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

Estimated Recruitment for ENGAGE AF - TIMI 48: 20,500 Patients

STOCKHOLM, September 1, 2010 - 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: 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.
content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowPDF&ArtikelNr=318095&Ausgabe=254413&ProduktNr=224034&filename=318095.pdf

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

[6] The ENGAGE AF-TIMI 48 trial:
www.clinicaltrials.gov/ct2/show/record/NCT00781391?term=DU-176b&rank=1
. Last accessed 13.08.2010.

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

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

[9] 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

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