Bristol-Myers Squibb (BMS) and Pfizer have collaborated with Portola Pharmaceuticals (PTLA) to develop and commercialise its investigational agent andexanet alfa in Japan.
Andexanet alfa is currently in Phase III clinical development in the US and Europe, and it will be developed as an antidote for Factor Xa inhibitors, including Eliquis (apixaban).
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Currently, three oral Factor Xa inhibitors are available in the Japanese market including BMS and Pfizer’s apixaban, Bayer HealthCare’s rivaroxaban and Daiichi Sankyo’s edoxaban, but an antidote is not yet approved.
In Japan, a universal antidote for Factor Xa inhibitors is needed for certain patients, as the clinical use of these new oral anticoagulants is growing.
The US Food and Drug Administration (FDA) has also granted breakthrough therapy designation for andexanet alfa, which is being developed by Portola for patients treated with a direct or indirect Factor Xa inhibitor when reversal of anticoagulation is needed, such as in uncontrolled bleeding or for emergency surgery / urgent procedures.
Portola will retain worldwide commercial rights to andexanet alfa outside of Japan and remain responsible for the manufacturing supply.
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By GlobalDataSeparately, Portola has agreed with Bayer HealthCare to include its Factor Xa inhibitor rivaroxaban in this clinical development programme in Japan.
Bristol-Myers Squibb specialty development head Douglas Manion said: "We are committed to reducing the risk of stroke in nonvalvular atrial fibrillation patients and treating deep vein thrombosis and pulmonary embolism.
"The ability to reverse the anticoagulation effect of Eliquis and other Factor Xa inhibitors may be helpful for some patients who experience a major bleeding event or require emergency surgery while onEliquis or another Factor Xa inhibitor."
As part of the deal, Portola will receive an upfront payment of $15m and is eligible to receive potential regulatory and sales-based milestone payments totalling $90m, as well as double-digit royalties based on andexanet alfa net sales in Japan.
BMS and Pfizer will be responsible for all development, regulatory activities and commercialisation of andexanet alfa in Japan, after securing regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW).
Pfizer senior vice-president and Global Medical Affairs head Rory O’Connor said: "This agreement in Japan is another great example of the alliance’s commitment to the patients we serve.
"Eliquis has proven to be an important treatment option for patients at risk for stroke and blood clots due to nonvalvular atrial fibrillation and for the treatment of deep vein thrombosis and pulmonary embolism, but currently there is no approved reversal agent."
