ADMA Biologics Highlights Launch of COVID-19
ImmunoRank™ Neutralization MICRO-ELISA Assay to Detect SARS-CoV-2
Neutralizing Antibodies in Plasma
ImmunoRank Offers a Faster, Simpler, More Cost
Effective Way to Identify High Titer Convalescent Plasma for Use in Both
Treating COVID-19 Patients and for Creating COVID-19 Hyperimmune
Globulins
Proprietary Assay Developed in Collaboration with Leinco Technologies
RAMSEY,
N.J. and BOCA RATON, Fla., Sept. 03, 2020 (GLOBE NEWSWIRE) -- 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.
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
BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in the BioPharma, MedTech, Digital Health and Health Systems that collectively employ nearly 107,000 Floridians. Source: TEConomy/BIO (released 2022)
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