Pharmaceutical Business review

Bayer to develop Isis Pharmaceuticals’ ISIS-FXI Rx for prevention of thrombosis

As part of the deal, Bayer will further develop and commercialize ISIS-FXIRx in areas of high unmet medical need.

Under the clinical development program, Bayer will 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.

Bayer HealthCare member of the Executive Committee and head of Global Development Dr Joerg Moeller said: "This first-in-class FXI inhibitor perfectly complements our in-house thrombosis pipeline and is an innovative development candidate for a variety of anti-coagulation needs.

"We believe the novel mechanism of Factor XI inhibition may offer an additional pathway for treating patients for whom there are currently no suitable therapeutic options available. We share a common vision with Isis in developing ISIS-FXIRx."

The deal will see Isis receive about $155m in near-term payments, including an immediate $100m up-front payment and a $55m payment upon advancement of the program following a Phase II trial in patients with compromised kidney function.

In addition, Isis is also eligible to get milestone payments as the drug advances toward the market as well as receive tiered royalties in the low to high twenty percent range on gross margins of ISIS-FXIRx.

Upon completion of ongoing activities at Isis, Bayer will assume all global clinical development as well as worldwide regulatory and commercialization responsibilities for ISIS-FXIRx.