In its attempt to win approval in the United States for its groundbreaking T-cell therapy Ebvallo (tabelecleucel), Atara Biotherapeutics is turning to the same partner it used to gain a green light in Europe—Pierre Fabre Laboratories.
In this geographic expansion of Pierre Fabre’s licensing rights, the French pharma takes over manufacturing, clinical and regulatory activities for Ebvallo in the U.S., Canada and other markets outside of the European Union.
In October of 2021, Atara signed over the same rights to Pierre Fabre in Europe. Fourteen months later, Ebvallo scored its EU endorsement, the first in the world for an off-the-shelf, allogenic cell therapy. The thumbs up triggered a $30 million milestone payment to Atara, which is based in Thousand Oaks, Calif.
The expansion of the deal kicks in after the FDA approves Atara’s submission of its biologics licensing application (BLA). The company expects to submit in the second quarter of next year.
In the latest deal, Atara will receive up to $640 million, plus double-digit tiered royalties on Pierre Fabre’s net sales of Ebvallo. In the near-term, Atara will receive $30 million up front, with $100 million in potential regulatory milestones available through approval.
The treatment is for patients ages 2 and older who have a malignancy following a solid organ or bone marrow transplant. The potentially deadly disorder is called Epstein-Barr virus-positive (EBV) post-transplant lymphoproliferative disease (EBV+PTLD) and occurs when a patient’s T-cell immune responses are compromised by medication used to prevent rejection of the transplanted organ or cells.
Ebvallo is for relapsed or refractory patients who have tried at least one prior therapy. For those who have had solid organ transplants, chemotherapy qualifies as a prior therapy unless Ebvallo is inappropriate for the patient.
Patients in Germany have been treated with Ebvallo and others in Europe have gained access through an early-access program, Eric Ducourau, Pierre Fabre’s CEO, said in a release.
“This expansion of our partnership with Atara will allow us to make a first step in the US, by far the largest oncology market in the world, and to reach even more patients,” said Ducournau.
In April of this year, Pierre Fabre offered up to $553 million in biobucks to work with Scorpion Therapeutics on developing and potentially commercializing two of the biotech’s preclinical lung cancer candidates.