Covalent Group Signs $1.0 Million Contract to Study Vaccine Against Plague
May 05 2004 - 9:51AM
PR Newswire (US)
Covalent Group Signs $1.0 Million Contract to Study Vaccine Against
Plague Company's Third Counter-Bioterrorism Contract WAYNE, Pa.,
May 5 /PRNewswire-FirstCall/ -- Covalent Group, Inc. today
announced the signing of its third counter-bioterrorism vaccines
contract within the past five months. This $1.0 million contract
with DynPort Vaccine Company LLC (DVC) is for a Phase 1 study for
the development of a recombinant vaccine for protection against
Yersinia pestis infection, the bacterium that causes plague.
Covalent will provide study design consultation, project
management, clinical site management and monitoring, data
management, biostatistics and medical safety surveillance. The
total duration of the study is approximately 18 months. Covalent
will begin recognizing revenue on the study in the second half of
2004 with initial subject enrollment beginning in early 2005. The
vaccine being studied is the plague recombinant vaccine conceived
and developed at the U.S. Army Medical Research Institute of
Infectious Diseases. The U.S. Army has a U.S. Patent Application
pending for this vaccine. Plague is an infection caused by Y.
pestis, a gram-negative bacterium. It results in an acute and often
fatal disease. In nature, people usually get plague as a result of
a bite by a rodent flea that is carrying plague bacterium or by
handling an infected animal. During the course of history, plague
pandemics have killed millions of people. Today, human weapons are
much more likely than rodent fleas to cause a plague pandemic.
Plague is considered one of the most dangerous agents of
bioterrorism. Over the past 60 years, there have been numerous
examples of malevolent groups trying to weaponize Y. pestis. The
threat would come through pneumonic plague, the most deadly and
contagious form of the disease that results from inhalation of the
bacterium. Currently, there is no licensed plague vaccine available
in the United States. Kenneth M. Borow, M.D., Covalent Group's
President and Chief Executive Officer, commented, "An effective
vaccine against plague would have enormous benefit for military
personnel as well as civilian populations in the case of a
bioterrorist attack with Y. pestis. The Working Group on Civilian
Biodefense wrote in their Consensus Statement on Plague as a
Biological Weapon, 'The availability of Y. pestis around the globe,
the capacity for its mass production and aerosol dissemination, and
the potential for secondary spread of infectious cases during an
epidemic make the use of plague as a biological weapon a great
concern. (Journal of the American Medical Association
2000;283:2281-2290).'" Dr. Borow concluded, "Covalent and DVC are
currently working together on the assessment of vaccines for
protection against botulinum neurotoxin, Venezuelan equine
encephalitis (VEE), and plague. We look forward to the opportunity
to work closely with DVC on other vaccine development programs in
the future. We believe that the development of successful vaccines
against bioterrorist agents is a very valuable addition to the
armamentarium against global terror. As such, we are proud to be on
the cutting-edge of this important effort." About DynPort Vaccine
Company LLC DynPort Vaccine Company LLC (DVC) is a
biopharmaceutical company dedicated to the development and
licensure of safe and efficacious biodefense vaccines for the
Department of Defense and civilian populations. As the prime
systems contractor for the Joint Vaccine Acquisition Program, DVC
engages the expertise of subcontractors, research centers and
biologics development industry leaders. Biodefense biologics in
development include vaccinia immune globulin, smallpox vaccine,
next-generation anthrax vaccine, plague vaccine, Venezuelan equine
encephalitis vaccine, tularemia vaccine, botulinum bivalent and
multivalent vaccines and botulinum polyclonal antitoxin. Founded in
1997, DVC employs nearly 120 professionals at its headquarters in
Frederick, Md. For more information about DVC visit
http://www.dynport.com/. About the U. S. Army Medical Research
Institute of Infectious Diseases USAMRIID, located at Fort Detrick,
Maryland, is the lead medical research laboratory for the U.S.
Biological Defense Research Program, and plays a key role in
national defense and in infectious disease research. The
Institute's mission is to conduct basic and applied research on
biological threats resulting in medical solutions (such as
vaccines, drugs and diagnostics) to protect the warfighter.
USAMRIID is a subordinate laboratory of the U.S. Army Medical
Research and Materiel Command. About Covalent Group Covalent Group
is a clinical research organization that is a leader in the design
and management of complex clinical trials for the pharmaceutical,
biotechnology and medical device industries. The Company's mission
is to provide its clients with high quality, full-service support
for their clinical trials. Covalent offers therapeutic expertise,
experienced team management and advanced technologies. The Company
has clinical trial experience across a wide variety of therapeutic
areas such as vaccines, biologics, gene therapy, immunology,
cardiovascular, endocrinology/metabolism, diabetes, neurology,
oncology, infectious diseases, gastroenterology, dermatology,
hepatology, womens' health and respiratory medicine. Covalent
believes that its leadership in the design of complex clinical
trials, its application of innovative technologies, therapeutic
expertise and commitment to quality offer its clients a means to
more quickly and cost effectively develop products through the
clinical trial process. In addition, the Company's use of its
proprietary TeleTrial(R) technology to support its drug development
services creates consistency in the way it conducts clinical trials
globally. With its wholly-owned international subsidiary, Covalent
Group, Ltd., as well as its Strategic Partners operating in South
America, Eastern Europe, Russia and Ukraine, and Australia, New
Zealand, and the Asia-Pacific region, Covalent is able to meet the
global drug development needs of its clients. This press release
contains forward-looking statements identified by words such as
"estimate," "project," "expect," "intend," "believe," "anticipate"
and similar expressions. Actual results might differ materially
from those projected in, expressed in or implied by the
forward-looking statements. Potential risks and uncertainties that
could affect the Company's future operating results and financial
condition include, without limitation: (i) our success in
attracting new business and retaining existing clients and
projects; (ii) the size, duration, and timing of clinical trials;
(iii) the termination, delay or cancellation of clinical trials;
(iv) the timing difference between our receipt of contract
milestone or scheduled payments and our incurring costs to manage
these trials; (v) outsourcing trends in the pharmaceutical,
biotechnology and medical device industries; (vi) the ability to
maintain profit margins in a competitive marketplace; (vii) our
ability to attract and retain qualified personnel; (viii) the
sensitivity of our business to general economic conditions; and
(ix) other economic, competitive, governmental and technological
factors affecting our operations, markets, products, services and
prices. Additional information concerning factors that could cause
actual results to materially differ from those in forward-looking
statements is contained in Covalent Group's SEC filings, including
its Registration Statement on Form S-3, Annual Report on Form 10-K
and other periodic reports under the Securities Exchange Act of
1934, as amended, copies of which are available upon request from
Covalent Group's investor relations department. Investor relations
contact: John Capodanno, (646) 536-7026 Media contact: Cynthia
Isaac, PhD., (646) 536-7028 Contact us on-line:
http://www.covalentgroup.com/ DATASOURCE: Covalent Group, Inc.
CONTACT: Investor relations - John Capodanno, +1-646-536-7026, or
Media - Cynthia Isaac, PhD., +1-646-536-7028, both for Covalent
Group, Inc. Web site: http://www.covalentgroup.com/
http://www.dynport.com/
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