Wednesday, January 30, 2013

Lee Pharma Collaborate with Portola for development of new generation anticoagulant Betrixaban in China

Portola Pharmaceuticals, Inc. and Lee’s Pharmaceutical have entered into an agreement to jointly expand the Phase 3 APEX study of betrixaban into China, with an option for Lee’s to negotiate for 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 acute medically 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 acute medically ill patient population. So far no other new generation anticoagulant (Eliquis, Xarelto or Pradaxa) have been able to demonstrate benefit over the current standard of care (Lovenox) in this patient group.

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 identify leading clinicians and clinical sites to participate in the study. Lee’s also will lead regulatory interactions with China’s State Food and Drug Administration (SFDA). Following completion of the study, Lee’s will have an exclusive period in which to negotiate the commercial rights to betrixaban in China.

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