Date: 2017-09-05
Type of information: Production agreement
Compound: AndexXa®(US)/ IndexXa™ (EU)
Company: Portola Pharmaceuticals (USA - CA) Lonza (Switzerland)
Therapeutic area:
Type agreement: production - manufacturing
Action mechanism:
- protein. 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.
Disease:
Details:
- • On September 5, 2017, Lonza announced that it has entered into a long-term commercial supply agreement with Portola Pharmaceuticals. The focus of the agreement is to provide Portola with security of supply and the flexibility to react swiftly to changes in market demand scenarios. Both companies are strengthening their relationship after a successful collaboration on the clinical manufacturing of AndexXa® (andexanet alfa), a recombinant protein reversal agent for patients on FXa inhibitors who experience a major bleed or need urgent surgery.
- Under the agreement with Portola, Lonza will extend current manufacturing commitments at Lonza’s Porrino (ES) facility and add long-term manufacturing production in Visp (CH) for AndexXa®. With this agreement Lonza adds the first customer to its innovative new manufacturing complex IbexTM. This expanded manufacturing collaboration guarantees access to Lonza’s capacity for Portola and allows coverage of the full range of anticipated demand scenarios for commercial supply.
Financial terms:
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Is general: Yes
