Full Press Release Details
ADMA Biologics to Present at Upcoming
Investor Conferences
Jefferies 2019 Healthcare Conference
Raymond James Life Sciences and MedTech
RAMSEY, N.J. and BOCA RATON, FL., - May 29, 2019 -
ADMA Biologics, Inc. (NASDAQ: ADMA) ("ADMA" or the "Company"), a vertically integrated commercial biopharmaceutical
and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment
of immune deficiencies and the prevention of certain infectious diseases, announces that President and Chief Executive Officer,
Adam Grossman and Executive Vice President and Chief Financial Officer, Brian Lenz are scheduled to present a corporate overview
at the following conferences in June 2019:
A webcast of the live presentation will be available on the
Company's website at https://ir.admabiologics.com/events-webcasts and will be archived for 90 days following the event.
ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a vertically integrated biopharmaceutical manufacturer with three FDA approved commercial specialty plasma-based
biologics. 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 and management of immune compromised patient populations. 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.
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's website at: www.admabiologics.com.
BIVIGAM is an immune globulin intravenous (human), 10%
liquid, indicated for the treatment of primary humoral immunodeficiency. This includes, but is not limited to, X-linked and congenital
agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency. These PIs
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 PI patients against serious infections. BIVIGAM is a purified,
sterile, ready-to-use preparation of concentrated human 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 BPC in December 2012, and production of BIVIGAM was halted by BPC in December 2016. ADMA obtained ownership and
all rights, title and interest in BIVIGAM in June 2017 as part of the Biotest Therapy Business Unit ("BTBU") asset
acquisition and resumed the production of BIVIGAM during the fourth quarter of 2017. Using ADMA's optimized IVIG manufacturing
process, FDA approved a PAS to amend the BLA for the product on May 9, 2019 allowing the Company to resume the supply of drug to
Nabi-HB is a hyperimmune globulin that is rich in
antibodies to the Hepatitis B virus. Nabi-HB is a purified human polyclonal antibody product collected from plasma donors
who have been previously vaccinated with a Hepatitis B vaccine. Nabi-HB is indicated for the treatment of acute exposure to
blood containing Hepatitis B surface antigen ("HBsAg"), prenatal exposure to infants born to HBsAg-positive mothers,
sexual exposure to HBsAg-positive persons and household exposure to persons with acute Hepatitis B virus infection. Hepatitis B
is a potentially life-threatening liver infection caused by the Hepatitis B virus. It is a major global health problem and can
cause chronic infection and put people at high risk of death from cirrhosis and liver cancer. Nabi-HB has a well-documented
record of long-term safety and effectiveness since its initial market introduction. FDA approval for Nabi-HB was received
on March 24, 1999. Biotest acquired Nabi-HB from Nabi Biopharmaceuticals in 2007. ADMA resumed production of Nabi-HB
in the third quarter of 2017, as substantially all of the Nabi-HB inventory received as part of the Biotest Transaction has
been sold in the normal course of business.
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.
Executive Vice President and Chief Financial Officer | 201-478-5552
INVESTOR RELATIONS CONTACT:
Managing Director, LifeSci Advisors, LLC | 212-915-2568 |