BAYER SOLICITA AUTORIZACION DE LA UE PARA LA COMERCIALIZACION DEL RIVAROXABAN (TRATAMIENTO TROMBOSIS PROFUNDA Y EMBOLIA PULMONAR).

Bayer has submitted an application for marketing authorization to the European Medicines Agency (EMA) for the oral anticoagulant rivaroxaban in stroke prevention in patients with atrial fibrillation (SPAF), as well as for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE). Rivaroxaban is an oral direct Factor Xa inhibitor, and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD).

The submission for stroke prevention in patients with AF is supported by data from the pivotal, global Phase III ROCKET AF trial that was presented at the American Heart Association (AHA) Congress in November 2010.

Submission for the treatment of DVT, and prevention of recurrent DVT and PE, is based on data from the Phase III EINSTEIN-DVT trial that was presented at the European Society of Cardiology (ESC) Congress in August 2010, and data from the Phase III EINSTEIN-Extension trial that was presented in December 2009 at the 51st Annual Meeting of the American Society of Hematology (ASH). The EINSTEIN-DVT and EINSTEIN-Extension data have recently been published in the New England Journal of Medicine (NEJM).

ROCKET AF, EINSTEIN-DVT and EINSTEIN-Extension are part of the global development program that has demonstrated the benefit of rivaroxaban in the seven Phase III studies completed to date.

Bayer also confirmed that J&JPRD filed its complete response with the U.S. Food & Drug Administration (FDA) seeking approval to use rivaroxaban for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing total hip or total knee replacement surgery. The filing includes specific information requested by the FDA in a Complete Response Letter on May 28, 2009, and is primarily supported by data from the pivotal, global Phase III RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program.

If approved by the FDA, Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company), will commercialize rivaroxaban in the U.S. The U.S. Bayer HealthCare sales force will support the Ortho-McNeil sales force by detailing rivaroxaban in designated hospital accounts. Bayer HealthCare is exclusively responsible for the marketing of rivaroxaban in countries outside the U.S.