Saturday, November 04, 2023
Pierre Fabre Laboratories has recently announced an expanded global partnership with Atara Biotherapeutics, a leading company specializing in T-cell immunotherapy. This partnership aims to utilize Atara's innovative allogeneic Epstein-Barr virus (EBV) T-cell platform for the promotion of EBVALLO® (tabelecleucel), a monotherapy that has already received approval in the EU. EBVALLO® is indicated for the treatment of adult and pediatric patients aged two and older who have relapsed or have refractory Epstein–Barr virus positive post–transplant lymphoproliferative disease (EBV+ PTLD) and have undergone at least one prior therapy. EBV+ PTLD is a rare, severe hematologic malignancy that occurs after transplantation when the patient's T-cell immune responses are compromised due to immunosuppression.
This expanded partnership now encompasses the USA, Canada, and all remaining territories, building upon Pierre Fabre Laboratories' acquisition of the European rights in October 2021 and the approval of EBVALLO® by the EMA in December 2022. As of today, EBVALLO® is commercially available in Germany and Austria.
Pierre Fabre Laboratories, has expressed their dedication to achieving FDA milestones in the coming months to make EBVALLO® accessible to American patients with EBV+ PTLD. Pascal Touchon, President and CEO of Atara, has expressed their pride in expanding the global partnership to provide this groundbreaking treatment to patients worldwide.
Under this expanded partnership, Atara will receive up to $640 million, along with significant double-digit tiered royalties on net sales by Pierre Fabre Laboratories. Additionally, Pierre Fabre Laboratories will reimburse Atara for expected EBVALLO® global development costs until the FDA approves the Biologics License Application (BLA) in the US and will purchase the current and future EBVALLO® inventory up to the BLA transfer date.
Near-term payments to Atara include an upfront cash payment of approximately $30 million and an initial inventory purchase at the closing of the deal, as well as potential regulatory milestones of $100 million upon BLA approval. Most EBVALLO® manufacturing, clinical, and regulatory activities are scheduled to transition from Atara to Pierre Fabre Laboratories when the BLA approval transfer takes place.
Atara expects to submit the EBVALLO® PTLD BLA in the second quarter of 2024. The transaction is expected to close in December 2023, subject to the waiting period's expiration under the Hart-Scott-Rodino Antitrust Improvements Act and customary closing conditions.
Pierre Fabre Laboratories, emphasized their commitment to oncology as their top priority in Medical Care, with a significant increase in revenues in this therapeutic field. This expanded partnership with Atara will enable them to enter the US, the world's largest oncology market, and provide innovative treatments to more patients in need.
EBVALLO® (tabelecleucel) is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells in a specific manner. EBV+ PTLD is a rare, life-threatening hematologic malignancy that occurs after transplantation, impacting patients who have undergone solid organ transplants or allogeneic hematopoietic cell transplants. Patients with EBV+ PTLD who have not responded to standard treatments have a poor median survival rate of 0.7 months and 4.1 months for HCT and SOT, respectively, highlighting the urgent need for new therapeutic options.
EBVALLO® has orphan designation in Europe, which is reserved for medicines treating rare diseases that are life-threatening or chronically debilitating and affect no more than five in 10,000 people in the EU.