FDA Approves ASCENIV™, a Novel Intravenous Immune Globulin
- Category: Antibodies
- Published on Tuesday, 02 April 2019 09:51
- Hits: 472
- Approved for Use in the Treatment of Primary Humoral Immunodeficiency Disease (“PIDD” or “PI”) in Adults and Adolescents (12 to 17 Years of Age)
- FDA Approval Triggers Funding up to $27.5M from Existing Credit Facility with Perceptive Advisors
RAMSEY, NJ and BOCA RATON, FL, USA I April 01, 2019 I ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops 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 ASCENIV™, Immune Globulin Intravenous, Human – slra 10% Liquid, formerly referred to as RI-002. ASCENIV™ is an Intravenous Immune Globulin (“IVIG”) drug product for the treatment of Primary Humoral Immunodeficiency Disease (“PIDD” or “PI”) in adults and adolescents (12 to 17 years of age). The Company anticipates having the product available for commercial launch during the second half of 2019.
The ASCENIV™ pivotal Phase III clinical study followed FDA guidance for treatment of patients with PI. The study enrolled fifty-nine patients with PI at nine sites across the U.S. in which study patients received regular infusions of ASCENIV™ over the course of one year. The trial’s primary endpoint evaluated the rate of Serious Bacterial Infections (“SBI”) in patients treated with ASCENIV™. Secondary endpoints included time to first SBI and to first serious infection, days on antibiotics, days off school or work due to infections, all confirmed infections of any kind, and hospitalizations due to infection. There were zero SBIs during the 12-month study period. The manuscript and data set describing the results are published by Dr. Richard Wasserman, et al in the Journal of Clinical Immunology (2016) Volume 36: 590-599. The approved labeling will include a boxed warning about potential thrombosis and renal dysfunction or failure, as well as the most common adverse events observed in the pivotal study, which were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.
“We are excited about this significant achievement in receiving FDA approval for ASCENIV™ a novel, patented IVIG product that we feel is a necessary addition to existing available therapies for patients who suffer from PI. We hope availability of ASCENIV™ will help ameliorate a portion of the current shortages facing U.S. IVIG supply,” stated Adam Grossman, President and CEO of ADMA Biologics. “There are approximately 250,000 PI patients diagnosed and living in the U.S., and we believe there is an opportunity to treat meaningful segments of this patient population with ASCENIV™. As previously disclosed, ASCENIV™ 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. Going forward, we believe this FDA approval better positions ADMA to further its mission to evaluate ASCENIV™ in immune-compromised patients infected with or at-risk for Respiratory Syncytial Virus (“RSV”) infection. We look forward to working with the FDA and the immunology and infectious disease community on developing a clinical investigation to evaluate use of ASCENIV™ in this patient population in the near future.”
Mr. Grossman continued, “We are grateful to the clinical trial subjects, investigators, and health care workers who participated in our Phase III trial and thank them for their extraordinary efforts. We are also thankful to our dedicated and loyal employees who relentlessly contributed to the approval of ASCENIV™ and exemplify our corporate mission of working tirelessly because patients are counting on us.”
“With the receipt of ASCENIV’s™ FDA approval, ADMA, at its sole option, can elect to access up to an additional $27.5M of available funding from Perceptive Advisors under ADMA’s existing credit facility. This option remains available to the Company through June 2020, and such funds could be used to support the launch of ASCENIV™, procure plasma raw material inventory, and begin construction on potential new plasma centers, as well as for general corporate activities,” concluded Mr. Grossman.
About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a vertically integrated commercial biopharmaceutical company that manufactures, markets and develops specialty plasma-based biologics for the treatment of Primary Immune Deficiency Disease (“PIDD” or “PI”) and the prevention and treatment of certain infectious diseases. 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. 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 and 9,969,793 related to certain aspects of its products. For more information, please visit www.admabiologics.com.
About ASCENIV™ (Formerly referred to as RI-002)
ASCENIV™, Immune Globulin Intravenous, Human – slra 10% Liquid, is a plasma-derived, polyclonal, intravenous immune globulin (“IVIG”). ASCENIV™ is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886. ASCENIV™ 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. ASCENIV™ contains naturally occurring polyclonal antibodies. ASCENIV™ is indicated for the treatment of Primary Humoral Immunodeficiency (“PI”) in adults and adolescents (12 to 17 years of age). ADMA received FDA approval for ASCENIV™ on April 1, 2019. 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. ASCENIV™ prevented serious bacterial infection among fifty-nine patients treated for twelve months during the pivotal investigation. The most common adverse reactions to ASCENIV™ (≥5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea. ADMA anticipates the commercial launch of ASCENIV™ during the second half of 2019. Certain data and other information about ASCENIV™ or ADMA Biologics and its products can be found on the Company website at: 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.
SOURCE: ADMAS Biologics