DAIICHI SANKYO Announces Enrollment in the Two Largest Single Phase III Trials so far for the Prevention of Stroke in AF and for the Treatment of VTE is Proceeding as Planned

Stockholm (ots/PRNewswire) - DAIICHI SANKYO announced
today that the ongoing trials ENGAGE AF-TIMI 48 (The Effective
Anticoagulation with Factor Xa Next Generation in Atrial
Fibrillation) and HOKUSAI VTE with their investigational factor Xa
inhibitor edoxaban are enrolling in accordance to plan. The projected
recruitment of ENGAGE AF-TIMI 48 and HOKUSAI VTE are 20,500 and 7,500
patients, respectively. ENGAGE AF-TIMI 48 and HOKUSAI VTE are the two
largest single phase III trials in atrial fibrillation (AF) and
venous thromboembolism (VTE) to date.

It is estimated that throughout Europe 4.5 million people suffer
from AF[1], and approximately 370,000 deaths are related to VTE per
year in six major European countries (France, Germany, Italy, Spain,
Sweden, and the UK).[2] Due to the aging population, the number of
patients with AF is likely to increase 2.5 fold by the year 2050.[3]

The ENGAGE AF-TIMI 48 study is investigating the safety and
efficacy of edoxaban in preventing strokes and systemic embolic
events in patients with AF. ENGAGE AF-TIMI 48 is the only phase III
trial in atrial fibrillation in which a factor Xa inhibitor is
investigated at two different dose levels. The study was initiated in
late 2008, and DAIICHI SANKYO expects the study to be concluded in
2012.

The HOKUSAI VTE study is evaluating the safety and efficacy of
edoxaban in preventing recurrent venous thromboembolic events in
patients with deep vein thrombosis (DVT) and/or pulmonary embolism
(PE). The study was initiated in late 2009, and DAIICHI SANKYO
expects the study to be concluded in 2012.

In addition to ENGAGE AF-TIMI 48 and HOKUSAI VTE, edoxaban has
been investigated for the prevention of VTE after major orthopedic
surgery in Japanese and Taiwanese patients in the STARS-E3 (Studying
Thrombosis After Replacement Surgery) trial. The first, positive
results of this phase III trial were presented in July of this year
at the International Congress of Thrombosis (ICT) in Milan.[4],[5]

ENGAGE AF-TIMI 48 Study Design[6],[7]

The ENGAGE AF-TIMI 48 study is investigating the safety and
efficacy profile of two different doses of edoxaban versus warfarin
in individuals with AF at moderate to high risk of stroke. Patients
are randomized to one of three treatment groups: high dose regimen
(edoxaban 60 mg once-daily), low dose regimen (edoxaban 30 mg
once-daily), and warfarin. Approximately 20,500 patients will be
enrolled making ENGAGE AF-TIMI 48 the largest stroke prevention study
in AF with a novel anticoagulant so far, and the expected median
treatment duration is 24 months. The primary efficacy endpoint is the
composite clinical outcome of stroke and systemic embolic events; the
primary safety endpoint is the incidence of major bleeding.

HOKUSAI VTE Study Design[8],[9]

The HOKUSAI VTE trial is evaluating the safety and efficacy of
edoxaban in the treatment and prevention of recurrent thromboembolic
events in patients with deep-vein thrombosis and/or pulmonary
embolism. Two different treatment groups will receive enoxaparin or
unfractionated heparin for at least five and up to 12 days, followed
by double-blind warfarin or edoxaban 60 mg once-daily. The primary
efficacy endpoint is the composite clinical outcome of symptomatic
recurrent DVT, non-fatal symptomatic recurrent PE, and fatal PE; the
primary safety endpoint is the incidence of major and clinically
relevant non-major bleeding. Patients will be treated for up to 12
months in accordance to the standard of care and international
guidelines.

About Edoxaban

Edoxaban, an investigational direct oral factor Xa inhibitor, is
a potential new therapy with the promise to overcome current
therapeutic limitations in anticoagulation. Edoxaban is anticipated
to be given once-daily; require no dietary restrictions; require no
routine monitoring. Edoxaban could become an attractive treatment
alternative for patients. Furthermore, edoxaban is the only factor Xa
inhibitor being investigated in phase III in two different doses in
patients with AF. Therefore stroke prevention therapy with edoxaban
in AF may be tailored to account for individual characteristics of
patients and further improve the risk benefit profile of
anticoagulation.

About Daiichi Sankyo

The Daiichi Sankyo Group is dedicated to the creation and supply
of innovative pharmaceutical products to address the diversified,
unmet medical needs of patients in both mature and emerging markets.
While maintaining its portfolio of marketed pharmaceuticals for
hypertension, hyperlipidemia, and bacterial infections, the Group is
engaged in the development of treatments for thrombotic disorders and
focused on the discovery of novel oncology and
cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo
Group has created a "Hybrid Business Model," which will respond to
market and customer diversity and optimize growth opportunities
across the value chain. For more information, please visit:
http://www.daiichisankyo.com.

The company's world headquarters are in Tokyo. Its European base
is located in Munich. DAIICHI SANKYO EUROPE has affiliates in 12
European countries in addition to a global manufacturing site located
in Pfaffenhofen, Germany.

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] Fuster V, Ryden LE, Cannom DS et al. ACC/AHA/ESC 2006
Guidelines for the management of patients with Atrial Fibrillation.
Circulation. 2006; 114;e257-e354.

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

[3] Santini M, Ricci RP. The worldwide social burden of atrial
fibrillation: What should be done and where do we go? J Interv Card
Electrophysiol. 2006; 17:183-188.

[4] T. Fuji et al., Edoxaban versus enoxaparin for
thromboprophylaxis after total knee replacement: The STARS E-3 trial
21st International Congress of Thrombosis, July 6 - 9 2010, Milano.
Abstract Number OC 297. http://content.karger.com/ProdukteDB/produkte
.asp?Aktion=ShowPDF&ArtikelNr=318095&Ausgabe=254413&ProduktNr=224034&
filename=318095.pdf

[5] http://www.daiichisankyo.com/news/detail/003667.html. Last
accessed 23.07.2010.

[6] The ENGAGE AF-TIMI 48 trial: http://www.clinicaltrials.gov/ct
2/show/record/NCT00781391?term=DU-176b&rank=1 . Last accessed
13.08.2010.

[7] http://www.daiichi-sankyo.de/_uploads/media/2199_PI_DAIICHI%2
0SANKYO_Edoxaban%20ESC.doxc.pdf. Last accessed 13.08.2010.

[8] The HOKUSAI VTE trial:
http://clinicaltrials.gov/ct2/show/NCT00986154?term=HOKUSAI&rank=1.
Last accessed 13.08.2010.

[9] http://www.daiichisankyo.com/news/detail/003226.html. Last
accessed 23.07.2010

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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@daiichi-sankyo.eu
Dr. Felix Münzel
Vice Director
Medical and Scientific Affairs CV
Phone +49(0)89-78-08-471
felix.muenzel@daiichi-sankyo.eu

ots Originaltext: DAIICHI SANKYO EUROPE GmbH
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