Daiichi Sankyo Launches LIXIANA® (edoxaban), a Direct Oral Factor Xa Inhibitor, in Japan for the Prevention of Venous Thromboembolism After Major Orthopaedic Surgery

Tokyo (ots/PRNewswire) -

-- First Direct Oral Factor Xa Inhibitor Available to Japanese
Patients --

Building on its cardiovascular portfolio, Daiichi Sankyo Company,
Limited (hereafter, Daiichi Sankyo), is proud to announce the launch
of LIXIANA(R) (JAN: Edoxaban Tosilate Hydrate, INN: edoxaban) in
Japan. This announcement follows the first marketing approval for
edoxaban 15 mg and 30 mg tablets by the Japanese Ministry of Health,
Labour and Welfare in April 2011,[1] and marks the first time
edoxaban is commercially available to patients in any global market.

Edoxaban is a once-daily, oral anticoagulant that specifically,
reversibly and directly inhibits the enzyme, Factor Xa, a clotting
factor in the blood. Results from clinical studies supported the
approval of edoxaban for the prevention of venous thromboembolism
(VTE) in patients with total knee arthroplasty, total hip
arthroplasty and hip fracture surgery.

"Today's launch of edoxaban marks the global debut of the
medication, which is an exciting breakthrough for patients who
require VTE prevention after major orthopaedic surgery," said Joji
Nakayama, President and CEO of Daiichi Sankyo. "Edoxaban demonstrates
solid efficacy in clinical trials[2,3] in this population of
patients. Its predictable pharmacokinetic and pharmacodynamic profile
allows for a convenient, once-daily dosing."

The global clinical development program for edoxaban is focused
on several indications, including stroke prevention in atrial
fibrillation (AF) patients, and treatment and prevention of recurrent
VTE.

Edoxaban is currently being assessed in the Phase III ENGAGE
AF-TIMI 48 study[4], an ongoing, multinational, randomised,
double-blind trial evaluating the efficacy and safety of edoxaban in
preventing stroke and systemic embolic events in patients with AF.
More than 21,000 patients with AF in 46 countries are being examined,
making this the largest trial in this indication to date.In addition,
Daiichi Sankyo is currently enrolling patients in its HOKUSAI VTE
study[5] - the largest single, double-blind, randomised,
multinational Phase III study for the treatment and prevention of
recurrent VTE, involving approximately 7,500 patients in 450 clinical
sites in approximately 40 countries worldwide.

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 such a clot that breaks off and
then travels to the lungs, lodging in the pulmonary arteries.

About Edoxaban

Edoxaban is a once-daily oral anticoagulant that directly
inhibits Factor Xa, an important factor in the coagulation process.
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[1]. 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 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 is 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
or http://www.daiichi-sankyo.eu

References

1) http://www.pmda.go.jp/operations/shonin/info/new/file/H23Pharmaceutical.pdf
2) 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.
3) 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.
4) Clinicaltrials.gov: NCT00781391. Last accessed July 2011.
Available at:
http://clinicaltrials.gov/ct2/show/NCT00781391?term=ENGAGE++AF-TIMI+48&rank=1
5) Clinicaltrials.gov: NCT00986154. Last accessed: July 2011.
Available at
http://www.clinicaltrials.gov/ct2/show/NCT00986154?term=hokusai&rank=1

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.

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

Contact:
For more information, please contact: Toshiaki Sai, DaiichiSankyo,
Co., Ltd. (Japan), +81-3-6225-1126 (office); Alyssa Dargento,Daiichi
Sankyo, Inc. (US),+1-(973)-944-2913 (office), +1-(973)-727-1464
(mobile); Dr. Michaela Paudler-Debus, Daiichi Sankyo Europe
GmbH,+49-(0)89-78-08-685 (office), +49-(0)172-845-8974 (mobile)