Pfizer, BMS Loan $50 Million for AnticoagulantBy
Pfizer and Bristol-Myers Squibb (BMS) have signed agreements in which each company will loan $25 million to Portola Pharmaceuticals, a South San Francisco, California-based biopharmaceutical company focused on thrombosis and other hematologic diseases.
The combined $50 million provides additional funding for development and clinical studies of an investigational anti-coagulant compound, AndexXa (andexanet alfa), which Portola needs in order to resubmit its biologics license application (BLA) for the drug. In August 2016, the company received a Complete Response Letter to the BLA from the US Food and Drug Administration requesting that Portola provide additional information primarily related to manufacturing.
Under the agreement with BMS and Pfizer, the loan principal and interest will be repaid primarily through royalties on AndexXa 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.
Portola expects to resubmit the BLA for AndexXa in 2017.
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 US 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 a modified human Factor Xa molecule, a blood coagulant, that has been designed to alter the activity of Factor Xa inhibitors by binding to the inhibitors to prevent them from forming clots in the blood, according to information from Portola. The FDA granted AndexXa breakthrough therapy status, and the drug 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 the EU, the European Medicines Agency is reviewing the marketing authorization application for andexanet alfa for reversal of Factor Xa inhibition in patients experiencing a life-threatening or uncontrolled bleed and for patients requiring urgent or emergency surgery. A decision is expected in 2017.
Source: Portola Pharmaceuticals