ATARA Biotherapeutics (ATRA) Granted Access to CHMP, CAT PRIME Regulatory Imitative

October 18, 2016 8:09 AM EDT
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Atara Biotherapeutics, Inc. (Nasdaq: ATRA) announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) have granted access to the EMA’s newly established Priority Medicines (PRIME) regulatory initiative for EBV-CTL in the treatment of patients with rituximab refractory EBV-PTLD following hematopoietic cell transplant (HCT). PRIME provides early and enhanced regulatory support to optimize regulatory applications and accelerate the review of medicines that address a high unmet need. EBV-CTL is an investigational therapy in which a healthy donor’s T-cells are stimulated to recognize EBV antigens, or viral proteins, expressed in the cells of certain liquid and solid tumors, as well as in autoimmune diseases.

"We are pleased to be selected by the CHMP and CAT to participate in this innovative program designed to spur development of therapies for patients with serious diseases that have few therapeutic options," noted Isaac Ciechanover, M.D., President, and Chief Executive Officer of Atara Bio. "We look forward to working closely with the CHMP and CAT, and to seeking Scientific Advice in the fourth quarter of this year to continue to advance our development efforts in Europe."

Access to the Priority Medicines initiative is granted by the EMA to support the development and accelerate the review of new therapies to treat patients with unmet medical need. The criteria for the Priority Medicines initiative require early clinical evidence that the therapy offers a therapeutic advantage over existing treatments or benefits patients without treatment options. This designation provides appointment of a rapporteur, early dialogue and scientific advice at key development milestones, and the potential to qualify products for accelerated review earlier in the application process.

The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to EBV-CTL for the treatment of patients with rituximab refractory EBV-PTLD after HCT in February 2015. The company anticipates the initiation of two Phase 3 trials in rituximab refractory EBV-PTLD after HCT or solid organ transplant (SOT) later this year.



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