Full Press Release Details
ADMA Biologics Provides Regulatory Update
FDA PDUFA Action Anticipated
RAMSEY, N.J. and BOCA RATON, FL., - December 19, 2018
- ADMA Biologics, Inc. (NASDAQ: ADMA) ("ADMA" or the "Company"), announces that as of the time of
this press release the Company has not received any formal written communication from the U.S. Food and Drug Administration regarding
BIVIGAM's Prior Approval Supplement under the Prescription Drug User Fee Act.
When the Company receives official written communication from
FDA the Company will promptly provide appropriate disclosures.
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 ("PIDD") 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
lead product candidate, RI-002. For more information, please visit www.admabiologics.com.
BIVIGAM is an intravenous immune globulin indicated for
the treatment of primary humoral immunodeficiency. This includes, but is not limited to, agammaglobulinemia, common variable immunodeficiency,
Wiskott-Aldrich syndrome and severe combined immunodeficiency. These primary immunodeficiencies ("PI") are a group
of genetic disorders. Initially thought to be very rare, it is now believed that as many as 250,000 people in the U.S. have some
form of PI. 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 PIDD patients against serious infections. BIVIGAM is a purified,
sterile, ready-to-use preparation of concentrated polyclonal Immunoglobulin ("IgG") antibodies. Antibodies are proteins
in the human immune system that work to defend against infections and disease. FDA's initial approval for BIVIGAM was
received by Biotest Pharmaceuticals Corporation ("BPC" or "Biotest") on December 19, 2012, and production
of BIVIGAM was halted by Biotest in December 2016. ADMA Biologics obtained ownership and all rights, title and interest in
BIVIGAM on June 6, 2017 as part of the Biotest Therapy Business Unit ("BTBU") asset acquisition and resumed the
production of BIVIGAM during the fourth quarter of 2017. ADMA optimized the production process for BIVIGAM and submitted a
Prior Approval Supplement ("PAS") to the United States Food and Drug Administration ("FDA") to amend the
Biologics License Application ("BLA") for BIVIGAM in June of 2018, with a target action date of December 18, 2018
under the Prescription Drug User Fee Act ("PDUFA"). If the PAS is approved by the FDA, ADMA expects to be able to relaunch
the product for commercial sale during the first half of 2019.
About Primary Immune Deficiency Disease (PIDD)
PIDD 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 PIDD. 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. PIDD 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. As patients suffering
from PIDD 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. PIDD
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
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 |