Isis Pharmaceuticals Licenses ISIS-FXI Rx to Bayer to Develop and Commercialize for the Prevention of Thrombosis

Isis Pharmaceuticals has entered into an exclusive license agreement with Bayer HealthCare to develop and commercialize ISIS-FXIRx for the prevention of thrombosis. 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 twenty percent 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.

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.

"We believe Bayer, a leading pharmaceutical company in the treatment of thrombotic disease, is the ideal partner for ISIS-FXIRx. This transaction further demonstrates Bayer's commitment to the field. Bayer has the expertise, commitment and resources to develop ISIS-FXIRx in areas where unmet medical needs exist. We are pleased with the value of this partnership, which supports a robust development program to maximize the value of ISIS-FXIRx globally and which allows us to participate significantly in future commercial success," said Stanley Crooke, CEO at Isis Pharmaceuticals. "We believe that this transaction represents the right deal, with the right partner and the right development plan."

"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," said Dr Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. "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 to its full potential."

This transaction is subject to clearances under the Hart-Scott Rodino Antitrust Improvements Act.