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
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.
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
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
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
. 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:
Accessed, September 23, 2009
For more information, please contact:
Daiichi Sankyo Co., Ltd (Tokyo)
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