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Lee’s Pharma Gains Negotiation Option for China Rights to Anticoagulant

Jan. 28, 2013

Portola Pharmaceuticals and Lee’s Pharmaceutical have announced an agreement to jointly expand the Phase 3 APEX study of betrixaban, with an option to negotiate the commercial rights to the drug in China. The APEX Study is evaluating betrixaban, a novel oral, once-daily Factor Xa inhibitor for extended duration venous thromboembolism (VTE) prophylaxis, for superiority compared with the current standard of care in acutely ill patients. If successful, betrixaban will be the first novel oral anticoagulant approved for use in this indication and the first anticoagulant approved for extended duration VTE prophylaxis in the acutely ill patient population. Under the agreement, Lee’s will provide Portola with upfront and continuing payments to support the expansion of the APEX study into China and work with Portola to identy leading clinicians and clinical sites to participate in the study. Lee’s will also lead regulatory interactions with China’s SFDA. Following completion of the study, Lee’s will have an exclusive period in which to negotiate the commercial rights to betrixaban in China.