- Portola Pharmaceuticals has broadened its partnership with Japanese drugmaker Daiichi Sankyo, agreeing to expand an open-label study in Germany of its Factor Xa inhibitor antidote AndexXa (andexanet alfa).
- AndexXa is designed to reverse the effects of Daiichi Sankyo's blood thinner edoxaban, along with other Factor Xa inhibitors made by Bristol-Myers Squibb and Johnson & Johnson.
- Under the new deal, Daiichi Sankyo will pay Portola $15 million upfront, with the potential for another $10 million contingent on Portola meeting site initiation and enrollment targets.
Portola hopes for U.S. approval of AndexXa took at hit in August when the Food and Drug Administration turned down the company's biologics license application, citing issues with the chemistry, manufacturing and controls section in a complete response letter.
The company believes it can resolve the issues, but a timeline for resubmission remains unclear. Since receiving the CRL, Portola has unveiled new data from a Phase 3b/4 trial which showed treatment with the drug effectively stopped bleeding in 79% of patients who presented with an acute major bleed while on a Factor Xa inhibitor.
AndexXa is currently under review by the European Medicines Agency for approval as a reversal agent for patients who experience a life-threatening bleed or require emergency surgery.
"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," said Tao Fu, chief commercial and business officer of Portola.
There is currently no FDA-approved antidote to Factor Xa inhibitors, which include Bristol-Myers Squibb's fast-selling Eliquis (apixaban) and Johnson & Johnson's Xarelto (rivaroxaban). Given the unmet medical need, development of AndexXa has been closely watched.
In EU5 countries, over 70,000 Factor Xa inhibitor-treated patients will be hospitalized this year with a major bleed or for urgent surgery, Portola said citing figures from IMS Health. Half of those patients are in Germany, where Portola and Daiichi are expanding their clinical collaboration.