ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an
end-to-end commercial biopharmaceutical company dedicated to
manufacturing, marketing and developing specialty plasma-derived
biologics, today announced that a poster presentation was made at
the virtual 2021 International Society for Influenza and other
Respiratory Virus Diseases - World Health Organization (ISIRV-WHO)
Conference. The abstract and poster presentation detailed the use
of ASCENIV TM, a novel intravenous immune globulin (IGIV)
human-slra, as concomitant therapy in a 70-year-old African
American male with a history of bronchiectasis who presented with
severe respiratory viral disease and confirmed COVID-19 infection.
In the abstract and poster presentation, ADMA described the use
of ASCENIV as concomitant therapy in an adult hospitalized with
COVID-19 infection and rapidly progressive acute respiratory
distress syndrome (ARDS). A 70-year-old African American male
with history of bronchiectasis presented to the emergency
department with a one-week history of increasing dyspnea, dry
cough, sudden onset of high-grade fevers, and body chills. The
patient was initiated on broad-spectrum anti-infectives and
steroids. Initial blood chemistries were unremarkable, pan cultures
were negative but a COVID-19 diagnostic was confirmed positive. The
patient’s respiratory status deteriorated over the next week with
continued progression of pneumonia requiring mechanical
ventilation. On Day 11, the patient was initiated on ASCENIV at
1500 mg/kg. In the days following, the patient developed high-grade
fevers, prompting modification of anti-infectives and a second dose
of ASCENIV at 750 mg/kg. Over the next several days, respiratory
function improved, prompting extubation, but complications with a
bout of severe tachypnea and declined respiratory function led to
temporary re-intubation. With continued clinical management, the
patient’s respiratory status steadily improved, warranting
extubation and transition to rehabilitation with a confirmed
negative COVID-19 test result, no documented co-infections, reduced
inflammatory markers, and recovery of lung function.
This case documents the clinical outcome of a multi-modality
therapeutic approach with broad-spectrum anti-infectives and
concomitant ASCENIV (IVIG human-slra) utilization for the
management of severe respiratory infection. Further investigation
is warranted to evaluate the use of ASCENIV as adjunctive therapy
in vulnerable and immune compromised patients with severe
respiratory disease.
Abstract Title: Clinical Impact of Concomitant
Use of a Novel High-Titer Immune Globulin in an Adult with COVID-19
and Severe Acute Respiratory Distress Syndrome (ARDS)
Authors: Gene A. Wetzstein, PharmD, BCOP;
Mourad Ismail, MD; Jeffrey Gruenglas, DHSc(c), MBE, MA; Dima A.
Decker, PhD; James Mond, MD, PhD
Dates: October 19-22, 2021
Poster Number: 124
About ADMA Biologics, Inc.
(ADMA)
ADMA Biologics is 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 others at risk
for certain infectious diseases. ADMA currently manufactures and
markets three United States Food and Drug Administration
(FDA)-approved plasma-derived biologics for the treatment of immune
deficiencies and the prevention of certain infectious diseases:
ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for
the treatment of primary humoral immunodeficiency (PI); BIVIGAM®
(immune globulin intravenous, human) for the treatment of PI; and
NABI-HB® (hepatitis B immune globulin, human) to provide enhanced
immunity against the hepatitis B virus. ADMA manufactures its
immune globulin products at its FDA-licensed plasma fractionation
and purification facility located in Boca Raton, Florida. Through
its ADMA BioCenters subsidiary, ADMA also operates as an
FDA-approved source plasma collector in the U.S., which provides a
portion of its blood plasma for the manufacture of its products.
ADMA’s mission is to manufacture, market and develop specialty
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
who suffer from an underlying immune deficiency, 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 ASCENIV™
ASCENIV (immune globulin intravenous, human –
slra 10% liquid) is a plasma-derived, polyclonal, intravenous IVIG.
ASCENIV was approved by the United States Food and Drug
Administration (FDA) in April 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
respiratory syncytial virus (RSV) plasma obtained 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. Certain data and other
information about ASCENIV can be found by visiting www.asceniv.com.
Information about ADMA and its products can be found on the
Company’s website at www.admabiologics.com.
Additional Important Safety Information
about ASCENIV™
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).
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 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. |
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. Medications such as epinephrine should be available for
treatment of acute hypersensitivity reactions.
Thrombosis may occur following treatment with
immunoglobulin products, including ASCENIV™. Thrombosis may occur
in the absence of known risk factors.
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.
Hyperproteinemia, increased serum viscosity, and
hyponatremia may occur in patients receiving IGIV treatment,
including ASCENIV™.
Aseptic meningitis syndrome (AMS) may occur with
IGIV treatments, including ASCENIV™. AMS may occur more frequently
in association with high doses (2 g/kg) and/or rapid infusion of
IGIV.
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 pulmonary adverse
reactions. If TRALI is suspected, perform appropriate tests for the
presence of anti-neutrophil antibodies in both the product and the
patient’s serum.
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.
Periodic monitoring of renal function and urine
output is particularly important in patients 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.
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.
Adverse Reactions
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.
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.
COMPANY CONTACT: Skyler
BloomDirector, Investor Relations and Corporate Strategy |
201-478-5552 | sbloom@admabio.com
INVESTOR RELATIONS
CONTACT:Michelle Pappanastos Senior Managing Director,
Argot Partners | 212-600-1902 | michelle@argotpartners.com
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