Breaking News

Portola, Daiichi Expand Clinical Collaboration

July 8, 2014

Establishes Phase III agreements for Factor Xa inhibitors

Portola Pharmaceuticals has entered a second clinical collaboration with Daiichi Sankyo to study andexanet alfa, Portola's investigational Factor Xa inhibitor in Phase III studies with Daiichi's Factor Xa inhibitor edoxaban.
 
Portola will receive an upfront payment and is eligible to receive additional development and regulatory milestones. Portola retains full commercial rights to andexanet alfa. Financial details were not disclosed.
 
The original alliance, dating back to June 2013, covered the conduct of a Phase II proof-of-concept study, for which results are expected later this year.  
 
"We have now established Phase III collaboration agreements with all of the manufacturers of Factor Xa inhibitors. This, combined with the FDA's designation of andexanet alfa as a breakthrough therapy, underscores the significant need for an antidote for the millions of patients currently being treated with these novel anticoagulants," said William Lis, chief executive officer. "We are pursuing an accelerated approval pathway for andexanet alfa in order to bring this novel therapy to market as quickly as possible for the benefit of patients."

Related Contract Manufacturing:

Related Compliance:

  • CROs and Today’s  R&D Landscape

    CROs and Today’s R&D Landscape

    Kristin Brooks, Associate Editor, Contract Pharma||November 9, 2016
    John Lewis of ACRO discusses opportunities, challenges, and the future CRO

  • Choosing Oral Formulations for First-in-man Clinical Trials

    Choosing Oral Formulations for First-in-man Clinical Trials

    Jon Sutch, Senior Manager of Formulation Development, Patheon||October 11, 2016
    Early formulations should be simple, but selecting a simple formulation isn’t as easy as it seems

  • Robust Assay Designs

    Robust Assay Designs

    Tim Wright, Editor, Contract Pharma||October 11, 2016
    Easing the transition from preclinical to clinical research