Atara Biotherapeutics to Receive Additional Near-Term Milestone Payment Under Updated Tabelecleucel (Tab-cel) Commercialization Agreement with Pierre Fabre
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, today announced an update to its existing collaboration agreement with Pierre Fabre for the commercialization of tabelecleucel (tab-cel) for Epstein-Barr virus (EBV)-positive cancers.
Under the amended terms, Atara will receive an additional USD 30 million milestone payment upon tab-cel EC approval and subsequent filing of the Marketing Authorization Application (MAA) transfer to Pierre Fabre in exchange for reduced tab-cel royalties and supply price mark-up for Pierre Fabre. Tiered royalties on sales remain at a significant double-digit rate following this amendment.
“With an anticipated European approval in Q4 2022, tab-cel is positioned to become the first ever allogeneic off-the-shelf T-cell therapy available for patients with significant need,” said Pascal Touchon, President and CEO of Atara. “This update to our agreement with Pierre Fabre reaffirms our strong partnership and shared belief in the transformative potential of tab-cel, while enabling Atara to further extend our cash runway.”
In October 2021, Atara entered into an exclusive commercialization agreement with Pierre Fabre for tab-cel in Europe, Middle East, Africa and other select emerging markets for EBV-positive cancers, receiving an upfront payment of USD 45 million, and up to approximately USD 320 million in additional regulatory and sales milestone payments. In addition to responsibility for the pivotal ALLELE study in EBV+ post-transplant lymphoproliferative disease (EBV+ PTLD) and securing European Commission approval, Atara also remains 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 other 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. Atara retains full commercialization rights to tab-cel in the United States and other major markets.
“Tab-cel has the potential to be a transformational product for EBV-positive cancers and is eagerly awaited by physicians and patients in Europe with limited treatment options,” said Eric Ducournau, CEO of Pierre Fabre. “This update to our agreement with Atara confirms our confidence and commitment to tab-cel in Europe, where the Pierre Fabre team is excited to bring the first allogeneic T-cell therapy to European patients in a rare oncology condition.”