Total Government Funding Committed to Valortim(TM) Exceeds $24 Million
ANNAPOLIS, Md. and PRINCETON, N.J., Sept. 26 /PRNewswire-FirstCall/ --
PharmAthene, Inc. (AMEX: PIP), a biodefense company developing medical
countermeasures against biological and chemical threats, and Medarex, Inc.
(Nasdaq: MEDX), a leading monoclonal antibody company, today announced that
the National Institute of Allergy and Infectious Diseases (NIAID) and the
Biomedical Advanced Research and Development Authority (BARDA), part of the
National Institutes of Health (NIH), has awarded PharmAthene a contract for
the advanced development of Valortim(TM), a fully human monoclonal antibody
generated by Medarex's UltiMAb(R) technology that is being co-developed by
the two companies. The up to $13.9 million contract supports the
development of Valortim for use as an anti-toxin therapeutic to prevent and
treat inhalation anthrax infection. The contract is effective as of
September 28, 2007 and will be incrementally funded through 2009. Funding
for the contract's initial fiscal year could reach up to $10.3 million.
"We are very pleased to have the NIAID/BARDA's continuing support for
the Valortim program and look forward to a long-term and highly productive
relationship to achieve our mutual objective of developing effective
countermeasures to biological and chemical weapons of mass destruction,"
said David P. Wright, President and Chief Executive Officer of PharmAthene.
"This award furthers PharmAthene's strategy of securing a leadership
position in biodefense. We believe Valortim possesses favorable
characteristics that make it an ideal choice for procurement in the
Strategic National Stockpile under Project BioShield. We look forward to
continuing to advance the development of this important therapeutic."
"We commend PharmAthene for their excellent work on the NIAID/BARDA
proposal," remarked Israel Lowy, M.D., Ph.D., Senior Director of Infectious
Disease for Medarex. "PharmAthene has been instrumental in securing this
follow-on external funding to advance the development of Valortim toward
potential commercial success. The initial work conducted at Medarex on
Valortim has demonstrated a novel mechanism of action, animal efficacy,
favorable human safety and pharmacokinetic data, and development of an
efficient and scalable manufacturing process. We are pleased that continued
funding for this project may help PharmAthene secure a contract to supply
Valortim to the government and obtain FDA approval."
"The latest contract from NIAID/BARDA brings the total amount of
government funding allocated to Valortim to date to over $24 million,"
remarked Valerie Riddle, M.D., Vice President and Medical Director for
PharmAthene. "This is the second substantial government funding contract
PharmAthene has been awarded in less than a year."
"We look forward to a long-term, cooperative and highly productive
relationship with the U.S. Government to achieve our mutual objective of
ensuring protection of the U.S. population against biological and chemical
threats," said Dr. Riddle.
This project has been funded in whole or in part with Federal funds
from the National Institute of Allergy and Infectious Disease, National
Institutes of Health and the Biomedical Advanced Research and Development
Authority, Department of Health and Human Services, under Contract No.
HHSN272200700033C.
About Valortim
Valortim (MDX-1303) is a fully human antibody designed to protect
against anthrax infection, including inhalation anthrax, the most lethal
form of illness in humans caused by the Bacillus anthracis bacterium. The
investigational antibody is designed to target a protein component known as
the anthrax protective antigen (PA) of the lethal toxin complex produced by
the bacterium. The anthrax protective antigen is believed to initiate the
onset of the illness by attaching to cells in the infected person, and then
is believed to facilitate the entry of additional destructive toxins into
the cells. Valortim is designed to target anthrax protective antigen and
protect the cells from damage by the anthrax toxins.
Valortim has been administered intravenously and intramuscularly to
healthy human volunteers in a completed phase I study, was well tolerated
at doses as high as 20 mg/kg (IV), and was not immunogenic. These study
results were presented at the 2006 Annual Meeting of the Infectious
Diseases Society of America. Pharmacokinetic analysis suggested that doses
as low as 1 mg/kg resulted in circulating levels of antibody after a month,
with a similar potency for neutralizing anthrax toxin in vitro as was seen
with serum obtained from subjects who had been vaccinated with anthrax
vaccine.
Preclinical studies suggest that Valortim has the potential to provide
significant protection against anthrax infection when administered
prophylactically (prior to the emergence of symptoms of anthrax infection)
and also may increase survival when administered therapeutically (once
symptoms become evident).
About Anthrax
According to the Centers for Disease Control and Prevention, anthrax is
an acute infectious disease caused by the spore-forming bacterium Bacillus
anthracis. Anthrax most commonly occurs in hoofed mammals and can also
infect humans. Symptoms of disease vary depending on how the disease is
contracted, but usually occur within seven days after exposure. The serious
forms of human anthrax are inhalation anthrax, cutaneous anthrax, and
intestinal anthrax. Initial symptoms of inhalation anthrax infection may
resemble a common cold. After several days, the symptoms may progress to
severe breathing problems and shock. Inhalation anthrax is often fatal,
even if treated by antibiotics. Currently, antibiotics are the only drugs
available for therapeutic or prophylactic use, and post-exposure
prophylaxis is the only FDA-approved indication for such products. However,
antibiotic therapy, while useful, is believed to be associated with a
number of limitations, including: (1) lack of activity against the toxins
produced by the B. anthracis bacteria (2) need for long-term dosing to
achieve full protection, complicated by side effects and non-compliance (3)
lack of efficacy when administered late in the anthrax disease cycle, and
(4) lack of effectiveness against multi-drug resistant or genetically
engineered strains of anthrax.
About PharmAthene, Inc.
PharmAthene (AMEX: PIP) 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
programs include Valortim(TM) for the prevention and treatment of anthrax
infection and Protexia(R) for the prevention and treatment of morbidity and
mortality associated with exposure to chemical nerve agents. For more
information on PharmAthene, please visit http://www.PharmAthene.com.
About Medarex, Inc.
Medarex is a biopharmaceutical company focused on the discovery,
development and potential commercialization of fully human antibody-based
therapeutics to treat life-threatening and debilitating diseases, including
cancer, inflammation, autoimmune disorders and infectious diseases. Medarex
applies its UltiMAb(R) technology and product development and clinical
manufacturing experience to generate, support and potentially commercialize
a broad range of fully human antibody product candidates for itself and its
partners. More than 30 of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with seven of the most advanced product candidates
currently in Phase III clinical trials. Medarex is committed to building
value by developing a diverse pipeline of antibody products to address the
world's unmet healthcare needs. For more information about Medarex, visit
its website at http://www.medarex.com.
Statement on Cautionary Factors
For PharmAthene: 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"; or similar statements are
forward-looking statements. PharmAthene disclaims, however, any intent or
obligation to update these forward-looking statements. Risks and
uncertainties include risks associated with the reliability of the results
of the studies relating to human safety and possible adverse effects
resulting from the administration of Valortim in humans, timely and
successful development of an efficient and scalable manufacturing process,
unexpected funding delays by NIAID/BARDA, unforeseen safety issues
resulting from the handling of Bacillus anthracis, as well as risks
detailed from time to time in PharmAthene's public disclosure filings with
the U.S. Securities and Exchange Commission (the "SEC"). There can be no
assurance that such development efforts will succeed or that other
developed products will receive required regulatory clearance or that, even
if such regulatory clearance were received, such products would ultimately
achieve commercial success. Copies of PharmAthene's public disclosure
filings are available from its investor relations department.
For Medarex: Except for the historical information presented herein,
matters discussed herein 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"; "suggest"; "may"; or similar
statements are forward-looking statements. Medarex disclaims, however, any
intent or obligation to update these forward-looking statements, except as
required by law. Risks and uncertainties include risks associated with the
reliability of the results of the initial work conducted on Valortim
relating to animal efficacy, human safety and likelihood of successful
development of an efficient and scalable manufacturing process, unexpected
funding delays by NIAID/BARDA, unforeseen safety issues resulting from the
handling of Bacillus anthracis, unforeseen safety issues resulting from the
administration of Valortim(TM) (MDX-1303) in human subjects, uncertainties
related to product manufacturing as well as risks detailed from time to
time in Medarex's public disclosure filings with the U.S. Securities and
Exchange Commission (SEC), including its Annual Report on Form 10-K for the
fiscal year ended December 31, 2006 and its quarterly reports on Form 10-Q.
There can be no assurance that such development efforts will succeed or
that other developed products will receive required regulatory clearance or
that, even if such regulatory clearance were received, such products would
ultimately achieve commercial success. Copies of Medarex's public
disclosure filings are available from its investor relations department.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks
of Medarex, Inc. All rights are reserved. Valortim(TM) is a trademark of
PharmAthene, Inc. All rights are reserved.
SOURCE Medarex, Inc. and PharmAthene, Inc
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Related links:
http://www.medarex.com
http://www.pharmathene.com
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CONTACT:
Laura S. Choi, Investor Relations,
+1-609-430-2880, ext. 2216 or Jean Mantuano, Corporate
Communications, +1-609-430-2880, ext. 2221, both of Medarex,
Inc.; or Stacey Jurchison, Director, Corporate Communications of
PharmAthene, Inc., +1-410-269-2610, cell: +1-410-474-8200,
jurchisons@pharmathene.com
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