Atara Biotherapeutics’ Ebvallo™ (tabelecleucel) Wins Prix Galien International Award for Best Product for Orphan/Rare Diseases

Rhea-AI Summary

Atara Biotherapeutics announced that its product Ebvallo™ (tabelecleucel or tab-cel®) has won the 2024 Prix Galien International Award for Best Product for Orphan/Rare Diseases. Ebvallo, developed in collaboration with Pierre Fabre Laboratories, is the first and only approved therapy in Europe for adults and children with EBV+ post-transplant lymphoproliferative disease (PTLD). This prestigious award is often compared to the Nobel Prize in biopharmaceutical research.

Ebvallo received European marketing authorization in December 2022, and Atara submitted a Biologics License Application to the U.S. FDA in May 2024. EBV+ PTLD is a rare and potentially fatal condition affecting transplant patients, with poor survival rates for those who have relapsed or are refractory to prior treatments. The award underscores the innovative and potentially life-saving nature of Ebvallo.

Positive

• Ebvallo won the 2024 Prix Galien International Award for Best Product for Orphan/Rare Diseases.
• Ebvallo is the first and only approved therapy in Europe for EBV+ PTLD.
• Marketing authorization granted by the European Commission in December 2022.
• Biologics License Application submitted to the U.S. FDA in May 2024.
• Potential to change outcomes for EBV+ PTLD patients with no approved therapies.

Negative

• Poor median survival rates for EBV+ PTLD patients who have failed at least one therapy (0.7 months for HCT and 4.1 months for SOT).

Ebvallo is the First and Only Approved Therapy in Europe for Adults and Children with EBV+ PTLD

THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that Ebvallo^TM (tabelecleucel or tab-cel^®) has been awarded the prestigious 2024 Prix Galien International Award for “Best Product for Orphan/Rare Diseases.” The award was presented to Pierre Fabre Laboratories, Atara’s global development and commercialization partner for Ebvallo.

The Prix Galien International Awards for Life Science Research is organized every two years and is judged by a committee of distinguished independent experts and specialists. They select the most innovative therapy from the winners of the 15 National Prix Galien awards in each category over the previous two years. Worldwide, the Prix Galien is regarded as the equivalent of the Nobel Prize in biopharmaceutical research.

“The Prix Galien International Award for Ebvallo highlights the importance of this first ever allogeneic T-cell therapy in potentially changing outcomes for patients that previously had no approved therapies in this treatment setting and poor overall survival,” said Pascal Touchon, President and Chief Executive Officer of Atara. “Receiving this award is a great honor and I want to thank Atara and Pierre Fabre teams that have worked to bring this important medicine to patients. Following Ebvallo approval and launch in Europe, we look forward to continuing our work together to expand patient access in the U.S. and other markets.”

Tab-cel was developed by Atara and was granted marketing authorization under the brand name Ebvallo™ in December 2022 by the European Commission indicated as a monotherapy 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 (r/r EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

In the U.S., Atara submitted a Biologics License Application in May 2024 to the U.S. Food and Drug Administration for tab-cel indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with EBV+ PTLD who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. There are no FDA approved therapies in this treatment setting.

EBV+ PTLD is an ultra-rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when a patient’s T-cell immune response is compromised by immunosuppression. It can impact patients who have undergone solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). Poor median survival of 0.7 months and 4.1 months for HCT and SOT, respectively, is reported in EBV+ PTLD patients who have failed at least one therapy, underscoring the significant need for new therapeutic options.

About Atara Biotherapeutics, Inc.

Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases, in addition to next-generation AlloCAR-Ts designed for best-in-class opportunities across a broad range of hematological malignancies and B-cell driven autoimmune diseases. Atara is headquartered in Southern California. For more information, visit atarabio.com and follow @Atarabio on X and LinkedIn.

Forward-Looking Statements

This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding the development, timing and progress of tab-cel®, including the BLA filed for tab-cel®, the potential characteristics and benefits of tab-cel®, the indication(s) for which tab-cel could potentially obtain FDA approval for, and the global partnership with Pierre Fabre Laboratories involving tab-cel®. Because such statements deal with future events and are based on Atara’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; the COVID-19 pandemic and the wars in Ukraine and the Middle East, which may significantly impact (i) our business, research, clinical development plans and operations, including our operations in Southern California and Denver and at our clinical trial sites, as well as the business or operations of our third-party manufacturer, contract research organizations or other third parties with whom we conduct business, (ii) our ability to access capital, and (iii) the value of our common stock; the sufficiency of Atara’s cash resources and need for additional capital; and other risks and uncertainties affecting Atara and its development programs, including those discussed in Atara’s filings with the Securities and Exchange Commission, including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240621317043/en/

Investor and Media Relations

Jason Awe, Ph.D.

Senior Director, Corporate Communications & Investor Relations

(805) 217-2287

jawe@atarabio.com

Source: Atara Biotherapeutics, Inc.

FAQ

What award did Atara Biotherapeutics' Ebvallo win?

Ebvallo won the 2024 Prix Galien International Award for Best Product for Orphan/Rare Diseases.

What is Ebvallo used for?

Ebvallo is used for treating adults and children with EBV+ post-transplant lymphoproliferative disease (PTLD).

Is Ebvallo approved in Europe?

Yes, Ebvallo received marketing authorization from the European Commission in December 2022.

Has Atara submitted an application for Ebvallo to the U.S. FDA?

Yes, Atara submitted a Biologics License Application for Ebvallo to the U.S. FDA in May 2024.

What is the significance of the Prix Galien International Award?

The Prix Galien International Award is regarded as the equivalent of the Nobel Prize in biopharmaceutical research.

What are the survival rates for EBV+ PTLD patients?

The median survival rates are 0.7 months for HCT patients and 4.1 months for SOT patients who have failed at least one therapy.