Full Press Release Details
ADMA Biologics Granted U.S. Patent for
Treatment and Prevention of Pneumococcal Infections
Fifth Patent Issued to the Company in
the U.S. Provides Coverage for Expanding the Company's Hyperimmune IVIG Portfolio Through 2037
RAMSEY, N.J. and BOCA RATON, FL., April 17, 2019 - ADMA Biologics,
Inc. (NASDAQ: ADMA) ("ADMA" or the "Company"), today announced that the United States Patent and Trademark
Office issued to the Company U.S. Patent No. 10,259,865 related to methods of treatment and prevention of S. pneumonia infection.
The patent claims encompass methods of preparing immune globulin via harvesting plasma from S. pneumonia vaccinated, healthy
adult human donors and pooling the harvested plasma as the source for manufacturing a hyperimmune anti-pneumococcal immune
globulin containing elevated opsonic antibodies to a plurality of S. pneumonia serotypes. The issued claims also encompass
hyperimmune anti-pneumococcal immune globulin so prepared, methods of treating S. pneumonia infection and methods
of providing immunotherapy using the hyperimmune anti-pneumococcal immune globulin.
This patent will enable ADMA to protect its proprietary rights
and at the same time attract collaborators interested in the development, marketing and commercialization of a much needed therapeutic
for the treatment and prevention of infection in immune compromised, immunodeficient, and elderly patients who are poorly responsive
to available S. pneumonia vaccines. The term of the patent extends to March 2037.
"We are very pleased to have another patent issued to
add to our intellectual property estate for novel, differentiated hyperimmune globulins as we look to develop, manufacture and
commercialize immune globulin therapies to treat and prevent serious infections in the immune compromised, immunodeficient, and
elderly patients," stated Adam Grossman, President and CEO of ADMA.
Mr. Grossman concluded, "This will be the first patent
to issue in ADMA's immune globulin program tailored specifically to anti-pneumococcal hyperimmune globulin compositions
and treatment modalities. As stated in the National Foundation for Infection Diseases, it is estimated that about one million U.S.
adults get pneumococcal pneumonia each year and as many as 400,000 hospitalizations from pneumococcal pneumonia occur annually
in the U.S. and about 5-7% of those who are hospitalized from it will die despite the widespread use of multiple vaccines for disease
prevention, as stated in the National Foundation for Infectious Diseases. With large pharmaceutical companies developing vaccines
for S. pneumonia, we believe our proprietary technology creates unique collaboration opportunities for ADMA with developers
ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a vertically integrated commercial biopharmaceutical company that manufactures, markets and develops specialty
plasma-based biologics for the treatment of Primary Immune Deficiency Disease ("PI") and the prevention and treatment
of certain infectious diseases. ADMA's mission is to develop and commercialize plasma-derived, human immune globulins targeted
to niche patient populations for the treatment and prevention of certain infectious diseases. The target patient populations include
immune-compromised individuals 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.
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 U.S.
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 the words "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 concerning our plans to develop,
manufacture, market, launch and expand our own commercial infrastructure and commercialize our current products and future products,
the safety, efficacy and expected timing of, and our ability to, obtain and maintain regulatory approvals of our current products,
product expansions into new fields of use, indications and product candidates, and the labeling or nature of any such approvals,
our ability to successfully pursue commercialization and prelaunch activities for our products, the potential of our specialty
plasma-based biologics products and product candidates to provide meaningful clinical improvement for patients living with Primary
Immune Deficiency Disease or other indications, our ability to realize increased prices for plasma growth in the plasma collection
industry and our expectations for future capital requirements. 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. In light of the significant
uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded
as a representation or warranty by ADMA or any other person that the objectives and plans of ADMA will be achieved in any specified
time frame, if at all. 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.
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