Edited Press Release

FRANKFURT -(Dow Jones)- German chemicals and pharmaceuticals company Bayer AG said Wednesday its cooperation partner Johnson & Johnson Pharmaceutical Research and Development has submitted the new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, for rivaroxaban (Xarelto), a novel anticoagulant taken as one tablet, once-daily.

It seeks approval for the use of rivaroxaban in the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.

Rivaroxaban was invented in Bayer's Wuppertal laboratories and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Once marketing authorization has been granted in the U.S., rivaroxaban will be commercialized by Ortho-McNeil, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Rivaroxaban is the first oral anticoagulant to demonstrate superior efficacy over the U.S. approved twice-daily injectable regimen of enoxaparin, with a similar safety profile and no significant increase in major bleeding. Upon FDA approval, rivaroxaban will be the first novel oral anticoagulant introduced in the U.S. market for more than 50 years.

In addition to the FDA submission, filings are under review with regulatory agencies around the world. On Jul. 24, rivaroxaban was recommended for approval in Europe for the prevention of venous thromboembolism following elective hip and knee replacement surgery.

Click here to go to Dow Jones NewsPlus, a web front page of today's most important business and market news, analysis and commentary: http:// www.djnewsplus.com/al?rnd=RpBLwY2%2BwBMpPkHqa4Duuw%3D%3D. You can use this link on the day this article is published and the following day.

  (END) Dow Jones Newswires
  07-30-08 0129ET
  Copyright (c) 2008 Dow Jones & Company, Inc.