Full Press Release Details
ADMA Biologics Announces First Commercial
RAMSEY, N.J. and BOCA RATON, FL., - October 21, 2019
- 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,
"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
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 medicalaffairs@admabio.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
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
Thrombosis may occur with immune globulin (IGIV) products,
including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous
or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors.
Thrombosis may occur in the absence of known risk factors.
Renal dysfunction, acute renal failure, osmotic nephrosis,
and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients.
Renal dysfunction and acute renal failure occur more commonly
in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or
renal failure, administer ASCENIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before
administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
For additional safety information about ASCENIV, please see full
Prescribing Information.
ASCENIV is contraindicated in:
-Patients who have had an anaphylactic or severe systemic
reaction to the administration of human immune globulin.
-IgA-deficiency patients with antibodies to IgA and a history
of hypersensitivity.
Warnings and Precautions
Severe hypersensitivity reactions may occur with IGIV products,
including ASCENIV. In case of hypersensitivity, discontinue ASCENIV infusion immediately and institute appropriate treatment. Patients
with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
Thrombosis may occur following treatment with immunoglobulin
products and in the absence of known risk factors. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity
and ensure adequate hydration before administration. For patients at risk of thrombosis, administer ASCENIV at the minimum dose
and infusion rate practicable. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for
Acute renal dysfunction/failure, osmotic nephrosis, and death
may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering ASCENIV. Periodic
monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing
acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the
initial infusion of ASCENIV and at appropriate intervals thereafter. Discontinue ASCENIV if renal function deteriorates. In at
risk patients, administer ASCENIV at the minimum infusion rate practicable.
Hyperproteinemia, increased serum viscosity, and hyponatremia
or pseudohyponatremia may occur in patients receiving IGIV treatment, including ASCENIV. It is critical to clinically distinguish
true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia. Treatment aimed at
decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity,
and a possible predisposition to thrombotic events.
Aseptic meningitis syndrome (AMS) may occur with IGIV treatments,
including ASCENIV. AMS usually begins within several hours to 2 days following IGIV treatment. AMS may occur more frequently in
association with high doses (2 g/kg) and/or rapid infusion of IGIV. Conduct a thorough neurological examination on patients exhibiting
signs and symptoms of AMS, including cerebrospinal fluid (CSF) studies, to rule out other causes of meningitis.
IGIV products, including ASCENIV, may contain blood group antibodies
that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct
antiglobulin reaction and hemolysis. Monitor patients for clinical signs and symptoms of hemolysis, including appropriate confirmatory
Non-cardiogenic pulmonary edema may occur with IV administered
IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil in
both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.
Because ASCENIV is made from human blood, it may carry a risk
of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob
disease (CJD) agent. All infections suspected by a physician to possibly have been transmitted by this product should be reported
to ADMA Biologics at (1-800-458-4244).