Edoxaban Demonstrates Superior Efficacy Compared With Enoxaparin Sodium in Preventing VTE After Total Knee Replacement

Tokyo, July 12, 2010 (ots/PRNewswire) - Daiichi Sankyo Company, Limited
announced that its investigational once-daily oral, direct factor Xa
inhibitor, edoxaban, was shown to be superior to enoxaparin in
preventing venous thromboembolic (VTE) events in patients following
total knee replacement (TKR), a type of major orthopedic surgery.
Results from the Phase III STARS E-3 (Studying Thrombosis After
Replacement Surgery) study were presented at the 21st International
Congress on Thrombosis (ICT) in Milan, Italy.[i]

This multicenter, double-blind, double dummy, centrally
randomized trial evaluated the efficacy and safety of edoxaban
compared with enoxaparin in patients undergoing TKR in Japan and
Taiwan. A total of 716 patients received either 30 mg once-daily oral
dose of edoxaban or subcutaneous injection of enoxaparin 2,000
international units (equivalent to 20 mg) twice-daily for 11 to 14
days. The primary efficacy endpoint of the trial was the incidence of
symptomatic pulmonary embolism (PE) and symptomatic and asymptomatic
deep vein thrombosis (DVT). The primary safety endpoint was the
incidence of major bleeding and clinically relevant non-major
bleeding.

DVT occurred in 7.4 percent of patients receiving edoxaban
once-daily compared with 13.9 percent of patients who received
enoxaparin (relative risk reduction of 46.8 percent; p=0.01). There
were no PE events observed in either treatment group. There was no
statistically significant difference in major and clinically relevant
non-major bleeding (p=0.13). There were no cases of intracranial
hemorrhage or death in either treatment group.

Indicators for potential liver damage in both treatment groups
were carefully monitored during this trial by measuring bilirubin and
serum aminotransferase levels.[ii] Elevations greater than three
times the upper limit of the normal range of serum aminotransferase
levels occurred in 1.4 percent of patients taking edoxaban compared
with 8.0 percent of those taking enoxaparin.

"The combination of efficacy, tolerability and convenient
once-daily oral dosing in this clinical setting further supports the
potential role of edoxaban in helping patients and physicians
avoiding thrombotic events," said Dr. Takeshi Fuji, Head of
Orthopedic Surgery, Osaka Koseinenkin Hospital. "These results are
encouraging as they demonstrate superior efficacy of once-daily
edoxaban compared with twice daily subcutaneous enoxaparin, the
current standard of care for this patient population."

In March 2010, Daiichi Sankyo submitted a New Drug Application to
the Ministry of Health, Labor and Welfare in Japan seeking approval
of edoxaban for the prevention of VTE after major orthopedic surgery.

Global Development of Edoxaban

The global clinical development program for edoxaban comprises
several indications, including the prevention of stroke and systemic
embolic events in patients with atrial fibrillation, as well as the
acute treatment and long-term secondary prevention of VTE.

Global studies include:
- ENGAGE AF-TIMI 48: Investigates two different doses of once-daily
edoxaban versus warfarin in approximately 20,500 patients with atrial
fibrillation for the prevention of stroke and systemic embolic events.
ENGAGE AF-TIMI 48 began enrollment in late 2008 and is expected to be
completed in 2012.
- HOKUSAI VTE: To date, the largest single trial for the secondary
prevention of recurrent VTE in approximately 7,500 patients with deep
vein thrombosis and/or pulmonary embolism as well as for the acute
treatment of VTE. HOKUSAI VTE trial enrollment began in early 2010.

Both HOKUSAI VTE and ENGAGE AF-TIMI 48 are Phase III,
multi-national, randomized, double-blind studies.

About Edoxaban

Edoxaban is a once-daily oral anticoagulant that directly
inhibits factor Xa, an important factor in the coagulation process.
Daiichi Sankyo is developing edoxaban as a potential new treatment
for the prevention of both arterial and venous thromboembolism.
Notably, Daiichi Sankyo has more than 25 years experience conducting
research in the area of factor Xa inhibition, and was the first
company to study these compounds in humans. Edoxaban is being
developed solely by Daiichi Sankyo.

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 7.3 billion
EUR in fiscal year 2009 (as of March 31st), DAIICHI SANKYO is one of
the world's 20 leading pharmaceutical companies. The company's world
headquarters is in Tokyo, 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, hematology, anti-infectives and cancer.
Its aim is to develop medications that are "best" in their class or
to create new classes of pharmaceutical drugs.

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, Co. Ltd, DAIICHI SANKYO,
Inc., and 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, Co. Ltd,
DAIICHI SANKYO, Inc., and DAIICHI SANKYO EUROPE GmbH assume no
responsibility for the updating of such forward-looking statements
about future developments of the sector, legal and business
conditions and the company.

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[i] 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.
[ii]Liver Blood Tests. Available at:
http://www.medicinenet.com/liver_blood_tests/page2.htm.
Accessed June 18, 2010.

ots Originaltext: DAIICHI SANKYO EUROPE GmbH
Im Internet recherchierbar: http://www.presseportal.de

Contact:
CONTACT: For more information, please contact: Toshiaki Sai,
DaiichiSankyo, Co., Ltd. (Japan), +81-3-6225-1126 (office). Dr.
MichaelaPaudler-Debus, Daiichi Sankyo Europe GmbH,
+49-(0)89-78-08-685 (office),+49-(0)172-845-8974 (mobile)