HOKUSAI VTE - Largest Single Phase III Trial for the Treatment and Prevention of Recurrent VTE Started in Europe

Nuremberg, Germany, February 26, 2010 (ots/PRNewswire) - Edoxaban, a
direct oral factor Xa inhibitor, is now being investigated in a
second large-scale pivotal phase III trial, HOKUSAI (pronounced
hoek-sigh) VTE. This phase III trial is evaluating the safety and
efficacy of edoxaban in the treatment and prevention of recurrent
thromboembolic events in patients with deep-vein thrombosis (DVT)
and/or pulmonary embolism (PE). HOKUSAI VTE[1] is currently the
largest single, randomised, multinational phase III trial for
treatment and prevention of recurrent venous thromboembolism (VTE),
involving approximately 7,500 patients in 450 clinical sites in 40
countries.

"In Europe, VTE affects more than 750,000 people in six major
European countries and approximately 370,000 deaths per year are
related to VTE in these countries,[2]" said Henri Bounameaux, MD,
Professor of Medicine, Director of the Division of Angiology and
Hemostasis, Chairman of the Department of Medicine at the University
Hospital of Geneva, Switzerland, during a press conference organized
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 heparins and vitamin K antagonists, although effective, have
several limitations. Heparins are injectable agents and therefore
less suitable for long-term treatment. Vitamin K antagonists are
given orally, but associated with numerous drug-drug and drug-food
interactions.

"The current chronic standard treatment of VTE, vitamin K
antagonists, requires extensive monitoring and continuous dose
adaptation to avoid excessive bleedings and to ensure effective
anticoagulation," said Sebastian Schellong, MD, Professor for
Internal Medicine, Head of Medical Division 2, Municipal Hospital
Friedrichstadt, Dresden, Germany. "Based on the data on edoxaban we
have seen so far, it has a predictable pharmacokinetic and dynamic
profile that allows for a convenient once-daily dosing that can be
kept constant throughout the treatment period."

The data are encouraging for patients and supports edoxaban's
potential to significantly improve the management of anticoagulation,
while providing effective protection against recurrent thromboembolic
events.

"HOKUSAI VTE is intended to show that VTE patients can be treated
effectively and safely with the most simple and most convenient
dosing regimen among factor Xa inhibitors," said Harry R. Büller, MD,
Professor of Internal Medicine, Chairman of the Department for
Vascular Medicine at the Academic Medical Center, Amsterdam, The
Netherlands and lead investigator for HOKUSAI VTE.

HOKUSAI VTE is an event-driven, double-blind, double-dummy,
parallel-group study, which will randomise patients to two different
treatment groups. Both groups will receive enoxaparin or
unfractionated heparin for at least five and up to 12 days, followed
by double-blind warfarin with a target INR of 2-3 or edoxaban 60 mg
once-daily. Patients will be treated for up to 12 months in
accordance to the standard of care and international guidelines.

The primary efficacy endpoint for HOKUSAI VTE is the recurrence
of symptomatic VTE (i.e. the composite of DVT, non-fatal PE, and
fatal PE). The primary safety assessment of the trial is the
incidence of major and clinically relevant non-major bleeding. The
sponsor, DAIICHI SANKYO, expects the study to conclude in 2012.

The HOKUSAI VTE study is named after the famous Japanese artist
and painter Katsushika Hokusai (1760-1849) of the former Edo period;
"Edo" is the city currently known as Tokyo, the location of the
DAIICHI SANKYO global headquarters.

In addition to the HOKUSAI VTE study, an ongoing, multinational,
randomised, double blind, phase III study, aims to demonstrate the
safety and efficacy profile of edoxaban amongst more than 16,500
patients with atrial fibrillation (ENGAGE AF-TIMI 48) [3].

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
EUR 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.

For more information, please visit: http://www.daiichi-sankyo.eu

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.

References:

[1] Clinicaltrials.gov : NCT00986154, Available at http://www.cli
nicaltrials.gov/ct2/show/NCT00986154?term=hokusai&rank=1. Accessed
December 3, 2009.

[2] Cohen AT et al. Venous Thromboembolism (VTE) in Europe.
Thromb Haemost 2007; 98:756-64.

[3] ClinicalTrials.gov Identifier: NCT00781391

http://www.clinicaltrials.gov/ct2/show/NCT00781391?term=DU-176b&rank=
1. Accessed December 3, 2009.

ots Originaltext: Daiichi Sankyo
Im Internet recherchierbar: http://www.presseportal.de

Contact:
CONTACT: CONTACT: Dr. Michaela Paudler-Debus, Vice Director, Head
ofProduct PR, Corporate Communications and Public Affairs,
Phone+49(0)89-78-08-685, michaela.paudler-debus@daiichi-sankyo.eu;
Dr. FelixMünzel, Vice Director, Medical and Scientific Affairs CV,
Phone+49(0)89-78-08-471, felix.muenzel@daiichi-sankyo.eu