Agreements

Date: 2017-02-14

Type of information: Milestone

Compound: IONIS-FXIRx

Company: Bayer Healthcare (Germany) Ionis Pharmaceuticals (USA - CA)

Therapeutic area:

Type agreement: licensing - development - commercialisation

Action mechanism:

antisense drug. IONIS-FXIRx and IONIS-FXI-LRx are antisense drugs designed to reduce the production of clotting Factor XI. High levels of Factor XI increase the risk of thrombosis. People who are deficient in Factor XI have a lower incidence of thromboembolic events with minimal increase in bleeding risk. Factor XI deficiency results in a lower incidence of thromboembolic events with minimal increase in bleeding risk.

Disease:

Details:

• On May 4, 2015, Ionis Pharmaceuticals has entered into an exclusive license agreement with Bayer HealthCare (Bayer) to develop and commercialize ISIS-FXIRx for the prevention of thrombosis. 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.

Financial terms:

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 2 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.

Latest news:

• On February 14, 2017, Ionis Pharmaceuticals announced today the advancement of IONIS-FXIRx in clinical development under an existing exclusive license agreement with Bayer. Under this agreement, Ionis will also initiate development of IONIS-FXI-LRx, which uses Ionis' proprietary LIgand Conjugated Antisense, or LICA, technology. In conjunction with the decision to advance these programs, Ionis will receive a $75 million payment from Bayer.
Under the agreement, Ionis plans to conduct a Phase 2b study evaluating IONIS-FXIRx in approximately 200 patients with end-stage renal disease on hemodialysis to finalize dose selection. Additionally, Ionis plans to rapidly develop IONIS-FXI-LRx through Phase 1.