ADMA Biologics Executes Long-Term Manufacturing, Supply and License Agreements with Biotest

  ADMA Biologics Executes Long-Term Manufacturing, Supply and License
  Agreements with Biotest

       Secured Long-Term Contract Manufacturing for Lead Drug Candidate

  Out-Licensed RI-002 for Europe and Selected Countries in North Africa and
                                 Middle East

  In-Licensed Varicella Zoster Immune Globulin for United States and Canada

Business Wire

HACKENSACK, N.J. -- January 10, 2013

ADMA Biologics, Inc. (ADMA), a late-stage biotechnology company focused on
developing specialty immune globulin therapeutics and the commercialization of
human plasma, today announced that it has entered into a long-term
manufacturing, supply and license agreement with Biotest Pharmaceuticals
Corporation (BPC) and a license agreement with Biotest AG, BPC’s parent
company.

The long-term manufacturing, supply and license agreement with BPC, which
operates a US Food and Drug Administration (FDA) approved manufacturing
facility, requires ADMA to purchase exclusively from BPC its worldwide product
supply for RI-002, its lead product candidate. RI-002 is a specialty immune
globulin for primary immune deficiency patients, which is derived from human
plasma containing high levels of Respiratory Syncytial Virus (RSV) antibodies.
The ten-year agreement began on January 1, 2013 and is renewable for two
additional five year periods, upon the mutual consent of ADMA and BPC.

Also in connection with the manufacturing, supply and license agreement, ADMA
has out-licensed RI-002 to Biotest AG, to market and sell in Europe and
selected countries in North Africa and the Middle East. In return for this
license, Biotest AG will provide ADMA with certain services at no charge and
will also compensate ADMA with cash upon the completion of certain milestones
as well as pay a royalty based on a percentage of sales of RSV immune globulin
in the territory. Additionally, Biotest AG has granted ADMA an exclusive
license for marketing and sales of Biotest AG’s Varicella Zoster Immune
Globulin (VZIG) in the United States and Canada, for which terms will be
finalized in the next sixty days.

“The execution of these agreements with our partner, Biotest AG and BPC,
solidifies the manufacturing and long-term supply for our lead product
candidate as we initiate our Phase III clinical trial. Additionally, we are
pleased to have Biotest AG as our partner to expand the market potential for
our lead product candidate. Biotest has a successful track record of
developing and commercializing novel plasma derived therapeutics in
international markets,” stated Adam Grossman, President and Chief Executive
Officer of ADMA. “We are very pleased to have also enhanced our product
candidate pipeline through the in-licensing of VZIG for the United States and
Canada.”

Further information with respect to these agreements may be obtained from a
Current Report on Form 8-K which has been filed with the Securities and
Exchange Commission and can also be viewed on the company’s website at:
www.admabio.com.

About ADMA’s lead product candidate

ADMA’s lead product candidate, RI-002 is a specialty plasma-derived,
polyclonal, Intravenous Immune Globulin, or IGIV, prepared with high levels of
antibodies against respiratory syncytial virus, or RSV. ADMA is pursuing an
indication for the use of this specialty IGIV product for treatment of
patients diagnosed with primary immunodeficiency disease, or PIDD. Polyclonal
antibodies are the primary component of IGIV products. PIDD is a disorder that
causes a person’s immune system to not function properly. PIDD is caused by
hereditary or genetic defects and can affect anyone regardless of age or
gender.

About ADMA Biologics, Inc.

ADMA is a late-stage biotechnology company focused on developing specialty
immune globulin therapeutics and commercialization of human plasma. ADMA’s
mission is to develop and commercialize plasma-derived, human immune globulins
targeted at niche patient populations some with unmet medical needs. In
addition, ADMA operates ADMA Bio Centers, a wholly-owned subsidiary which is
an FDA-licensed source plasma collection facility located in Norcross,
Georgia.

Cautionary Statement Regarding Forward-Looking Information

This press release contains “forward looking statements.” 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,”
“anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “will likely,”
“should,” “could,” “would,” “may” or, in each case, their negative, or words
or expressions of similar meaning. These forward-looking statements include,
but are not limited to, statements concerning the timing, progress and results
of the clinical development, regulatory processes, potential clinical trial
initiations, potential investigational new product applications, biologics
license applications, and commercialization efforts of the Company's product
candidate(s). Forward-looking statements are subject to many risks and
uncertainties that could cause our actual results to differ materially from
any future results expressed or implied by the forward-looking statements,
including, but not limited to, the risks listed under the heading “Risk
Factors” in Amendment No. 3 to the Current Report on Form 8-K filed with the
Securities and Exchange Commission on June 22, 2012 and Amendment No. 4 to our
Registration Statement on Form S-1 filed with the Securities and Exchange
Commission on August 10, 2012. Therefore, 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 to 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.

Contact:

ADMA Biologics, Inc.
Brian Lenz, CPA, 201-478-5552
Vice President & Chief Financial Officer
www.adambio.com
info@admabio.com
 
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