• ADMA received a CRL in July of 2016
• The Company was able to resubmit RI-002’s BLA as a direct result of the recent improvement in compliance status for the Company’s Boca Raton, FL manufacturing facility
• The CRL did not cite any concerns with the clinical safety and efficacy data for RI-002 submitted by ADMA in the original BLA

ADMA Biologics, Inc. (NASDAQ: ADMA) announced on 10/1/18 that the Company has responded to the July 2016 Complete Response Letter (“CRL”) and resubmitted its Biologics License Application (“BLA”) for RI-002 its product candidate to the U.S. Food and Drug Administration (“FDA”) on September 28, 2018.

The Company was able to resubmit RI-002’s BLA as a direct result of the recent improvement in compliance status for the Company’s Boca Raton, FL manufacturing facility to Voluntary Action Indicated (“VAI”), as previously announced in September 2018.

ADMA received the CRL in July of 2016. The CRL did not cite any concerns with the clinical safety and efficacy data for RI-002 submitted by ADMA in the original BLA, nor did the FDA requested any additional clinical studies be conducted prior to FDA approval of RI-002 for PIDD.

The FDA identified in the CRL certain outstanding inspection issues and deficiencies at ADMA’s third-party contract manufacturers, including its contract drug substance and product manufacturer, its contract fill and finisher and compliance issues with a third-party contract testing laboratory, and requested documentation of corrections for a number of those issues.

“We are pleased that our remediation efforts have been successful and we are now operating our biologics production facility in accordance with the FDA’s quality and compliance expectations. Because of the hard work of our dedicated and talented staff, ADMA is now in a position to submit applications to FDA for substantive review and approval including our BLA for RI-002, our lead pipeline-product candidate. We have been informed by FDA that the Company should no longer receive CRL’s solely for compliance reasons,” stated Adam Grossman, President and Chief Executive Officer. “This is an exciting time for the Company and for immune compromised patients with PIDD. RI-002 was developed to provide a polyclonal immune globulin alternative for clinicians when making a determination on how to care for these chronically ill patients and tailor treatment regimens that specific patients deserve and require. RI-002’s pivotal Phase III clinical trial successfully met its primary and secondary endpoints. We believe RI-002, if approved, will have the ability to provide meaningful outcomes for patients.”

The FDA typically provides companies with a notification of BLA acceptance within sixty (“60”) days of submission, and ADMA anticipates that the agency will set a Prescription Drug User Fee Act (“PDUFA”) target action date for RI-002 at that time.

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 polyclonal IVIG product for treatment of patients diagnosed with Primary Immunodeficiency Diseases (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. Data review which has been published in peer reviewed journals indicates that the polyclonal antibodies present in RI-002 support its ability to prevent infections in immune-compromised patients.

Between Between 2001 and 2007, prevalence of any PIDD diagnosis increased from 38.9 to 50.5 per 100,000 among privately insured and from 29.1 to 41.1 per 100,000 among publicly insured persons. There are as many as 300+ different manifestations of disease related to PIDD.