Phase III clinical trials to assess its effectiveness in the prevention of venous thromboembolism will be initiated in the next weeks. Following the launch in the U. In the U. Ortho-McNeil will receive exclusive marketing rights for the cardiology, primary care and hospital specialty markets.
BHC will retain an option to co-promote Bay in the hospital and specialty markets through its Specialty Pharmaceutical unit in the U. BHC will also retain sole marketing rights for the compound in countries outside the United States.
Arthur J. We are confident that this alliance will help us to fully exploit the potential of our Factor Xa inhibitor and will also support our strategic plans for the U. BHC will receive the full profit from the urology prescription sales of Elmiron in the United States. We share a common vision with Bayer and look forward to contributing to the successful development of this promising compound by capitalizing on our clinical and commercial expertise in the area of thrombosis through our cardiology company Scios.
Factor Xa plays a central role in the blood coagulation cascade. BAY has been shown to inhibit free Factor Xa and prothrombinase activity. In this way, the direct Factor Xa inhibitor BAY prevents thrombin generation in the coagulation pathway. Clinical development of BAY BAY is currently being developed, in parallel, in three different indications: venous thromboembolism prevention after major orthopedic surgery, venous thromboembolism treatment and stroke prevention in atrial fibrillation.
BHC is planning to initiate phase III clinical studies for the prevention of venous thromboembolism after major orthopedic surgery in the fourth quarter of A further ongoing phase IIb study is being performed to assess the safety and efficacy of a once-daily dosing regimen of BAY for venous thromboembolism prevention after elective total hip replacement surgery. Taken together, the combined findings of these two phase IIb studies will drive the decision on the dosing regimen to be used in the phase III program.
