Atara Biotherapeutics and Pierre Fabre announced an exclusive commercialization agreement for tabelecleucel (tab-cel®) in Europe, Middle East, Africa, and other select emerging markets for Epstein-Barr virus (EBV)-positive cancers. Atara will retain full rights to tab-cel® in other major markets, including North America, Asia Pacific, and Latin America.
“Tab-cel® is a highly innovative immunotherapy with the potential to serve patients with high unmet need in rare conditions. This partnership with Atara epitomizes our corporate purpose: ‘every time we take care of one single person, we make the world better,’” said Eric Ducournau, CEO of Pierre Fabre. “We expect strong synergies with our existing capabilities in oncology across regulatory, distribution, medical, marketing and sales and look forward to bringing this advanced product to patients.”
Atara will receive an upfront payment of $45 million, and up to $320 million in additional regulatory and sales milestone payments, plus significant double-digit tiered royalties as a percentage of net sales. Atara will continue to be responsible for the pivotal ALLELE study in PTLD as well as submitting the EU Marketing Authorization Application (MAA) for tabelecleucel in patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), which is on track for November 2021. Atara will also remain responsible for the Phase 2 multi-cohort study, which is evaluating tab-cel® in six additional patient populations with the goal of label expansion in EBV-driven cancers. Pierre Fabre will lead all commercialization and distribution activities in the territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe. As part of the transaction, Atara will also provide manufacturing services for tab-cel® to be paid by Pierre Fabre.
Atara is a leader in T-cell immunotherapy, leveraging its first-in-kind allogeneic off-the-shelf EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases. Tab-cel® is the Company’s lead candidate in development for EBV-positive cancers, including EBV+ PTLD, where it is currently being investigated in adults and children in the Phase 3 ALLELE study. Tab-cel® has been granted Breakthrough Therapy Designation by the U.S. FDA and Priority Medicines (PRIME) designation by the European Medicines Agency (EMA).
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