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Phase III Trial Results Show Superiority of Rivaroxaban over,Enoxaparin for the Prevention of Venous Thromboembolism in Patients,Undergoing Knee Replacement Surgery

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Garry Neil, MD, group president for central nervous system and internal medicine research & development at Johnson & Johnson Pharmaceutical Research and Development commented: "We believe rivaroxaban could alter the landscape of antithrombotic therapy. An effective once-daily oral anticoagulant that can be administered safely and conveniently in the hospital and home settings has the potential to improve upon current therapies and help to treat the significant number of under- and un-treated patients at risk for life-threatening thrombotic events."

The trade name of rivaroxaban is expected to be Xarelto(R), pending health authority approval.

Results from other phase III trials in the RECORD program, RECORD1 and RECORD2 are expected to be available by H2 2007.

Unmet Needs in Venous Thromboembolism (VTE)

VTE is a type of thromboembolic disease that affects approximately 6.5 million people worldwide annually. Thromboembolic disease, which is caused by the obstruction of a blood vessel by a blood clot, is a leading cause of global mortality and a concern for many patient populations, including those with atrial fibrillation at risk for stroke; those at risk for myocardial infarction (heart attack); those undergoing orthopaedic surgery at risk for developing DVT and PE; and hospitalized, medically ill patients immobilized by cancer, congestive heart failure, acute respiratory disease, or other illnesses.

About Rivaroxaban (Xarelto(R))

Phase IIb data - presented at ISTH in 2005, and published in the Journal of Thrombosis and Haemostasis in 2005 and 2006, and the additional once-daily ODIXa HIP study published in Circulation in 2006 - indicate that rivaroxaban offers predictable anticoagulation, which strongly suggests that routine coagulation monitoring will not be required. In addition, data show that rivaroxaban does not interact with a wide variety of drugs that are commonly given concomitantly with an anticoagulan
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