INmune Bio Inc. (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced that it has entered into a Master Services Agreement with Uniphar Durbin Ireland Limited (“Uniphar”) establishing a scalable framework to support international access, distribution and commercialization of Ebstrocel™, the Company’s allogeneic stromal cell therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB).
INmune Bio initially intends to use the framework to pursue named-patient access in selected European countries and in the Middle East and North Africa (MENA), subject to applicable law and country-specific statements of work. The relationship may subsequently expand across Europe and other territories by mutual agreement.
The Company expects named-patient access to be an important component of its international commercialization strategy for Ebstrocel™. Where permitted by local law and implemented through statements of work, this pathway may allow physicians to request Ebstrocel™ for individual eligible patients before local marketing approval or broad commercial availability.
The Uniphar framework is designed to provide the Company with scalable international commercial infrastructure, beginning with named-patient supply, and potentially expanding to broader commercial distribution as regulatory approvals, pricing and reimbursement are secured in individual countries. Depending on the services agreed in individual statements of work, Uniphar may support regulatory feasibility assessments, market access, product storage and distribution, healthcare-provider and treatment-site onboarding, order-to-cash services, medical information, pharmacovigilance support and end-to-end shipment tracking. By leveraging Uniphar’s established infrastructure rather than building country-by-country capabilities internally, the Company believes this model provides a capital-efficient path to establish Ebstrocel™’s international commercial footprint and scale as additional markets become available.
This agreement marks an important step in moving Ebstrocel™ from clinical development toward commercialization and bringing Ebstrocel to patients internationally. Uniphar provides access to established market-access, distribution and order-to-cash capabilities across multiple international markets without requiring INmune Bio to build those capabilities country by country. We believe this provides a capital-efficient way to pursue named-patient opportunities in appropriate markets while building the physician relationships, treatment-center experience and commercial infrastructure needed to support broader international commercialization.”
David Moss, Chief Executive Officer, INmune Bio
“We are pleased to partner with INmune Bio as it prepares Ebstrocel for international commercialization,” said Ruth Rostron, Head of Expanded Access at Uniphar. “Uniphar has built an integrated global platform to help innovative medicines navigate the complexities of international access, distribution and commercialization. We believe our infrastructure and experience are well suited to support INmune Bio’s strategy for Ebstrocel, beginning with named-patient access opportunities and expanding as the product progresses through its regulatory and commercial journey.”
About Ebstrocel™
Ebstrocel™ (pobistrocel) is INmune Bio’s investigational, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell therapy being developed through the Company’s CORDStrom™ platform for the treatment of RDEB. The platform is designed to address donor variability and manufacturing inconsistency. Ebstrocel™ is investigational and has not been approved by the FDA, MHRA, EMA or any other regulatory authority.