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 United States Food and Drug Administration’s (“FDA”)
approval to extend the expiration dating from 24 to 36 months for
both its ASCENIV and BIVIGAM immune globulin (“IG”) drug product
stored at 2-8°C. The expiration date extension applies to all
existing ASCENIV and BIVIGAM lots currently in the commercial
supply chain as well as to future production of ASCENIV and BIVIGAM
in all vial sizes, production scales as well as internal and
external fill-finished drug product.
“The extension of ASCENIV’s and BIVIGAM’s shelf life to 36
months dating is a meaningful enhancement of each product’s go-to
market offering as it should provide for a more efficient net
working capital cycle for the Company as well as allow for more
versatile utilization and inventory management by providers,” said
Adam Grossman, President and Chief Executive Officer of ADMA. “The
approval represents an important milestone as it pertains to the
culmination of remediation initiatives enacted since ADMA acquired
the Boca Raton, FL manufacturing facility in 2017. We believe this
FDA approval of shelf-life extension clearly demonstrates ADMA’s IG
portfolio and production processes are of a high-quality and meet
all requirements for stability in the eyes of regulators.”
Mr. Grossman continued, “The milestone approval validates the
optimization of ADMA’s manufacturing processes and ongoing
regulatory compliance, which has been spearheaded by the Company’s
industry-leading regulatory, compliance, quality, production and
supply chain teams. In an IG market faced with volatile supply and
demand dynamics, we believe this approval will lend confidence to
our distribution partners and caregivers in their procurement
decision making. The new 36-month dating for ASCENIV and BIVIGAM
now puts ADMA’s IG portfolio on a level playing field with
competitor product offerings. We look forward to increasing market
penetration with our complete portfolio of IG products to better
serve the growing needs of U.S. patients and physicians in the
periods ahead.”
The newly approved 36-month dating for ASCENIV and BIVIGAM is
immediately effective and product is available to U.S. healthcare
providers and patients. At the present time, ADMA expects
continuous and increasing supply across its IG product suite going
forward.
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 and European Patent No. 3375789 related to certain
aspects of its products and product candidates. For more
information, please visit www.admabiologics.com.
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 and its
products can be found on the Company’s website at
www.admabiologics.com.
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.
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.
and its subsidiaries (collectively, “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; the anticipated benefits and significance of the shelf
life extension of ASCENIV and BIVIGAM lots from 24 months to 36
months; and supply of the Company’s IG products. 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 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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