Upon AndexXa’s approval, Daiichi Sankyo will be eligible to receive a low single-digit royalty on AndexXa sales up to a total of $8m. Under the terms of the non-exclusive agreement with Daiichi Sankyo, Portola will receive a $15m upfront payment and is eligible to receive up to an additional $10m upon meeting site initiation and enrollment targets. “Our long-standing collaboration with Daiichi Sankyo, as well as all of the other manufacturers of Factor Xa inhibitors, demonstrates the confidence these companies have in the AndexXa program.” Germany is the second largest market for Factor Xa inhibitors and one where edoxaban has experienced significant growth. “With this support from Daiichi Sankyo, we will be able to improve our ability to gather data on AndexXa as a reversal agent for edoxaban. Portola chief commercial and business officer Tao Fu said: “As an industry, we need to address the significant unmet medical need for managing Factor Xa inhibitor-related major bleeding by bringing to market an antidote that specifically reverses anti-Factor Xa activity, the anticoagulant mechanism of these agents. As part of the updated agreement, Portola will expand the ongoing ANNEXA-4 study in bleeding patients in Germany. AndexXa is currently under EMA review for reversal of Factor Xa inhibition in patients experiencing a life-threatening or uncontrolled bleed and for patients requiring urgent or emergency surgery.

Andexxa trial