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Portola Pharmaceuticals Expands Clinical Collaboration Agreement with Daiichi Sankyo Worth Up to $25 Million to Develop AndexXa™ (andexanet alfa) in Germany
“As an industry, we need to address the significant unmet medical need for managing Factor Xa inhibitor-related major bleeding by bringing to market an antidote that specifically reverses anti-Factor Xa activity, the anticoagulant mechanism of these agents. With this support from
Under the terms of the non-exclusive agreement with
Portola previously entered into nine separate non-exclusive clinical collaboration agreements with
The Urgent Need for a Factor Xa Inhibitor Antidote
Annually, 1 to 4 percent of patients treated with Factor Xa inhibitors may experience major bleeding, and an additional 1 percent may require emergency surgery. Commensurate with the increase in the use of Factor Xa inhibitors -- for stroke prevention in atrial fibrillation; treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism; and prevention of DVT following knee or hip replacement surgery -- the number of hospital admissions due to bleeding associated with these agents continues to grow. In large randomized trials of Factor Xa inhibitors in patients with atrial fibrillation, the 30-day mortality rate in patients with intracranial hemorrhage (ICH) exceeded 40 percent. Based on the current adoption of all three Factor Xa inhibitors in
ANNEXA-4 Study Design
ANNEXA-4 is a global, single-arm, open-label clinical trial designed to evaluate AndexXa (andexanet alfa), a
AndexXa (andexanet alfa), an investigational drug, 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 potentially allowing for the restoration of normal hemostatic processes. AndexXa is the first compound being studied as an antidote for Factor Xa inhibitors that directly and specifically reverses anti-Factor Xa activity – the anticoagulant mechanism of these agents.
About Portola Pharmaceuticals, Inc.
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 the timing of our development efforts for andexanet alfa and the projected need for a Factor Xa inhibitor antidote. Risks that contribute to the uncertain nature of the forward-looking statements include the risk that our data fail to demonstrate safety and efficacy of andexanet alfa to the satisfaction of the
i Portola estimate based on IMS reported oral Factor Xa inhibitor sales in the EU5
Ana Kapor Portola Pharmaceuticalsir@portola.com Media Contact: Julie Normart W2O Groupjnormart@w2ogroup.com 415.946.1087