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Daiichi Sankyo Announces Clinical Study Data for Oral Factor Xa Inhibitor DU-176b
Date:9/1/2008

MUNICH, Germany, Sept. 2 /PRNewswire-FirstCall/ -- Data presented today at the Annual Congress of the European Society of Cardiology showed that the investigational oral Factor Xa inhibitor DU-176b reduced the incidence of venous thromboembolism (VTE) compared with dalteparin among patients undergoing elective unilateral hip replacement surgery. There was a statistically significant dose response in efficacy (P <0.01), and the observed bleeding rates were low across the groups. DU-176b is being developed solely by Daiichi Sankyo Company, Limited (TSE: 4568) and the data were presented by lead investigator Dr. Gary Raskob.

This randomized, double-blind comparative study examined the safety and efficacy of four doses of DU-176b (15, 30, 60 and 90 mg once daily) versus the low molecular weight heparin, dalteparin. The study was conducted among 903 patients in Europe and North America undergoing total hip replacement surgery.

"These findings are encouraging and we look forward to further study on this Factor Xa inhibitor," said Gary Raskob, Ph.D., Dean, College of Public Health at the University of Oklahoma Health Sciences Center. "These findings indicate DU-176b may provide a high degree of efficacy, but further study is needed."

"As the company that discovered one of the first Factor Xa small molecules (DX-9065a), we are proud to be building on our innovation in cardiovascular disease and tackling the need for better and more effective ways to prevent thrombosis," said John Alexander M.D., president, Daiichi Sankyo Pharma Development. "We expect to commence phase III studies for DU-176b, targeting patients with atrial fibrillation, before the end of 2008.

Study Result Details

VTE incidence (%) Bleeding occurrence*** (%)

Dalteparin 43.8 [35.5-52.3]# 0 [0-2.1]

DU-176b 15mg 28.2 [21.6-35.6]* 1.6 [0.3-4.5]

30mg 21.2 [15.0-28.
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SOURCE Daiichi Sankyo
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