ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA”), an end-to-end
commercial biopharmaceutical company dedicated to manufacturing,
marketing and developing specialty plasma-derived biologics, today
announced the launch of COVID-19 ImmunoRank Neutralization
MICRO-ELISA, a proprietary, fully-validated ELISA assay for the
detection of SARS-CoV-2 neutralizing antibodies in plasma.
ImmunoRank™ was developed in collaboration with Leinco
Technologies, Inc. (“Leinco”). ImmunoRank is intended for use as an
aid to identify individuals who produce an adaptive immune response
to SARS-CoV-2, indicating recent or prior infection, and
specifically for the detection of circulating SARS-CoV-2
neutralizing antibodies in human plasma of all immune globulin
classes.
ImmunoRank is designed to test up to 90 samples per test kit
with 99.8% specificity. The assay procedure takes approximately 80
minutes. An Emergency Use Authorization (EUA) submission is
currently being prepared for review and potential approval by the
U.S. Food and Drug Administration. We will report on material
regulatory and commercial developments as we progress. ADMA
has submitted patents for ImmunoRank in the U.S. and certain
foreign markets. Both ADMA and Leinco are named as co-inventors on
the patents.
“We are confident the ImmunoRank assay will be an efficient and
effective tool for selecting high titer convalescent plasma units
containing neutralizing antibodies to SARS-CoV-2 both for the
treatment of COVID-19 patients as well as identifying plasma that
can be used for development and production of hyperimmune globulins
to treat COVID-19,” said Adam Grossman, President and Chief
Executive Officer of ADMA. “Current screening methods to
identify circulating SARS-CoV-2 neutralizing antibodies are labor
and cost intensive and take multiple days to complete. This assay
can be run in approximately 80 minutes, resulting in numerous tests
per day, and can be performed at a fraction of the cost of other,
more laborious assays. We believe this proprietary assay
will result in important potential product and business development
opportunities as we continue to seek out meaningful ways to help
patients battling COVID-19.”
Under the terms of the collaboration agreement between ADMA and
Leinco, ADMA has the right to use, market and commercialize
ImmunoRank for the screening and selection of human plasma units or
plasma pools containing SARS-CoV-2 neutralizing antibodies, for
manufacturing products such as plasma proteins for therapeutic use,
including but not limited to producing intravenous immunoglobulins
(“IVIG”) or hyperimmune globulin products, for the screening of
convalescent plasma or vaccinated plasma donors, as well as
combining these products with SARS-CoV-2 neutralizing monoclonal
antibodies. ADMA also has the rights for commercializing
ImmunoRank test kits for use by plasma donation centers to screen
donors for neutralizing antibodies to SARS-CoV-2. Leinco will be
responsible for manufacturing ImmunoRank and has the right to
market and sell the assay for all other potential markets, other
than those reserved exclusively to ADMA.
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:
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 Bio Centers 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.
About Leinco Technologies Inc.
(Leinco)
Leinco Technologies, Inc. is a biotechnology company founded in
1992 as a specialty manufacturer of early discovery research
products including antibodies, recombinant proteins, ELISA kits,
second step reagents and other life sciences products. Shortly
thereafter, we also established ourselves as a premier provider of
custom R&D and manufacturing services focusing on monoclonal
antibodies and recombinant proteins. Our innovative products and
services are used to augment the early discovery process in life
science research, diagnostics and ground breaking development of
protein therapeutics. To order the ImmunoRank Neutralization
MICRO-ELISA Assay to Detect SARS-CoV-2 Neutralizing Antibodies in
Plasma for academic use or for more information visit
www.leincotechnologies.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. (“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 “estimate,” “project,” “intend,”
“forecast,” “target,” “anticipate,” “plan,” “planning,” “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
opportunities relating to the use, sale, and marketing of
ImmunoRank™, the potential approval of Emergency Use Authorization
for the use of ImmunoRank™, and the opportunities presented by the
collaboration between ADMA and Leinco. Actual events or results may
differ materially from those described in this document 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:
Brian Lenz
Executive Vice President and Chief Financial Officer |
201-478-5552 | www.admabiologics.com
INVESTOR RELATIONS CONTACT:
Sam Martin
Managing Director, Argot Partners | 212-600-1902 |
sam@argotpartners.com
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