ANNAPOLIS, Md., Aug. 5, 2016 /PRNewswire/ -- PharmAthene, Inc.
(NYSE MKT: PIP), a biodefense company developing medical
countermeasures against anthrax, today filed a formal protest
against the Department of Health and Human Services, challenging
its solicitation for a next-generation Anthrax vaccine
provider.
According to the protest, filed with the U.S. Government
Accountability Office, the government's "Request for Proposals" was
written in a way that eliminates competition and assures a sole
source award to Emergent BioSolutions Inc., the company that has
long been the sole-source provider of the vaccine. The protest
requests the GAO suspend the award under the solicitation while it
reviews PharmAthene's complaint. Under federal procurement
regulations, GAO has 100 days to review the complaint.
"The government wrote its solicitation in a way that protects
its long-time, sole-source provider without regard to what is best
for the public," said PharmAthene CEO John
M. Gill. "The Anthrax biodefense is too important to sole
source to one vaccine provider."
The only FDA-approved anthrax vaccine in the U.S. is Anthrax
Vaccine Absorbed (AVA), which was developed by government
scientists in the 1960s. Emergent BioSolutions, then known as
the BioPort Corporation, later purchased it from the government and
"continues to be the sole-source supplier of tens of millions of
doses of AVA at a 300% markup," according to the complaint.
The government purchases the vaccine under Project BioShield,
which was signed into law 2004 as a part of the strategy to defend
America against weapons of mass destruction. While Emergent has
been the sole source supplier to the government since it purchased
the vaccine, PharmAthene has worked with two government agencies,
the Biomedical Advanced Research and Development Authority (BARDA)
and the National Institute of Allergy and Infectious Diseases
(NIAID) to develop a more effective next-gen vaccine with an
improved stability and immunogenicity profile. Combined the two
agencies have spent nearly $200
million on development of PharmAthen's SparVax® and
SparVax-L® formulations.
The U.S. Government has identified the need for a
next-generation Anthrax vaccine with improved potency (protective
immunity in two doses), post-exposure prophylaxis efficacy (PEP),
at least a four-year shelf life (later changed to a three-year
shelf life), a temperature-stable formula with no cold storage
chain, and a lower cost. Temperature-stability has been a
priority for the military. PharmAthene's SparVax-L vaccine
candidate is specifically designed to meet the Government's goals
for the next-gen anthrax vaccine.
"SparVax-L's reduced procurement costs positions it to provide
substantially better value to U.S. taxpayers," Gill said. "The
government has invested a lot of money into our innovative,
next-gen product that will be wasted if they give everything they
have to Emergent without a fair, competitive review. That's not
good for public health. And American taxpayers deserve better."
Contact: Terry Neal,
202-879-9384, tneal@podestagroup.com
About PharmAthene
PharmAthene is a biodefense company engaged in the development
of next generation medical countermeasures against biological
threats. The Company's development portfolio includes a next
generation Anthrax vaccine that is intended to improve protection
while having favorable dosage and storage requirements compared to
other Anthrax vaccines.
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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
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uncertainties include risks associated with our ability to fully
collect a money judgment from SIGA; risks relating to the timing of
payments, if any, under the SIGA litigation; our ability to make
distributions of a substantial portion of the cash proceeds we may
receive from SIGA; the timing, amount and form of such a
distribution; our ability to develop a successful transition plan
and strategy for operating SIGA as a separate business; risks
relating to our continuing ability to recognize cost reductions;
funding delays and/or reductions or elimination of U.S. government
funding and/or non-renewal of expiring funding; risks associated
with the availability of our NOLs, the amounts of available NOLs
and any increases thereof and preservation of such NOLs; risks
associated with our implementation of the shareholder rights plan
to protect the tax benefits of our NOLs; risks associated with
accomplishing any future strategic partnerships or business
combinations; and other 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
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to update these forward-looking statements other than as required
by law. Copies of PharmAthene's public disclosure filings are
available on our website under the investor relations tab at
www.PharmAthene.com.
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SOURCE PharmAthene