Pierre Fabre, Atara Partner on T-cell Immunotherapy

Pierre Fabre Laboratories has expanded its global partnership with Atara Biotherapeutics, a T-cell immunotherapy company, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform for EBVALLO (tabelecleucel), a monotherapy registered in the EU for the treatment of relapsed or refractory Epstein–Barr virus positive post–transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.

EBV+ PTLD is a rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when patient T-cell immune responses are compromised by immunosuppression.
The geographical expansion of the licensing rights encompasses the U.S., Canada, and all remaining territories. Pierre Fabre Laboratories already acquired the rights for Europe in October 2021 and EBVALLO was approved by EMA in December 2022. EBVALLO is commercialized in Germany and Austria.

Atara will receive up to $640 million and royalties on sales from Pierre Fabre Laboratories. In addition, Pierre Fabre Laboratories has agreed to reimburse Atara for expected EBVALLO global development costs through transfer of the BLA (Biologics License Application) approval by the FDA in the U.S. and purchase current and future EBVALLO inventory through the BLA transfer date.

“Since EBVALLO’s marketing authorization in Europe less than a year ago, patients have already been treated in Germany, or have benefited from the treatment through the Early Access Program in place in other European countries,” said Eric Ducournau, CEO of Pierre Fabre Laboratories. “We are now eager to progress on the upcoming FDA milestones in the next months and ensure American patients diagnosed with EBV+ PTLD can access this novel therapy.”

“We are proud to expand our global EBVALLO partnership with Pierre Fabre Laboratories, who is committed to deliver this first-of-its kind treatment to patients in need across the globe,” said Pascal Touchon, President, and CEO of Atara.