Atara to Receive Additional USD 30 Million Upon European Commission (EC) Approval and Filing of Tab-cel® Marketing Authorization Transfer to Pierre Fabre
Responses Submitted to European Medicines Agency for Final Day 180 List of Outstanding Issues
Anticipated Tab-cel® EC Approval on Track for Q4 2022
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, today announced an update to its existing collaboration agreement with Pierre Fabre for the commercialization of tabelecleucel (tab-cel®) for Epstein-Barr virus (EBV)-positive cancers.
Under the amended terms, Atara will receive an additional USD 30 million milestone payment upon tab-cel® EC approval and subsequent filing of the Marketing Authorization Application (MAA) transfer to Pierre Fabre in exchange for reduced tab-cel® royalties and supply price mark-up for Pierre Fabre. Tiered royalties on sales remain at a significant double-digit rate following this amendment.
“With an anticipated European approval in Q4 2022, tab-cel® is positioned to become the first ever allogeneic off-the-shelf T-cell therapy available for patients with significant need,” said Pascal Touchon, President and CEO of Atara. “This update to our agreement with Pierre Fabre reaffirms our strong partnership and shared belief in the transformative potential of tab-cel®, while enabling Atara to further extend our cash runway.”
In October 2021, Atara entered into an exclusive commercialization agreement with Pierre Fabre for tab-cel® in Europe, Middle East, Africa and other select emerging markets for EBV-positive cancers, receiving an upfront payment of USD 45 million, and up to approximately USD 320 million in additional regulatory and sales milestone payments. In addition to responsibility for the pivotal ALLELE study in EBV+ post-transplant lymphoproliferative disease (EBV+ PTLD) and securing European Commission approval, Atara also remains responsible for the Phase 2 multi-cohort study, which is evaluating tab-cel® in six additional patient populations with the goal of label expansion in other EBV-driven cancers. Pierre Fabre will lead all commercialization and distribution activities in the territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe. Atara retains full commercialization rights to tab-cel® in the United States and other major markets.
“Tab-cel® has the potential to be a transformational product for EBV-positive cancers and is eagerly awaited by physicians and patients in Europe with limited treatment options,” said Eric Ducournau, CEO of Pierre Fabre. “This update to our agreement with Atara confirms our confidence and commitment to tab-cel® in Europe, where the Pierre Fabre team is excited to bring the first allogeneic T-cell therapy to European patients in a rare oncology condition.”
Atara is leveraging its first-in-kind allogeneic off-the-shelf EBV T-cell platform to develop transformative therapies for patients including tab-cel®, which is the Company’s lead candidate in development for EBV-positive cancers, including EBV+ PTLD, where it is currently being investigated in adults and children in the Phase 3 ALLELE study. Tab-cel® has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation by the European Medicines Agency (EMA).
Further information about Pierre Fabre can be found at www.pierre-fabre.com and @PierreFabre.
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. (@Atarabio) is a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune disease. With our lead program in Phase 3 clinical development and currently under review to support registration in Europe, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-associated diseases, or other serious diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors). Atara is applying this one platform, which does not require TCR or HLA gene editing, to create a robust pipeline including: tab-cel® (tabelecleucel) in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD); ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple next-generation chimeric antigen receptor T-cell (CAR-T) immunotherapies for both solid tumors and hematologic malignancies. Improving patients’ lives is our mission and we will never stop working to bring transformative therapies to those in need. Atara is headquartered in South San Francisco, California.
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 Atara’s cash runway and statements regarding tab-cel®,including: the timing of, and Atara’s plans for, and potential decision by, the EMA regarding the MAA submission for EBV+ patients with PTLD, the development, timing and progress of tab-cel®, the potential characteristics and benefits of tab-cel®, and the progress and results of, and prospects for, Atara’s collaboration with Pierre Fabre involving tab-cel®, the commercial prospects and business opportunity for tab-cel® in the territories licensed to Pierre Fabre, and the potential financial and other benefits to Atara as a result of the collaboration (and the amended terms of such collaboration) with Pierre Fabre. 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, which may significantly impact (i) our business, research, clinical development plans and operations, including our operations in South San Francisco and Southern California 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’s and its development programs, including those discussed in Atara’s filings with the Securities and Exchange Commission (SEC), 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.