ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces that the U.S. Food and Drug Administration (“FDA”) has approved the Company’s Prior Approval Supplement (“PAS”) for Bivigam (immune globulin intravenous (human), 10% liquid). The FDA’s approval of the PAS for Bivigam approves the use of the Company’s optimized intravenous immune globulin (“IVIG”) manufacturing process and enables ADMA to commence the marketing of Bivigam in the U.S. to patients with Primary Humoral Immunodeficiency (“PI”).
“This FDA approval for ADMA’s third commercial product is a significant milestone, and we look forward to commencing sales of Bivigam in the near-term,” stated Adam Grossman, President and Chief Executive Officer of ADMA. “The FDA’s approval of Bivigam’s modified manufacturing process validates our commitment to optimizing the ADMA IVIG manufacturing process and signifies the extensive and successful remediation and turnaround of our Boca Raton, Florida manufacturing facility.”
“We are pleased to re-introduce Bivigam into the market, where demand for IVIG therapy continues to outpace supply.” Mr. Grossman continued, “The $6 billion U.S. market for IVIG continues to grow and the relaunch of BIVIGAM® can help to alleviate a portion of the tight supply for this important patient population, where dependable and consistent supply of IVIG is critical to patients’ well-being.”
Bivigam received its initial FDA approval in December 2012. The Bivigam pivotal clinical study was a prospective, open-label, single-arm multicenter trial, which achieved its primary endpoints for safety, efficacy and tolerability. The results were published by Dr. Richard Wasserman, et al. in the Journal of Clinical Immunology in 2014. In December 2016, Biotest Pharmaceuticals Corporation (“BPC”) voluntarily suspended commercial production of Bivigam due to certain manufacturing and compliance issues. Subsequent to ADMA’s acquisition of the Biotest Therapy Business Unit (“BTBU”) assets in June 2017, of which Bivigam was a part, ADMA resumed production of Bivigam during the fourth quarter of 2017, successfully manufacturing three conformance lots using the Company’s optimized IVIG manufacturing process. ADMA anticipates the re-launch of Bivigam for commercial sale during the second half of 2019.
About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a vertically integrated biopharmaceutical manufacturer with three FDA approved commercial specialty plasma-based biologics. ADMA's mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations. The target patient populations include immune compromised individuals who suffer from an underlying immune deficiency disease, or who may be immune compromised for other medical reasons. ADMA has received U.S. Patents 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.
About Primary Immune Deficiency Disease (“PI”)
PI is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system. According to the World Health Organization, there are approximately 350 different genetic mutations encompassing PI. Some disorders present at birth or in early childhood, the disorders can affect anyone regardless of age or gender. Some affect a single part of the immune system, others may affect one or more components of the system. PI patients are vulnerable to infections and more likely to suffer complications from these infections as compared to individuals with a normal functioning immune system. The infections may occur in any part of the body. Because patients suffering from PI lack a properly functioning immune system, they typically receive monthly treatment with polyclonal immune globulin products. Without this exogenous antibody replacement, these patients would remain vulnerable to persistent and chronic infections. PI has an estimated prevalence of 1:1,200 in the United States, or approximately 250,000 people in the U.S.
About Bivigam
Bivigam is an immune globulin intravenous (human), 10% liquid, indicated for the treatment of primary humoral immunodeficiency. This includes, but is not limited to, X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency. These PIs are a group of genetic disorders. Initially thought to be very rare, it is now believed that as many as 250,000 people in the U.S. have some form of PI. Bivigam contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses, and help to protect PI patients against serious infections. Bivigam is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin (“IgG”) antibodies. Antibodies are proteins in the human immune system that work to defend against infections and disease. FDA’s initial approval for Bivigam was received by BPC in December 2012, and production of Bivigam was halted by BPC in December 2016. ADMA obtained ownership and all rights, title and interest in Bivigam in June 2017 as part of the Biotest Therapy Business Unit (“BTBU”) asset acquisition and resumed the production of Bivigam during the fourth quarter of 2017. Using ADMA’s optimized IVIG manufacturing process, FDA approved a PAS to amend the BLA for the product allowing the Company to resume the supply of drug to the U.S. market.
