ANNAPOLIS, Md., Feb. 2, 2015 /PRNewswire/ -- PharmAthene,
Inc. (NYSE MKT: PIP) announced today that its recombinant
Protective Antigen (rPA) was one of the vaccines reported by
Immunovaccine, Inc., to be effective at providing protection to
animals when administered as a single unit dose anthrax vaccine
formulated with novel DepoVax™ technology in a non-clinical anthrax
challenge study conducted through the National Institute of Allergy
and Infectious Diseases, National Institutes of Health (NIAID/NIH)
Preclinical Services Program. DepoVax™ is a
patented formulation, developed by Immunovaccine that provides
controlled and prolonged exposure of antigens plus adjuvant to the
immune system, resulting in a strong, specific and sustained immune
response with the potential for single-dose effectiveness.
"The development of next generation anthrax vaccines that can
achieve protective immunity in fewer than three doses – less than
the currently licensed anthrax vaccine, is an important priority
for the United States Government," said Eric I. Richman, President and Chief Executive
Officer. "The potential for reduced dosing with rapid immunity,
which these preliminary DepoVax™/rPA data suggest is possible,
could yield substantial improvements in cost, convenience and
effectiveness for the Government. PharmAthene has
demonstrated its ability to manufacture rPA bulk drug substance at
commercial scale under Current Good Manufacturing Practices
regulated by the U.S. Food and Drug Administration and is pleased
to be at the forefront of the development of improved, next
generation vaccine options."
The DepoVax™/rPA study was conducted through the NIAID's Animal
Model of Infectious Diseases preclinical services program
(HHSN2722012000022I/HHSN27200001).
About PharmAthene
PharmAthene is a biodefense company engaged in the development
and commercialization of next generation medical countermeasures
against biological and chemical threats. PharmAthene's current
biodefense portfolio includes the following product candidates:
- SparVax® - a next generation recombinant protective
antigen (rPA) anthrax vaccine (liquid and lyophilized
formulations)
- rBChE bioscavenger - a medical countermeasure for nerve agent
poisoning by organophosphorous compounds, including nerve gases and
pesticides
- Valortim® - a fully human monoclonal antibody for
the prevention and treatment of anthrax infection
On January 15, 2015, the
Delaware Court of Chancery issued
its Final Order and Judgment in PharmAthene's litigation against
SIGA Technologies, Inc. The Court of Chancery awarded to
PharmAthene lump sum expectation damages for the value of
PharmAthene's lost profits for SIGA's smallpox antiviral,
Tecovirimat, also known as ST-246® (formerly referred to
as "Arestvyr™" and referred to by SIGA in its Quarterly Report on
Form 10-Q for the quarterly period ended September 30, 2014 as "Tecovirimat"). In
addition, the Court of Chancery ordered SIGA to pay pre-judgment
interest and varying percentages of PharmAthene's reasonable
attorneys' and expert witness fees. The court's determination of
the final amount of the award, along with the decision itself, will
remain subject to appeal by SIGA to the Delaware Supreme Court and
our ability to collect a money judgment from SIGA remains subject
to further proceedings in the Bankruptcy Court.
Forward-Looking Statement Disclaimer
Except for the historical information presented herein, matters
discussed may constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that are subject to certain risks and uncertainties that could
cause actual results to differ materially from any future results,
performance or achievements expressed or implied by such
statements. Statements that are not historical facts, including
statements preceded by, followed by, or that include the
words "potential"; "believe"; "anticipate"; "intend"; "plan";
"expect"; "estimate"; "could"; "may"; "should"; "will"; "project";
"potential"; or similar statements are forward-looking statements.
PharmAthene disclaims any intent or obligation to update these
forward-looking statements other than as required by law. Risks and
uncertainties include risks associated with our interest in
Tecovirimat, also known as ST-246® (formerly referred to
as "Arestvyr™" and referred to by SIGA in its Quarterly Report on
Form 10-Q for the quarterly period ended September 30, 2014 as "Tecovirimat"); risks
associated with the reliability of the results of the studies
relating to human safety and possible adverse effects resulting
from the administration of the Company's product candidates;
funding delays and/or reductions or elimination of U.S. government
funding and/or non-renewal of expiring funding for one or more of
the Company's development programs, such as BARDA's recent decision
to de-scope the current SparVax® anthrax vaccine
contract through a partial termination for convenience, or a
decision by NIAID not to exercise its options under our
September 2014 contract after we
receive funding of approximately $5.2
million over the base period; risks associated with our
common stock, risks associated with the GE Loan Agreement, risks
associated with our net operating loss carryforwards, or NOLs,
risks associated with the award of government contracts to our
competitors or delays caused by third parties challenging
government contract awards to us; risks associated with unforeseen
safety and efficacy issues; risks associated with challenges
related to the development, technology transfer, scale-up, and/or
process validation of manufacturing processes for our product
candidates; risks associated with unexpected determinations that
these product candidates prove not to be effective and/or capable
of being marketed as products; risks associated with accomplishing
any future strategic acquisitions or business combinations; and
other risks detailed from time to time in PharmAthene's Forms 10-K
and 10-Q under the caption "Risk Factors" and in its other
reports filed with the U.S. Securities and Exchange
Commission. Further, at this point, future government funding
to support the development of Valortim®, rBChE and
SparVax® is unlikely. Even if we received such
funding, significant additional non-clinical animal studies, human
clinical trials, and manufacturing development work remain to be
completed for all of our product candidates. On
January 15, 2015, the Delaware Court of Chancery issued its Final
Order and Judgment in PharmAthene's litigation against SIGA
Technologies, Inc. The Court of Chancery awarded to
PharmAthene lump sum expectation damages for the value of
PharmAthene's lost profits for SIGA's smallpox antiviral,
Tecovirimat. In addition, the Court of Chancery ordered SIGA to pay
pre-judgment interest and varying percentages of PharmAthene's
reasonable attorneys' and expert witness fees. The court's
determination of the final amount of the award, along with the
decision itself, will remain subject to appeal by SIGA to the
Delaware Supreme Court. As a result, the decision could be
reversed, remanded or otherwise changed. There can be no assurances
if and when PharmAthene will receive any payments from SIGA as a
result of the decision. SIGA has stated publicly that it does
not currently have cash sufficient to satisfy the potential award.
Furthermore, because SIGA has filed for protection under the
federal bankruptcy laws, PharmAthene is automatically stayed from
taking any enforcement action in the Delaware Court of Chancery. By agreement of
the parties, and with the approval of the Bankruptcy Court, the
automatic stay has been lifted for the sole purpose of allowing the
Delaware Court of Chancery to
enter a money judgment and to allow the parties to exercise their
appellate rights. Our ability to collect a money judgment from SIGA
remains subject to further proceedings in the Bankruptcy Court.
Copies of PharmAthene's public disclosure filings are available
from its investor relations department and our website under the
investor relations tab at www.PharmAthene.com.
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SOURCE PharmAthene, Inc.