Full Press Release Details
ADMA Biologics Provides Regulatory Update
on BIVIGAM PAS Submissions
FDA Issues Complete Response Letter
for PAS Drug Substance, Approves PAS for Drug Product
RAMSEY, N.J. and BOCA RATON, FL., - December 19, 2018
- 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 the U.S. Food and Drug
Administration ("FDA") has issued a Complete Response Letter ("CRL") for the drug substance Prior Approval
Supplement ("PAS") submission and previously approved the drug product PAS submission.
The FDA approved ADMA's drug product PAS submission which
was comprised of fill, finish and final release information of the drug product. The FDA issued a CRL to ADMA pertaining to only
the drug substance PAS submission which pertains to chemistry, manufacturing and controls information. In the CRL, the FDA did
not request any information pertaining to compliance status, clinical study safety and efficacy nor any information requests regarding
third party contract manufacturers and vendors. The CRL did not contain any requests for additional manufacturing runs. The Company
believes the FDA comments to the drug substance PAS submission are addressable and resolvable. The Company will request a meeting
with the FDA and plans to promptly provide the FDA with clarification and responses to the issues raised in the CRL. The Company
looks forward to working with the FDA to resolve the outstanding issues identified in the CRL.
The Company will provide updates as appropriate.
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.
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 |