Atara Biotherapeutics, Inc. (Nasdaq: ATRA) and Pierre Fabre today announced an exclusive commercialization agreement for tabelecleucel (tab-cel®) in Europe, Middle East, Africa, and other select emerging markets for Epstein-Barr virus (EBV)-positive cancers. Atara will retain full rights to tab-cel® in other major markets, including North America, Asia Pacific, and Latin America.
Under the terms of the agreement, Atara will receive an upfront payment of USD 45 million, and up to approximately USD 320 million in additional regulatory and sales milestone payments, plus significant double-digit tiered royalties as a percentage of net sales. Atara will continue to be responsible for the pivotal ALLELE study in PTLD as well as submitting the EU Marketing Authorization Application (MAA) for tabelecleucel in patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), which is on track for November 2021. Atara will also remain 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 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. As part of the transaction, Atara will also provide manufacturing services for tab-cel® to be paid by Pierre Fabre.
Atara is a leader in T-cell immunotherapy, leveraging its first-in-kind allogeneic off-the-shelf EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases. Tab-cel® 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).
“Pierre Fabre is a science-driven company that brings significant commercialization expertise through its integrated Oncology Business Unit, its deep knowledge of Bone Marrow Transplant centers and a track record of successful launches through partnerships,” commented Pascal Touchon, President and CEO of Atara. “Our Companies’ complementary capabilities will expand access to tab-cel®, a potentially transformative investigational allogeneic off-the-shelf T-cell immunotherapy, to patients worldwide who suffer from EBV+ PTLD and other EBV-driven cancers.”
Pierre Fabre enjoys a 35-year long experience in oncology covering innovation, development, manufacturing and commercialization. Its Medical Care division has declared oncology as its main R&D and commercial priority, focusing on targeted therapies, biotherapies, and immuno-oncology. Its therapeutic areas include high unmet medical needs and cover colorectal, breast, lung cancers, melanoma, and pre-cancerous conditions like actinic keratosis. The company has also developed a strong know-how in leveraging global partnerships with biotechnology and pharmaceutical companies, as demonstrated by several successful collaborations in oncology.
“Tab-cel® is a highly innovative immunotherapy with the potential to serve patients with high unmet need in rare conditions. This partnership with Atara epitomizes our corporate purpose: ‘every time we take care of one single person, we make the world better,’” said Eric Ducournau, CEO of Pierre Fabre. “We expect strong synergies with our existing capabilities in oncology across regulatory, distribution, medical, marketing and sales and look forward to bringing this advanced product to patients.”
PJT Partners served as the exclusive financial advisor to Atara.
Atara Conference Call
In connection with this announcement, Atara will host a webcast and conference call today at 8:30 a.m. EDT. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13723585. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of www.atarabio.com. An archived replay will be available on the Company's website for 30 days.
Tabelecleucel (tab-cel®) is an off-the-shelf, allogeneic T-cell immunotherapy in development for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a type of lymphoma (cancer) that may occur after a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). There are currently no approved treatments indicated to treat PTLD and if left untreated, PTLD can have life-threatening consequences.
Tab-cel® is currently being investigated in the Phase 3 ALLELE study to assess efficacy and safety for the treatment of EBV+ PTLD in SOT and HCT after failure of standard of care.
Tab-cel® has been granted Breakthrough Therapy Designation for EBV+ PTLD following allogeneic HCT by the U.S. Food and Drug Administration (FDA) and PRIME designation by the European Medicines Agency (EMA) for the same indication. Tab-cel® has orphan drug designation in the U.S. and EU.
About Pierre Fabre
Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies. Its portfolio ranges across several medical franchises and international brands, including Pierre Fabre Oncology, Pierre Fabre Dermatology, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive and Pierre Fabre Oral Care. In 2020, Pierre Fabre generated €2.3 billion in revenues, 65% of which came from international sales.
Established in the South-West area of France since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognized public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan. In 2020, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard for the 2nd consecutive year and confirmed its “Excellence” level. For further information, please visit the Pierre Fabre website at www.pierre-fabre.com.
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, 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 to create a robust pipeline including: tab-cel® in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) and other EBV-driven diseases; 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 and our leading-edge research, development and manufacturing facility is based in Thousand Oaks, 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 tab-cel®: 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, any collaboration involving tab-cel®, the commercial prospects and business opportunity for tab-cel® in the territories licensed to Pierre Fabre, and the potential financial benefits to Atara as a result of the 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.