Full Press Release Details
ADMA Biologics Receives BioNJ 2020 Innovator
RAMSEY, NJ and BOCA RATON, FL, February 11, 2020 -- ADMA
Biologics, Inc. (Nasdaq: ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing
specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and for the prevention of
certain infectious diseases, today announced that it was awarded the BioNJ 2020 Innovator Award in recognition of the development
and approval of ASCENIV (immune globulin intravenous, human - slra 10% liquid) by the U.S. Food and Drug Administration
"We are honored to be recognized by BioNJ with this prestigious
award," said Adam Grossman, President and Chief Executive Officer of ADMA. "The robust life sciences community in New
Jersey provides ADMA with talented and dedicated healthcare professionals that are contributing to the launch and commercialization
of ASCENIV, our novel, proprietary immune globulin product, which we believe can help appropriate patients in the U.S."
"The purpose of the BioNJ Innovator Award is to celebrate
the dominant role New Jersey plays in the healthcare landscape and to highlight the vision and innovation contributed by these
recipients," said Debbie Hart, President and Chief Executive Officer of BioNJ. "We are delighted to present ADMA with
the 2020 Innovator Award for its success in bringing ASCENIV to market to help immune deficient patients."
About Primary Humoral Immunodeficiency
Primary humoral immunodeficiency (PI), also known as primary
immune deficiency disease (PIDD), 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 are present at birth or in early childhood and 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 are more likely to suffer complications from these infections compared to individuals with a normal functioning
immune system. 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. Initially thought to be very rare, it is now estimated that the prevalence of PI in the U.S.
is 1 in 1,200, which translates to approximately 250,000 people.
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 (PI), also known as primary immune deficiency disease (PIDD),
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 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).
After infusion of immunoglobulin, the transitory rise of the
various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the
potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause
a positive direct or indirect antiglobulin (Coombs') test.
The most common adverse reactions to ASCENIV ( 5% of study
subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis,
You are encouraged to report side effects of prescription
drugs to ADMA Biologics @ 1-800-458-4244 or the FDA. Visit www.fda.gov/MedWatch or
call 1-800-FDA-1088.
About ADMA Biologics, Inc. (ADMA)