First Recombinant BChE to Meet Department of Defense Selection Criteria
ANNAPOLIS, Md., Sept. 25 /PRNewswire/ -- PharmAthene, Inc., a leading
biodefense company specializing in the development and commercialization of
medical countermeasures against chemical and biological terrorism,
announced today that it has been awarded a multi-year contract valued at up
to $213 million from the Department of Defense (DoD) U.S. Army Space and
Missile Command, for advanced development of the Company's broad spectrum
chemical nerve agent prophylaxis, Protexia(R).
"We are extremely pleased to have been chosen by the Department of
Defense as the recipient of this important biodefense contract," commented
David P. Wright, President and Chief Executive Officer of PharmAthene. "The
Department of Defense continues to be at the forefront of the development
and procurement of novel therapeutic countermeasures to combat chemical and
biological warfare and we are very excited to partner with them to carry
out advanced development of Protexia."
Under the contract, PharmAthene will be responsible for the conduct and
oversight of all product development activities. The initial stage of
development, for which $34.7 million has been allocated, includes
manufacturing process development, preclinical safety and toxicity testing,
submission of an Investigational New Drug (IND) Application with the United
States Food and Drug Administration (FDA), and initiation of a Phase I
clinical trial. Following the successful completion of the Phase I clinical
trial, the government may exercise its option to fund additional
development activities beyond the initial $34.7 million, leading to FDA
licensure. The contract also provides the Department of Defense with the
option to procure an initial 90,000 doses of Protexia.
"Today's announcement highlights the intense commitment and strong
technical capability PharmAthene has demonstrated in assembling and rapidly
advancing a comprehensive portfolio of biodefense-focused therapeutics to
meet the urgent biosecurity needs of our nation and allies," said Mr.
Wright. "Since our acquisition of Protexia last year, we have made rapid
progress defining a viable manufacturing process for commercial scale
production and demonstrated proof of concept showing protection with
Protexia against highly lethal doses of nerve agent exposure. Our proven
internal expertise in drug development, in combination with the funding
provided under the DoD contract, will significantly enhance our ability to
ensure that Protexia becomes an important part of the nation's military and
civilian biodefense arsenal."
Mr. Wright continued, "Upon the completion of our proposed merger with
SIGA Technologies, Inc., we believe PharmAthene will have one of the
broadest portfolios in biodefense with three best-in-class products
targeting the highest priority threat assessments identified by the U.S.
Government. In addition to Protexia, our post-merger portfolio will include
Valortim(TM), for the prevention and treatment of anthrax infection, and
ST-246, a small molecule, orally-active antiviral therapeutic for the
treatment of smallpox and other orthopox virus infections. We look forward
to completing the merger with SIGA and making progress advancing each of
these important products."
The Protexia contract was awarded through a full and open competitive
solicitation seeking novel second generation prophylactic products for use
in humans to prevent and treat poisoning from organophosphorus (OP) nerve
agents such as sarin gas, soman, tabun and VX. Protexia is a form of
recombinant human butyrylcholinesterase (rBChE), a potent organophosphorus
(OP) scavenger protein, being developed for use as a prophylactic to
protect U.S. military personnel and civilians from the toxic effects of
chemical nerve agents.
"In collaboration with the United States Army Medical Research
Institute of Chemical Defense (USAMRICD) and DRDC Suffield we have amassed
an impressive collection of data which supports the superior benefit of
rBChE in the prevention and treatment of nerve agent toxicity," said Dr.
Solomon Langermann, Vice President and Chief Scientific Officer of
PharmAthene. "Preclinical studies suggest that in contrast to currently
available treatments, rBChE can provide protection against both the
physiological and neurological toxicities associated with nerve agent
poisoning. In addition, our proprietary manufacturing method enables
substantially larger production yields than what is possible with human
plasma-derived BChE, suggesting that when developed, Protexia (rBChE) can
adequately fulfill the U.S. military and civilian stockpile requirements.
It is these unique characteristics which make Protexia the superior choice
for military and civilian chemical defense and we look forward to
continuing our collaborative work with DoD."
This communication is being made in respect of the proposed merger
transaction involving SIGA Technologies, Inc. and PharmAthene, Inc. In
addition, SIGA has filed a preliminary proxy statement with the SEC in
connection with the transaction and will mail the definitive proxy
statement to SIGA shareholders of record at the record date for the special
meeting of the shareholders to be held to provide approvals relating to the
proposed transaction. The definitive proxy statement that SIGA plans to
file with the SEC and mail to its shareholders will contain information
about SIGA, PharmAthene, the proposed merger, and related matters.
SHAREHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT CAREFULLY
WHEN IT IS AVAILABLE, AS IT WILL CONTAIN IMPORTANT INFORMATION THAT
SHAREHOLDERS SHOULD CONSIDER BEFORE MAKING A DECISION ABOUT THE MERGER. In
addition to receiving the proxy statement and proxy card by mail,
shareholders will also be able to obtain the definitive proxy statement, as
well as other filings containing information about SIGA, without charge,
from the SEC's website (http:/www.sec.gov) or, without charge, by
contacting Thomas Konatich at SIGA at (212) 672-9100. This announcement is
neither a solicitation of proxy, an offer to purchase, nor a solicitation
of an offer to sell shares of SIGA.
SIGA and its executive officers and directors may be deemed to be
participants in the solicitation of proxies from SIGA's shareholders with
respect to the matters relating to the proposed merger. PharmAthene may
also be deemed a participant in such solicitation. Information regarding
SIGA's executive officers and directors is available in SIGA's Annual
Report on Form 10-K, for the year ended December 31, 2005. Information
regarding any interest that PharmAthene or any of the executive officers or
directors of PharmAthene may have in the transaction with SIGA will be set
forth in the definitive proxy statement that SIGA intends to file with the
SEC in connection with the matters to be approved in connection with the
proposed merger. Shareholders of SIGA can obtain this information by
reading the definitive proxy statement when it becomes available.
About Protexia(R): Recombinant Human Butyrylcholinesterase (rBChE)
Protexia is a form of recombinant human butyrylcholinesterase (rBChE),
a potent organophosphorus (OP) scavenger protein produced in the milk of
transgenic goats, which is being developed for use as a prophylactic
against acute organophosphorus (OP) nerve agent toxicity.
About Chemical Weapons
Organophosphorus nerve agents, or anti-cholinesterase agents, were
discovered in the 1930s following intensive research into new insecticides.
Their discovery represents the beginning of modern chemical warfare. These
agents cause toxicity by binding to and inhibiting acetylcholinesterase, an
enzyme in the body that is essential for nervous system function, leading
to increases in acetylcholine and "cholinergic crisis" that can cause loss
of muscle control, respiratory failure, paralysis, convulsions, permanent
brain damage and eventually death.
These so-called nerve gases, which are actually all liquids at room
temperature, are lethal far more quickly and in far lower concentrations
than other classical chemical warfare agents such as vesicants, choking
agents and blood agents, and are effective both when inhaled and when
absorbed through the skin. Nerve agents can be classified as either
G-agents (sarin, soman, tabun) or V-agents (VX), both of which are
exceedingly toxic.
About PharmAthene, Inc.
PharmAthene, a privately-held biotechnology company, is dedicated to
the rapid development of important and novel biotherapeutics to address
biological pathogens and chemicals that may be used as weapons of
bioterror. PharmAthene's lead programs include Valortim(TM), a treatment
for anthrax, which is being co-developed with Medarex, Inc., and
Protexia(R), a treatment for nerve agent exposure. On June 8, 2006,
PharmAthene and SIGA Technologies (Nasdaq: SIGA) entered into an Agreement
and Plan of Merger pursuant to which SIGA and PharmAthene Inc. have agreed
to combine their businesses through a merger. PharmAthene is located in the
Chesapeake Innovation Center in Annapolis, MD, America's first business
accelerator for the homeland and national security sectors. PharmAthene has
been successful in obtaining U.S. Government and Venture Capital funding to
finance the development of its portfolio products. For more information on
PharmAthene, please visit http://www.PharmAthene.com.
Forward Looking Statement Disclosure
This press release contains certain "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including statements regarding the efficacy of potential products,
the ability of SIGA or PharmAthene to complete the development of any
products, the ability of SIGA or PharmAthene to complete the development of
manufacturing processes for any potential products, the timelines for
bringing such products to market and the availability of funding sources
for continued development of such products. Forward-looking statements are
based on management's estimates, assumptions and projections, and are
subject to uncertainties, many of which are beyond the control of SIGA and
PharmAthene. Actual results may differ materially from those anticipated in
any forward- looking statement. Factors that may cause such differences
include the risks that (a) shareholders of one or both companies may not
approve the merger, (b) the NASDAQ market may not accept the shares of the
merged company for continued listing, (c) potential products that appear
promising to SIGA and or PharmAthene or any of their collaborators cannot
be shown to be efficacious or safe in subsequent preclinical or clinical
trials, or may not be able to be manufactured in a commercially reasonable
manner, (d) SIGA, PharmAthene or their collaborators will not obtain
appropriate or necessary governmental approvals to market these or other
potential products, (e) SIGA or PharmAthene may not be able to obtain
anticipated funding for their development projects or other needed funding,
(f) SIGA or PharmAthene may not be able to secure funding from anticipated
government contracts and grants, and (g) SIGA or PharmAthene may not be
able to secure or enforce adequate legal protection, including patent
protection, for their products.
More detailed information about SIGA and risk factors that may affect
the realization of forward-looking statements, including the
forward-looking statements in this press release is set forth in SIGA's
filings with the Securities and Exchange Commission, including the
Preliminary Proxy Statement, SIGA's Annual Report on Form 10-K for the
fiscal year ended December 31, 2005, and in other documents that SIGA has
filed with the Commission. SIGA urges investors and security holders to
read those documents free of charge at the Commission's Web site at
http://www.sec.gov. Interested parties may also obtain those documents free
of charge from SIGA. Forward-looking statements speak only as to the date
they are made, and except for any obligation under the U.S. federal
securities laws, SIGA undertakes no obligation to publicly update any
forward-looking statement as a result of new information, future events or
otherwise.
SOURCE PharmAthene, Inc.
 back to top
Related links:
http://www.pharmathene.com/
CONTACT:
Stacey Jurchison, Director, Corporate
Communications, of PharmAthene, Inc., +1-410-571-8925, Cell:
+1-410-474-8200, JurchisonS@PharmAthene.com
|
