Date: 2016-02-01
Type of information: Development agreement
Compound: andexanet alfa and Eliquis® (apixaban)
Company: BMS (USA - NY) Pfizer (USA - NY) Portola Pharmaceuticals (USA - CA)
Therapeutic area: Cardiovascular diseases - Hematologic diseases
Type agreement: development - commercialisation
Action mechanism:
- protein/antithrombotic. Andexanet alfa, an FDA-designated breakthrough therapy, is a first-in-class recombinant, modified Factor Xa molecule. It is being developed as an antidote for patients receiving a Factor Xa inhibitor who suffer a major bleeding episode or who may require emergency surgery. Andexanet alfa acts as a Factor Xa decoy that targets and sequesters with high specificity both direct and indirect Factor Xa inhibitors in the blood. Once bound, the Factor Xa inhibitors are unable to bind to and inhibit native Factor Xa, thus allowing for the restoration of normal hemostatic processes. Andexanet alfa has the potential to address numerous clinical scenarios by allowing for flexible and controlled reversal, which can be short-acting through the administration of an IV bolus or longer-acting with the addition of an extended infusion.
- Eliquis® (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood-clotting protein, Eliquis® decreases thrombin generation and blood clot formation. Eliquis® is approved for multiple indications in the U.S. based on efficacy and safety data, including results from seven Phase 3 clinical trials. Eliquis® is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE; and to reduce the risk of recurrent DVT and PE following initial therapy.
Disease: reversion of the anticoagulant activity of Eliquis®
Details: • On February 1, 2016, BMS and Pfizer announced that the companies have entered into a collaboration agreement with Portola Pharmaceuticals to develop and commercialize andexanet alfa in Japan. Andexanet alfa is currently in Phase 3 clinical development in the U.S. and Europe. This agreement builds on the companies’ existing clinical collaboration to develop andexanet alfa in the U.S. and Europe. In December 2015, Portola announced it had completed the submission of a Biologics License Application to the U.S. Food and Drug Administration (FDA) for andexanet alfa and was awaiting acceptance for filing. The FDA assigned a PDUFA date of August 17, 2016, under an Accelerated Approval pathway.
Financial terms:
- Under the terms of the agreement, Portola will receive an upfront payment of $15 million, potential regulatory milestones of $20 million and sales-based milestones of $70 million as well as compensation based on andexanet alfa net sales. BMS and Pfizer will co-fund with Portola the development and commercialization of andexanet alfa in Japan. Portola will retain rights to andexanet alfa outside of Japan and remain responsible for the manufacturing supply.
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