DAIICHI SANKYO Announces Clinical Study Data for Oral Factor Xa Inhibitor DU-176b
Munich, Germany, September 2, 2008 – 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.”
| VTE incidence (%) | Bleeding occurence*** (%) | |
| Dalteparin | 43.8 [35.5-52.3]# | 0 [0-2.1] |
| DU-176b 15 mg | 28.2 [21.6-35.6]* | 1.6 [0.3-4.5] |
| 30 mg | 21.2 [15.0-28.6]** | 1.8 [0.4-5.1] |
| 60 mg | 15.2 [10.0-21.8]** | 2.2 [0.6-5.4] |
| 90 mg | 10.6 [6.2-16.6]** | 2.3 [0.6-5.7] |
#95% confidence interval, * p=0.005, **p<0.001, ***Major+Clinically Relevant
About DU-176b
DU-176b is an oral anticoagulant that directly inhibits Factor Xa, a clotting factor in the blood. DAIICHI SANKYO is developing DU-176b as a potential new treatment for the prevention of both arterial and venous thromboembolism.
For more information, please contact:
Toshiaki Sai
General Manager, Corporate Communications Department
DAIICHI SANKYO Company, Limited
Phone: +81-3-6225-1126
Kimberly Wix
DAIICHI SANKYO, Inc. (United States)
Phone: +1 (973) 695-8338
Mobile : +1 (908) 656-5447
Dr. Felix Münzel
DAIICHI SANKYO EUROPE GmbH
Phone + 49-(0)-89-7808-471
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.









