Portola expands collaboration with Daiichi to develop AndexXa in Germany
Portola Pharmaceuticals (PTLA) has expanded its existing clinical collaboration agreement with Daiichi Sankyo to develop AndexXa (andexanet alfa) as an antidote for the former’s Factor Xa inhibitor named as edoxaban.
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. As part of the updated agreement, Portola will expand the ongoing ANNEXA-4 study in bleeding patients in Germany.
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.
“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. Germany is the second largest market for Factor Xa inhibitors and one where edoxaban has experienced significant growth.
“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.”
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.
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.
Portola previously entered into nine separate non-exclusive clinical collaboration agreements with Daiichi Sankyo, BMS, Pfizer, Bayer and Janssen to support Phase 2 and registrational studies of AndexXa in the United States, Europe and Japan. P
ortola retains all rights, including full commercial and financial rights, for AndexXa outside of Japan.
Annually, 1 to 4% of patients treated with Factor Xa inhibitors may experience major bleeding, and an additional 1% may require emergency surgery.
Commensurate with the increase in the use of Factor Xa inhibitors — for stroke prevention in atrial fibrillation; treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism; and prevention of DVT following knee or hip replacement surgery — the number of hospital admissions due to bleeding associated with these agents continues to grow.
In large randomized trials of Factor Xa inhibitors in patients with atrial fibrillation, the 30-day mortality rate in patients with intracranial hemorrhage (ICH) exceeded 40%.
Based on the current adoption of all three Factor Xa inhibitors in the United States, this results in an estimated 300 deaths per month due to ICH related bleeding.
According to IMS Health, worldwide sales of oral Factor Xa inhibitors were $9.5 billion in the 12 months ending June 2016, a 52% growth over the same period of last year.
In the EU5, an estimated 73,000 oral Factor Xa inhibitor-treated patients will be hospitalized this year due to major bleeding or will require urgent surgery, with half of those patients in Germany.