Portola Pharmaceuticals PTLA, Bristol-Myers Squibb Company BMY and Pfizer Inc. PFE announced encouraging full data from the second part of the phase III ANNEXA(TM)-A (andexanet alfa a novel antidote to the anticoagulant effects of FXa inhibitors – apixaban) study on andexanet alfa. The full data set was presented at the International Society on Thrombosis and Haemostasis 2015 meeting. Portola was up approximately 8% on the news.
The registration-enabling, randomized, double-blind, placebo-controlled ANNEXA-A study evaluated the safety and efficacy of andexanet alfa in reversing Bristol-Myers/Pfizer's Eliquis-induced anticoagulation in older healthy volunteers aged 50– 75 years. In the study, andexanet alfa was administered as an intravenous bolus followed by a continuous two-hour infusion.
In this second part of the study, andexanet alfa achieved all primary and pre-specified secondary endpoints with high statistical significance. In the study, andexanet alfa demonstrated rapid reversal of the anticoagulant effect of Eliquis, which was sustained for the duration of the infusion. Additionally, andexanet alfa significantly lowered the level of free unbound Eliquis in the plasma and restored thrombin generation to normal. Andexanet alfa was well tolerated.
Andexanet alfa has been designated breakthrough therapy by the FDA. Portola plans to submit data from ANNEXA-A as part of its Biologics License Application for andexanet alfa to the FDA under an accelerated approval pathway by the end of this year.
Currently, Portola carries a Zacks Rank #1 (Strong Buy), while Bristol-Myers and Pfizer hold a Zacks Rank #3 (Hold). Valeant Pharmaceuticals International, Inc. VRX is a well-ranked stock in the health care sector carrying the same Zacks Rank as Portola.
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