ADMA Biologics is an advanced clinical stage biopharmaceutical company focusing on the development of plasma based biologics as a potential treatment for respiratory syncytial virus (RSV) infection in patients suffering from primary immune deficiency disease (PIDD) and also affords benefit for RSV infection management in patients undergoing stem cell and solid organ transplantation.
The company is conducting a Phase III study for potential approval of their lead product, RI-002 as an intravenous immune globulin (IVIG). Given the ongoing pivotal Phase III study design is based on a well-established IVIG clinical development guidance issued by the FDA, and the fact that multiple IVIG products have been successfully developed; we view the hurdle for achieving a positive Phase III study outcome leading to a potential approval is relatively modest.
In addition to the development of RI-002, ADMA Biologics also participated in operating plasma collection centers as second value driver for ADMA shareholders. The company currently operates one plasma collection center and plans to build and operate two more plasma collection centers over the next few years.