Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Submits New Drug Application To FDA For Rivaroxaban

Main Category: Vascular
Also Included In: Blood / Hematology;  Regulatory Affairs / Drug Approvals
Article Date: 31 Jul 2008 - 4:00 PDT

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for rivaroxaban, an investigational, oral, once-daily anticoagulant for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery.

In 2005, J&JPRD entered into an agreement with Bayer HealthCare AG to jointly develop rivaroxaban. If approved by the FDA, Ortho-McNeil, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market the drug in the U.S. Bayer HealthCare holds marketing rights in countries outside the U.S.

Venous blood clots, also known as venous thromboembolism (VTE), include DVT - a blood clot in a large vein, usually in the legs - and PE - a blood clot that has traveled to the lungs - both of which are life-threatening but often preventable complications following major orthopedic surgery. Annually in the U.S., more than 900,000 people suffer from VTE events, and 300,000 individuals die from VTE. Patients undergoing hip or knee replacement surgery are at high risk for VTE because the large veins of the leg that carry blood back to the heart are significantly damaged during these procedures. In fact, venous blood clots occur in up to 40% of patients undergoing major orthopedic surgery who do not receive preventative care. Each year, approximately 700,000 Americans elect to have hip and knee replacement surgeries, and a blood clot is the most common cause of re-hospitalization for this patient group.

The filing was supported by data from the global RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program. The RECORD program involved more than 12,500 patients in four studies and compared rivaroxaban to injected enoxaparin, for the prevention of total VTE in patients undergoing either total knee or hip replacement surgery.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a wholly-owned subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas, including CNS, Internal Medicine and Oncology, to address unmet medical needs worldwide. More information can be found at http://www.jnjpharmarnd.com.

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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