Full Press Release Details
Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics
License Application for Tabelecleucel (Tab-cel ) for the Treatment of Epstein-Barr
Post-Transplant Lymphoproliferative Disease
Prescription Drug User Fee Act (PDUFA) Target Action Date of January 15, 2025
If Approved, Tab-cel Would Be First Approved Therapy in U.S. for EBV+ PTLD
BLA Acceptance Triggers $20 Million Milestone Payment from Pierre Fabre Laboratories, with Additional
$60 Million Milestone if Approved by FDA
THOUSAND OAKS, Calif. July 17, 2024 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 the U.S. Food
and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for tabelecleucel (tab-cel ) indicated as monotherapy for treatment of adult and pediatric
patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (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.
The BLA has been granted Priority Review with a
Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2025.
The acceptance of the tab-cel BLA is a significant milestone
towards making this first-of-its-kind treatment available to patients in the U.S., said Pascal Touchon, President and Chief
Executive Officer of Atara. The FDA s granting of priority review highlights the high unmet need in EBV+ PTLD, which is a devastating disease with limited treatment options and a poor overall survival rate. We continue to work closely
with the Pierre Fabre Laboratories team to help prepare for the potential launch in the U.S. in early 2025, along with the potential label expansion multicohort Phase 2 EBVision trial.
Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target
and eliminate EBV-infected cells. The BLA is supported by pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases including the latest pivotal
ALLELE study data that demonstrated a statistically significant 48.8% Objective Response Rate (ORR) (p<0.0001) and favorable safety profile consistent with previous analyses.
Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated
lymphoproliferative disease by the U.S. FDA and has orphan drug designation.
In December 2023, Atara announced the closing of the expanded global
partnership with Pierre Fabre Laboratories for the U.S. and remaining global commercial markets for tab-cel, building on an initial partnership covering Europe, Middle East, Africa, and other select emerging markets. With the acceptance of the
tab-cel BLA, Atara will receive a $20 million milestone payment from Pierre Fabre, with the potential to receive a $60 million milestone payment from Pierre Fabre contingent upon FDA approval of the tab-cel BLA. In addition, Pierre Fabre
is reimbursing Atara for expected tab-cel global development costs through the BLA transfer and purchasing tab-cel inventory through the manufacturing transfer date. Atara is also eligible to receive sales milestones and double-digit tiered
royalties on net sales of tab-cel in the U.S. and remaining global commercial markets referenced above.
Tab-cel was granted marketing authorization under
the brand name Ebvallo in December 2022 by the European Commission. Marketing authorization was also granted by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom
in May 2023 and by Swissmedic in Switzerland in May 2024. In all three territories, Ebvallo is indicated as monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory EBV+ PTLD who have
received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. Ebvallo was awarded the 2024 Prix Galien International Award for Best Product for Orphan/Rare
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: (i) the development, timing and progress of tab-cel ,
including the BLA filed for tab-cel ; (ii) the potential characteristics and benefits of tab-cel , the indication(s) for which
tab-cel could potentially obtain FDA approval for; (iii) the global partnership with Pierre Fabre Laboratories involving tab-cel ; and (iv) Atara s planned transition of
substantially all activities relating to tab-cel at the time of the BLA transfer to Pierre Fabre and the timing thereof. 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.
Investor and Media Relations
Head of Corporate Communications & Investor Relations