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Atara Biotherapeutics to Net $30M From Pierre Fabre for European Tab-Cel Approval

NEW YORK – Atara Biotherapeutics on Wednesday announced a new component of its collaboration with Pierre Fabre in which Atara will receive an additional $30 million milestone payment should the European Commission approve tabelecleucel (tab-cel) for Epstein-Barr virus (EBV)-positive cancers.

South San Francisco, California-based Atara expects that tab-cel, an allogeneic off-the-shelf T-cell therapy, will net European approval during the fourth quarter of this year. If it does, the approval and subsequent transfer of the marketing authorization application filing to French drugmaker Pierre Fabre would spur the milestone payment. Atara would also receive reduced tab-cel royalties and supply mark-up for Pierre Fabre. The tiered royalties for tab-cel sales will be in the "significant double-digit" rate range, according to the firms.

The announcement comes a year after Atara submitted an application to the European Medicines Agency for tab-cel as a treatment for EBV-positive cancers. The application included early data from the Phase III ALLELE trial in which tab-cel demonstrated a 50 percent objective response rate among 38 patients with EBV-positive lymphoproliferative disease, all of whom had received at least one prior therapy following solid organ transplant or hematopoietic cell transplant. Among 19 patients who responded to the cell therapy, 11 experienced responses longer than six months. The one-year survival rate was 89.2 percent.

Under the commercialization deal with Pierre Fabre, initially inked in October 2021, Atara received an upfront payment of $45 million for Pierre Fabre to acquire the rights to commercialize tab-cel in Europe, the Middle East, and Africa, among other select emerging markets, for EBV-positive cancers. Additionally, the agreement stated that Atara would receive up to $320 million in regulatory and sales milestone payments.

Atara remains responsible for the ALLELE study as well as a Phase II study evaluating tab-cel in six additional EBV-positive patient populations. The firm is also holding onto US commercialization rights as well as the rights to 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," Pierre Fabre CEO Eric Ducournau said in a statement. "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."