Portola Pharmaceuticals has signed a $50 million loan agreement with Bristol-Myers Squibb and Pfizer providing additional funding for development and clinical studies of AndexXa (andexanet alfa), an investigational compound that is a potential antidote for Factor Xa inhibitors.

BMS and Pfizer will each loan Portola $25 million. The principal and interest will be repaid primarily through royalties on AndexXa sales.

AndexXa, an FDA-designated Breakthrough Therapy, is in development for patients treated with a direct (apixaban, rivaroxaban or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. In August, Portola received a Complete Response Letter from the FDA regarding its BLA for AndexXa and expects to resubmit in 2017.

Portola previously entered into two separate clinical collaborations with BMS and Pfizer to support Phase II and registrational studies of andexanet alfa in the U.S. and Europe. BMS and Pfizer are also collaborating with Portola to develop and commercialize andexanet alfa in Japan. Portola retains all rights for andexanet alfa outside of Japan.

“This agreement reflects the commitment and support of the andexanet alfa program by our long-standing partners BMS and Pfizer and helps Portola to continue moving rapidly toward our goal of gaining regulatory approval in 2017,” said Tao Fu, chief commercial and business officer of Portola. “We are committed to working with the FDA to bring AndexXa to market as patients currently have no approved antidote available to reverse Factor Xa inhibitors.”