Atara and Pierre Fabre Collaborate to Commercialize Tabelecleucel for Rare Cancer
October 5, 2021
Atara Biotherapeutics and Pierre Fabre entered into an exclusive commercialization agreement for tabelecleucel in Europe, Middle East, Africa, and other select emerging markets for Epstein-Barr virus-positive cancers.
Atara will retain full rights to tabelecleucel (tab-cel) in other major markets, including North America, Asia Pacific, and Latin America.
Under the terms of their agreement, Atara will receive an upfront payment of $45 million, and up to approximately $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 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.
“Pierre Fabre is a science-driven company that brings significant commercialization expertise through its integrated Oncology Business Unit, its deep knowledge of Bone Marrow Transplant centers and a track record of successful launches through partnerships,” said Pascal Touchon, president and CEO of Atara. “Our companies’ complementary capabilities will expand access to tab-cel, a potentially transformative investigational allogeneic off-the-shelf T-cell immunotherapy, to patients worldwide who suffer from EBV+ PTLD and other EBV-driven cancers.”
Tab-cel, Atara’s lead candidate, is an off-the-shelf, allogeneic T-cell immunotherapy in development for the treatment of EBV+ PTLD. EBV+ PTLD is a type of lymphoma that may occur after a solid organ transplant or allogeneic hematopoietic cell transplant. There are currently no approved treatments indicated to treat PTLD and if left untreated, PTLD can have life-threatening consequences.
Tab-cel is currently being investigated in the phase 3 ALLELE study to assess efficacy and safety for the treatment of EBV+ PTLD in solid organ transplant and hematopoietic cell transplant after failure of standard of care.
Tab-cel has been granted Orphan Drug and Breakthrough Therapy designations for EBV+ PTLD following allogeneic HCT by the U.S. Food and Drug Administration and Orphan Drug and PRIME designations by the European Medicines Agency for the same indication.
“Tab-cel is a highly innovative immunotherapy with the potential to serve patients with high unmet need in rare conditions,” 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.”
Author: Rare Daily Staff
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