Full Press Release Details
ADMA Receives Department of Health and
RAMSEY, N.J. and BOCA RATON, FL., - April 2, 2019 -
ADMA Biologics, Inc. (NASDAQ: ADMA) ("ADMA" or the "Company"), a vertically integrated commercial biopharmaceutical
and specialty immunoglobulin company that manufactures, markets and develops plasma-derived biologics for the treatment of immune
deficiencies and the prevention of certain infectious diseases, announces that the U.S. Food and Drug Administration ("FDA")
has issued a Department of Health and Human Services U.S. license No. 2019 to the Company in connection with the approval of ASCENIV
Immune Globulin Intravenous, Human - slra 10% Liquid.
The license covers the Boca Raton, FL manufacturing facility
which has demonstrated compliance with FDA requirements as well as authorizes ADMA to manufacture and enter into interstate commerce
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 and 9,969,793 related to certain aspects of its
products. For more information, please visit www.admabiologics.com.
About ASCENIV (Formerly referred to as RI-002)
ASCENIV , Immune Globulin Intravenous, Human - slra
10% Liquid, is a plasma-derived, polyclonal, intravenous immune globulin ("IVIG"). ASCENIV is protected by U.S.
Patents: 9,107,906, 9,714,283 and 9,815,886. ASCENIV is manufactured using our unique, patented plasma donor screening methodology
and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using our proprietary microneutralization
assay. ASCENIV contains naturally occurring polyclonal antibodies. ASCENIV is indicated for the treatment of Primary
Humoral Immunodeficiency ("PI") in adults and adolescents (12 to 17 years of age). ADMA received FDA approval for ASCENIV
on April 1, 2019. Polyclonal antibodies 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 prevented serious bacterial infection among fifty-nine
patients treated for twelve months during the pivotal investigation. The most common adverse reactions to ASCENIV ( 5%
of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection,
bronchitis, and nausea. ADMA anticipates the commercial launch of ASCENIV during the second half of 2019. Certain data and
other information about ASCENIV or ADMA Biologics and its products can be found on the Company website at: 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 and product candidates, and the labeling or nature of any such approvals, the success
of our work with our third party vendors and the U.S. Food and Drug Administration (the "FDA") in furtherance of and
progress towards an approval of our Biologics License Application for specialty plasma-based biologics and the ability of such
third parties to respond adequately or in a timely manner to the issues raised by the FDA, our ability to successfully pursue commercialization
and prelaunch activities, the timeframe within which we may receive approval from the FDA for specialty plasma-based biologics,
if at all, the potential of our specialty plasma-based biologics 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.
Executive Vice President and Chief Financial Officer |201-478-5552
INVESTOR RELATIONS CONTACT:
Managing Director, LifeSci Advisors, LLC | 212-915-2568 |