Date: 2016-04-04
Type of information: Clinical research agreement
Compound: andexanet alfa and edoxaban
Company: Portola Pharmaceuticals (USA - CA) Daiichi Sankyo (Japon)
Therapeutic area: Cardiovascular diseases - Hematologic diseases
Type agreement: clinical research
Action mechanism:
- anticoagulant agent/ blood coagulation factor XA inhibitor/antithrombotic.
- Andexanet alfa is a first-in-class recombinant, modified Factor Xa molecule. It is being developed as a direct reversal agent for patients receiving a Factor Xa inhibitor who suffer a major bleeding episode or who may require emergency surgery. Andexanet alfa 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 the restoration of normal hemostatic processes.
- Edoxaban is an investigational, oral, once-daily anticoagulant that specifically inhibits factor Xa.
Disease: reversion of the anticoagulant activity of edoxaban
Details:
- • On April 4, 2016, Portola Pharmaceuticals announced that it has entered into a clinical collaboration agreement with Daiichi Sankyo to develop andexanet alfa as an antidote for edoxaban, Daiichi Sankyo’s Factor Xa inhibitor, in Japan.
- Portola is developing andexanet alfa for patients treated with a direct or indirect Factor Xa inhibitor when reversal of anticoagulation is needed, such as for life-threatening or uncontrolled bleeding or emergency surgery and urgent procedures.
Financial terms:
- Under the terms of the agreement with Daiichi Sankyo, Portola will receive an upfront payment and is eligible to receive an additional milestone payment based on Japanese Ministry of Health, Labor and Welfare (MHLW) approval of andexanet alfa as an antidote for edoxaban. Daiichi Sankyo will provide technical support and fund all clinical studies of andexanet alfa with edoxaban in Japan. Daiichi Sankyo will receive no commercial or financial rights under this agreement.
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