Atara Biotherapeutics and Pierre Fabre Enter Strategic Collaboration to Commercialize Tabelecleucel (Tab-cel®)

Atara Biotherapeutics, Inc. | October 04, 2021

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, 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.

- Pascal Touchon, President and CEO of Atara.

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.

PJT Partners served as the exclusive financial advisor to Atara.

About Tabelecleucel
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

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.


If you’ve ever bought a car, remodeled a room in your home, or shopping for a high-end TV, chances are the business you purchased from offered you a financing plan. The appeal of financing is simple: it helps people buy things they normally couldn’t afford. Financing is a convenient solution for consumers, who can turn an expensive, big-ticket item into a more budget-friendly monthly payment. It’s also great for business owners, who can improve their sales by easily increasing customer’s purchasing power. As a dentist, you likely already offer at least one financing option.


If you’ve ever bought a car, remodeled a room in your home, or shopping for a high-end TV, chances are the business you purchased from offered you a financing plan. The appeal of financing is simple: it helps people buy things they normally couldn’t afford. Financing is a convenient solution for consumers, who can turn an expensive, big-ticket item into a more budget-friendly monthly payment. It’s also great for business owners, who can improve their sales by easily increasing customer’s purchasing power. As a dentist, you likely already offer at least one financing option.

Related News


Citius Pharmaceuticals Receives FDA Response and Guidance to Pre-IND Consultation Submission for Mino-Wrap

Citius Pharmaceutical | December 10, 2020

Citius Pharmaceuticals, Inc. ("Citius" or the "Organization") (Nasdaq: CTXR), a strength drug organization zeroed in on creating and commercializing basic consideration drug items, declared its receipt of a composed reaction and direction from the U.S. Food and Drug Administration (FDA) Division of Anti-Infective Products to the Company's Pre-Investigational New Drug (Pre-IND) meeting demand for its Mino-Wrap preparation bundle. Through its worldwide permit concurrence with The University of Texas MD Anderson Cancer Center, Citius is creating Mino-Wrap, a novel way to deal with lessening post-mastectomy contaminations related with the utilization of a tissue expander. The preparation bundle contained data in regards to pre-clinical information and a clinical improvement plan, alongside inquiries for the FDA with respect to security and adequacy information that would be needed to progress Mino-Wrap into clinical preliminaries. The FDA conceded a Written Response Only gathering with respect to direction and bearing on the Mino-Wrap advancement plan. The organization showed that bio retention reenactment studies may give data to help the improvement of Mino-Wrap and made recommendations on what should be given comparative with non-clinical help. The FDA gave direction on the plan of the medication elution contemplates and concurred that a huge creature pharmacology study would be fitting. They additionally concurred that a 28-day toxicology study seems suitable and that microbiology uphold through existing information is worthy. "The FDA furnished us with important direction and affirmed some of our underlying plans on the advancement of Mino-Wrap," said Myron Holubiak, President and CEO of Citius Pharmaceuticals. "We are exceptionally satisfied to have direction uphold from the organization since this is quite an under-perceived issue, and current preventative measures have not yielded entirely worthy outcomes. We think we have a significant development for the prevention of post-employable diseases related with bosom reconstructive medical procedure after mastectomies."

Read More


Eagle Pharmaceuticals Agreed to Acquire Acacia Pharma Group plc

Eagle Pharmaceuticals, Inc. | March 29, 2022

Eagle Pharmaceuticals, Inc. reported that it had achieved an agreement with Acacia Pharma Group plc on the parameters of a plan of arrangement under Part 26 of the United Kingdom's Companies Act 2006. Acacia Pharma's current issued and to be issued, share capital is valued at approximately €94,700,000, or the equivalent of €0.90 per share, under the terms of the proposed transaction. Each Acacia Pharma shareholder would get €0.68 in cash and 0.0049 shares of Eagle common stock in exchange for each Acacia Pharma share owned. Eagle will additionally guarantee about €25.0 million of debt within the Acacia Pharma group under the proposed acquisition terms. In conjunction with the proposed transaction, the Company and Acacia Pharma entered into a collaboration agreement on March 27, 2022, and (ii) certain shareholders and directors of Acacia gave irrevocable undertakings to the Company and Acacia. The proposed deal has been authorized by the boards of directors of both businesses. It is scheduled to complete in late Q2 2022, subject to shareholder approval, approval by the High Court of England and Wales, and satisfaction of standard closing conditions for transactions of this kind. There is no guarantee that the proposed transaction will be completed on the given terms, on the anticipated schedule, or at all. The proposed transaction is expected to provide Eagle with two currently marketed acute care hospital products with the potential to disrupt the marketplace: • BARHEMSYS® is the first and only antiemetic authorized by the Food and Drug Administration (FDA) for the rescue treatment of postoperative nausea and vomiting (PONV) in the absence of prophylaxis. Eagle is now targeting healthcare providers and institutions, which account for more than 70% of the anticipated addressable market potential for BARHEMSYS. • BARHEMSYS is also licensed for the treatment and prevention of PONV in patients who have not received prophylaxis. The projected yearly addressable market for prophylaxis and rescue in the United States is $2.7 billion. • BYFAVO® is authorized for the induction and maintenance of procedural sedation in adults having operations lasting 30 minutes or less, with a total addressable market for procedural sedation in the United States estimated at more than $0.4 billion per year. “We are delighted to announce that we have agreed to terms for the proposed acquisition of Acacia Pharma. This will be a very important acquisition for us, both financially and strategically. In recent years, the pharmaceutical industry has witnessed slower uptake of new products and longer ramp periods. In the face of further challenges brought about by the COVID-19 pandemic, many smaller underfunded companies experienced significant hurdles launching products. We therefore believe that Eagle is well suited to drive uptake of these two new products, building from Acacia Pharma’s established foundation since its launch, through our experienced and specialized hospital-based sales organization with minimal additional infrastructure,” President and Chief Executive Officer of Eagle Pharmaceuticals, Scott Tarriff “We have been extremely disciplined in managing our balance sheet over the years, and we believe that the proposed acquisition is a wise use of the cash we have generated. With these two products, together with landiolol, which is on track for an NDA submission to the FDA in May of this year, Eagle will potentially have three NCEs going into their launch phase. We believe these efforts will strengthen our leadership position in the hospital and oncology space and establish a strong foundation for sustainable long-term growth and bring value to our shareholders,” concluded Tarriff. “We believe that BARHEMSYS and BYFAVO address unmet clinical needs and are nearing usage inflection points, with strong formulary acceptance, and that with our longstanding relationships in the hospital space, we can accelerate uptake and capture the commercial potential of these assets. In doing so, we strive to impact and improve the care of patients undergoing medical treatments such as surgery and invasive procedures. Additionally, their value to anesthesia providers, who are key users, is important, facilitating precision medicine for patients. We see our sales infrastructure as a strategic asset, and as we add to our commercial product portfolio going forward, we plan to expand the size of our salesforce over the next two years,” stated Executive Vice President and Chief Commercial Officer of Eagle Pharmaceuticals, Michael Moran.

Read More


TransPerfect Life Sciences Introduces Trial Interactive CTMS Solution

Trial Interactive | November 12, 2021

TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, announced the release of the Trial Interactive (TI) Clinical Trial Management System (CTMS). This release marks the industry's only mobile-first CTMS, placing important actions and information at the fingertips of study managers and CRAs and supporting a full author-to-archive process. Trial Interactive delivers user-friendly document and trial management solutions to help pharmaceutical, biotechnology, medical device, and contract research organizations (CROs) effectively streamline product development life cycles. The platform improves speed, quality, and compliance across site identification, site feasibility, study start-up, site personnel training, regulated content management, eISF, and eTMF management. The addition of TI CTMS enables a single source of truth across the entire life cycle, providing transparency into Trial Interactive solutions and any sponsor or CRO systems of record. A fully connected solution, Trial Interactive offers fast-to-implement and cost-effective solutions in a secure 21 CFR Part 11-compliant environment. Designed by clinical professionals for clinical professionals, TI CTMS benefits include World-Class User Experience – The time-saving and pain-free mobile-first interface, with full-text and segmented metadata search, flexible filtering and exports, dark mode, and one-click navigation, creates the industry's friendliest user experience. By Clinical, for Clinical – Enjoy greater efficiency without the hassle, and get started quickly with no heavy configuration required and best practices built into the default configuration. True SaaS Solution – TI CTMS is a single-study or enterprise SaaS solution developed by experts. TransPerfect's award-winning service teams support rapid implementation plans with full validation. Enterprise Ready – With the flexibility to align with large-scale operations, TI CTMS enables enterprises with complex study teams to easily update the system to meet unique requirements and have access to a comprehensive web services API supporting third-party integrations. Author-to-Archive Platform – Streamline processes and oversight with content management solutions supporting the workflow of documents across the life cycle from site and study personnel to the eTMF in one seamless process. As clinical operations become more decentralized, TI CTMS continues Trial Interactive's mission of providing practical innovation to improve the efficiency of global clinical processes while reducing costs. "Having consulted with many organizations and colleagues over the years about CTMS, we've recognized common challenges like time-consuming configurations, difficult navigation, and user experiences that are clearly developed without the input of clinical operations experts. The end result is that existing platforms have fallen short of the features that study managers and CRAs really needTI CTMS was built by clinical professionals for clinical professionals and cuts configuration times while delivering powerful capabilities in a clean user experience that perfectly addresses the needs of sponsors and CROs." Michael Smyth, Division President of TransPerfect Life Sciences TransPerfect President and CEO Phil Shawe stated, "The launch of TI CTMS comes at a time when conducting remote and decentralized clinical trials is more important than ever. The CTMS is connected to our eTMF and other platform solutions to deliver a mobile-first experience that ensures study teams can work effectively and at scale from any location." About Trial Interactive TransPerfect's Trial Interactive is an industry leader in practical eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR part 11 compliant unified platform delivers an author to archive collaboration experience with solutions for clinical document management, site selection, site activation, eLearning, compliance training, quality, and more with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence. About TransPerfect Life Sciences TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact. About TransPerfect TransPerfect is the world's largest provider of language and technology solutions for global business. From offices in over 100+ cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. More than 5,000 global organizations employ TransPerfect's GlobalLink® technology to simplify management of multilingual content. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong.

Read More