Full Press Release Details
ADMA Biologics Reports FDA Compliance
Status for its Manufacturing Facility has Improved
FDA Inspection Database Confirms VAI
Status of Boca Raton, FL Facility
RI-002's Biologics License Application ("BLA") Resubmission Targeted for
RAMSEY, N.J. and BOCA RATON, FL., - September 5, 2018
- ADMA Biologics, Inc. (NASDAQ: ADMA) ("ADMA" or the "Company"), a vertically integrated commercial
biopharmaceutical company that manufactures, markets and develops specialty plasma-based biologics for the prevention and treatment
of certain infectious diseases, announces that the United States Food and Drug Administration ("FDA") inspection database
classification website has been updated and confirms ADMA's compliance status has improved to Voluntary Action Indicated
"We are pleased that the FDA has acknowledged the improved
current good manufacturing practice ("cGMP") conditions at our manufacturing facility and updated its database accordingly,"
stated Adam Grossman, President and Chief Executive Officer of ADMA Biologics, Inc. "We are excited to finally be in a position
to resubmit our Biologics License Application ("BLA") for RI-002 during the third quarter of 2018, which we believe
is a needed Intravenous Immune Globulin ("IVIG") option for patients who suffer with Primary Humoral Immunodeficiency
Disease ("PIDD"). We will announce related information pertaining to RI-002's BLA filing when the Company receives
correspondence from FDA."
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.
ADMA's lead portfolio product candidate, RI-002, which has demonstrated positive Phase III pivotal clinical trial data, is a specialty
plasma-derived, polyclonal, intravenous immune globulin ("IVIG") derived from human plasma containing naturally occurring
polyclonal antibodies (e.g., Streptococcus pneumoniae, H. influenza type B, cytomegalovirus ("CMV"), measles, tetanus,
etc.) as well as plasma from donors tested to have high levels of neutralizing antibodies to respiratory syncytial virus ("RSV").
ADMA is pursuing an indication for the use of this specialty IVIG product for treatment of patients diagnosed with PIDD. Polyclonal
antibodies are the primary active component of IVIG products. 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. Data review which has been
published in peer reviewed journals indicates that the polyclonal antibodies present in RI-002 support its ability to prevent
infections in immune-compromised patients. This data and other information about RI-002 or ADMA Biologics products can be found
on the Company website at: www.admabiologics.com/therapies and www.admabiologics.com. RI-002 is protected by U.S. Patents: 9,107,906,
9,714,283, 9,815,886 and 9,969,793, the latter of which affords the Company patent exclusivity for the use of an immune globulin
as a prevention and/or treatment for any type of respiratory infection.
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 | www.admabiologics.com
INVESTOR RELATIONS CONTACT:
Managing Director, LifeSci Advisors, LLC | 212-915-2568