On November 3, 2023 Pierre Fabre Laboratories reported an expanded global partnership with Atara Biotherapeutics, a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform, for EBVALLO (tabelecleucel) a monotherapy already registered in the EU for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein–Barr virus positive post–transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy (Press release, Pierre Fabre, NOV 3, 2023, View Source [SID1234636921]). 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.

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This geographical expansion of the licensing rights encompasses the USA, Canada and all remaining territories. Pierre Fabre Laboratories already acquired the rights for Europe in October 2021 and EBVALLO was approved by EMA in December 2022. EBVALLO is, as of today, commercialized in Germany and Austria.

"Since EBVALLO’s marketing authorization in Europe less than a year ago, patients have already been treated in Germany, or have benefited from the treatment through the Early Access Program in place in other European countries" said Eric Ducournau, CEO of Pierre Fabre Laboratories. "We are now eager to progress on the upcoming FDA milestones in the next months and ensure American patients diagnosed with EBV+ PTLD can access this novel therapy".

"We are proud to expand our global EBVALLO partnership with Pierre Fabre Laboratories, who is committed to deliver this first-of-its kind treatment to patients in need across the globe" said Pascal Touchon, President and Chief Executive Officer of Atara.

According to the expanded Global EBVALLO Partnership between Pierre Fabre Laboratories and Atara Biotherapeutics:

Atara will receive up to $640M and significant double-digit tiered royalties on net sales from Pierre Fabre Laboratories. In addition, Pierre Fabre Laboratories has agreed to reimburse Atara for expected EBVALLO global development costs through transfer of the BLA (Biologics License Application) approval by the FDA in the US and purchase current and future EBVALLO inventory through the BLA transfer date.
Near-term payments to Atara include:
Approximately $30M in cash up front and initial inventory purchase at closing
Approximately $30M in cash up front and initial inventory purchase at closing
$100M in potential regulatory milestones through BLA approval
Substantially all EBVALLO manufacturing, clinical, and regulatory activities are planned to transition from Atara to Pierre Fabre Laboratories at the time of BLA approval transfer

Atara expects to submit the EBVALLO PTLD BLA in Q2 2024
The closing of the transaction, subject to expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions, is expected to occur in December 2023.

"Pierre Fabre Laboratories have made oncology their top priority in Medical Care. Since 2019, we have almost tripled our revenues in this therapeutic field, and we expect to pass the 500M€ bar this year. 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 in need for innovative treatments" added Eric Ducournau, CEO of Pierre Fabre Laboratories.

About EBVALLO and EBV+ PTLD
EBVALLO (tabelecleucel) is an allogeneic, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells in an HLA-restricted manner. 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. It can impact patients who have undergone solid organ transplant (SOT) or allogeneic HCT. Poor median survival of 0.7 months and 4.1 months for HCT and SOT, respectively, is reported in EBV+ PTLD patients for whom standard of care failed, underscoring the significant need for new therapeutic options.

EBVALLO has orphan designation in Europe. Orphan designation is reserved for medicines treating life-threatening or chronically debilitating diseases that are rare (affecting not more than five in 10,000 people in the EU).