ANNAPOLIS, Md., Sept. 26 /PRNewswire-FirstCall/ -- PharmAthene, Inc.
(Amex: PIP), a biodefense company developing medical countermeasures
against biological and chemical threats, announced today that the National
Institute of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH), has awarded the Company a multi-year contract
for up to $83.9 million for advanced development of a third generation
recombinant protective antigen (rPA) anthrax vaccine.
The objective of the government's third generation program is to
develop an rPA anthrax vaccine which can be stored, transported and used
without the need for a conventional cold chain - an important advantage for
civilian biodefense deployment within the Strategic National Stockpile. In
particular, the vaccine must maintain stability for three years at 35º C
and induce protective immunity in just one or two doses.
Under the contract, PharmAthene will receive initial funding of
approximately $13.2 million during a "base period" of performance. During
this time the Company will be responsible for preclinical activities,
including, development and qualification of assays, stability testing,
toxicology studies and development of non-clinical animal models. During
the base period NIAID retains the option of extending the contract under
two separate options with a combined value of up to $9.7 million.
Additional options covering advanced manufacturing and clinical development
could bring the total potential value of the contract up to approximately
$83.9 million, provided that certain milestones are achieved and that all
contract options and extensions are exercised by the government.
"We are pleased that NIAID has awarded such a significant contract to
fund the continued development of our third generation rPA anthrax vaccine
program. This latest contract is in addition to an earlier NIH contract for
up to $6.9 million, which was awarded in 2005," commented David P. Wright,
President and Chief Executive Officer. "PharmAthene has built a
diversified, best-in-class portfolio of novel biodefense product candidates
and we view this latest award as a direct validation of our technology as
well as a reaffirmation of the U.S. government's commitment to the
development and procurement of next generation medical countermeasure
solutions."
Mr. Wright added, "Based on development efforts to date, PharmAthene's
third generation vaccine could offer significant improvements in both
stability and storage compared to the current FDA approved vaccine, thereby
meeting the government's requirements for civilian deployment in the
Strategic National Stockpile. By comparison, the currently available
anthrax vaccine, BioThrax(R) Anthrax Vaccine Adsorbed, which was initially
licensed by the Food and Drug Administration in 1970, requires six doses
over a period of eighteen months to achieve protective immunity and is
required to be stored at between 2 degrees Celsius and 8 degrees Celsius."
PharmAthene believes that the third generation rPA anthrax vaccine
contract is part of a broader strategy by the Department of Health and
Human Services to ensure that the Strategic National Stockpile (SNS)
contains the most efficacious anthrax medical countermeasures currently
available. Near-term, the Company believes second generation rPA anthrax
vaccine will gradually replace the currently licensed vaccine. Longer-term,
third generation rPA vaccine -- with substantial improvements in stability
and storage requirements -- will be the procurement option of choice.
Mr. Wright continued, "PharmAthene is strategically building a leading
franchise in anthrax countermeasures - a potential billion dollar market.
This includes not only our third generation rPA vaccine candidate, but also
our novel second generation rPA anthrax vaccine, SparVax(TM) which is
positioned for near-term procurement consideration. As previously disclosed
on July 31, 2008, we submitted our response to a request for proposals to
the Department of Health and Human Services (DHHS) for SparVax(TM). The
solicitation outlined a requirement to procure 25 million doses of a second
generation rPA anthrax vaccine intended for inclusion in the Strategic
National Stockpile. We were notified by DHHS recently that our proposal was
technically acceptable and within the competitive range. The second
generation rPA vaccine market represents another significant opportunity
for PharmAthene, with a total potential contract award of between $350
million and $600 million. We are confident in the Company's competitive
prospects for this award, which DHHS has stated should be announced by
year-end 2008."
About Anthrax
Anthrax is an acute infectious disease caused by the spore-forming
bacterium Bacillus anthracis and has the potential to be used as a weapon
of bioterror when delivered in an aerosolized form. Following germination
of the spores, the bacteria replicates and produces three toxins. Anthrax
Protective Antigen (PA) initiates the onset of the illness by attaching to
cells in the infected person where it then facilitates entry of the two
additional destructive toxins -- Lethal Factor and Edema Factor, into the
cell.
Antibiotics are the first line of defense against anthrax infection.
However, early identification and treatment are critical for successful
outcome. Even with aggressive antibiotic therapy, five of the eleven
victims of the 2001 anthrax postal attacks died, underscoring the need for
improved vaccines and anti-toxins for the civilian population.
About SparVax(TM) and the Third Generation Anthrax Vaccine
SparVax(TM) is a novel second generation recombinant protective (rPA)
anthrax vaccine consisting of rPA adsorbed onto Alhydrogel and packaged as
a liquid filled syringe for intramuscular injection. Preclinical studies
suggest that two or three doses of SparVax(TM), administered several weeks
apart, should be sufficient to induce protective immunity. Phase I and
Phase II clinical trials involving more than 750 healthy human subjects
have been completed and showed that SparVax(TM) appears to be safe and well
tolerated and induces an immune response in humans. In preclinical studies,
SparVax(TM) has also demonstrated the capability to protect non-human
primates against a lethal aerosol challenge of the anthrax Ames strain. A
third generation rPA vaccine, requiring fewer doses to achieve protective
immunity, and obviating the need for cold chain storage, is the ultimate
goal for inclusion in the country's Strategic National Stockpile.
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(TM) - a second generation recombinant protective antigen (rPA)
anthrax vaccine
-- Third generation rPA anthrax vaccine
-- Valortim(R) - a fully human monoclonal antibody for the prevention and
treatment of anthrax infection
-- Protexia(R) - a novel bioscavenger for the prevention and treatment of
morbidity and mortality associated with exposure to chemical nerve
agents
-- RypVax(TM) - a recombinant dual antigen vaccine for plague
For more information about PharmAthene, please visit http://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 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, 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 under the
caption "Risk Factors" and in its other reports filed with the U.S.
Securities and Exchange Commission (the "SEC"). In particular, just because
the DHHS has awarded this contract to the Company for the advanced
development of our third generation rPA anthrax vaccine, there can be no
assurance that (1) the work under this contract will result in a safe and
effective anthrax vaccine approved for use in humans, (2) DHHS will
exercise all options under the contract, or (3) DHHS or any other
government agencies or departments will ever procure doses of our third
generation rPA vaccine for civilian or military purposes. Copies of
PharmAthene's public disclosure filings are available from its investor
relations department and our website under the investor relations tab at
http://www.PharmAthene.com .
SOURCE PharmAthene, Inc.
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Related links:
http://www.pharmathene.com
CONTACT:
Stacey Jurchison of PharmAthene, Inc.,
+1-410-269-2610, JurichsonS@PharmAthene.com
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