Atara Biotherapeutics is looking to Pierre Fabre Laboratories, the same collaborator it used to secure permission for its cutting-edge T-cell treatment Ebvallo (tabelecleucel) in Europe, in an effort to win approval for the drug in the U.S.
As part of this geographical extension of Pierre Fabre’s license rights, the French pharmaceutical company will now be responsible for the production, clinical testing, and regulatory oversight of Ebvallo in the U.S., Canada, and other territories beyond the European Union.
In October 2021, Atara transferred the same licenses to Pierre Fabre throughout Europe through a written agreement. After another fourteen months, the European Union gave its approval to Ebvallo, making it the first organization anywhere in the world to do so for a commercially available allogenic cell treatment. The positive verdict resulted in a milestone payment of $30 million being made to Atara, which is situated in San Francisco.
After the Food and Drug Administration (FDA) gives its approval to Atara’s filing of its biologics license application (BLA), further development of the arrangement will go into effect. The firm anticipates making its submission during the second quarter of the following year.
Under the terms of the most recent agreement, Atara will be entitled to a payment of up to $640 million, in addition to layered royalties at double-digit percentages on Pierre Fabre’s net sales of Ebvallo. In the short term, Atara will get an up-front payment of $30 million, and there is the possibility of receiving an additional $100 million in possible regulatory milestone payments via approval.
Patients must be at least 2 years old and have a tumor following a transplant of a solid tissue or bone marrow transplant in order to get this treatment. The potentially fatal condition is known as Epstein-Barr virus-positive (EBV) post-transplant lymphoproliferative disease (EBV+PTLD), and it arises when a person’s T-cell immune reactions are weakened as a result of the medicine that is used to avoid rejection of the donated organ or cells.
Ebvallo is for individuals who have experienced a recurrence or resistant response to at least one previous treatment. Chemotherapy might count as a prior therapy for patients who have previously had solid organ transplants, unless Ebvallo is not the proper treatment for the patient.
The Chief Executive Officer of Pierre Fabre, Eric Ducourau, stated in a press release that individuals in Germany have been given Ebvallo and that other patients in Europe have gotten accessibility by means of an early-access initiative.
“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,” stated Ducournau.
This year in April, Pierre Fabre made an offer to collaborate with Scorpion Therapeutics on the research, development, and possible commercialization of two of the biotech company’s preclinical lung cancer medicines. The offer was for up to $553 million in biobucks.