) The
incidence of major and clinically relevant non-major bleeding events
reported in the 30 mg and 60 mg once daily edoxaban treatment groups
was similar to, or better than, those in the warfarin treated group.
These doses of edoxaban are being compared with warfarin in the
ongoing ENGAGE AF-TIMI 48 trial.

- Edoxaban demonstrated significant dose-dependent reductions in
venous thromboembolism after total knee or hip replacement
surgery.(3,4)

These data are encouraging for patients and support edoxaban's
potential to significantly streamline anticoagulation management,
while providing effective protection against severe thromboembolic
events like stroke. Results from the phase II studies are important
because they have been used to establish the optimal dosing regimen
to pursue in the phase III clinical trial ENGAGE AF-TIMI 48.

Experts are anticipating the outcome of this phase III study.
"This study is intended to show that atrial fibrillation patients can
be treated simply, effectively and safely with once-daily
administration of the factor Xa inhibitor edoxaban" said Robert
Giugliano, MD, SM, FACC, Senior Investigator, TIMI-Study Group,
Associate Physician and Assistant Professor in Medicine, Brigham and
Women's Hospital, Harvard Medical School, Boston, USA.

ENGAGE AF-TIMI 48 compares two different doses of edoxaban with
warfarin in patients with AF. Approximately 16,500 patients will be
enrolled in this double-blind trial from 1,400 clinical sites
worldwide. Patients will be assigned, in a double-blind, double-dummy
fashion, to one of three treatment groups: 30 mg edoxaban once daily,
60 mg edoxaban once daily or warfarin. Edoxaban will be given in
fixed doses without coagulation monitoring. In contrast, the dose of
warfarin will be adjusted to maintain the international normalised
ratio (INR) between 2.0 and 3.0. The primary efficacy endpoint is
stroke and systemic events, while the primary safety endpoint is the
occurrence of major and clinically relevant non-major bleeding
events, using the sensitive ISTH (International Society on Thrombosis
and Haemostasis) scale. The expected median treatment duration in the
study is 24 months; the sponsor, DAIICHI SANKYO, expects the study to
conclude in the first half of 2012.

Notes to editors:

- Phase III trials will also be conducted to assess edoxaban for
the prevention of venous thromboembolism (VTE) after hip or knee
replacement surgery in Asian markets.

- Factor Xa is a key enzyme in blood coagulation. When factor Xa
is inhibited, blood clot formation is attenuated, thereby minimising
the possibility of thromboembolic events, like stroke.

About DAIICHI SANKYO

DAIICHI SANKYO is a global pharmaceutical company that focuses on
researching and marketing innovative medications. The company was
created in 2005 through the merger of two traditional Japanese
enterprises, Daiichi and Sankyo. With net sales of nearly 5.9 billion
? in fiscal year 2008, DAIICHI SANKYO is one of the world's 20
leading pharmaceutical companies. The company's world headquarters is
in Tokyo, and its European base is located in Munich. DAIICHI SANKYO
has affiliates in 12 European countries and has been one of the
strongest Japanese pharmaceutical companies located in Europe since
it set up European production facilities and marketing offices in
1990. The company's research activities focus on the areas of
cardiovascular diseases, haematology, diabetes, anti-infectives and
cancer. Its aim is to develop medications that are "best" in their
class or to create new classes of pharmaceutical drugs.
http://www.daiichi-sankyo.eu

References:

(1). Weitz JI, Bates SM. New anticoagulants. J Thromb Haemost.
2005; 3: 1843-53.

(2). Weitz JI, Connolly SJ, Kunitada S, Jin J, Patel I.
Randomised, parallel group, multicentre, multinational study
evaluating safety of DU-176b compared with warfarin in subjects with
non-valvular atrial fibrillation. ASH Annual Meeting 2008; 112:
Abstract 33.

(3). Fuji T, Fujita S, Tachibana S, Kawai Y. Randomised, double
blind, multi-dose efficacy, safety and biomarker study of the oral
factor Xa inhibitor DU-176b compared with placebo for prevention of
venous thromboembolism in patients after total knee arthroplasty. ASH
Annual Meeting 2008; 112: Abstract 34.

(4). Raskob G, Cohen A, Eriksson B et al. Randomised, double
blind, multi dose trial of the oral factor Xa inhibitor DU-176b
versus LMW heparin (Dalteparin) for prevention of venous
thromboembolism after total hip replacement. European Heart Journal.
2008; 29: Abstract supplement 609.

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 EUROPE GmbH. 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
EUROPE GmbH assumes no responsibility for the updating of such
forward-looking statements about future developments of the sector,
legal and business conditions and the company.

Originaltext: DAIICHI SANKYO EUROPE GmbH
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Contact:

Dr. Michaela Paudler-Debus
Head of Product PR
Corporate Communications and Public Affairs
DAIICHI SANKYO EUROPE GmbH
+ 49 89 7808 685 (direct)
+ 49 172 845 8974 (mobile)
michaela.paudler-debus@daiichi-sankyo.eu

Medical contact:

Dr. Felix Münzel
Vice Director Medical & Scientific Affairs CV
DAIICHI SANKYO EUROPE GmbH
+ 49 89 7808 0
felix.muenzel@daiichi-sankyo.eu