Rare Daily Staff
Atara Biotherapeutics, in its third quarter financial report, said it is expanding its global partnership with Pierre Fabre Laboratories for Ebvallo, a monotherapy already registered in the European Union for the treatment of adult and pediatric patients with Epstein-Barr virus positive post–transplant lymphoproliferative disease.
Ebvallo is approved for patients 2 years of age and older who have received at least one prior therapy.
One week after announcing the expanded partnership and corporate restructuring, however, Atara revealed primary analysis data from the ATA188 phase 2 EMBOLD study in multiple sclerosis, which did not meet the primary endpoint of confirmed disability improvement by expanded disability status scale at 12 months compared to placebo. The news cut Atara’s share price in half.
Concurrent with the execution of the global partnership, Atara is undertaking a strategic restructuring and is reducing its current workforce by approximately 30 percent, enabling Atara to execute its remaining responsibilities under the collaboration with Pierre Fabre Laboratories, and focusing on the advancement of ATA188 and its differentiated allogeneic CAR T programs.
After reporting the disappointing results, Atara said it plans to evaluate strategic options for the ATA188 program and further focus resources on advancing its differentiated allogeneic CAR-T pipeline. Atara said the strategic restructuring, combined with certain anticipated payments from the expanded global partnership and the company’s existing cash, cash equivalents, and short-term investments as of September 30, 2023, is expected to fund the company’s planned operations into the third quarter of 2025.
Epstein-Barr virus positive post–transplant lymphoproliferative disease (EBV+ PTLD) is a rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when patient T-cell immune responses are compromised by immunosuppression.
The geographical expansion of the licensing rights encompass the United States, Canada, and all remaining territories. Pierre Fabre Laboratories acquired the rights for Europe in October 2021 and Ebvallo was approved by EMA in December 2022. As of now, it has been commercialized in Germany and Austria.
“In light of our expanded tab-cel partnership and to strategically position the company going forward, we are also restructuring our operations to significantly reduce expenses, meaningfully extend our cash runway to nearly two years, and enable organizational focus on generating the greatest value from our pipeline,” said Pascal Touchon, president and CEO of Atara.
Under the terms of the expanded partnership with Pierre Fabre Laboratories, Atara is eligible to receive up to $640 million and significant double-digit tiered royalties on net sales. In addition, Pierre Fabre Laboratories has agreed to reimburse Atara for expected tab-cel global development costs through Biologics License Application transfer, and purchase current and future tab-cel inventory through the BLA transfer date.
Near-term payments to Atara include approximately $30 million in upfront cash and initial inventory purchase at closing; $100 million in potential regulatory milestones through BLA approval; and substantially all tab-cel manufacturing, clinical, and regulatory activities are planned to transition from Atara to Pierre Fabre Laboratories at the time of BLA transfer.
Atara expects to submit the tab-cel post-transplant lymphoproliferative disease (PTLD) BLA in the second quarter of 2024.
Photo: Pascal Touchon, president and CEO of Atara
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