Pierre Fabre and Atara Biotherapeutics, Inc. announced today that the European Commission granted marketing authorization for LINK, tabelecleucel, as a monotherapy to treat adult and pediatric patients aged 2 and older with relapsed Epstein-Barr virus-positive post-transplant lymphoproliferative disorder (EBV+ PTLD). Prior therapy for solid organ transplant patients includes chemotherapy, unless chemotherapy is ineffective.
This approval comes after a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency. It is applicable to all 27 EU member states, Iceland, Norway and Liechtenstein. Based on the results of the pivotal Phase 3-ALLELE study1, EbvalloTM showed a favorable risk-benefit ratio.
Pascal Touchon, Atara's President and Chief Executive Officer, stated that EbvalloTM's approval in Europe was a medical breakthrough for patients who have significant unmet needs. This approval by any international regulatory agency marks a landmark moment for Atara, Pierre Fabre, our European partner, and the wider cell therapy field.
EBV+ PTLD, a rare and severe hematologic malignancy, can develop after transplantation. It occurs when the patient's T cell immune response is impaired by immunosuppression. Patients who have had solid organ transplant (SOT), or allogeneic hemotopoietic cells transplant (HCT) can be affected. Patients with EBV+ PTLD who received inadequate care have had a poor median survival rate of 0.7 months and 4.11 months respectively for SOT and HCT. This highlights the need for innovative therapeutic options.
Pierre Fabre, under a previously announced License Agreement, will be responsible for all commercialization, distribution, and medical activities in Europe and select markets.
"LINK is a landmark in cell therapy and a breakthrough in treatment for European patients suffering from EBV+PTLD," said Eric Ducournau (CEO of Pierre Fabre), Atara's European commercialization partner. "We are proud to announce this new therapy on the market, which will strengthen Pierre Fabre's portfolios in oncology and hematology as well as rare diseases.
EbvalloTM is an orphan drug in Europe. Orphan status is reserved for medicines that treat rare, life-threatening or chronically debilitating conditions (not more than five people per 10,000 in the EU). Orphan medicines are protected from competition by similar medicines that have the same therapeutic indication for ten years.
Pierre Fabre, a French healthcare company, has over 35 years of experience in the areas of innovation, development and manufacturing as well as commercialization in oncology. It owns several international brands and medical franchises, including Pierre Fabre Dermatology and Pierre Fabre Oncology. Oncology has been declared the company's top priority in medical care R&D, commercialization and marketing. The company focuses on biotherapies, targeted therapies and immuno-oncology. Its portfolio includes oncology (colorectal and breast cancers, lung, and pre-cancerous conditions such as actinic Keratosis), hematology, and rare diseases. Pierre Fabre generated 2.5 billion euros in revenue in 2021. 66% of that came from international sales to more than 100 countries.
Additional information on Pierre Fabre is available at URL and URL.
Atara Biotherapeutics, Inc., (URL), is a pioneering company in T-cell immunotherapy. It leverages its allogeneic EBV-T-cell platform to create transformative therapies for patients suffering from serious diseases, including solid tumors, autoimmune disease, and hematologic cancers. Atara Biotherapeutics, Inc. has received European marketing authorization for its lead program. This allows it to quickly deliver off-the shelf treatments to patients who have high unmet medical needs. Our platform harnesses the unique biology and potential to treat many EBV-associated diseases or other serious conditions through the incorporation of engineered CARs or TCRs (chimeric-antigen receptors). Atara has created a robust pipeline using this platform that does not require TCR gene editing or HLA gene modification. This includes tab-cel for Epstein-Barr viral positive post-transplant Lymphoma (EBV+ PTLD), and ATA188, a T-cell immunotherapy for EBV antigens, as a potential treatment of multiple sclerosis. There are also multiple next-generation chimeric-antigen receptor T-cell (CAR-T), immunotherapies for solid tumors and hematologic malignancies. Our mission is to improve the lives of patients and will continue to work to provide transformative therapies for those who need them. Atara's headquarters is in Southern California. Visit atarabio.com for more information and follow us on Twitter or LinkedIn.
This press release may contain or imply "forward-looking statements" within the meaning of Section 27A of Securities Act of 1933 and Section21E of Securities Exchange Act of 1934. Forward-looking statements may include statements about tab-cel (r), including statements about tab-cel's development, timing, and progress, the potential benefits and characteristics of tabcel(r), as well as the progress and results and prospects of any collaboration involving tabcel(r), in territories licensed to Pierre Fabre. Pierre Fabre's success in launching and commercializing tab-cel, and the potential financial rewards to Atara from the collaboration with Pierre Fabre. These statements are based upon Atara's current expectations and may not reflect actual results. These forward-looking statements involve risks and uncertainties. They include, without limitation: the cost-intensive and time-consuming process of developing a pharmaceutical product and uncertainty regarding clinical success; and the COVID-19 pandemic. This could have a significant impact on (i) Atara’s business, research, and clinical development plans, as well the business of third-party manufacturers, contract research organisations, and our business operations. (iii). The Company's periodic reports filed with the Securities and Exchange Commission (SEC) contain sections. Atara does not intend to revise or update any forward-looking statements unless required by law.