UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of
Report (Date of earliest event reported): February 22,
2010
PHARMATHENE,
INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-32587
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20-2726770
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(State
or other jurisdiction
of
incorporation)
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(Commission
File
Number)
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(IRS
Employer
Identification
No.)
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One Park Place, Suite 450, Annapolis,
Maryland
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21401
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number including area code: (410) 269-2600
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
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¨
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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¨
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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¨
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
1.01.
Entry into a Material
Definitive Agreement
On
February 22, 2010, PharmAthene, Inc., a Delaware corporation
(“PharmAthene”), amended its existing research and development contract with the
U.S. Department of Health and Human Services (HHS), operating through the
Biomedical Advanced Research and Development Authority (BARDA)
(HHSO100200900103C), to support the continued advanced development of
SparVax™, a second generation recombinant protective antigen (rPA) anthrax
vaccine targeted for future procurement in the U.S. Strategic National Stockpile
(SNS).
The
contract modification, which is effective February 22, 2010 and extends through
December 31, 2012, provides for additional advanced development funding for
SparVax™. During the base period of performance under the contract
modification, i.e., through December 31, 2012, PharmAthene could receive
payments of up to approximately $61 million on a
cost-reimbursement-plus-fixed-fee basis, assuming that all milestones are
achieved.
Under the
contract modification, the government, at its sole discretion, may exercise
three contract options during the base period of
performance. Assuming that the government exercises all three
options, PharmAthene could receive up to an additional $17 million under the
contract modification.
As disclosed in PharmAthene’s previous
SEC filings, on September 28, 2007, NIAID and BARDA awarded to PharmAthene a
$13.9 million contract for the advanced development of Valortim® as an
anti-toxin therapeutic to treat inhalation anthrax
infection.
Attached
hereto as Exhibit 99.1 is a press release from February 23, 2010, in which
PharmAthene announced the contract modification.
Item 9.01 Financial Statements and
Exhibits
(d) Exhibits
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No.
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Description
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99.1
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Press
release, dated February 23, 2010, issued by the
Company.
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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PHARMATHENE,
INC.
(Registrant)
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Date: February
26, 2010
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By:
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/s/ Charles A. Reinhart III |
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Charles
A. Reinhart III
Senior
Vice President and Chief Financial
Officer
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FOR
IMMEDIATE RELEASE
Contact:
PharmAthene,
Inc.
Stacey
Jurchison
Phone:
410-269-2610
Stacey.Jurchison@PharmAthene.com
PHARMATHENE
AWARDED UP TO ADDITIONAL $78.4 MILLION UNDER EXISTING
CONTRACT
FOR ADVANCED DEVELOPMENT OF SPARVAX™ ANTHRAX VACCINE
“We are
pleased to be awarded additional development funding for our SparVax™ anthrax
vaccine program, which may offer a promising improved alternative to existing
anthrax vaccine options,” commented David P. Wright, President and Chief
Executive Officer. “There is widespread acknowledgement among various government
agencies that the United States must develop and stockpile a second generation
anthrax vaccine employing modern vaccine technology that offers the potential
for improved safety, convenience and enhanced cost effectiveness. New
and improved anthrax vaccines, based on modern state-of-the-art recombinant
vaccine technology, incorporate significant product development and
technological advancements and ultimately may provide meaningful health and
economic advantages.”
In
addition to the funding announced today, on February 1, 2010 PharmAthene also
submitted a White Paper seeking further development funding for SparVax™, in
response to a Broad Agency Announcement (Solicitation Number:
BAA-BARDA-09-34).
“We
believe that, if awarded, funding provided under the BAA, along with the
additional funding announced today, could be sufficient to advance SparVax™ to a
stage where it will be eligible for consideration for a Project BioShield
procurement contract,” said Mr. Wright.
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SparVax™
is a highly purified recombinant protective antigen vaccine being developed for
pre and post exposure protection against anthrax infection. Phase I
and Phase II clinical trials involving 770 healthy human subjects have been
completed and demonstrated that SparVax™ appears to be well tolerated and
immunogenic in humans. These studies suggest that three doses of
SparVax™, administered over a 56 day period, are sufficient to induce protective
immunity. The vaccination regimen for the currently licensed anthrax
vaccine, BioThrax®,
requires five doses over a period of eighteen months.
The
contract modification, which is effective February 22, 2010 and extends until
December 31, 2012, provides for up to $61 million during a “base period” of
performance with options for an additional $17 million on a cost reimbursement
plus fixed fee basis in additional advanced development funding for
SparVax™. Provided that certain milestones are achieved, and that all
contract options and extensions are exercised by the government, the contract
has a total potential value of $78.4 million. The activities outlined
under the contract modification are designed to continue existing development
activities already under contract (HHSO100200900103C). The
modification will include non-clinical safety and efficacy studies, assay
development and qualification, and process scale up and validation.
“PharmAthene
has a strong track record of successfully collaborating with a number of U.S.
government agencies, including, the National Institutes of Health (NIH), BARDA,
the United States Army Medical Research Institute for Infectious Diseases, and
the Department of Defense, to advance the development of our biodefense product
portfolio to address biological and chemical threats and preserve the security
and well-being of our military personnel and citizens. We are deeply
committed to providing improved medical countermeasures for anthrax, which is
considered to be the number one biological threat facing the
Nation. We applaud President Obama’s renewed commitment to protecting
our Nation against the threat of bioterrorism and look forward to continuing our
work with the government. It is our shared goal to develop the
medical countermeasures necessary to successfully deter or quickly respond to a
biologic attack and save American lives," said Mr. Wright.
Including
the additional funding announced today, PharmAthene’s SparVax™ program has been
awarded funding commitments from the U.S. government totaling up to $213.2
million.
The rPA
contract modification was announced via a Special Notice (Solicitation Number:
HHSO100200900103C) rPA Anthrax
Vaccine Advance Development, issued by HHS on December
29, 2009. The original development contract for rPA vaccine (N01-Al-30052) was
issued in 2003 and transferred to BARDA on April 1, 2009.
About
SparVax™
SparVax™
is a novel second generation recombinant protective (rPA) anthrax vaccine being
developed for pre and post exposure protection against anthrax
infection. SparVax™ is a highly purified, well characterized, sub
unit vaccine comprised of a single protein (recombinant PA) manufactured in
E.coli. Phase I and Phase II clinical trials involving 770 healthy human
subjects have been completed and showed that SparVax™ appears to be well
tolerated and immunogenic in humans. These studies suggest that three
doses of SparVax™, administered several weeks apart, should be sufficient to
induce protective immunity. In non-clinical studies SparVax™ has also
demonstrated the capability to protect rabbits and non-human primates against a
lethal aerosol spore challenge of the anthrax Ames
strain.
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About
PharmAthene, Inc.
PharmAthene
was formed to meet the critical needs of the United States and its allies by
developing and commercializing medical countermeasures against biological and
chemical weapons. PharmAthene's lead product development programs
include:
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SparVax™ -
a second generation recombinant protective antigen (rPA) anthrax
vaccine
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Third
generation rPA anthrax vaccine
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Valortim® -
a fully human monoclonal antibody for the prevention and treatment of
anthrax infection
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Protexia® -
a novel bioscavenger for the prevention and treatment of morbidity and
mortality associated with exposure to chemical nerve
agents
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For more
information about PharmAthene, please visit www.PharmAthene.com.
Statement
on Cautionary Factors
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”; or similar statements are forward-looking
statements. PharmAthene disclaims, however, any intent or obligation
to update these forward-looking statements. Risks and uncertainties
include 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, unexpected funding delays
and/or reductions or elimination of U.S. government funding for one or more of
the Company’s development programs, the award of government contracts to our
competitors, unforeseen safety issues, challenges related to the development,
scale-up, and/or process validation of manufacturing processes for our product
candidates, unexpected determinations that these product candidates
prove not to be effective and/or capable of being marketed as
products as well as risks detailed from time to time in PharmAthene’s
Form 10-K and 10-Q under the caption “Risk Factors” and in its other reports
filed with the U.S. Securities and Exchange Commission (the
“SEC”). In particular, the funding provided for under this contract
modification is not sufficient to complete the development work needed for
SparVax™ to meet the criteria for procurement into the Strategic National
Stockpile or to achieve FDA licensure. There can be no assurance that
the government will provided additional funding to support the further advanced
development of this product candidate to achieve these objectives. Furthermore, significant additional
non-clinical animal studies, human clinical trials, and manufacturing
development work remain to be completed for SparVax™. At this point there can
be no assurance that this product candidate will be shown to be safe and
effective and approved by regulatory authorities for use in humans.
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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