NeoStem's Lead Immuno-Oncology Product Candidate, NBS20, Receives ATMP Classification From the European Medicines Agency

NeoStem, Inc.

, a biopharmaceutical company developing novel cell-based individualized medicine therapies, announced today that the European Medicines Agency (EMA) has classified the Company's lead immuno-oncology product candidate, NBS20, as an Advanced Therapeutic Medicinal Product (ATMP). ATMP classification, which is approved by the Committee for Advanced Therapies (CAT), was established to regulate cell and gene therapy and tissue engineered medicinal products, support development of these products and provide a benchmark for the level of quality compliance for pharmaceutical practices. As a designated ATMP product, NBS20 would follow the Centralized Procedure through the European Medicines Agency and benefit from a single evaluation and authorization process. Additional benefits established through the ATMP regulation include pathways for Scientific Advice and significant fee reductions for such advice. NBS20 is the Company's patient-specific targeted cancer immunotherapy candidate being investigated in the Intus Phase 3 trial in patients with stage III recurrent or stage IV metastatic melanoma. Treatment of metastatic melanoma continues to be an unmet medical need globally. In Europe, over 20,000 deaths from melanoma were estimated in 2008, approximately twice the number of recent estimates of annual deaths in the US. NeoStem's global Intus trial has been granted a Special Protocol Assessment (SPA) by the U.S. Food and Drug Administration (FDA). In addition, NBS20 has US Orphan Drug and Fast Track designations by FDA. Patient screening began in the first quarter of 2015 and the Company anticipates the randomization of the first patient in the Intus trial in the second quarter of 2015. "We thank the EMA for this validation of the technically advanced nature of NBS20 as a therapy for melanoma. The ATMP classification will facilitate discussions with EMA as part of our strategy to seek product registration in the EU," said Dr. David J. Mazzo, Chief Executive Officer of NeoStem. "This designation sets NBS20 apart from the immunologic approaches being developed to treat melanoma based on inhibition of a single target and emphasizes its ability to address the complex and multiple tumor-specific targets found on each patient's metastatic tumors."