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Portola signed a $50-million loan agreement with BMS and Pfizer to provide additional funding for the development of andexanet alfa.
On Dec. 19, 2016, Portola Pharmaceuticals signed a $50-million loan agreement with Bristol-Myers Squibb Company (BMS) and Pfizer that provides additional funding toward 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 interests will be repaid primarily through royalties on AndexXa commercial sales. Portola said in a statement the non-secured loan does not involve any transfer of patent ownership or licenses.
Portola previously entered into two separate clinical collaboration agreements with BMS and Pfizer to support Phase II and registrational studies of andexanet alfa in the United States and Europe. BMS and Pfizer also have a collaboration agreement with Portola to develop and commercialize andexanet alfa in Japan. Portola retains all rights, including full commercial and financial rights, for andexanet alfa outside of Japan.
AndexXa is an FDA-designated breakthrough therapy and 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 FDA regarding its biologics license application (BLA) for AndexXa. In a press release, Portola said the company expects to resubmit the BLA in 2017.