Daiichi Sankyo Initiates Phase 3 VTE Trial of Edoxaban

February 3, 2010—Daiichi Sankyo Company, Ltd. (Tokyo, Japan) announced that it has initiated the largescale, pivotal HOKUSAI VTE phase 3 trial to evaluate the safety and efficacy of edoxaban in reducing recurrent venous thromboembolism (VTE) complications in patients with deep vein thrombosis and/or pulmonary embolism (PE). Edoxaban, the free base of DU-176b, is the company's oral anticoagulant that directly inhibits factor Xa. Daiichi Sankyo is developing edoxaban as a potential new treatment for preventing both arterial and venous thromboembolism.

HOKUSAI VTE is a multicenter study that will include approximately 7,500 patients in more than 450 clinical sites in 40 countries worldwide. It is an eventdriven, randomized, double-blind, double-dummy, parallel- group study. Patients will be randomized to two different treatment groups. Both groups will receive open-label enoxaparin or unfractionated heparin for at least 5 days, and up to 12 days, followed by doubleblind warfarin or edoxaban 60 mg once daily. Patients will be treated for up to 12 months in accordance with the standard of care and international guidelines.

The primary efficacy endpoint for HOKUSAI VTE is the recurrence of symptomatic VTE (the composite of deep vein thrombosis, nonfatal PE, and fatal PE). The primary safety assessment of the trial is the incidence of major and clinically relevant nonmajor bleeding.

“The incidence of VTE is predicted to double by 2050,” commented Professor Harry R. Büller, MD, chairman of the Steering Committee for HOKUSAI VTE. “Based on what we've seen in phase 2 and other trials, edoxaban shows promise as a safer, more effective, and more convenient treatment option than the current standard of care, which requires extensive monitoring, careful dose adjusting, and may have the potential for various drug and food interactions.”