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Portola Pharmaceuticals Initiates Phase II Trial of Betrixaban, its Novel Oral Factor Xa Inhibitor for Stroke Prevention in Atrial Fibrillation
Date:11/3/2008

use it is minimally excreted in the kidneys, betrixaban may be the only drug of its kind available for the large and growing population of moderately and severely renally-impaired patients who are at high risk for bleeding. This would dramatically expand the treatment index for this type of drug."

Betrixaban has been specifically designed to have ideal properties for chronic therapy and to be the only true, once-daily oral anticoagulant with distinct advantages over other currently available anticoagulants or those in clinical trials such as rivaroxaban, apixaban and dabigatran.

Betrixaban inhibits Factor Xa, a validated target for which there are approved drugs on the market. Inhibiting Factor Xa activity appears to offer advantages over other anticoagulation targets. Portola believes betrixaban will offer several key differentiating features including a long half-life and a low peak-to-trough drug concentration ratio to support once-daily dosing and the potential for an improved benefit/risk profile. Betrixaban is minimally excreted through the kidneys and therefore, unlike other novel agents, may not require dose adjustment in patients with moderately impaired renal function and may be the only novel oral anticoagulant available for patients with severe renal disease. And because betrixaban is neither an inhibitor nor an inducer of cytochrome P450 enzymes, it minimizes the risk of drug-drug interactions often seen with other Factor Xa inhibitors in development and with warfarin.

Portola has completed EXPERT, a 200-patient Phase II trial, demonstrating betrixaban's clinical proof of concept in preventing venous thromboembolism in patients undergoing knee replacement surgery. Preclinical and Phase I studies, in addition to EXPERT, have shown that betrixaban is well tolerated over a range of dose levels.

Portola may develop betrixaban for additional indications including prevention of venous thromboembolism (VTE) in medically ill patients
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SOURCE Portola Pharmaceuticals, Inc.
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