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AVANT to Develop an Oral Anthrax and Plague Vaccine for U.S. Department of Defense
NEEDHAM, Mass., Jan 22, 2003 (BUSINESS WIRE) -- AVANT Immunotherapeutics, Inc.
(Nasdaq: AVAN) today announced it has been awarded a subcontract to develop for
the U.S. Department of Defense an oral combination vaccine against anthrax and
plague using AVANT's proprietary vaccine technologies. Under the agreement,
AVANT may receive in excess of $8 million over a two-year period, covering
vaccine development through preclinical testing. AVANT executed the subcontract
with DynPort Vaccine Company LLC ("DVC"), the prime contractor for the Defense
Department's Joint Vaccine Acquisition Program (JVAP). Headquartered in Fort
Detrick, MD, JVAP is the lead Defense Department organization for the
development and purchase of vaccines for the U.S. military.
"This contract represents one of the first awards from a major U.S. Department
of Defense (DoD) initiative to apply modern biotechnological innovations to the
development of vaccines that can offer rapid, effective protection from multiple
biological agents," said Una S. Ryan, Ph.D., President and Chief Executive
Officer of AVANT Immunotherapeutics, Inc. "Current vaccines against bacterial
bioweapons like anthrax (Bacillus anthracis) and plague (Yersinia pestis)
require a protracted dosing regimen or provide only limited protection, and each
vaccine protects against only a single agent. The Defense Department is looking
for new, improved generation vaccines that are effective, single-dose, and can
protect against multiple agents. The choice of AVANT to conduct this development
program is an important recognition of the strength of AVANT's vaccine and
vector technologies for accomplishing these aims."
"This contract is very important to AVANT since it provides non-dilutive funding
to the company and it means that AVANT now has over two years of cash and cash
equivalents on hand," Dr. Ryan concluded.
Senator Edward M. Kennedy (D-MA), Ranking Democrat of the Senate Committee on
Health and a senior member of the Senate Armed Services Committee, stated, "I am
very pleased that the Defense Department has chosen AVANT, a leading
Massachusetts biotechnology firm, to conduct this pioneering effort in the
development of a next-generation biodefense vaccine. The anthrax attacks of 2001
were a tragic reminder of the need for modern vaccines to protect our men and
women in uniform as well as the public at large. I commend DoD's efforts in this
area, and I look forward to yet another successful application of AVANT's
vaccine technology to meeting this vital national security and healthcare
challenge."
Senator John Kerry (D-MA), Ranking Member of the Senate Committee on Small
Business, stated, "AVANT's success in this area is proof that America's small
businesses can play a vital role in protecting our fighting men and women from
biological weapons. Small business offers the innovation and flexibility our
forces need to defeat novel threats that are constantly changing. As we
contemplate sending our forces into battle where they could face biological
weapons, it is reassuring to see that the Defense Department is moving ahead to
acquire the most effective means of safeguarding them."
Dr. Ryan commended Senator Kennedy and Senator Kerry for their support of the
JVAP program funding biodefense vaccine development: "Without support from
enlightened legislators like Senator Kennedy and Senator Kerry, the development
of required advanced-technology vaccines would continue to lag behind the
threats our nation faces.
We are grateful for their leadership in making this program possible."
DVC is currently developing seven vaccines for the Department of Defense Joint
Vaccine Acquisition Program and is the first company to initiate clinical trials
on the new smallpox vaccine for the Department of Defense. They are also
expected to be the first to complete the trials for vaccinia immune globulin
(VIG), an antiserum needed for the smallpox vaccination program. DVC's mission
is to develop vaccines that meet the highest standards and requirements for
today's soldiers. "Vaccination of a large number of individuals would be
facilitated if an orally administered vaccine were available," said Terry
Irgens, RPh, President of DVC. "AVANT's concept that several vaccines could be
delivered simultaneously would be state-of-the-art. We look forward to
investigating this technology as an alternative to an injectable vaccine."
Under the subcontract, AVANT will develop a rapid-acting oral anthrax and plague
vaccine based on the company's modified live vaccine technology. This technology
will use genetically modified bacteria as vectors, or "buses," to deliver plague
and anthrax antigens to the immune system in a way that quickly stimulates
protective immunity against these microbes - both of which have potential for
use as bioweapons. AVANT expects to conduct the vaccine research at both its
Needham, Massachusetts and St. Louis, Missouri laboratories.
The proposed vaccine will offer dramatic advances over current-generation
biodefense vaccines. For example, the current generation anthrax vaccine
administered to U.S. troops requires individuals to undergo a series of six
injections over an 18-month period. This vaccine confers immunity to anthrax
gradually, over a number of weeks. Recipients of this vaccine have complained of
considerable muscular soreness in reaction to the injections. By contrast, the
proposed anthrax-plague vaccine to be developed by AVANT is designed to have the
attributes of AVANT's travelers' vaccines against cholera and typhoid
fever--require a single oral dose, confer immunity within days, and cause
minimal side effects.
Scientists at AVANT created the vectoring technology as part of the company's
development of orally administered bacterial vaccine candidates against cholera
(Vibrio cholerae, Peru-15) and typhoid fever (Salmonella typhi, Ty800). Peru-15
and Ty800 were created using genetic techniques to delete genes known to be
essential to the virulence of the parent microorganism. As a result of these
alterations, AVANT's vaccine candidates have been shown in the clinic to be well
tolerated by humans. Moreover, results of a Phase IIb challenge study with
AVANT's Peru-15 cholera vaccine candidate demonstrated the ability of a single
dose of that vaccine to protect subjects against moderate or severe diarrhea
following administration of live Vibrio cholerae bacteria. This study was
conducted under the sponsorship of the National Institute of Allergy and
Infectious Disease (NIAID) of the National Institutes of Health (NIH) in
collaboration with the Walter Reed Army Institute of Research (WRAIR)
About DVC
DVC, a joint venture between DynCorp of Reston, Virginia and Porton
International, Inc., is chartered with providing an integrated approach for the
advanced development of specific vaccines and other products to protect against
the threat of biological warfare agents. In 1997, the U.S. Department of Defense
initiated the Joint Vaccine Acquisition Program, which includes a 10-year
contract with DVC for the development of vaccines against certain acute
infectious diseases and contagious diseases.
About AVANT
AVANT Immunotherapeutics, Inc. is engaged in the discovery, development and
commercialization of products that harness the human immune system to prevent
and treat disease. The company is developing a broad portfolio of vaccines
against viral and bacterial diseases, including single-dose oral vaccines aimed
at protecting travelers from cholera, typhoid fever and other illnesses. In
addition, the company is conducting clinical studies of a proprietary vaccine
candidate for cholesterol management. AVANT further leverages the value of its
technology portfolio through corporate partnerships. Current collaborations
encompass the development of an oral human rotavirus vaccine, vaccines to combat
threats of biological warfare, and vaccines addressed to human food safety and
animal health.
Additional information on AVANT Immunotherapeutics, Inc. can be obtained through
our site on the World Wide Web: www.avantimmune.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of
1995: This release includes forward-looking statements which reflect AVANT's
current views with respect to future events and financial performance. These
forward-looking statements are based on management's beliefs and assumptions and
information currently available. The words "believe," "expect," "anticipate,"
"intend," "estimate," "project" and similar expressions which do not relate
solely to historical matters identify forward-looking statements. Investors
should be cautious in relying on forward-looking statements because they are
subject to a variety of risks, uncertainties, and other factors that could cause
actual results to differ materially from those expressed in any such
forward-looking statements. These factors include, but are not limited to: (1)
the proposed acquisition of UPT and related transactions may not be consummated
on the terms currently anticipated or at all; (2) the ability to adapt AVANT's
vectoring systems to develop new, safe and effective orally administered
vaccines against anthrax and plague or any other microbes used as bioweapons;
(3) the ability to successfully complete development and commercialization of
CholeraGarde(TM) (Peru-15), Ty800 and of other products; (4) the cost, timing,
scope and results of ongoing safety and efficacy trials of CholeraGarde(TM)
(Peru-15), Ty800 and other preclinical and clinical testing; (5) the ability to
successfully complete product research and further development, including
animal, pre-clinical and clinical studies of CholeraGarde(TM) (Peru-15), Ty800
and other products; (6) the ability of the Company to manage multiple late stage
clinical trials for a variety of product candidates; (7) the volume and
profitability of product sales of Megan(R)Vac 1 and other future products; (8)
changes in existing and potential relationships with corporate collaborators;
(9) the cost, delivery and quality of clinical and commercial grade materials
supplied by contract manufacturers (10) the timing, cost and uncertainty of
obtaining regulatory approvals to use CholeraGarde(TM) (Peru-15) and Ty800,
among other purposes, to protect travelers and people in endemic regions from
diarrhea causing diseases and for other products; (11) the ability to obtain
substantial additional funding; (12) the ability to develop and commercialize
products before competitors; (13) the ability to retain certain members of
management; and (14) other factors detailed from time to time in filings with
the Securities and Exchange Commission. We expressly disclaim any responsibility
to update forward-looking statements.
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