Date: 2014-02-03
Type of information: Clinical research agreement
Compound: andexanet alfa
Company: Portola Pharmaceuticals (USA) Bayer (Germany) Janssen Pharmaceuticals - J&J (USA)
Therapeutic area: Cardiovascular diseases
Type agreement: R&D
clinical research
Action mechanism: Andexanet alfa is a first-in-class recombinant, modified Factor Xa molecule 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.i Through its mechanism of action, andexanet alfa has the potential to act as a reversal agent and address the direct cause of the patient\'s inhibited clotting activity without being prothrombotic.
Disease:
Details: * On February 3, 2014, Portola Pharmaceuticals has announced that it has entered into a second clinical collaboration agreement with Bayer HealthCare and Janssen Pharmaceuticals to evaluate its investigational Factor Xa inhibitor reversal agent, andexanet alfa, in Phase 3 registration studies with the FDA -approved oral Factor Xa inhibitor Xarelto® (rivaroxaban). Portola\'s original collaboration agreement with Bayer and Janssen, announced in February 2013, covered the conduct of a Phase 2 proof-of-concept study. Interim results of that study were presented in December 2013 at the 55th American Society of Hematology (ASH) Annual Meeting and demonstrated that andexanet alfa can produce an immediate and dose-dependent reversal of the anticoagulation activity of Xarelto®. The new clinical collaboration agreement will be in effect through completion of Phase 3 studies with Xarelto® and any potential U.S. and EU regulatory approval of andexanet alfa. The Phase 3 studies are expected to start in the first half of 2014.
Under this non-exclusive collaboration agreement, Portola will receive an upfront payment and is eligible to receive additional development and regulatory milestone payments. Portola retains full, worldwide commercial rights to andexanet alfa, which was designated as a breakthrough therapy by the FDA in November 2013 and for which Portola is pursuing an Accelerated Approval pathway.
Portola has reported data from a Phase 2 proof-of-concept study of andexanet alfa and Xarelto®. Results showed that andexanet alfa can produce immediate, dose-dependent and well-tolerated reversal of anti-Factor Xa activity. The reversal can be either temporary through the administration of an intravenous bolus or sustained by the addition of an extended infusion. This is relevant for covering the clinical scenarios in which a reversal agent would be needed, which could include patients suffering major bleeding. Portola has also reported data from a Phase 2 proof-of-concept study of andexanet alfa and Eliquis® (apixaban). The Phase 2 studies, which have included more than 80 volunteers, have shown that andexanet alfa is well tolerated, with no thrombotic events, serious adverse events or antibodies to Factor Xa or Factor X observed. Additional Phase 2 proof-of-concept studies with the direct Factor Xa inhibitors, betrixaban and Savaysa™ (edoxaban), and the indirect Factor Xa inhibitor, enoxaparin, are either planned or ongoing.
Portola has entered into multiple clinical collaboration agreements with all of the manufacturers of direct Factor Xa inhibitors, while retaining full worldwide rights to the andexanet alfa program. These include Phase 3 collaborations to study andexanet alfa with Bayer HealthCare and Janssen Pharmaceuticals\' Xarelto® and with Bristol-Myers Squibb Company and Pfizer\'s Eliquis. These studies are expected to begin in the first half of 2014.
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