Bayer to develop and commercialise ISIS-FXI Rx for the prevention of thrombosis

Published: 5-May-2015

Makes an upfront payment of US$100m to US company Isis Pharmaceuticals


Bayer Healthcare has entered into a deal with Isis Pharmaceuticals, a US specialist in RNA targeted technology, to develop and commercialise ISIS-FXIRx for the prevention of thrombosis.

The German drugmaker has made an upfront payment of US$100m to Isis and has agreed a further $55m payment should the drug advance beyond the current Phase II study in patients with compromised kidney function.

After completion of this study Bayer will take over all global clinical development as well as worldwide regulatory and commercialisation responsibilities for ISIS-FXIRx.

Under the agreement, Isis will also be eligible to receive milestone payments as the drug progresses towards market launch. In addition, the company will receive tiered royalties on sales.

This first-in-class FXI inhibitor perfectly complements our in-house thrombosis pipeline

Bayer says it 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.

Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development, 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.'

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, while Factor XI deficiency results in a lower incidence of thromboembolic events with minimal increase in bleeding risk.

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