Lonza confirmed it has signed a “long-term” commercial supply agreement this week, explaining the focus “is to provide Portola with security of supply and the flexibility to react swiftly to changes in market demand scenarios.”
The Swiss firm- which made supplies of AndexXa used in clinical trials – said it will extend manufacturing commitments at its facility in Porrino, Spain and add long-term capacity to make the drug at its facility in Visp under its recently announced Ibex programme.
Resubmission
The contract comes just a month after Portola resubmitted AndexXa for review by the US Food and Drug Administration (FDA).
AndexXa – which is used to restore clotting ability in patients who have been treated with anticoagulants – was accepted for priority review by the FDA in February 2016.
However, the US regulator rejected AndexXa the following August, telling Portola in a complete response letter (CRL) that it needed more information related to how the drug is manufactured.
Undeterred Portola secured funding to address the issues raised by the FDA.
In February this year it confirmed it had signed a $150m (€125m) agreement with HealthCare Royalty Partners (HCR) under which it would receive $50m upfront to further AndexXa’s development and commercialization.
The funding deal – which will also see Portola receive $100m if the drug is approved by the US FDA - will see private equity firm HCR receive tiered, mid-single-digit royalty based on worldwide sales.
Portola announced it had refiled the drug with the US FDA on August 3, explaining that the submission included “supplemental information primarily related to manufacturing, as requested by the FDA.”
CMOs
Contracting Lonza for long-term supply has been Portola’s plan since 2014. In a US Securities and Exchange Commission (SEC) filing at the time the San Francisco biotech said “CMC Biologics will manufacture andexanet alfa for the expected U.S. launch in 2016.
“To meet anticipated global demand, Lonza will provide large-scale supply approximately 18-24 months following launch.”