Under the terms of the expanded partnership, the French drugmaker will extend its licencing rights to Ebvallo in the US, Canada, and all other territories, and pay Atara up to $640m, along with tiered royalties on net sales of the drug
Pierre Fabre expands Ebvallo licencing deal with Atara. (Credit: Steve Buissinne from Pixabay)
French pharmaceutical company Pierre Fabre Laboratories has extended its licencing partnership with Atara Biotherapeutics for rights to Ebvallo (tabelecleucel) in North America.
In October 2021, Pierre Fabre obtained the rights to commercialise Ebvallo in Europe.
Under the terms of the expanded partnership, Pierre Fabre will extend its licencing rights to Ebvallo in the US, Canada, and all other territories.
The French drugmaker will pay Atara up to $640m, along with significant double-digit tiered royalties on the net sales of the drug.
It will also reimburse Atara any potential Ebvallo development costs by transferring the US FDA Biologics License Application (BLA) approval and purchasing the Ebvallo inventory.
Atara will receive near-term payments, including up to $30m in upfront initial inventory purchase and $100m in potential regulatory milestone payments through BLA approval.
In addition, the US biotech company will transfer all the manufacturing, clinical, and regulatory activities related to Ebvallo to Pierre Fabre at the time of BLA approval transfer.
The transaction is expected to be completed in December this year, subject to the expiration of the waiting period under the Hart-Scott-Rodino Act and other customary closing conditions.
Pierre Fabre Laboratories CEO Eric Ducournau said: “Since Ebvallo’s marketing authorisation 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.
“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.”
Atara president and CEO Pascal Touchon said: “We are proud to expand our global EBVALLO partnership with Pierre Fabre Laboratories, which is committed to delivering this first-of-its-kind treatment to patients in need across the globe.”
Ebvallo is an Epstein-Barr virus (EBV)-specific allogeneic T-cell immunotherapy that works to target and eliminate EBV-infected cells in an HLA-restricted manner.
It has been approved in the EU to treat Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) in adults and children, aged two years and above.
EBV+ PTLD is a rare, acute, and dangerous hematologic malignancy that occurs after transplantation when a patient’s immune responses are compromised by immunosuppression.
The disease can impact patients who have undergone solid organ transplant (SOT) or allogeneic haematopoietic cell transplantation (HCT).
Ducournau added: “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 of innovative treatments.”