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 nd 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.
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