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Portola Pharmaceuticals to Present Preclinical Data with Andexanet Alfa and Factor Xa Inhibitor Edoxaban at European Society of Cardiology Congress 2015
Andexanet alfa, a
Portola previously conducted a successful Phase 2 proof-of concept study to evaluate andexanet alfa as an antidote for edoxaban in healthy volunteers. Portola is currently evaluating the antidote in two randomized, placebo-controlled Phase 3 ANNEXA™ registration studies with apixaban and rivaroxaban and in a Phase 4 confirmatory study in patients receiving apixaban, rivaroxaban, edoxaban or enoxaparin who present with an acute major bleed. The Company expects to submit a Biologics License Application (BLA) for andexanet alfa to the
Details of the moderated poster presentation follow.
|Abstract Title:||Andexanet alfa reverses edoxaban-induced anticoagulation in a rabbit|
|liver laceration model of acute bleeding (poster #P3088)|
|Presenting Author:||Polly Pine, Ph.D., senior director of pharmacology, Portola|
|Session Title:||Moderated Posters: Ischaemia, experimental studies|
|Presentation Date,||Monday, August 31, 10:51 a.m. BST at ExCel London, Poster Area,|
|Time and Location:||Moderated Poster Station|
About Andexanet Alfa
Andexanet alfa is a modified human Factor Xa molecule that acts as a decoy to target and sequester with high specificity both oral and injectable 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. Andexanet alfa has the potential to address numerous clinical scenarios where an antidote is needed by allowing for flexible and controlled reversal.
Andexanet alfa is the only compound being studied as a reversal agent for Factor Xa inhibitors that directly and specifically corrects anti-Factor Xa activity – the anticoagulant mechanism of these agents.
Andexanet alfa has been granted orphan drug designation by the
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Portola's plans for future clinical studies and pursuit of an Accelerated Approval process for andexanet alfa and the likelihood of clinical, regulatory and commercial success for andexanet alfa and its other product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: the accuracy of Portola's estimates regarding its ability to initiate and/or complete its clinical trials; the success of Portola's clinical trials and the demonstrated efficacy of Portola's product candidates thereunder; the accuracy of Portola's estimates regarding its expenses and capital requirements; Portola's ability to manufacture andexanet alfa; regulatory developments in
CONTACT: Investor Contact:
Michele Mantynen Portola Pharmaceuticalsir@portola.com Media Contact: Julie Normart W2O Groupjnormart@w2ogroup.com