ADMA Biologics Reports FDA Compliance Status Update

ADMA Biologics announces that the U.S. Food and Drug Administration (FDA) inspection database classification website has been updated and confirms ADMA’s compliance status has improved to Voluntary Action Indicated (VAI).

"We are pleased that the FDA has acknowledged the improved current good manufacturing practice (cGMP) conditions at our manufacturing facility and updated its database accordingly," said Adam Grossman, President and Chief Executive Officer of ADMA Biologics, Inc. "We are excited to finally be in a position to resubmit our Biologics License Application ("BLA") for RI-002 during the third quarter of 2018, which we believe is a needed Intravenous Immune Globulin ("IVIG") option for patients who suffer with Primary Humoral Immunodeficiency Disease ("PIDD"). We will announce related information pertaining to RI-002’s BLA filing when the Company receives correspondence from FDA."

ADMA's lead portfolio product candidate, RI-002, which has demonstrated positive Phase III pivotal clinical trial data, is a specialty plasma-derived, polyclonal, intravenous immune globulin (IVIG) derived from human plasma containing naturally occurring polyclonal antibodies (e.g., Streptococcus pneumoniae, H. influenza type B, cytomegalovirus (CMV), measles, tetanus, etc.) as well as plasma from donors tested to have high levels of neutralizing antibodies to respiratory syncytial virus (RSV). ADMA is pursuing an indication for the use of this specialty IVIG product for treatment of patients diagnosed with PIDD. Polyclonal antibodies are the primary active component of IVIG products. Polyclonal antibodies are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease.

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