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® 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™ 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™. 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™ and the Third Generation Anthrax Vaccine
SparVax™ 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™, 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™ appears to be safe and well
tolerated and induces an immune response in humans. In preclinical studies,
SparVax™ 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™ - 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
- RypVax™ - a recombinant dual antigen vaccine for plague
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 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 www.PharmAthene.com.
SOURCE: PharmAthene, Inc.
CONTACT:
Stacey Jurchison of PharmAthene, Inc.
+1-410-269-2610
JurichsonS@PharmAthene.com>/a>
Web site:
http://www.PharmAthene.com
