RAMSEY, N.J. and BOCA RATON, Fla., Oct. 21, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and the prevention of certain infectious diseases, today announced the first commercial sales of ASCENIV (formerly known as RI-002). ASCENIV received approval from the U.S. Food and Drug Administration (“FDA”) on April 1, 2019.
“The first commercial sales of ASCENIV, our third FDA-approved product, marks another major milestone in ADMA’s history,” said Adam Grossman, President and Chief Executive Officer of ADMA. “ASCENIV is a novel Intravenous Immune Globulin (“IVIG”), which is manufactured using our unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using our proprietary microneutralization assay. This proprietary biologic product is now commercially available for ordering in the U.S. and we are actively working with our distribution partner, BioCare SD, and the physician community, to drive adoption of ASCENIV for appropriate patients in the U.S. who could derive benefit.”
ASCENIV is a plasma-derived, polyclonal human immune globulin product. ASCENIV is indicated for the treatment of Primary Humoral Immunodeficiency or Primary Immune Deficiency Disease (“PI”) in adults and adolescents (12 to 17 years of age). ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.
ASCENIV is now available and can be ordered through BioCare SD, ADMA’s authorized distributor. Prescribers and healthcare professionals interested in purchasing ASCENIV for use with their PI patients should contact BioCare SD directly at 800-304-3064 or by visiting their website at www.BioCareSD.com.
Information about ASCENIV for healthcare professionals, patients with primary immune deficiency disease and their healthcare partners can be found at: www.asceniv.com. Through the ASCENIV website, physicians can access the prescription request form and request a meeting with a sales professional. Any medical or scientific questions regarding ASCENIV, or any other products produced by ADMA, should be directed to the Medical Affairs Department at email@example.com or 800-458-4244, prompt 2.
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 ASCENIV™ (Formerly RI-002)
ASCENIV, immune globulin intravenous, human – slra 10% liquid, is a plasma-derived, polyclonal, intravenous immune globulin (“IVIG”). ASCENIV was approved by the FDA on April 1, 2019 and is indicated for the treatment of Primary Humoral Immunodeficiency or Primary Immune Deficiency Disease (“PI”) in adults and adolescents (12 to 17 years of age). ASCENIV is manufactured using ADMA’s unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using the Company’s proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which 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. ASCENIV prevented serious bacterial infection among 59 patients treated for twelve months during the pivotal investigation. ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.
ASCENIV (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age). PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).