OREANDA-NEWS.  January 31, 2012. Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced an update on the current status of clinical trials for the priority development pipeline projects involving edoxaban, prasugrel, and denosumab.

1．Edoxaban (Once-daily oral Factor Xa inhibitor: DU-176b)

Edoxaban/ Atrial Fibrillation (AF)

ENGAGE AF-TIMI 48 study is an ongoing, multinational, randomized, double-blind phase III study evaluating the efficacy and safety of edoxaban, a once-daily oral anticoagulant, in preventing stroke and systemic embolic events in patients with AF. More than 21,000 patients with AF in 46 countries are being examined, making this the largest single trial in this indication to date.

The study started in 2008, patient enrollment was completed in November 2010 and the study is expected to be completed by end of fiscal year* 2012.
*: Daiichi Sankyo’s fiscal year is from April 1 to March 31.

Edoxaban/ Venous Thromboembolism (VTE)

HOKUSAI VTE study, is the largest single, double-blind, randomized, multinational phase III study evaluating edoxaban, a once-daily oral anticoagulant, for the treatment and prevention of recurrent VTE, involving approximately 7,500 patients in 450 clinical sites in approximately 40 countries worldwide. The study started in 2010, and enrollment is currently underway and expected to be completed by end of fiscal year 2012.

2．Prasugrel (Antiplatelet agent: CS-747)

TRILOGY ACS

TRILOGY ACS trial, a large phase III clinical trial to compare prasugrel (Effient/Efient®) against clopidogrel in acute coronary syndrome (ACS) patients with unstable angina (UA) or non-ST segment elevation myocardial infarction (known as NSTEMI - a type of heart attack) who are treated without coronary revascularization during their ACS hospitalization commenced in June 2008. It is the largest single randomized trial to date focusing on this patient population. Patient enrollment was completed in 2011, the study is expected to complete this spring, and the results are anticipated in second half of 2012.

Clinical Development in Japan

Japan domestic phase III trials on ACS patients who have undergone percutaneous coronary intervention (PCI), elective PCI patients and patients with ischemic cerebrovascular disease began in 2011. The trials are expected to complete between fiscal year 2013 and fiscal year 2014.

3．Denosumab (Anti RANKL antibody: AMG 162)

The phase III trial to confirm efficacy in Japanese osteoporosis patients began in 2008, and the pivotal evaluation period has been completed.  Since the anticipated data was obtained, Daiichi Sankyo is now in the process of preparing a new drug application in Japan.

Daiichi Sankyo is participating in the global phase III trial of adjuvant treatment for women with early-stage breast cancer, and is conducting phase II trials for Japanese patients with rheumatoid arthritis and giant cell tumor of bone, respectively.