The share price of Atara Biotherapeutics Inc. (NASDAQ: ATRA) gained 2.08% to $3.92 in pre-market trading following a collaboration update. ATRA gained 15.32% to close at $3.84 in the last trading session, fluctuating between $3.42 and $3.92.
ATRA has provided what kind of update?
As part of its collaboration with Pierre Fabre, Atara Biotherapeutics (ATRA) announced yesterday that it has updated the agreement for the commercialization of tabelecleucel (tab-cel) for cancer patients diagnosed with Epstein-Barr virus (EBV).
Upon tab-cel EC approval and subsequent filing of the Marketing Authorization Application (MAA), Atara Biotherapeutics will receive an additional USD 30 million milestone payment in exchange for a reduced tab-cel royalty and supply price markup for Pierre Fabre under the amended terms. A significant double-digit royalty rate remains after this amendment for sales royalties.
An exclusive commercialization agreement for tab-cel was signed by ATRA and Pierre Fabre in October 2021 for EBV-positive cancers in Europe, the Middle East, Africa, and selected emerging markets. A 45 million USD upfront payment was made to Atara Biotherapeutics, along with additional regulatory and sales milestone payments up to 320 million USD.
As part of the pivotal ALLELE study in EBV+ post-transplant lymphoproliferative disease (EBV+ PTLD) and approval by the European Commission, Atara Biotherapeutics is also responsible for the Phase 2 multi-cohort study, which aims to expand the label to other EBV-driven cancers by evaluating tab-cel in six additional populations.
The anticipated MAA approval in Europe will be followed by Pierre Fabre’s leading role in commercialization, distribution, and medical and regulatory activities in the territories. Tab-cel remains ATRA’s sole commercialization rights in the United States and other major markets.
With its first-of-its-kind off-the-shelf EBV T-cell platform, Atara Biotherapeutics is developing innovative therapies for patients, including tab-cel, which is currently being evaluated in adults and children in the Phase 3 ALLELE study in EBV+ PTLD and is the Company’s lead candidate in development for EBV-positive cancers. The US Food and Drug Administration (FDA) has awarded Tab-cel Breakthrough Therapy Designation and the European Medicines Agency (EMA) has designated Tab-cel a Priority Medicine (PRIME).
What further benefits will ATRA receive?
Upon European approval in Q4 2022, ATRA’s tab-cel is expected to be the first allogeneic off-the-shelf T-cell therapy available for patients with significant needs. In addition to strengthening Atara’s partnership and shared belief in tab-cel’s transformative potential, this agreement allows Atara Biotherapeutics (ATRA) to extend its cash runway in addition to reaffirming ATRA’s strong partnership and shared belief in tab-cel.