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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

Rivaroxaban, a New Oral, Once-Daily Direct Factor Xa Inhibitor, Shows a Significant Reduction in Deep Vein Thrombosis and Pulmonary Embolism Compared with Enoxaparin with Similarly Low Bleeding Rates

GENEVA, July 8, 2007 - Late-breaking Phase III clinical trial data presented today at the XXI International Society on Thrombosis and Haemostasis (ISTH) Congress demonstrate that once-daily rivaroxaban (Xarelto®) achieved superior efficacy in the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement surgery in a head-to-head comparison with enoxaparin, the current standard of care therapy.

Patients in the RECORD3 (REgulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) study who were treated with rivaroxaban demonstrated a 49% relative risk reduction (RRR) (p<0.001) of the composite primary endpoint of deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE) and all-cause mortality compared to those treated with enoxaparin. An even greater (62%) reduction of risk (p=0.01) of developing major VTE (the composite of proximal DVT, non-fatal PE and VTE-related death), the secondary endpoint of the trial, was observed in the patients treated with rivaroxaban. Importantly, rivaroxaban also demonstrated a similarly low rate of major bleeding compared to enoxaparin (0.6% and 0.5%, respectively).

Rivaroxaban is an investigational, oral, once-daily direct Factor Xa inhibitor. It is an anticoagulant (a drug designed to prevent and treat blood clots) in advanced clinical development for the prevention and treatment of thrombosis in acute and chronic settings, enabling convenient administration in both the hospital and at home.

Rivaroxaban is being jointly developed by Bayer HealthCare AG and Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), L.L.C.

Lead RECORD3 investigator, Michael R. Lassen
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