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The Phase III global study, Effective Anticoagulation with Factor Xa NextGeneration in Atrial Fibrillation (ENGAGE-AF TIMI 48), will compare DU-176bwith warfarin in preventing stroke and systemic embolic events (SEE) inpatients with atrial fibrillation. The primary safety assessment will be theincidence of bleeding.
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Results from a recently presented Phase II safety study showed that theincidence of major and clinically relevant non-major bleeding events reportedin the once-daily DU-176b treatment groups (30 mg or 60 mg) was similar tothat in the warfarin-treated patient group. The incidence of major andclinically relevant non-major bleeding events was significantly higher in thetwice-daily DU-176b treatment groups (30 mg or 60 mg), compared to thewarfarin group. The Phase III study will therefore randomize approximately16,500 patients to one of three treatment groups: 30 mg DU-176b once daily, 60mg DU-176b once daily, or warfarin. Those randomized to warfarin will bedosed once daily with dose adjustments to maintain International NormalizedRatio (INR) between 2.0 and 3.0.
This is an event-driven, Phase III, multinational, randomized,double-blind study with sites in North and South America, Africa, Asia,Europe, Australia and New Zealand. The expected median treatment duration ofthe study is 24 months; Daiichi Sankyo expects the study to conclude in thefirst half of 2012.
"There is a need for a safe and effective option for the prevention ofclotting or stroke in patients with atrial fibrillation other than the currentstandard of care, warfarin, which requires extensive monitoring and posespotentially serious drug and food interactions," said John Alexander, M.D.,M.P.H., global head of research and development, Daiichi Sankyo Company,Limited. "The start of our Phase III trial marks an important milestone inthe clinical development of DU-176b and we hope this compound will prove to beanother successful treatment in our cardiovascular portfolio."
About Atrial Fibrillation
Atrial fibrillation (AF) is an irregular heartbeat caused when the upperchambers of the heart (the atria) beat inconsistently and rapidly. When thishappens, blood can become stagnant near the walls of the atria and form bloodclots. These blood clots can break off and travel through the blood stream tothe brain where they can block blood vessels possibly causing a stroke. Theseclots can also cause damage to other organs in the body by blocking peripheralarteries.
About 90,000 strokes in the U.S. are caused by atrial fibrillation.(1)Patients with atrial fibrillation have five times higher risk of having astroke.(2) These patients also tend to have more serious first strokes thanpatients without atrial fibrillation, resulting in higher mortality rates andlonger hospital stays.(1)
About DU-176b
DU-176b is an oral anticoagulant that directly inhibits Factor Xa, aclotting factor in the blood. Daiichi Sankyo is developing DU-176b as apotential new treatment for the prevention of both arterial and venousthromboembolism. Notably, Daiichi Sankyo has more than 25 years experienceconducting research in the area of Factor Xa inhibition and was the firstcompany to test these compounds in humans.
About Daiichi Sankyo
A global pharma innovator, Daiichi Sankyo Co., Ltd., was established in2005 through the merger of two leading Japanese pharmaceutical companies. Thisintegration created a more robust organization that allows for continuousdevelopment of novel drugs that enrich the quality of life for patients aroundthe world. A central focus of Daiichi Sankyo's research and development arethrombotic disorders, malignant neoplasm, diabetes mellitus, and autoimmunedisorders. Equally important to the company are hypertension, hyperlipidemiaor atherosclerosis and bacterial infections. For more information, visitwww.daiichisankyo.com.
Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S.subsidiary of Daiichi Sankyo Co., Ltd. For more information on Daiichi Sankyo,Inc., please visit www.dsus.com.
Forward-Looking Statements This news release may contain forward-lookingstatements based on current assumptions and forecasts made by Daiichi Sankyogroup. Various known and unknown risks, uncertainties and other factors couldlead to material differences between the actual future results, financialsituation, development or performance of the company and the estimates givenhere. These factors include those discussed in our public reports, which areavailable on the website at www.daiichisankyo-us.com. The company assumes noliability whatsoever to update these forward-looking statements or to conformthem to future events or developments.
(1) Jorgensen, H.S., Nakayama, H, Reith, J. et. al. Acute stroke withatrial fibrillation. Stroke 1996;27: 1765-1769.(2) Hylek AM, et al. N Engl J Med. 2003; 349:1019-1026. Toshiaki Sai Dr. Felix Munzel Daiichi Sankyo Company, Limited (Tokyo) Daiichi Sankyo Europe GmbH Phone: +81-3-6225-1126 Phone: + 49-(0)-89-7808-471 Kimberly Wix Dr. Thomas Portz Daiichi Sankyo, Inc. (United States) Daiichi Sankyo Europe GmbH Phone: +1 (973) 695-8338 Phone: + 49 (0)89-78 08 468 Mobile: +1 (908) 656-5447 Mobile: + 49 (0)172-841 5904
SOURCE Daiichi Sankyo Company, Limited
