Arvelle Therapeutics
Situation
When Arvelle acquired the European rights to cenobamate from SK Biopharmaceuticals, InterPharmaLink was mandated to support the set-up of the European Supply Chain and Quality Management System.
Challenges
Within 12 months a Pan-European Early Access Program supply chain needed to be implemented and ready for go-live
Within 24 months a Pan-European outsourced commercial supply chain needed to be implemented and ready for go-live
Deliverables
Design and implementation of an outsourced European supply chain model from importation of bulk to distribution of finished products across Europe
Upgrade and implementation of the Quality Management System
Fulfillment of the QP role for the Arvelle HQ in Switzerland
Impact
Successful and on-time launch of Ontozry (cenobamate)
Successful regulatory inspections of the Arvelle HQ Quality operations by Swissmedic
Successful sale of Arvelle Therapeutics to Angelini Pharma for $960m in January 2021