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 at the 2021
Academy of Managed Care Pharmacy Virtual Annual Meeting (“AMCP”)
taking place April 12-16, 2021.
“Current CDC guidelines for post-exposure prophylaxis of
suspected Hepatitis B infection (“HBV”) offer no intervention for
sexual assault victims with perpetrators of unknown Hepatitis B
surface antigen status,” said Adam Grossman, President and Chief
Executive Officer of ADMA. “HBV is significantly more
infectious than is HIV, and can be transmitted by any bodily fluid,
and amounts to a roughly equivalent cost burden for the US
healthcare system. Our analysis suggests that amending CDC
guidelines in this at-risk population for HBV to mirror those of
HIV and specifically mandating a Hepatitis B Globulin intervention
like ADMA’s Nabi-HB hyperimmune, will provide a cost-effective
strategy for prophylactic seroprotection of these vulnerable
patients. It is our hope that lobby groups advocating on behalf of
at-risk patients will leverage this analysis to convey to
policymakers that failing to address this patient population, and
harmonizing treatment guidelines between HIV and HBV, may have
considerable clinical and cost implications for the US healthcare
system.”
Details for the AMCP 2021 poster presentation are as
follows:
Poster Title: Pharmacoeconomic Analysis
Comparing Medical Costs for Prophylaxis of HIV and HBV Infection in
Sexual Assault Patients
Author: Gruenglas, Pantello,
MondSession Title: Poster Abstract
SessionsSession Dates: Tuesday, April 13 –
Wednesday, April 14, 2021 (2:30 pm ET)Session
Location: Virtual Poster HallPoster No:
B3
View the presentation at the virtual 2021 AMCP Annual
Meeting
About Nabi-HB®
Nabi-HB® is a hyperimmune globulin that is rich in antibodies to
the Hepatitis B virus. Nabi-HB® is a purified human polyclonal
antibody product collected from plasma donors who have been
previously vaccinated with a Hepatitis B vaccine. Nabi-HB® is
indicated for the treatment of acute exposure to blood containing
Hepatitis B surface antigen (HBsAg), prenatal exposure to infants
born to HBsAg-positive mothers, sexual exposure to HBsAg-positive
persons and household exposure to persons with acute Hepatitis B
virus infection. Hepatitis B is a potentially life-threatening
liver infection caused by the Hepatitis B virus. It is a major
global health problem and can cause chronic infection and put
people at high risk of death from cirrhosis and liver cancer.
Nabi-HB® has a well-documented record of long-term safety and
effectiveness since its initial market introduction. Certain data
and other information about Nabi-HB® or ADMA Biologics and its
products can be found on the Company’s website at
www.admabiologics.com.
Additional Important Safety Information about
Nabi-HB®
Individuals known to have had an anaphylactic or severe systemic
reaction to human globulin should not receive Nabi-HB® [Hepatitis B
Immune Globulin (Human)] or any other human immune globulin.
Individuals who are deficient in IgA have the potential to develop
antibodies against IgA and anaphylactic reactions. In patients who
have severe thrombocytopenia or any coagulation disorder that would
contraindicate intramuscular injections, Nabi-HB should be given
only if the expected benefits outweigh the potential risks. Nabi-HB
is made from human plasma. Products made from human plasma may
carry a risk of transmitting infectious agents (e.g., viruses) and,
theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Nabi-HB
[Hepatitis B Immune Globulin (Human)], must be administered only
intramuscularly for post-exposure prophylaxis. Vaccination with
live virus vaccines (e.g., MMR) should be deferred until
approximately three months after administration of Nabi-HB. The
most common adverse reactions associated with Nabi-HB in clinical
trials were erythema and ache at the injection site as well as
systemic reactions such as headache, myalgia, malaise, nausea and
vomiting. No anaphylactic reactions with Nabi-HB have been
reported. Please see the full Prescribing Information for Nabi-HB
[Hepatitis B Immune Globulin (Human)].
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call
1-800-FDA-1088.
Warnings and Precautions: In patients who have
severe thrombocytopenia or any coagulation disorder that would
contraindicate intramuscular injections, Nabi-HB, Hepatitis B
Immune Globulin (Human), should be given only if the expected
benefits outweigh the potential risks. Nabi-HB is made from human
plasma. Products made from human plasma may contain infectious
agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob
disease (CJD) agent. The risk that such products can transmit an
infectious agent has been reduced by screening plasma donors
for prior exposure to certain viruses, by testing for the presence
of certain current viral infections, and by inactivating and/or
reducing certain viruses. The Nabi-HB manufacturing process
includes a solvent/detergent treatment step (using tri-n-butyl
phosphate and Triton® X-100) that is effective in inactivating
known enveloped viruses such as HBV, HCV, and HIV. Nabi-HB is
filtered using a Planova® 35 nm Virus Filter that is effective in
reducing the levels of some enveloped and non enveloped viruses.
These two processes are designed to increase product safety.
Despite these measures, such products can still potentially
transmit disease. There is also the possibility that unknown
infectious agents may be present in such products. ALL infections
thought by a physician possibly to have been transmitted by this
product should be reported by the physician or other health care
provider to Biotest Pharmaceuticals at 1-800-458-4244. The
physician should discuss the risks and benefits of this product
with the patient.
Nabi-HB, Hepatitis B Immune Globulin (Human), must be
administered only intramuscularly for post-exposure prophylaxis.
The preferred sites for intramuscular injections are the
anterolateral aspect of the upper thigh and the deltoid muscle. If
the buttock is used due to the volume to be injected, the central
region should be avoided; only the upper, outer quadrant should be
used, and the needle should be directed anterior (i.e., not
inferior or perpendicular to the skin) to minimize the possibility
of involvement with the sciatic nerve22. The 50 healthy volunteers
who received Nabi-HB in pharmacokinetic studies were followed for
84 days for possible development of anti-HCV antibodies. No subject
seroconverted.
Drug InteractionsVaccination with live virus vaccines should be
deferred until approximately three months after administration of
Nabi-HB, Hepatitis B Immune Globulin (Human). It may be necessary
to revaccinate persons who received Nabi-HB shortly after live
virus vaccination. There are no available data on concomitant use
of Nabi-HB and other drugs; therefore, NabiHB should not be mixed
with other drugs.
Pregnancy Category CAnimal reproduction studies have not been
conducted with Nabi-HB. It is also not known whether Nabi-HB can
cause fetal harm when administered to a pregnant woman or can
affect a woman’s ability to conceive. Nabi-HB should be given to a
pregnant woman only if clearly indicated.
Nursing MothersIt is not known whether this drug is excreted in
human milk. Because many drugs are excreted in human milk, caution
should be exercised when Nabi-HB is administered to a nursing
mother.
Pediatric UseSafety and effectiveness in the pediatric
population have not been established for Nabi-HB. However, the
safety and effectiveness of similar hepatitis B immune globulins
have been demonstrated in infants and children.
Geriatric UseClinical studies of Nabi-HB did not include
sufficient numbers of subjects aged 65 and over to determine
whether they respond differently than younger subjects. Other
reported clinical experience has not identified differences in
responses between the elderly and younger patients.
Adverse Reactions: Fifty male and female volunteers received
Nabi-HB, Hepatitis B Immune Globulin (Human), intramuscularly in
pharmacokinetics trials20. The number of patients with reactions
related to the administration of Nabi-HB included local reactions
such as erythema 6 (12%) and ache 2 (4%) at the injection site, as
well as systemic reactions such as headache 7 (14%), myalgia 5
(10%), malaise 3 (6%), nausea 2 (4%), and vomiting 1 (2%). The
majority (92%) of reactions were reported as mild. The following
adverse events were reported in the pharmacokinetics trials and
were considered probably related to Nabi-HB: elevated alkaline
phosphatase 2 (4%), ecchymosis 1 (2%), joint stiffness 1 (2%),
elevated AST 1 (2%), decreased WBC 1 (2%), and elevated creatinine
1 (2%). All adverse events were mild in intensity. There were no
serious adverse events. No anaphylactic reactions with Nabi-HB have
been reported. However, these reactions, although rare, have been
reported following the injection of human immune globulins.
About ADMA Biologics,
Inc.
ADMA Biologics is an end-to-end American
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: BIVIGAM® (immune globulin intravenous, human)
for the treatment of primary humoral immunodeficiency (PI);
ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) 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.
COMPANY CONTACT:Skyler BloomDirector, Investor
Relations and Corporate Strategy | 201-478-5552 |
sbloom@admabio.com
INVESTOR RELATIONS CONTACT:Sam MartinManaging
Director, Argot Partners | 212-600-1902 | sam@argotpartners.com
Adma Biologics (NASDAQ:ADMA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Adma Biologics (NASDAQ:ADMA)
Historical Stock Chart
From Sep 2023 to Sep 2024