Portola has numerous global clinical collaborations that continue to grow and expand throughout the US, Europe, and Japan.
We have nonexclusive clinical collaboration agreements with all of the manufacturers of direct Factor Xa inhibitors, in which they have provided cash payments, as well as input on the development and regulatory approval of andexanet alfa as an antidote to their direct Factor Xa inhibitors in Japan, Europe, and the US. Excluding Japan, Portola has retained all commercial rights to andexanet alfa on a worldwide basis.
As part of our Phase 2 proof-of-concept studies, we entered into 3 separate agreements to include cohorts dosed with the approved Factor Xa inhibitors apixaban (Eliquis®, Bristol-Myers Squibb and Pfizer), rivaroxaban (XARELTO®, Bayer and Janssen) and edoxaban (Savaysa®, Daiichi Sankyo). For each of these Factor Xa inhibitors, new agreements were entered into after the completion of the Phase 2 studies for andexanet alfa. These agreements covered Phase 3 development through US and European regulatory approvals for each agent. With respect to apixaban and rivaroxaban, the obligations under these agreements have largely been completed with the approval of andexanet alfa in the US and Europe. In addition, we have also entered into a separate agreement with Daiichi Sankyo in Germany focused on the expansion of the ANNEXA-4 study in bleeding patients.
In Japan, Bristol-Myers Squibb and Pfizer are responsible for the development and commercialization of andexanet alfa. Separately, we have established clinical collaboration agreements with Bayer and Daiichi Sankyo to include their Factor Xa inhibitors, rivaroxaban and edoxaban, respectively, in the Japanese clinical development program.
In December 2016, we licensed worldwide rights for the development and commercialization of our investigational SYK/JAK inhibitor cerdulatinib in topical applications beyond oncology to Dermavant Sciences. We retain full rights to all non-topical formulations, including oral formulations.
Syk Selective Inhibitors
In May 2015, we announced a collaboration with Ora, Inc. for the development of our highly selective Syk inhibitor PRT2761 in ophthalmic diseases.