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Rivaroxaban phase III pivotal data presented at EFORT annual meeting
Date:5/30/2008

Nice, France (May 30, 2008) Results from a pivotal Phase III clinical trial presented today demonstrate that rivaroxaban, an oral, once-daily, investigational anticoagulant medication, was superior in preventing venous blood clots in patients who underwent total knee replacement (TKR) surgery. The head-to-head study compared rivaroxaban with the U.S.-approved dosing regimen for enoxaparin, the current standard of care.

Data from the RECORD4 clinical trial were presented at the annual meeting of the European Federation of National Associations of Orthopaedics & Traumatology (EFORT). Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Bayer HealthCare AG.

The RECORD4 data show that rivaroxaban (10mg once-daily) provided TKR surgery patients a statistically significant 31% relative risk reduction (RRR) in total venous thromboembolism (VTE) events defined in the study as the composite of all deep vein thrombosis, non-fatal pulmonary embolism and all-cause mortality compared to enoxaparin (30mg twice-daily) (6.9% and 10.1%, respectively, p =0.012). Rates of major bleeding, the main safety endpoint, were low in both treatment groups, yet numerically greater in rivaroxaban-treated patients. This difference was not statistically significant from the rate of major bleeding in enoxaparin-treated patients (0.7% and 0.3% respectively; p=0.110). RECORD4 is the third of three, direct, head-to-head comparisons within the RECORD program to demonstrate the superior efficacy of rivaroxaban over enoxaparin with a similar adverse event profile.

"The superior efficacy and similar adverse event profile of rivaroxaban demonstrated in RECORD4 are in line with the outstanding results of the earlier RECORD studies," said Dr. A.G.G. Turpie, Professor of Medicine, McMaster University, Canada and Principal Investigator for the RECORD program. "The success of this trial strengthens my belief that d
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Contact: Stephen Cooper
stephen.cooper@edelman.com
Edelman Public Relations
Source:Eurekalert

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