Bayer HealthCare has entered into an exclusive license agreement with Isis Pharmaceuticals, Inc. on ISIS-FXIRx, an antisense drug in clinical development for the prevention of thrombosis. Under the agreement Bayer will further develop and commercialize ISIS-FXIRx in areas of high unmet medical need. As part of the clinical development program, Bayer plans to evaluate the therapeutic profile of ISIS-FXIRx in patients for whom currently available anticoagulants may not be used, such as in patients with a high risk of bleeding due to multiple co-morbidities.

Under the terms of the agreement, Isis is eligible to receive up to $155 million in near-term payments, including an immediate $100 million up-front payment and a $55 million payment upon advancement of the program following a Phase II study in patients with compromised kidney function. Isis is also eligible to receive milestone payments as the drug advances toward the market. In addition, Isis is eligible to receive tiered royalties in the low- to- high 20% range on gross margins of ISIS-FXIRx. After completion of ongoing activities at Isis, Bayer will assume all global clinical development as well as worldwide regulatory and commercialization responsibilities for ISIS-FXIRx. This transaction is subject to clearances under the Hart-Scott Rodino Antitrust Improvements Act.

ISIS-FXIRxis an antisense drug in development for the prevention of clotting disorders. Antisense drugs are single-stranded RNA molecules that are complementary to a messenger RNA (mRNA) strand that was transcribed from the DNA strand as part of the protein expression machinery within a cell. Antisense drugs bind to the target mRNA molecules in the cell and inhibit the production of disease-causing proteins. ISIS-FXIRx targets Factor XI, a clotting factor produced in the liver that is an important component of the coagulation pathway. High levels of Factor XI increase the risk of thrombosis, a process involving aberrant blood clot formation that can be responsible for heart attacks and strokes while Factor XI deficiency results in a lower incidence of thromboembolic events with minimal increase in bleeding risk, according to information from Bayer HealthCare.

Source: Bayer HealthCare