ANNAPOLIS, Md., Sept 15, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- PharmAthene, Inc.
(Amex: PIP) a biodefense company specializing in the development and
commercialization of medical countermeasures against chemical and biological
threats, announced today that it has received notification from the Department
of Health and Human Services (DHHS) that the Company's proposal for its
recombinant protective antigen anthrax vaccine, SparVax™, has completed a
comprehensive technical and business evaluation by DHHS and has been deemed to
be technically acceptable and within the competitive range. The negotiation
phase for a development and procurement contract is now underway. DHHS has
stated that it intends to make an award under the solicitation by end of the
year.
PharmAthene's submission was in response to a Request for Proposals for an
Anthrax Recombinant Protective Antigen (rPA) Vaccine for the Strategic
National Stockpile (Solicitation Number: RFP BARDA 08-15) issued by DHHS on
February 28, 2008, outlining a requirement to develop and procure 25 million
doses of an anthrax rPA vaccine.
"We are delighted by this news and remain committed to working
collaboratively with the government to develop leading, next-generation
biodefense medical countermeasures to ensure our Nation's biosecurity," said
David P. Wright, President and Chief Executive Officer of PharmAthene. "The
issuance by DHHS of a Request for Proposals for next generation anthrax
vaccines acknowledges a need for a new anthrax vaccine that offers the
potential for improved safety and convenience, and we believe that our product
candidate, SparVax™, is well positioned to meet the government's
requirements."
About SparVax™
SparVax™ is a novel second generation recombinant protective antigen
(rPA) anthrax vaccine being developed for administration by intramuscular
injection. Phase I and Phase II clinical trials involving more than 700
healthy human subjects have been completed and showed that SparVax™ appears
to be well tolerated and induces an immune response in humans. These studies
suggest that three doses of SparVax™, administered several weeks apart
should be sufficient to induce protective immunity. In preclinical 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.
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
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, the receipt of notification from the DHHS that our proposal
is technically acceptable and within the competitive range does not imply that
we will ultimately be awarded a contract. The receipt from DHHS of
notification does not in any way obligate the government to make a contract
award to us. Furthermore, while DHHS has stated it plans to make awards by
the end of this year, it is not legally obligated to do so and could
significantly extend the time line for an award or decide not to make any
awards under the solicitation. Finally, we are aware that at least one other
bidder has received a similar notification from the DHHS and there may now or
in the future be others. Even if we are selected to provide rPA vaccine to
the Strategic National Stockpile, there can be no assurance that such an award
will be for all or a significant portion of the 25 million dose procurement.
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.
http://www.pharmathene.com