On January 26, Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, announced that it has entered into a long-term strategic agreement with FUJIFILM Diosynth Biotechnologies (FDB), a subsidiary of FUJIFILM Corporation (Fujifilm), under which Fujifilm will acquire Atara's T-Cell Operations and Manufacturing (ATOM).
A long-term supply agreement, possibly lasting ten years, will also be signed by the parties. Following the completion of the transaction, FDB, a leading contract development, and manufacturing organization (CDMO) focused on advanced therapies, will provide Atara with access to the flexible capacity and specialized capability necessary to manufacture clinical-and commercial-stage allogeneic cell therapies for its maturing and promising pipeline, including tabelecleucel (tab-cel®), which is currently undergoing regulatory review in Europe for EBV+ PTLD, ATA188 for multiple sclerosis, and allogeneic CAR T. Additionally, FDB will increase its reliance on the Thousand Oaks facility and harness its experienced workforce to manufacture a broader array of cell therapies. Atara will retain its manufacturing process science expertise, personnel, and capabilities to continue developing the initial manufacturing and scale-up of allogeneic cell treatments.
"FUJIFILM Diosynth Biotechnologies is a highly respected, quality-focused, industry-leading manufacturing and development organization that shares our pioneering culture and belief that allogeneic cell therapies will transform the future of medicine, We are incredibly proud of our world-class ATOM staff and facility and believe that this strategic partnership will meet our long-term manufacturing needs. Our team has developed processes for our products, scaled them up, and built inventory for clinical trials and the potential commercial launch of tab-cel. We believe that now is the right time for a strategic relationship with FDB to provide us with expert manufacturing capabilities, as needed. Accordingly, we will further focus our capital resources on the development and commercialization of our pipeline of potentially transformative therapeutics for serious diseases."
-Pascal Touchon, President and CEO of Atara.
Atara anticipates having $371.1 million in cash, cash equivalents, and short-term investments as of December 31, 2021. This information is preliminary, has not been audited, and is subject to change upon the company's financial statements for the year ending December 31, 2021, being audited.
Atara will get USD 100 million upon closing, and Fujifilm intends to hire roughly 140 highly experienced manufacturing and quality personnel at the facility. In addition, the arrangement is projected to result in a multi-year reduction in Atara's planned operating expenses. Following the transaction's close, the upfront consideration, combined with the decrease in operating expenses, is expected to fund Atara's planned operations through Q4 2023, beyond the anticipated completion of the randomized, placebo-controlled Phase 2 study of ATA188, the company's investigational off-the-shelf T-cell candidate with the potential to reverse disability in progressive multiple sclerosis.
Atara retains the recently established Atara Research Center (ARC) in Thousand Oaks, California. The ARC is fully operational and will house Atara's Pre-Clinical, Translational Sciences, Manufacturing Process Sciences, and Analytical Development teams, enabling the company to accelerate innovation by using the company's unique and differentiated allogeneic cell therapy platform. Additionally, Atara will retain a competent technical operations staff to manage external production, quality, logistics, and supply chain management.
"We are thrilled that through this acquisition, we will add approximately 140 talented staff from Atara’s cell therapy manufacturing facility to the FUJIFILM Diosynth Biotechnologies family. The collective expertise of the team will further support our efforts as a world-class CDMO, We also look forward to adding the facility to FUJIFILM Diosynth Biotechnologies’ existing global footprint and to bolstering the expansion of our advanced therapies CDMO business."
-Martin Meeson, chief executive officer, FUJIFILM Diosynth Biotechnologies
ATOM is a 90,000-square-foot state-of-the-art T-cell therapy manufacturing facility that is fully qualified to support clinical and commercial production and is built to scale to meet various production requirements and capacities. The transaction is scheduled to close in April 2022, subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other standard closing conditions.
Atara is advised by Evercore Group LLC on a strategic level and by Gibson Dunn & Crutcher LLP on a legal one.
*This press release contains or may contain "forward-looking statements," as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.