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Atara Biotherapeutics and Pierre Fabre Enter Strategic Collaboration to Commercialize Tabelecleucel (Tab-cel®)
Pierre Fabre to Commercialize Tab-cel® for Epstein-Barr Virus (EBV)-Positive Cancers in Europe, Middle East, Africa, and Other Select Emerging Markets Atara
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nPierre Fabre to Commercialize Tab-cel® for Epstein-Barr Virus (EBV)-Positive Cancers in Europe, Middle East, Africa, and Other Select Emerging Markets\n\nAtara to Receive Upfront Payment of USD 45 Million, and Up to Approximately USD 320 Million in Total Milestones, Plus Significant Double-digit Tiered Royalties as a Percentage of Net Sales\n\nAtara Retains Full Commercialization Rights to Tab-cel® in the United States and Other Major Markets\n\nTab-cel®, Recently Granted EMA Accelerated Assessment, Remains On-Track for European MAA Filing in November 2021\n\nAtara to Host Conference Call on Monday, October 4 at 8:30 a.m. EDT\n\n SOUTH SAN FRANCISCO, Calif. & CASTRES, France--(BUSINESS WIRE)--\nAtara Biotherapeutics, Inc. (Nasdaq: ATRA) and Pierre Fabre today 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.\n\nUnder the terms of the agreement, Atara will receive an upfront payment of USD 45 million, and up to approximately USD 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.\n\nAtara 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 ...