Portola Pharmaceuticals has signed a US$50 million loan agreement with Bristol-Myers Squibb and Pfizer that provides additional funding toward development and clinical studies of andexanet alfa (AndexXa), an investigational compound that is a potential antidote for Factor Xa inhibitors.
Tao Fu, chief commercial and business officer of Portola, says, “We are committed to working with the US Food and Drug Administration (FDA) to bring [andexanet alfa] to market as patients currently have no approved antidote available to reverse Factor Xa inhibitors.”
Under the terms of the agreement, Bristol-Myers Squibb and Pfizer will each loan Portola US$25 million. The principal and interest will be repaid primarily through royalties on andexanet alfa commercial sales. No shares, warrants, options or other equity components were or will be issued in connection with the loan. The non-secured loan does not involve any transfer of patent ownership or licenses.
Andexanet alfa, 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. On August 17, 2016, Portola received a Complete Response Letter from the FDA regarding its Biologics License Application for the product. Portola expects to resubmit the BLA in 2017.
Portola previously entered into two separate clinical collaboration agreements with Bristol-Myers Squibb and Pfizer to support phase two and registrational studies of andexanet alfa in the US and Europe. Bristol-Myers Squibb and Pfizer also have a collaboration agreement with Portola to develop and commercialise andexanet alfa in Japan. Portola retains all rights, including full commercial and financial rights, for andexanet alfa outside of Japan.