ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA”), an end-to-end
commercial biopharmaceutical company dedicated to manufacturing,
marketing and developing specialty plasma-derived biologics,
announced the commercial availability of additional vial sizes of
BIVIGAM and NABI-HB, which are currently in stock and commercially
available to U.S healthcare providers and patients.
“The availability of these additional NABI-HB and BIVIGAM vial
sizes meaningfully enhances ADMA’s go-to-market offering for its
commercial Immune Globulin (“IG”) product portfolio and allows for
more versatile utilization by providers and patients,” said Adam
Grossman, President and Chief Executive Officer of ADMA. “We
anticipate the broader suite of BIVIGAM and NABI-HB vial
configurations will help in providing more targeted dosing levels,
minimize drug wastage and allow ADMA’s IG products to have vial
presentations in line with competitor offerings. These new vial
sizes, which further advance the Company’s mission to differentiate
through its hands-on approach to manufacturing and developing
plasma-derived therapeutics, represent yet another important
milestone achieved by ADMA’s regulatory, commercial and supply
chain teams. We look forward to increasing market penetration with
our complete portfolio of IG and hyperimmune globulin products to
better serve the growing needs of U.S. patients and physicians in
the periods ahead.”
NABI-HB 1 mL and 5 mL vial sizes are available to U.S.
healthcare providers and patients and, at the present time, ADMA
expects continuous supply availability of both vial sizes going
forward.
Earlier this year, ADMA received United States Food and Drug
Administration (“FDA”) approval for the production of a 100 mL vial
presentation of BIVIGAM which, with today’s announcement, is now
commercially available in limited quantities. The new vial size
will supplement ADMA’s currently marketed BIVIGAM 50 mL vial
offering, for which the Company expects uninterrupted supply
availability. The wider range of vial sizes now offered for NABI-HB
and BIVIGAM is anticipated to aid physicians and providers with
targeted dosing and avoiding unnecessary drug wastage while
providing for an easier, more convenient way to prepare and
administer the products according to the respective labeled use for
both NABI-HB and BIVIGAM.
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:
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-licensed 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 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)].
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, Nabi-HB
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 BIVIGAM®
BIVIGAM (immune globulin intravenous, human –
10% liquid) is a plasma-derived, polyclonal, intravenous immune
globulin (IVIG). BIVIGAM was approved by the FDA in May 2019 and is
indicated for the treatment of primary humoral immunodeficiency
(PI), including, but not limited to, the following group of genetic
disorders: X-linked and congenital agammaglobulinemia, common
variable immunodeficiency, Wiskott-Aldrich syndrome and severe
combined immunodeficiency. BIVIGAM contains a broad range of
antibodies similar to those found in normal human plasma. These
antibodies are directed against bacteria and viruses and help to
protect PI patients against serious infections. BIVIGAM is a
purified, sterile, ready-to-use preparation of concentrated human
Immunoglobulin antibodies. Certain data and other information about
BIVIGAM or ADMA and its products can be found on the Company’s
website at www.admabiologics.com.
Additional Important Safety Information
for BIVIGAM® [Immune Globulin Intravenous (Human), 10%
Liquid]
BIVIGAM® [Immune Globulin Intravenous (Human),
10% Liquid] is indicated for the treatment of primary humoral
immunodeficiency (PI). This includes, but is not limited to, the
humoral immune defect in common variable immunodeficiency (CVID),
X-linked agammaglobulinemia, congenital agammaglobulinemia,
Wiskott-Aldrich syndrome, and severe combined
immunodeficiencies.
WARNING: THROMBOSIS, RENAL DYSFUNCTION,
AND ACUTE RENAL FAILURE
Thrombosis may occur with immune globulin
intravenous (IGIV) products, including BIVIGAM. Risk factors may
include: advanced age, prolonged immobilization, hypercoagulable
conditions, a history of venous or arterial thrombosis, the use of
estrogens, indwelling vascular catheters, hyperviscosity and
cardiovascular 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. BIVIGAM does not contain sucrose.
For patients at risk of thrombosis, renal
dysfunction, or renal failure, administer BIVIGAM 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.
BIVIGAM is contraindicated in patients who have
had an anaphylactic or severe systemic reaction to the
administration of human immune globulin and in IgA-deficient
patients with antibodies to IgA and history of
hypersensitivity.
Thrombosis may occur following treatment with
IGIV products, including BIVIGAM. Thrombosis may occur in the
absence of known risk factors.
Consider baseline assessment of blood viscosity
in patients at risk for hyperviscosity, including those with
cryoglobulins, fasting chylomicronemia/ markedly high
triacylglycerols (triglycerides), or monoclonal gammopathies. For
patients at risk of thrombosis, administer BIVIGAM at the minimum
dose and infusion rate practicable.
In patients at risk of developing acute renal
failure, renal function, including blood urea nitrogen (BUN), serum
creatinine, and urine output need to be monitored.
Hyperproteinemia, increased serum viscosity, and
hyponatremia or pseudohyponatremia can occur in patients receiving
IGIV therapy. Aseptic meningitis syndrome (AMS) has been reported
with IGIV treatments; AMS may occur more frequently in association
with high doses (2 g/kg) and/or rapid infusion of IGIV.
As hemolysis can develop subsequent to treatment
with IGIV products, monitor patients for hemolysis and hemolytic
anemia. Monitor patients for pulmonary adverse reactions
(transfusion-related acute lung injury [TRALI]). If TRALI is
suspected, test the product and patient for antineutrophil
antibodies.
Because BIVIGAM is made from human blood, it may
carry a risk of transmitting infectious agents, e.g., viruses, and
theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Passive transfer of antibodies with IGIV
treatment may yield positive serological testing results, with the
potential for misleading interpretation.
Serious adverse reactions observed in clinical
trial subjects receiving BIVIGAM were vomiting and dehydration in
one subject. The most common adverse reactions to BIVIGAM (reported
in ≥ 5% of clinical study subjects) were headache, fatigue,
infusion site reaction, nausea, sinusitis, blood pressure increase,
diarrhea, dizziness, and lethargy.
For more information about BIVIGAM, please see
full Prescribing Information.
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.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains “forward-looking
statements” pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995 about ADMA Biologics, Inc.
(“we,” “our” or the “Company”). Forward-looking statements include,
without limitation, any statement that may predict, forecast,
indicate, or imply future results, performance or achievements, and
may contain such words as “anticipate,” “intend,” “target,” “plan,”
“expect,” “believe,” “will,” “is likely,” “will likely,” “should,”
“could,” “would,” “may,” or, in each case, their negative, or words
or expressions of similar meaning. These forward-looking statements
also include, but are not limited to, statements about ADMA’s
future results of operations; and the anticipated benefits, and
supply of, the additional BIVIGAM and NABI-HB vial sizes. Actual
events or results may differ materially from those described in
this press release due to a number of important factors. Current
and prospective security holders are cautioned that there also can
be no assurance that the forward-looking statements included in
this press release will prove to be accurate. Except to the extent
required by applicable laws or rules, ADMA does not undertake any
obligation to update any forward-looking statements or to announce
revisions to any of the forward-looking statements. Forward-looking
statements are subject to many risks, uncertainties and other
factors that could cause our actual results, and the timing of
certain events, to differ materially from any future results
expressed or implied by the forward-looking statements, including,
but not limited to, the risks and uncertainties described in our
filings with the U.S. Securities and Exchange Commission, including
our most recent reports on Form 10-K, 10-Q and 8-K, and any
amendments thereto.
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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