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February 3, 2014
08:11 EDTPTLA, BAYRYPortola Pharmaceuticals enters into clinical collaboration agreement with Bayer
Portola Pharmaceuticals (PTLA) announced that it has entered into a second clinical collaboration agreement with Bayer HealthCare (BAYRY) and Janssen Pharmaceuticals to evaluate its investigational Factor Xa inhibitor reversal agent, andexanet alfa, in Phase 3 registration studies with the FDA-approved oral Factor Xa inhibitor XARELTO. Portola's original collaboration agreement with Bayer and Janssen, announced in February 2013, covered the conduct of a Phase 2 proof-of-concept study. Interim results of that study were presented in December 2013 at the 55th American Society of Hematology Annual Meeting and demonstrated that andexanet alfa can produce an immediate and dose-dependent reversal of the anticoagulation activity of XARELTO. The new clinical collaboration agreement will be in effect through completion of Phase 3 studies with XARELTO and any potential U.S. and EU regulatory approval of andexanet alfa. The Phase 3 studies are expected to start in the first half of 2014. Under this non-exclusive collaboration agreement, Portola will receive an upfront payment and is eligible to receive additional development and regulatory milestone payments. Portola retains full, worldwide commercial rights to andexanet alfa, which was designated as a breakthrough therapy by the FDA in November 2013 and for which Portola is pursuing an Accelerated Approval pathway.
News For PTLA;BAYRY From The Last 14 Days
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February 12, 2016
07:06 EDTPTLAPortola shares have minimal downside risk into data, says Citi
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February 2, 2016
08:36 EDTBAYRYPiper Jaffray biopharma analyst holds an analyst/industry conference call
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February 1, 2016
06:58 EDTPTLAPortola Pharma licensed right to andexanet alfa to Bristol-Myers and Pfizer
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06:57 EDTPTLABristol-Myers and Pfizer sign collaboration with Portola Pharmaceuticals
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