Press Release

TOKYO, Japan and EDISON, New Jersey, February 3 /PRNewswire/ -- Daiichi Sankyo Company, Limited (TSE: 4568), announced today that it hasinitiated a new large-scale pivotal Phase III trial for edoxaban, itsinvestigational oral Factor Xa inhibitor. This new study, called HOKUSAI(pronounced hoe-koo-sigh) VTE, is evaluating the safety and efficacy ofedoxaban in reducing recurrent venous thromboembolic (VTE) complications inpatients with deep-vein thrombosis (DVT) and/or pulmonary embolism (PE).

It is estimated that more than 900,000 fatal and non-fatal VTE eventsoccur in the U.S. annually, and approximately 300,000 deaths are related toVTE per year.[i] In Europe, VTE affects more than 750,000 people in six majorEuropean countries (France, Germany, Italy, Spain, Sweden, UK) annually, andapproximately 370,000 deaths are related to VTE per year in thesecountries[ii].

"The incidence of VTE is predicted to double by 2050,[iii]" said Harry R.Büller, M.D., Professor of Internal Medicine, chairman of the Department forVascular Medicine at the Academic Medical Center, Amsterdam and chairman ofthe Steering Committee for HOKUSAI VTE. "Based on what we've seen in Phase IIand other trials, edoxaban shows promise as an agent to help fulfill the needfor treatment options that are safe, effective and more convenient than thecurrent standard of care, which requires extensive monitoring, careful doseadjusting and may have the potential for various drug and food interactions."

The primary efficacy endpoint for HOKUSAI VTE is the recurrence ofsymptomatic VTE (i.e., the composite of DVT, non-fatal PE and fatal PE). Theprimary safety assessment of the trial is the incidence of major andclinically relevant non-major bleeding.

"HOKUSAI VTE is the largest, single Phase III study ever undertaken inthe area of VTE, and is our second large-scale edoxaban trial," said GlennGormley, president of Daiichi Sankyo Pharma Development. "Daiichi Sankyo isproud 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 includeapproximately 7,500 patients in more than 450 clinical sites in approximately40 countries worldwide. This is an event-driven, randomized, double-blind,double-dummy, parallel-group, multi-center, multi-national study, which willrandomize patients to two different treatment groups. Both groups willreceive open label enoxaparin or unfractionated heparin for at least fivedays and up to 12 days, followed by double-blind warfarin or edoxaban 60 mgonce-daily. Patients will be treated for up to 12 months in accordance to thestandard of care and international guidelines.

The HOKUSAI VTE study is named after the famous Japanese artist andpainter Katsushika Hokusai (1760-1849) of the former Edo period; Edo is thecity currently known as Tokyo, the location of the Daiichi Sankyo globalheadquarters.

About Venous Thromboembolism

Venous thromboembolism (VTE) is the term for the generation of a bloodclot 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. DVTis a blood clot anywhere in the deep veins of the legs or pelvis. PE iscaused by a clot that travels to the lungs, lodging in the pulmonaryarteries.

About Edoxaban

Edoxaban, the free base of DU-176b, is an oral anticoagulant thatdirectly inhibits Factor Xa, an important factor in the coagulation process.Daiichi Sankyo is developing edoxaban as a potential new treatment for theprevention of both arterial and venous thromboembolism. Notably, DaiichiSankyo has more than 25 years experience conducting research in the area ofFactor Xa inhibition, and was the first company to study these compounds inhumans. Edoxaban is being developed solely by Daiichi Sankyo.

Daiichi Sankyo is also actively enrolling 16,500 patients in its pivotalPhase III trial for edoxaban in patients with atrial fibrillation. The PhaseIII study, Effective Anticoagulation with Factor Xa Next Generation in AtrialFibrillation (ENGAGE AF-TIMI 48), began enrolling patients in late 2008 andis comparing edoxaban with warfarin (target INR 2-3) for the prevention ofstroke and systemic embolic events (SEE) among patients with atrialfibrillation.

In Japan, edoxaban is currently being developed for the prevention of VTEin patients after total knee (TKR) and total hip replacement (THR) surgery:results from one pivotal Phase III trial for TKR were announced in late 2009and a second Phase III trial for THR is ongoing.

About Daiichi Sankyo

A global pharmaceutical innovator, Daiichi Sankyo Co., Ltd., wasestablished in 2005 through the merger of two leading Japanese pharmaceuticalcompanies. This integration created a more robust organization that allowsfor continuous development of novel drugs that enrich the quality of life forpatients around the world. Areas of central focus of Daiichi Sankyo researchand development are thrombotic disorders, malignant neoplasm, diabetesmellitus, and autoimmune disorders. Equally important to the company arehypertension, hyperlipidemia or atherosclerosis and bacterial infections. Formore information, visit http://www.daiichisankyo.com.

Forward-Looking Statements

This news release may contain forward-looking statements based on currentassumptions and forecasts made by Daiichi Sankyo group. Various known andunknown risks, uncertainties and other factors could lead to materialdifferences between the actual future results, financial situation,development or performance of the company and the estimates given here. Thesefactors include those discussed in our public reports, which are available onthe website at http://www.daiichisankyo-us.com orhttp://www.daiichi-sankyo.eu. The company assumes no liability whatsoever toupdate these forward-looking statements or to conform them to future eventsor developments.

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[i] Heit JA, Cohen AT, Anderson FAJ, on behalf of the VTE ImpactAssessment Group. Estimated annual number of incident and recurrent,non-fatal and fatal venous thromboembolism (VTE) events in the US. ASH AnnualMeeting Abstracts. 106:910. 2005.

[ii] Cohen AT et al. Venous Thromboembolism (VTE) in Europe. ThrombHaemost 2007: 98:756-64

[iii] 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: +1-973-944-2338, Mobile: +1-908-656-5447 ; Dr. Michaela Paudler-Debus, Daiichi Sankyo Europe, Phone: +49-(0)89-7808-685, Mobile: +49-(0)172-845-8974.