Q3 2019

24 EU BUSINESS NEWS / Q3 2019 , Portola Launches European Sales of Ondexxya ® Portola expands patient access to the first and only factor Xa reversal agent approved in Europe for life-threatening bleeds associated with the use of rivaroxaban or apixaban. Portola Pharmaceuticals, Inc. ® announced the Company’s first sales of Ondexxya ® (andexanet alfa) in Europe. These sales mark the initiation of commercial access in Europe to Ondexxya – the first and only reversal agent approved for adult patients treated with the Factor Xa inhibitors rivaroxaban or apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Portola is executing a phased launch of Ondexxya in Europe, with an initial focus on Germany, Austria, the United Kingdom, the Netherlands, Sweden, Denmark and Finland, where Factor Xa inhibitor use, and related bleeds, are among the highest in Europe. “The number of Europeans taking a Factor Xa inhibitor is nearly double that of the U.S. and continues to grow at a significant rate. The speed with which these first European orders were received and the number of medical societies that have already added Ondexxya to their guidelines speaks to the potential unmet need and demand for Ondexxya,” said Scott Garland, Portola’s president and chief executive officer. “We are pleased to now be providing European clinicians with this important new medicine and to have the opportunity to impact hundreds of thousands of lives.” “As the first and only Factor Xa reversal agent approved in Europe to address life- threatening bleeds associated with apixaban or rivaroxaban, Ondexxya represents a significant step forward in patient care,” said Gerwin Winter, senior vice president and Portola’s head of Europe. “We look forward to continuing discussions with individual reimbursement authorities and further expanding access to Ondexxya in Europe.” The worldwide use of Factor Xa inhibitors is rapidly growing because of their efficacy and safety profile compared to warfarin and enoxaparin in preventing and treating thromboembolic conditions such as stroke, pulmonary embolism and venous thromboembolism (VTE). This growth has come with a related increase in the incidence of hospital admissions and deaths related to bleeding, the major complication of anticoagulation. Prior to its approval in Europe, international guidelines from the American College of Chest Physicians (CHEST) and the European Society of Cardiology (ESC) recommended Ondexxya for first-line use based on its clinical attributes. Ondexxya is now recognized in nine European medical society guidelines, including the European Stroke Organisation. The European Commission (EC) granted conditional Marketing Authorization for Ondexxya in Europe in April 2019. It was approved by the U.S. Food and Drug Administration (FDA) in May 2018 under the FDA’s Accelerated Approval pathway and is marketed by Portola in the U.S. under the trade name Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo].