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

By Daiichi Sankyo, PRNE
Thursday, February 25, 2010

Potential New Treatment Option for Patients With Venous Thromboembolism (VTE) Offers Effective and Convenient Dosing Regimen

NUREMBERG, Germany, February 26, 2010 - 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:
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
www.clinicaltrials.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

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

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

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