Edoxaban Significantly Reduces Risk of Venous Thromboembolism by Half Compared to Enoxaparin in Japanese and Taiwanese Patients Following Knee or Hip Arthroplasty Surgery

Munich (ots/PRNewswire) -

Pooled results of the STARS E-III and STARS J-V studies presented at the
2011 American Society of Hematology (ASH) Annual Meeting

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today
announced the results of a pooled analysis showing that edoxaban*, a
direct oral once-daily factor Xa inhibitor, significantly reduced the
risk of developing venous thromboembolism (VTE) following total knee
or hip arthroplasty when compared to enoxaparin.[1] Patients
receiving edoxaban had a lower incidence of a composite of deep vein
thrombosis (DVT) and pulmonary embolism (PE) than those treated with
enoxaparin (5.1% vs. 10.7%, P<0.001, Relative Risk Reduction [RRR]
52.7%, Absolute Risk Reduction [ARR] -5.6%), an effect that was shown
without a statistically significant difference in bleeding between
the groups.[1]

The analysis drew data from two randomised, double-blind,
double-dummy, phase III studies (STARS E-III and STARS J-V) of 1,326
Japanese and Taiwanese patients[1] who had underwent total knee
arthroplasty (TKA) or total hip arthroplasty (THA).[2,3] Results were
presented in an oral session at the 53rd Annual Meeting of the
American Society of Hematology in San Diego, USA.[1]

"Total hip and knee arthroplasty surgeries place patients at a
higher risk of DVT, which can lead to thromboembolic disease such as
PE," said Dr. Takeshi Fuji, Head of Orthopaedic Surgery, Osaka
Koseinenkin Hospital, Osaka Japan. "As the number of these surgeries
increases and the incidence of VTE is expected to double by the year
2050,[4] it will become increasingly important for physicians to have
a number of treatment options to prevent DVT and PE following these
surgeries."

The incidence of major and Clinically Relevant Non-Major (CRNM)
bleeding events in the edoxaban* and enoxaparin groups was 4.6% vs.
3.7%, respectively (P=0.427).[1] A further subgroup analysis of major
and CRNM bleeding indicated no significant difference between
edoxaban and enoxaparin in any of the patient subgroups evaluated,
based on age, weight, or creatinine clearance.[1]

Patients enrolled in the STARS E-III (Japanese and Taiwanese
patients) and STARS J-V (Japanese patients) studies were randomised
to receive either oral edoxaban 30 mg once daily or subcutaneous
enoxaparin 20 mg (2,000 IU) twice daily for 11-14 days,[2,3] in line
with standard clinical practice in Japan.

"We are pleased to see positive outcomes with edoxaban in this
patient population," said Dr. Kazunori Hirokawa, Global, Head of R&D
Unit, Daiichi Sankyo Co., Ltd. "These results further support the
safety and efficacy of edoxaban in the prevention of DVT and PE
following major orthopaedic surgery. Daiichi Sankyo remains committed
to developing edoxaban in our global clinical trials program."

About Edoxaban

Edoxaban is a once-daily oral anticoagulant that directly
inhibits Factor Xa, an important factor in the coagulation
process.[5] Edoxaban is currently available only in Japan, licensed
for the prevention of venous thromboembolism (VTE) in patients
undergoing total knee arthroplasty, total hip arthroplasty and hip
fracture surgery.[6] Daiichi Sankyo continues to develop edoxaban at
a global level as a potential new treatment for stroke prevention in
atrial fibrillation, and the treatment and prevention of recurrent
VTE. 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.

About the Pooled STARS Analysis

The analysis drew data from two Phase III comparative studies,
STARS E-III and STARS J-V.[2,3]

- The STARS E-III study was a double-blind, enoxaparin-controlled,
randomised study comparing edoxaban 30 mg once daily and enoxaparin 20 mg (2,000 IU)
in the prevention of VTE in a total of 716 Japanese and Taiwanese patients undergoing
TKA.[2]
- The STARS J-V study was a double-blind, enoxaparin-controlled, randomised
study comparing edoxaban 30 mg once daily and enoxaparin 20 mg (2,000 IU) in the
prevention of VTE in 610 Japanese patients undergoing THA.[3]

Both studies supported the March 2010 edoxaban New Drug
Application (NDA) in Japan seeking approval for the prevention of VTE
after major orthopaedic surgery. In the studies, edoxaban was
initiated six to 24 hours after surgery; enoxaparin was initiated 24
to 36 hours after surgery,[2] the standard of care in Japan. The
primary efficacy outcome in both studies was the composite of
symptomatic and asymptomatic DVT and PE.[2,3] The principal safety
outcome was incidence of major and clinically relevant non-major
bleeding.[2,3]

About Venous Thromboembolism

VTE is the term for the generation of a blood clot within a vein,
or the subsequent breaking off of that clot into a pulmonary (lung)
artery.[7,8] Deep vein thrombosis (DVT) and pulmonary embolism (PE)
are the two sub-types of VTE.[7] DVT is a blood clot anywhere in the
deep veins of the legs, pelvis or arms.[9] PE is a clot that detaches
from the vein and travels to the lungs,[9] lodging in the pulmonary
arteries causing a potentially fatal condition.[9,10] PE is often
accompanied by DVT and a DVT can develop into a PE suddenly.[10]

Patients with diagnosed VTE are treated for three to six months
(and sometimes even longer) based on their individual risk profile to
prevent a second (recurrent) DVT or PE.[10] VTE is the cause of
significant mortality; 30% of people with VTE die within one month of
diagnosis and about 25% of those with PE experience sudden death.[11]
Additionally, about 30% of those affected will experience a
recurrence of DVT/PE within 10 years of the initial DVT/PE
diagnosis.[11]

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.

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.

For more information, please visit: http://www.daiichisankyo.com/
[http://www.daiichisankyo.com ] or http://www.daiichi-sankyo.eu/
[http://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.

*. Edoxaban is licensed only in Japan for the prevention of VTE
after major orthopaedic surgery, under the brand name Lixiana(R) In
Europe, edoxaban has not been approved yet. Daiichi Sankyo continues
to develop edoxaban at a global level as a potential new treatment
for stroke prevention in atrial fibrillation, and the treatment and
prevention of recurrent VTE.

References

1) T. Fuji et al., Edoxaban Versus Enoxaparin for the Prevention of Venous
Thromboembolism: Pooled Analysis of Venous Thromboembolism and Bleeding from STARS
E-III and STARS J-V: The 53rd American Society of Hematology Annual Meeting and
Exposition, December 10-13, 2011.
2) T. Fuji et al., Edoxaban versus enoxaparin for thromboprophylaxis after total
knee replacement: The STARS E-III trial 21st International Congress of Thrombosis,
July 6 - 9 2010, Milano.
3) T. Fuji et al., Efficacy and Safety of Edoxaban Versus Enoxaparin for the
Prevention of Venous Thromboembolism Fol-lowing Total Hip Arthroplasty: STARS J-V
trial, American Society of Hemotology, December 4-7 2010, Orlando, Florida.
4) Deitelzweig S, Lin J, Johnson BH, Schulman KL. Prevalence of venous
thromboembolism in the USA: now and future. Journal of Thrombosis and Haemostasis
2009; Volume 7, Supplement 2: Abstract OC-WE-018Accessed: 06 December 2011.
5) Raskob G, Cohen AT, Eriksson BI, et al. Oral direct factor Xa inhibition with
edoxaban for thromboprophylaxis after elective total hip replacement. Journal of
Thrombosis and Haemostasis. 2010; 104: 642-649
6) http://www.pmda.go.jp/operations/shonin/info/new/file/H23Pharmaceutical.pdf
.
Accessed: 06 December 2011.
7) The Coalition to Prevent VTE. Available at:
http://coalitiontopreventvte.org/index.cfm/t/VTE theburden/vid/49CB8F2B-1422-16B3-7884634B147F9253
. Accessed: 06 December 2011.
8) Loue and Sajatovic Encyclopedia of Aging and Public Health 2008, XXIII, 843
p. 10 illus.
9) Lung Disorders 2007 By Peter B. Terry, M.D.
10) Kim and Bartholomew, Cleveland Clinic. Venous Thromboembolism. Available at:
http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/cardiology/venous-th
romboembolism/
[http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/cardiology/venous-thromboembolism ]
Accessed: 06 December 2011.
11) Beckman et al CDC Division of Blood Disorders : Public Health Research
Activities in Venous Thromboembolism, Arte-rioscler, Thromb Vasc Biol 2008,
28:394-395.

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

Contact:
Contact: Tetsuya Ohira, Daiichi Sankyo Europe GmbH,
+49(0)89-78-08-694 (office), +49(0)172-883-9656 (mobile); Daria
Munsel,
Daiichi Sankyo Europe GmbH, +49 (0)89-78-08-728 (office),
+49(0)176-1178-0826 (mobile)