Pierre Fabre Laboratories SA has extended its global partnership with Atara Biotherapeutics, licencing tabelecleucel commercialisation rights for Northern America and beyond.
Paris-based Pierre Fabre Laboratories SA already held a licence for the EU-approved tabelecleucel, an allogeneic T cell based second-line treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a rare, acute, and potentially deadly hematologicmalignancy that occurs after transplantation when patient T-cell immune responses are compromised by immunosuppression. The orphan diesease has a median survival of 0.7 months and 4.1 momths.
Under an extented licence agreement for the US and Canada, where the BLA for tabelecleucel is expected in Q2/2024, Atara will receive up to US$640m and significant double-digit tiered royalties on net sales from Pierre Fabre Laboratories. In addition, Pierre Fabre Laboratories has agreed to reimburse Atara for expected global development costs through transfer of the BLA (Biologics License Application) approval by the FDA in the US and purchase current and future tabelecleucel inventory through the BLA transfer date. Near-term payments to Atara include approximately US$30m in cash upfront and initial inventory purchase at closing as well as US$100m in potential regulatory milestones through BLA approval
The geographical expansion of the licensing rights encompasses the USA, Canada and all remaining territories. Pierre Fabre Laboratories already acquired the rights for Europe in October 2021.