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Daiichi Sankyo initiates largest single, double-blind, randomized, Phase III trial for treatment and prevention of recurrent venous thromboembolism

Tokyo, Japan and Edison, N.J. (ots)

First Patient Randomized and
Dosed in New Trial with Factor Xa Inhibitor, Edoxaban
Daiichi Sankyo Company, Limited (TSE: 4568), announced today that 
it has initiated a new large-scale pivotal Phase III trial for 
edoxaban, its investigational oral Factor Xa inhibitor. This new 
study, called HOKUSAI (pronounced hoe·koo·sigh) VTE, is evaluating 
the safety and efficacy of edoxaban in reducing recurrent venous 
thromboembolic (VTE) complications in patients with deep-vein 
thrombosis (DVT) and/or pulmonary embolism (PE).
It is estimated that more than 900,000 fatal and non-fatal VTE 
events occur in the U.S. annually, and approximately 300,000 deaths 
are related to VTE per year.(1)  In Europe, VTE affects more than 
750,000 people in six major European countries (France, Germany, 
Italy, Spain, Sweden, UK) annually, and approximately 370,000 deaths 
are related to VTE per year in these countries(2).
"The incidence of VTE is predicted to double by 2050,(3)" said 
Harry R. Büller, M.D., Professor of Internal Medicine, chairman of 
the Department for Vascular Medicine at the Academic Medical Center, 
Amsterdam and chairman of the Steering Committee for HOKUSAI VTE.  
"Based on what we've seen in Phase II and other trials, edoxaban 
shows promise as an agent to help fulfill the need for treatment 
options that are safe, effective and more convenient than the current
standard of care, which requires extensive monitoring, careful dose 
adjusting and may have the potential for various drug and food 
interactions."
The primary efficacy endpoint for HOKUSAI VTE is the recurrence of
symptomatic VTE (i.e., the composite of DVT, non-fatal PE and fatal 
PE). The primary safety assessment of the trial is the incidence of 
major and clinically relevant non-major bleeding.
"HOKUSAI VTE is the largest, single Phase III study ever 
undertaken in the area of VTE, and is our second large-scale edoxaban
trial," said Glenn Gormley, president of Daiichi Sankyo Pharma 
Development. "Daiichi Sankyo is proud to be advancing the research of
Factor Xa inhibitors with edoxaban, which may help prevent deadly 
clots in various patient populations."
HOKUSAI VTE Study Design
HOKUSAI VTE is a Phase III multi-center study that will include 
approximately 7,500 patients in more than 450 clinical sites in 
approximately 40 countries worldwide. This is an event-driven, 
randomized, double-blind, double-dummy, parallel-group, multi-center,
multi-national study, which will randomize patients to two different 
treatment groups. Both groups will receive open label enoxaparin or 
unfractionated heparin for at least five days and up to 12 days, 
followed by double-blind warfarin or edoxaban 60 mg once-daily. 
Patients will be treated for up to 12 months in accordance to the 
standard of care and international guidelines.
The HOKUSAI VTE study is named after the famous Japanese artist 
and painter Katsushika Hokusai (1760-1849) of the former Edo period; 
Edo is the city currently known as Tokyo, the location of the Daiichi
Sankyo global headquarters.
About Venous Thromboembolism
Venous thromboembolism (VTE) is the term for the generation of a 
blood clot and the obstruction of a vein or a pulmonary artery by a 
blood clot. Deep vein thrombosis (DVT) and pulmonary embolism (PE) 
are types of VTE. DVT is a blood clot anywhere in the deep veins of 
the legs or pelvis. PE is caused by a clot that travels to the lungs,
lodging in the pulmonary arteries.
About Edoxaban
Edoxaban, the free base of DU-176b, is an 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.
Daiichi Sankyo is also actively enrolling 16,500 patients in its 
pivotal Phase III trial for edoxaban in patients with atrial 
fibrillation. The Phase III study, Effective Anticoagulation with 
Factor Xa Next Generation in Atrial Fibrillation (ENGAGE AF-TIMI 48),
began enrolling patients in late 2008 and is comparing edoxaban with 
warfarin (target INR 2-3) for the prevention of stroke and systemic 
embolic events (SEE) among patients with atrial fibrillation.
In Japan, edoxaban is currently being developed for the prevention
of VTE in patients after total knee (TKR) and total hip replacement 
(THR) surgery:  results from one pivotal Phase III trial for TKR were
announced in late 2009 and a second Phase III trial for THR is 
ongoing.
About Daiichi Sankyo
A global pharmaceutical innovator, Daiichi Sankyo Co., Ltd., was 
established in 2005 through the merger of two leading Japanese 
pharmaceutical companies. This integration created a more robust 
organization that allows for continuous development of novel drugs 
that enrich the quality of life for patients around the world. Areas 
of central focus of Daiichi Sankyo research and development are 
thrombotic disorders, malignant neoplasm, diabetes mellitus, and 
autoimmune disorders.  Equally important to the company are 
hypertension, hyperlipidemia or atherosclerosis and bacterial 
infections. For more information, visit www.daiichisankyo.com.
Forward-Looking Statements
This news release may contain forward-looking statements based on 
current assumptions and forecasts made by Daiichi Sankyo group. 
Various known and unknown risks, uncertainties and other factors 
could lead to material differences between the actual future results,
financial situation, development or performance of the company and 
the estimates given here. These factors include those discussed in 
our public reports, which are available on the website at 
www.daiichisankyo-us.com or www.daiichi-sankyo.eu. The company 
assumes no liability whatsoever to update these forward-looking 
statements or to conform them to future events or developments.
# # #
(1) Heit JA, Cohen AT, Anderson FAJ, on behalf of the VTE Impact 
Assessment Group. Estimated annual number of incident and recurrent, 
non-fatal and fatal venous thromboembolism (VTE) events in the US. 
ASH Annual Meeting Abstracts. 106:910. 2005.
(2) Cohen AT et al. Venous Thromboembolism (VTE) in Europe. Thromb
Haemost 2007: 98:756-64
(3) Journal of Thrombosis and Haemostasis 2007; Volume 5, 
Supplement 2: abstract number OC-WE-018, Available at: 
http://www.blackwellpublishing.com/isth2009/abstract.asp?id=76605. 
Accessed, September 23, 2009
For more information, please contact:
Toshiaki Sai 
Daiichi Sankyo Co., Ltd (Tokyo) 
Phone: +81-3-6225-1126
Kimberly Wix 
Daiichi Sankyo, Inc. (US) 
Phone: (973) 944-2338 
Mobile: (908) 656-5447
Dr. Michaela Paudler-Debus 
Daiichi Sankyo Europe 
Phone: + 49-(0)89 7808 685 
Mobile: + 49-(0)172 845 8974

Weitere Storys: Daiichi Sankyo Europe GmbH
Weitere Storys: Daiichi Sankyo Europe GmbH