Date: 2014-10-16
Type of information: Production agreement
Compound: andexanet alfa
Company: Portola Pharmaceuticals (USA - CA) Lonza (Switzerland)
Therapeutic area: Cardiovascular diseases - Hematological diseases
Type agreement: production manufacturing
Action mechanism: Andexanet alfa has been designated as a breakthrough therapy. This recombinant Factor Xa molecule is being developed as a direct reversal agent (antidote) for patients receiving a Factor Xa inhibitor who suffer a major bleeding episode or who may require emergency surgery. It acts as a Factor Xa decoy that targets and sequesters with high specificity both direct and indirect Factor Xa inhibitors in the blood. Once bound, the Factor Xa inhibitors are unable to bind to and inhibit native Factor Xa, thus allowing for restoration of normal hemostatic processes. Portola has entered into clinical collaboration agreements with all of the manufacturers of direct Factor Xa inhibitors – BMS and Pfizer for Eliquis® (apixaban), Bayer HealthCare and Janssen Pharmaceuticals for Xarelto® (rivaroxaban), and Daiichi Sankyo for edoxaban – while retaining 100 percent worldwide commercialization rights to andexanet alfa. Two, pivotal Phase 3 studies, known ANNEXA™- A (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXA Inhibitors – Apixaban) and ANNEXA™- R (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXA Inhibitors – Rivaroxaban), with Eliquis and Xarelto® in healthy volunteers are ongoing. A third, known as ANNEXA™- E (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXA Inhibitors – Edoxaban), is planned. These randomized, double-blind, placebo-controlled studies are designed to evaluate the safety and efficacy of andexanet alfa in reversing Eliquis-, Xarelto® - or edoxaban-induced anticoagulation rapidly after an IV bolus and sustaining that effect through a continuous infusion.
Disease: antidote for patients receiving a Factor Xa inhibitor who suffer a major bleeding episode or who may require emergency surgery
Details: * On October 16, 2014, Portola Pharmaceuticals announced that it has executed a supply agreement with Lonza for the commercial manufacturing of andexanet alfa. With this global agreement, Portola has secured two commercial manufacturing contracts in order to supply the global market. CMC Biologics will manufacture andexanet alfa for the expected U.S. launch in 2016. To meet anticipated global demand, Lonza will provide large-scale supply approximately 18-24 months following launch.
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