Daiichi Sankyo Receives First Market Approval in Japan for LIXIANA(R) (Edoxaban), a Direct Oral Factor Xa Inhibitor, for the Prevention of Venous Thromboembolism After Major Orthopedic Surgery

By Daiichi Sankyo Company Limited, PRNE
Thursday, April 21, 2011

TOKYO, April 22, 2011 - Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), announced
today that the company has received its first marketing approval for
LIXIANA(R) (JAN: Edoxaban Tosilate Hydrate, INN:edoxaban) 15 mg and 30 mg
tablets, by the Ministry of Health, Labor and Welfare in Japan.

Edoxaban, which is being developed solely by Daiichi Sankyo, 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.

Commenting on receiving the first national marketing authorization for
edoxaban, Joji Nakayama, President and CEO of Daiichi Sankyo, said, "We are
pleased to confirm that an exciting milestone has been reached, and we are
confident that edoxaban will make a great contribution to VTE prevention
after major orthopedic surgery. Daiichi Sankyo also remains committed to
exploring the potential for edoxaban in several other indications, and has a
robust global clinical trial program."

The global clinical development program for edoxaban is focused on
several indications, including stroke prevention in atrial fibrillation (AF)
patients, as well as treatment and prevention of recurrent VTE. In the ENGAGE
AF-TIMI 48 study, an ongoing, multinational, randomized, double blind, phase
III study, the efficacy and safety of edoxaban in preventing stroke and
systemic embolic events in patients with AF are being examined in more than
21,000 patients in 46 countries.(1) The ENGAGE AF-TIMI 48 study is the
largest trial in this indication to date. Also currently ongoing, the HOKUSAI
VTE study is the largest single, double-blind, randomized, multinational
phase III study in the treatment and prevention of recurrent VTE, involving
approximately 7,500 patients in 450 clinical sites in approximately 40

Existing anticoagulants such as heparins and vitamin K antagonists,
although effective, have several clinical considerations. Heparins are
injectable agents and therefore less suitable for long-term treatment.
Vitamin K antagonists are given orally, but are associated with numerous drug
and food interactions.(3) Commenting on the future global potential for
edoxaban, Kazunori Hirokawa, Global Head of R&D Unit, Daiichi Sankyo, said,
"Based on the data we have seen so far, edoxaban has been shown to be an
effective anticoagulant with a predictable pharmacokinetic and
pharmacodynamic profile, which allows for a convenient, once-daily dosing.
The data are encouraging and support the potential for edoxaban in
anticoagulation management while being effective against thromboembolic

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

About Edoxaban

Edoxaban is a once-daily oral anticoagulant that directly inhibits Factor
Xa, an important factor in the coagulation process. Edoxaban is currently
approved only in Japan, licensed for the prevention of venous thromboembolism
(VTE) in patients undergoing total knee arthroplasty, total hip arthroplasty
and hip fracture surgery. 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 pro-ducts to address the diversified, unmet medical
needs of patients in both mature and emerging markets. The company was
created in 2005 through the merger of two traditional Japanese enterprises,
Daiichi and Sankyo. With net sales of nearly EUR7.3 billion, Daiichi Sankyo
is one of the world's 20 leading pharmaceutical companies. 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 cardiovas-cular-metabolic therapies. Furthermore, the Daiichi
Sankyo Group has created a "Hybrid Business Model", which will respond to
market and customer diversity and optimize 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,

For more information, please visit: www.daiichisankyo.com or


1. Clinicaltrials.gov: NCT00781391. Last accessed April 2011. Available

2. Clinicaltrials.gov: NCT00986154. Last accessed: April 2011. Available
at www.clinicaltrials.gov/ct2/show/NCT00986154?term=hokusai&rank=1

3. Mavrakanas T et al. Pharmacology & Therapeutics 2011;
doi:10.1016/j.pharmthera.2010.12.007 (in press)

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.
responsibility for the updating of such forward-looking statements about
future developments of the sector, legal and business conditions and the

    For more information, please contact:

    Toshiaki Sai
    Daiichi Sankyo, Co., Ltd. (Japan)
    +81-3-6225-1126 (office)

    Kimberly Wix
    Daiichi Sankyo, Inc. (US)
    +1-(973)-944-2338 (office)
    +1-(908)-656-5447 (mobile)

    Dr. Michaela Paudler-Debus
    Daiichi Sankyo Europe GmbH
    +49-(0)89-78-08-685 (office)
    +49-(0)172-845-8974 (mobile)


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