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 on-demand access to an exclusive
educational event at IDWeek 2021 on respiratory viral infections,
presented by nationally recognized clinical experts Dr. Michael
Ison from Northwestern University and Dr. Jolan Walter from the
University of South Florida and Johns Hopkins All Children’s
Hospital. During the live presentation and question and answer
session, Dr. Walter discussed real-world experiences in patients
that were successfully treated with ADMA’s ASCENIV™, a novel
intravenous immunoglobulin (IVIG) product with a unique
composition. The two cases presented detailed scenarios in which
ASCENIV administration demonstrated notable benefits in the
clinical course of two children diagnosed with primary
immunodeficiency (PI) and documented RSV infection.
Educational Event Presentation Title: Key
Insights on RSV and Other Respiratory Viruses Beyond COVID-19 in
the Immunocompromised: An Expert Discussion
- Michael
G. Ison, MD, MS, Professor of Medicine (Infectious
Diseases) and Surgery (Organ Transplantation) at the Feinberg
School of Medicine at Northwestern University, discussed
respiratory viruses in the immunocompromised, its clinical impact
and management strategies.
- Jolan
Walter, MD, PhD, Division Chief of the University of South
Florida (USF) and Johns Hopkins All Children’s Pediatric Allergy
& Immunology Programs, discussed management modalities and
introduced ASCENIV, a novel IVIG, and presented two challenging
patient cases:
- ASCENIV use in a
15-month-old immunocompromised male with chronic RSV
bronchiolitis
- ASCENIV use in a
12-month-old immunocompromised male with severe RSV
bronchiolitis
To view the on-demand presentation please visit the
IDWeek 2021 conference website.
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 Biologics and its products
can be found on the Company’s website at www.admabiologics.com.
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.
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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