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 a poster presentation and exclusive Key
Opinion Leader symposium by nationally recognized clinical experts
on the management of respiratory viral infections (RVIs) and
real-world experience with ADMA’s ASCENIV, a U.S. Food and Drug
Administration (FDA)-approved intravenous immunoglobulin (IVIG)
product with a unique composition.
Poster Presentation Title: ASCENIV™ Reduces
Viral Infections and Associated Comorbidities in a Primary
Immunodeficiency PatientSession Date: Friday,
April 1, 2022Session Time: 1:00 PM – 2:00 PM ET
Session Location: Exhibit Hall, Symphony Ballroom,
Sheraton Charlotte Hotel, 55 South McDowell Street South Tower,
Charlotte, NCPoster Presentation and Abstract
Number: #47
- Kevin Rosenbach,
MD, Medical Director of Naples Allergy & Immunology
Center, will share a live poster presentation of real-world
outcomes of ASCENIV, involving a challenging case of a patient
diagnosed with late-onset combined immunodeficiency (LOCID) with a
history of chronic and recurrent respiratory infections.
Educational Event Presentation Title:
Challenges Associated with Respiratory Viral Infections (RVIs) in
patients with Primary Immunodeficiency: An Expert Discussion &
Real-World Experience
Session Date: Saturday, April 2,
2022Session Time: 12:45 PM – 1:45 PM ET
Session Location: Sheraton Charlotte Hotel, 55
South McDowell Street South Tower, Charlotte, NC. Room Mecklenberg
1
- Jolan Walter, MD,
PhD, Division Chief of the University of South Florida
(USF) and Johns Hopkins All Children’s Pediatric Allergy &
Immunology Programs, will discuss risk factors, unmet clinical
needs, and key considerations in the management of RVIs in patients
with primary immunodeficiency.
- Dareen Siri, MD, FAAAAI
FACAAI FISAAI, Medical Director at Midwest Allergy Sinus
Asthma, will present on the management of immunoglobulin therapy,
introduce the clinical profile of ASCENIV™, and discuss its
clinical use in four challenging patient cases with a history of
respiratory infections and multiple comorbid, chronic
conditions.
About ASCENIV™
ASCENIV (immune globulin intravenous, human –
slra 10% liquid) is a plasma-derived, polyclonal, intravenous IVIG.
ASCENIV was approved by the 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 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 and European Patent
No. 3375789 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
BloomSenior Director, Business Development & 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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