Pierre Fabre Laboratories acquires the marketing rights for EBVALLO® in the United States, Canada and the rest of the markets from Atara Biotherapeutics

Following a transition period, Pierre Fabre Laboratories will take over all manufacturing, clinical and regulatory activities for EBVALLO®

This strategic acquisition allows Pierre Fabre Laboratories to establish itself in the United States in the field of oncology

CASTRES, France, Nov. 3, 2023 /PRNewswire/ -- Pierre Fabre Laboratories today announces an expanded global partnership with Atara Biotherapeutics, a leader in T-cell immunotherapy, leveraging its novel allogeneic T-cell platform against Epstein virus. Barr (EBV), for EBVALLO® (tabelecleucel), a monotherapy already registered in the EU for the treatment of adult and pediatric patients from two years of age with relapsed Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV-PTLD) or refractory who have received at least one previous treatment. EBV PTLD is a rare, acute, and life-threatening hematologic malignancy that occurs after transplantation when the patient's T-cell immune response is compromised by immunosuppression.

This geographical expansion of license rights covers the United States, Canada and the rest of the territories. Pierre Fabre Laboratories already acquired the rights for Europe in October 2021 and EBVALLO® was approved by the EMA in December 2022. As of today, EBVALLO® is also marketed in Germany and Austria.

"Since the marketing authorization of EBVALLO®' 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 force in other European countries," says Eric Ducournau, CEO of Pierre Fabre Laboratories. "We now look forward to advancing the FDA's upcoming milestones in the coming months and ensuring that American patients diagnosed with EBV PTLD can access this innovative therapy."

"We are proud to expand our global EBVALLO® partnership with Pierre Fabre Laboratories, who are committed to providing this pioneering treatment to patients around the world," said Pascal Touchon, President and CEO of Atara.

Pursuant to the partnership between Pierre Fabre Laboratories and Atara Biotherapeutics:

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 planned for December 2023.

"Pierre Fabre Laboratories has made oncology its top healthcare priority. Since 2019, we have almost tripled our revenue in this therapeutic field, and we expect to exceed €500M this year. This expansion of our partnership with Atara will allow us to give a first step in the United States, by far the largest oncology market in the world, and reach more patients who need innovative treatments," adds Eric Ducournau, CEO of Pierre Fabre Laboratories.

About EBVALLO® and ELPT VEBEBVALLO® (tabelecleucel) is an allogeneic EBV-specific T cell immunotherapy that targets and eliminates EBV-infected cells in an HLA-restricted manner. EBV PTLD is a rare, acute, and life-threatening hematologic malignancy that occurs after transplantation when the patient's T-cell immune response is compromised by immunosuppression. It can affect patients who have undergone solid organ transplantation (SOT) or allogeneic HCT. The median survival of EBV PTLD patients who have failed standard treatments is low, at 0.7 months and 4.1 months for HSCT and SOT, respectively, underscoring the great need for new therapeutic options.

EBVALLO® has the orphan drug designation in Europe. Orphan designation is reserved for medicines that treat rare, life-threatening or chronically debilitating diseases that affect a small number of patients (fewer than five people in every 10,000 in the EU).

About Pierre Fabre LaboratoriesPierre Fabre Laboratories is a leading French medical and care company with 4 decades of experience in innovation, development, manufacturing and marketing in the oncology sector. The company dedicated nearly 80% of its R&D spending to oncology in 2022 and recently declared targeted therapies as its top R&D priority. Its current commercial portfolio in oncology spans colorectal, breast and lung cancers, melanoma, hematology and precancerous skin conditions such as actinic keratosis.

In 2022, Pierre Fabre Laboratories had a turnover of €2.7 billion, 69% of which came from international sales in 120 countries. Established in the south-west of France since its creation in 1962, the Group manufactures more than 90% of its products in France and employs around 9,600 people worldwide. The company is 86% owned by the Pierre Fabre Foundation, a public interest foundation recognized by the government, and secondarily by its own employees through an international employee share plan. Pierre Fabre Laboratories' sustainability policy has been evaluated by the certification body AFNOR at the "Exemplary" level of its CSR label (ISO 26 000 standard for sustainable development).

More information about Pierre Fabre Laboratories can be found at www.pierre-fabre.com, @PierreFabre.

Press contacts:Laure Sgandurralaure.sgandurra@pierre-fabre.com

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