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01.09.2010 – 09:33

Daiichi Sankyo Europe GmbH

DAIICHI SANKYO Announces Enrollment in the Two Largest Single Phase III Trials so far for the Prevention of Stroke in AF and for the Treatment of VTE is Proceeding as Planned

Stockholm (ots/PRNewswire)

DAIICHI SANKYO announced today that the ongoing trials ENGAGE AF-TIMI 48 (The Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation) and HOKUSAI VTE with their investigational factor Xa inhibitor edoxaban are enrolling in accordance to plan. The projected recruitment of ENGAGE AF-TIMI 48 and HOKUSAI VTE are 20,500 and 7,500 patients, respectively. ENGAGE AF-TIMI 48 and HOKUSAI VTE are the two largest single phase III trials in atrial fibrillation (AF) and venous thromboembolism (VTE) to date.

It is estimated that throughout Europe 4.5 million people suffer from AF[1], and approximately 370,000 deaths are related to VTE per year in six major European countries (France, Germany, Italy, Spain, Sweden, and the UK).[2] Due to the aging population, the number of patients with AF is likely to increase 2.5 fold by the year 2050.[3]

The ENGAGE AF-TIMI 48 study is investigating the safety and efficacy of edoxaban in preventing strokes and systemic embolic events in patients with AF. ENGAGE AF-TIMI 48 is the only phase III trial in atrial fibrillation in which a factor Xa inhibitor is investigated at two different dose levels. The study was initiated in late 2008, and DAIICHI SANKYO expects the study to be concluded in 2012.

The HOKUSAI VTE study is evaluating the safety and efficacy of edoxaban in preventing recurrent venous thromboembolic events in patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE). The study was initiated in late 2009, and DAIICHI SANKYO expects the study to be concluded in 2012.

In addition to ENGAGE AF-TIMI 48 and HOKUSAI VTE, edoxaban has been investigated for the prevention of VTE after major orthopedic surgery in Japanese and Taiwanese patients in the STARS-E3 (Studying Thrombosis After Replacement Surgery) trial. The first, positive results of this phase III trial were presented in July of this year at the International Congress of Thrombosis (ICT) in Milan.[4],[5]

ENGAGE AF-TIMI 48 Study Design[6],[7]

The ENGAGE AF-TIMI 48 study is investigating the safety and efficacy profile of two different doses of edoxaban versus warfarin in individuals with AF at moderate to high risk of stroke. Patients are randomized to one of three treatment groups: high dose regimen (edoxaban 60 mg once-daily), low dose regimen (edoxaban 30 mg once-daily), and warfarin. Approximately 20,500 patients will be enrolled making ENGAGE AF-TIMI 48 the largest stroke prevention study in AF with a novel anticoagulant so far, and the expected median treatment duration is 24 months. The primary efficacy endpoint is the composite clinical outcome of stroke and systemic embolic events; the primary safety endpoint is the incidence of major bleeding.

HOKUSAI VTE Study Design[8],[9]

The HOKUSAI VTE trial is evaluating the safety and efficacy of edoxaban in the treatment and prevention of recurrent thromboembolic events in patients with deep-vein thrombosis and/or pulmonary embolism. Two different treatment groups will receive enoxaparin or unfractionated heparin for at least five and up to 12 days, followed by double-blind warfarin or edoxaban 60 mg once-daily. The primary efficacy endpoint is the composite clinical outcome of symptomatic recurrent DVT, non-fatal symptomatic recurrent PE, and fatal PE; the primary safety endpoint is the incidence of major and clinically relevant non-major bleeding. Patients will be treated for up to 12 months in accordance to the standard of care and international guidelines.

About Edoxaban

Edoxaban, an investigational direct oral factor Xa inhibitor, is a potential new therapy with the promise to overcome current therapeutic limitations in anticoagulation. Edoxaban is anticipated to be given once-daily; require no dietary restrictions; require no routine monitoring. Edoxaban could become an attractive treatment alternative for patients. Furthermore, edoxaban is the only factor Xa inhibitor being investigated in phase III in two different doses in patients with AF. Therefore stroke prevention therapy with edoxaban in AF may be tailored to account for individual characteristics of patients and further improve the risk benefit profile of anticoagulation.

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 optimize growth opportunities across the value chain. For more information, please visit:

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.

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 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 EUROPE GmbH assumes no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.



[1] Fuster V, Ryden LE, Cannom DS et al. ACC/AHA/ESC 2006 Guidelines for the management of patients with Atrial Fibrillation. Circulation. 2006; 114;e257-e354.

[2] Cohen AT et al. Venous Thromboembolism (VTE) in Europe. Thromb Haemost 2007; 98:756-64.

[3] Santini M, Ricci RP. The worldwide social burden of atrial fibrillation: What should be done and where do we go? J Interv Card Electrophysiol. 2006; 17:183-188.

[4] 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. Abstract Number OC 297. .asp?Aktion=ShowPDF&ArtikelNr=318095&Ausgabe=254413&ProduktNr=224034& filename=318095.pdf

[5] Last accessed 23.07.2010.

[6] The ENGAGE AF-TIMI 48 trial: 2/show/record/NCT00781391?term=DU-176b&rank=1 . Last accessed 13.08.2010.

[7] 0SANKYO_Edoxaban%20ESC.doxc.pdf. Last accessed 13.08.2010.

[8] The HOKUSAI VTE trial:;rank=1. Last accessed 13.08.2010.

[9] Last accessed 23.07.2010

(Due to the length of the above URLs, it may be necessary to copy and paste the hyperlinks into your Internet browser's URL address field. Remove the space if one exists.)

CONTACT: Dr. Michaela Paudler-Debus Vice Director Head of Product PR Corporate Communications and Public Affairs Phone +49(0)89-78-08-685 Dr. Felix Münzel Vice Director Medical and Scientific Affairs CV Phone +49(0)89-78-08-471


CONTACT: CONTACT: Dr. Michaela Paudler-Debus, Vice Director, Head
ofProduct PR, Corporate Communications and Public Affairs,
Dr. FelixMünzel, Vice Director, Medical and Scientific Affairs CV,

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