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

Tokyo (ots/PRNewswire) - 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 countries.(2)

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 events."

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 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,
Germany.

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

References

1. Clinicaltrials.gov: NCT00781391. Last accessed April 2011.
Available at: http://clinicaltrials.gov/ct2/show/NCT00781391?term=ENG
AGE++AF-TIMI+48&rank=1

2. Clinicaltrials.gov: NCT00986154. Last accessed: April 2011.
Available at http://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. 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.

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)

ots Originaltext: DAIICHI SANKYO EUROPE GmbH
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