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ADMA Biologics Announces Commercial Relaunch and its First Commercial Sales of BIVIGAM RAMSEY, N.J. and BOCA RATON, FL.

Key Takeaway: ADMA Biologics Announces Commercial Relaunch and its First Commercial Sales of BIVIGAM RAMSEY, N.J. and BOCA RATON, FL., - August 22, 2019 - ADMA Biologics, Inc. (NASDAQ: ADMA) ("ADMA" or the "Company"), a vertically integrated commercial biopharmaceutical and specialty immun

Full Press Release Details

ADMA Biologics Announces Commercial
Relaunch and its First Commercial Sales of BIVIGAM
RAMSEY, N.J. and BOCA RATON, FL., - August 22, 2019 -
ADMA Biologics, Inc. (NASDAQ: ADMA) ("ADMA" or the "Company"), a vertically integrated commercial biopharmaceutical
and specialty immunoglobulin company that manufactures and markets three approved plasma-derived biologics for the treatment of
immune deficiencies and the prevention of certain infectious diseases, announces the commercial relaunch and its first commercial
As previously reported, BIVIGAM had a Biologics
License Application ("BLA") manufacturing change Prior Approval Supplement ("PAS") approved by the United
States Food and Drug Administration ("FDA") on May 9, 2019, enabling ADMA to resume marketing BIVIGAM
to US- based prescribers and healthcare professionals. BIVIGAM is approved for the treatment of patients diagnosed
with 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.
"We are very excited to have received the timely FDA
PAS approval allowing ADMA to reintroduce BIVIGAM to market for PI patients in efforts to address their ongoing
medical needs and to address reported US market Intravenous Immune Globulin ("IVIG") supply constraints. BIVIGAM's
relaunch is a result of the culmination of many important milestones, and we are grateful for the efforts of our dedicated
staff at ADMA and of the FDA, which have enabled us to bring BIVIGAM to market. ADMA looks forward to working
with our distribution partner and the physician community as we are prepared and committed to provide a continuous supply of BIVIGAM
to PI patients," stated Adam Grossman, President and Chief Executive Officer.
Mr. Grossman continued, "As we have previously communicated
to our stakeholders, the manufacturing, testing and final packaging for a complex biologic product like BIVIGAM typically takes
anywhere from six to nine months and sometimes longer to deliver to customers and end users. ADMA believes it is doing everything
in its power to ramp up production to a steady state to ensure the continuity of care for patients, while continuing to operate
in accordance with the FDA's quality regulations and expectations. We want caregivers and patients to know that ADMA's
top priority remains unchanged: providing safe, high-quality and efficacious products."
BIVIGAM will be available through BioCare SD,
our authorized distributor. Prescribers and healthcare professionals interested in purchasing BIVIGAM for use
with their PI patients should contact BioCare SD directly at 800-304-3064 or by visiting their website at www.BioCareSD.com.
Information about BIVIGAM for healthcare professionals,
patients with primary immune deficiency disease and their healthcare partners can be found at: www.bivigam.com. Through the BIVIGAM
website, physicians can access the prescription request form and request a meeting with a sales professional. Any medical
or scientific questions regarding BIVIGAM , or any other products produced by ADMA Biologics, should be directed
to our Medical Affairs Department at medicalaffairs@admabio.com or 800-458-4244, prompt 2.
ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a vertically integrated commercial biopharmaceutical company that 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. ADMA's mission is to manufacture, market and develop 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 disease, 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.
Based in Phoenix, Arizona, BioCare SD has been devoted to delivering
specialty and therapeutic biological products to our customers since 1982. BioCare SD is committed to being the industry's
most trusted specialty distributor by providing customer-oriented solutions, unmatched service levels, and a unique distribution
network to ensure the highest quality in patient care. The BioCare SD customer support team and local, field-based account management
teams are available 24 hours a day, 7 days a week, 365 days a year by calling 800-304-3064. For more information, please visit
About Primary Immune Deficiency Disease ("PI")
PI is a class of inherited genetic disorders that causes an
individual to have a deficient or absent immune system. According to the World Health Organization, there are approximately 350
different genetic mutations encompassing PI. Some disorders present at birth or in early childhood, the disorders can affect anyone
regardless of age or gender. Some affect a single part of the immune system, others may affect one or more components of the system.
PI patients are vulnerable to infections and more likely to suffer complications from these
infections as compared to individuals with a normal functioning immune system. The infections may occur in any part of the
body. Because patients suffering from PI lack a properly functioning immune system, they typically receive monthly treatment with
polyclonal immune globulin products. Without this exogenous antibody replacement, these patients would remain vulnerable to persistent
and chronic infections. PI has an estimated prevalence of 1:1,200 in the United States, or approximately 250,000 people in the
BIVIGAM is an immune
globulin intravenous (human), 10% liquid, indicated for the treatment of primary humoral immunodeficiency. This includes, but
is not limited to, X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and
severe combined immunodeficiency. These PIs are a group of genetic disorders. Initially thought to be very rare, it is now believed
that as many as 250,000 people in the U.S. have some form of Primary Humoral Immunodeficiency
("PI"). 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 ("IgG")
antibodies. Antibodies are proteins in the human immune system that work to defend against infections and disease. FDA's
initial approval for BIVIGAM was received by BPC in December 2012, and production of BIVIGAM was
halted by BPC in December 2016. ADMA obtained ownership and all rights, title and interest in BIVIGAM in June
2017 as part of the Biotest Therapy Business Unit ("BTBU") acquisition in June 2017 and resumed the production of
BIVIGAM during the fourth quarter of 2017. Based on ADMA's optimized IVIG manufacturing process, the FDA
approved a Prior Approval Supplement to amend the Biologics License Application for the product on May 9, 2019, allowing the Company
to resume supplying BIVIGAM to the U.S. market. The FDA completed the license transfer for BIVIGAM
to ADMA on July 2, 2019. BIVIGAM was reintroduced to the US market on August 22, 2019. Certain
data and other information about BIVIGAM or ADMA Biologics and its products can be found on the Company's
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
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
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
Last updated: Aug 22, 2019