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): March 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
7.01
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Regulation
FD Disclosure
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PharmAthene,
Inc. (the “Company”) announced today that, in addition to discussing its
financial results for the year ended December 31, 2009 on the conference call
for investors that is scheduled for 4:30 p.m. Eastern Time on Tuesday, March 23,
2010, it plans to provide an update on the suspension of work under the
modification the Company announced on February 23, 2010 to its existing contract
with BARDA for the research and development of SparVax™.
The
dial-in number for accessing the conference call from within the United States
is 800-659-1942. The dial-in number for international callers is 617-614-2710.
The participant passcode is 35720559.
A replay
of the conference call will be available for 30 days, beginning at approximately
7:30 p.m. Eastern Time on Tuesday, March 23, 2010. The dial-in number from
within the United States is 888-286-8010. For international callers, the dial-in
number is 617-801-6888. The participant passcode is 63696931. The
webcast of the conference call can be accessed from the Company’s website at
http://www.pharmathene.com. A link to the webcast may be found on the Investor
Relations section of the website.
In
accordance with General Instruction B.2. of Form 8-K, the information in this
Current Report on Form 8-K, including Exhibit 99.1 hereto, shall not be deemed
to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”), or otherwise subject to the liabilities of that
section, and shall not be incorporated by reference into any registration
statement or other document filed under the Securities Act of 1933, as amended,
or the Exchange Act, except as shall be expressly set forth by specific
reference in such filing.
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Item
9.01
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Financial
Statements and Exhibits
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(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 March 22, 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: March
22, 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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PharmAthene
to Provide Update on SparVax™ Contract Modification Suspension During Year-End
2009 Financial and Operational Results Conference Call on Tuesday March 23,
2010
ANNAPOLIS,
Md., March 22, 2010 -- PharmAthene, Inc. (NYSE Amex: PIP), a biodefense company
developing medical countermeasures against biological and chemical threats,
announced today that in addition to its year end results, it will provide an
update on the contract modification suspension it received on Friday, March 19,
2010.
PharmAthene
is pursuing various options to move forward under the contract modification
announced on February 23, 2010 to its existing contract with BARDA for the
research and development of SparVax™ pending a final ruling under the protest.
The Company is confident that the protest is without merit and that the contract
modification will be upheld. While the protest is being resolved, all work under
the current contract for the development of SparVax™, including prior
modifications, will continue uninterrupted.
Anthrax
remains the foremost biological threat to the nation, and the government's
Requirement to procure a recombinant anthrax vaccine for the Strategic National
Stockpile, which remains unfulfilled, is an important national security
priority.The Company continues to believe that SparVax™ represents the most
advanced rPA vaccine candidate under development. Phase II human clinical
studies suggest that SparVax™ may induce protective immunity in three doses over
56 days whereas the currently licensed vaccine is approved for a 5 dose regimen
over 18 months. Various government agencies, including the Institute of
Medicine, have acknowledged the urgent need to stockpile next-generation anthrax
vaccines employing modern vaccine technology, which offer the potential for
improved safety, convenience and more rapid immunity. Further, BARDA has
demonstrated its commitment to continued development in this area, through the
contract modification and a revision to BAA-BARDA 09-34 to explicitly encourage
submissions by recombinant anthrax vaccine developers.
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.
Conference
Call and Webcast Information
PharmAthene
management will host a conference call to discuss the Company's year-end
financial results. The call is scheduled to begin at 4:30 p.m. Eastern Time on
Tuesday, March 23, 2010, and is expected to last approximately 45
minutes.
The
dial-in number within the United States is 800-659-1942. The dial-in number for
international callers is 617-614-2710. The participant passcode is
35720559.
A replay
of the conference call will be available for 30 days, beginning at approximately
7:30 p.m. Eastern Time on Tuesday, March 23, 2010. The dial-in number from
within the United States is 888-286-8010. For international callers, the dial-in
number is 617-801-6888. The participant passcode is 63696931.
The
conference call will also be webcast and can be accessed from the company's
website at www.pharmathene.com. A link to the webcast may be found under the
Investor Relations section of the website.
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:
· SparVax™
- - a second generation recombinant protective antigen (rPA) anthrax
vaccine
· Third
generation rPA anthrax vaccine
· Valortim®
- - a fully human monoclonal antibody for the prevention and treatment of anthrax
infection
· Protexia®
- - a novel bioscavenger for the prevention and treatment of morbidity and
mortality associated with exposure to chemical nerve agents
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";
"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 risk 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, technology transfer, 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 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 (the "SEC"). In particular,
while the Company believes that the protest to the recent modification to the
Company's existing contract with BARDA for the research and development of
SparVax™ is unlikely to be sustained, if the GAO were to rule in favor of the
protestor, such a ruling could have a material adverse effect on the financial
position and operations of the Company. In addition,, significant additional
research work, 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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