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

Tokyo (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
sodium in preventing venous thromboembolic (VTE) events in patients
following total hip replacement (THR), a type of major orthopedic
surgery. Results from the Phase III STARS J-V (Studying Thrombosis
After Replacement Surgery) study[1] were presented at the 52nd Annual
Meeting of the American Society of Hematology in Orlando.[2]

This multicentre, double-blind, double dummy, centrally
randomised trial evaluated the efficacy and safety of edoxaban
compared with enoxaparin sodium in patients undergoing THR in Japan.
A total of 610 patients received either 30 mg once-daily oral dose of
edoxaban or subcutaneous injection of enoxaparin sodium 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.

Asymptomatic DVT occurred in 2.4 percent of patients receiving
edoxaban once-daily compared with 6.9 percent of patients who
received enoxaparin sodium (relative risk reduction of 65.7 percent;
p=0.016). 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=0.475). 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[3]
and serum aminotransferase levels.[4] Elevations greater than three
times the upper limit of the normal range of serum aminotransferase
levels occurred in 2.6 percent of patients taking edoxaban compared
with 10 percent of those taking enoxaparin sodium.

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.

About Edoxaban

Edoxaban is a once-daily oral anticoagulant that directly
inhibits factor Xa, an important factor in the coagulation process.
Edoxaban was discovered by Daiichi Sankyo and is currently in phase
III of clinical development. 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

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 optimise growth opportunities
across the value chain. For more information, please visit
http://www.daiichisankyo.com

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.

References

[1] T. Fuji et al.,Efficacy and Safety of Edoxaban Versus
Enoxaparin for the Prevention of Venous Thromboembolism Following
Total Hip Arthroplasty: STARS J-V trial, December 4-7 2010, Orlando,
Florida.

[2] 52nd ASH Annual Meeting and Exposition. Available at http://a
sh.confex.com/ash/2010/webprogram/start.html#srch=words%7CEDOXABAN%20
%7Cmethod%7Cand%7Cpge%7C1 Accessed December 3, 2010

[3] Medline Bilirubin. Available at
http://www.nlm.nih.gov/medlineplus/ency/article/003479.htm Accessed
December 3, 2010

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

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For more information, please contact:

Toshiaki Sai
Daiichi Sankyo, Co., Ltd.
(Japan)
+81-3-6225-1126 (office)
Dr. Michaela Paudler-Debus
Daiichi Sankyo Europe GmbH
+49-(0)89-78-08-685 (office)
+49-(0)172-845-8974 (mobile)

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

Contact:
CONTACT: Toshiaki Sai, Daiichi Sankyo, Co., Ltd., (Japan),
+81-3-6225-1126(office); Dr. Michaela Paudler-Debus, Daiichi Sankyo
Europe GmbH,+49-(0)89-78-08-685 (office), +49-(0)172-845-8974
(mobile)