Avantogen and Hawaii Biotech to Combine Vaccine Businesses; New Vaccine Pure-Play, 50%-50% Owned, to Expand Research in Hawaii
March 16 2006 - 4:06PM
Business Wire
Avantogen Limited (Avantogen) (ASX:ACU), and Hawaii Biotech, Inc.
(Hawaii Biotech), a privately held company, today announced that
they have entered into a Definitive Agreement to combine their
respective vaccine businesses. The combined business, as yet
unnamed, will be 50% owned each by Hawaii Biotech's current
shareholders and Avantogen Limited and will focus exclusively on
prophylactic and therapeutic vaccine development. The transaction,
which is contingent on approval of both Avantogen and Hawaii
Biotech shareholders, is expected to close in late April, 2006. The
combined business will incorporate both Avantogen's and Hawaii
Biotech's complementary technologies, and will maintain the
existing vaccine development laboratories in Oahu, Hawaii, with
corporate headquarters in Southern California. This new agreement
builds upon a previously executed License Agreement between
Avantogen and Hawaii Biotech in which Hawaii Biotech successfully
evaluated Avantogen's proprietary immunostimulatory adjuvant,
GPI-0100, for use in Hawaii Biotech's West Nile vaccine. Under
terms of the agreement, Avantogen will contribute US $3.5 million
in cash, its vaccine adjuvant program (currently in Phase I human
trials) and Pentrys vaccine program (currently in Phase II human
trials), and its senior management team, while Hawaii Biotech will
contribute its vaccine research and development team, its
pre-clinical vaccine programs and facilities, its vaccine grant
funding, and US $1 million in cash. Under certain circumstances
applicable to both Avantogen and Hawaii Biotech, equity ownership
of the newly combined company can be adjusted to 60%-40% in either
direction. Leonard Firestone, M.D., current CEO of Avantogen, will
become CEO of the newly combined company, while Carolyn Weeks-Levy,
current VP of Research, Development, and Regulatory Affairs and
leader of Hawaii Biotech's vaccine programs, will become its Chief
Scientific Officer. Bruce Nye, Avantogen's CFO, will become CFO.
David G. Watumull will remain CEO of Hawaii Biotech's current
anti-inflammatory small molecule development business, which will
be spun out into a new entity, Cardax Pharmaceuticals, Inc., to be
wholly owned by current Hawaii Biotech shareholders. Initial board
members will be: Avantogen Chairman Richard Opara, who will serve
as Chairman; current Hawaii Biotech Chairman Nick Mitsakos; Leonard
Firestone, M.D., CEO; Joseph Boystak, formerly Managing Director
with Jefferies & Co and now with Chopin Capital Partners; and a
fifth member to be chosen by Hawaii Biotech. New Board Chairman Dr.
Richard Opara, who is also Chairman of Avantogen, commented: "This
combination will create a truly exceptional biotechnology company,
and is a pivotal step in restructuring Avantogen to optimize the
value of its assets for the benefit of its shareholders. Our vision
is to create a public company that is a world leader in the
development of recombinant vaccines for prevention of common,
deadly, incurable diseases using our proprietary, state-of-the-art
manufacturing methods. These methods will allow us to lead the
marketplace by rapidly delivering the quality and quantity of
vaccine product needed to address worldwide pandemic diseases such
as Influenza. We also see worldwide potential for the development
of the West Nile and Dengue Fever vaccines." "We have explored a
number of options over the past year for the development of our
vaccine business," added David G. Watumull, CEO of Hawaii Biotech.
"We believe that this strategy is our best choice as it brings
together the necessary financial, scientific, and management
resources to focus and accelerate development of our vaccines,
including those for avian flu, West Nile, and dengue fever." Hawaii
Biotech Vaccine Background Hawaii Biotech's vaccine development
platform is based on production of proprietary antigens (proteins)
that, when appropriately adjuvanted, provoke immune responses
equivalent to, or better than, traditional live or inactivated
viral vaccines -- with a significantly improved safety profile.
During the past 3 years, Hawaii Biotech received funding
commitments of over US$30 million from the U.S. National Institutes
of Health and other governmental agencies, to develop vaccines to
prevent human infection by the West Nile virus, Dengue Fever virus,
pandemic and annual Influenza viruses, and other serious incurable
diseases including hepatitis C, malaria, Tick-borne and Japanese
encephalitis, Ebola, and Eastern equine encephalitis. Avantogen
Adjuvant Background Avantogen's GPI-0100 product is currently under
license to Pfizer Animal Health, Inc., Endocyte, Inc., University
of Alabama, and Memorial-Sloan Kettering Cancer Center, to boost
immune responses to their respective vaccine-based products under
development. About Pandemic Influenza and "Bird Flu" The Centers
for Disease Control (CDC) defines an influenza pandemic as a global
outbreak that occurs when a new, virulent influenza A virus
"emerges" in the human population, and spreads easily from person
to person worldwide. Local outbreaks of "bird flu" may be a source
of a new flu virus. Pandemics are different from seasonal outbreaks
or "epidemics" of influenza. Seasonal outbreaks are caused by
subtypes of influenza viruses that already circulate among people,
whereas pandemic outbreaks are caused by new subtypes that
"emerge," or by subtypes that haven't circulated among people for a
long time, or ever. Past influenza pandemics have led to high
levels of illness, death, social disruption, and economic loss. The
severity of the next pandemic cannot be predicted, but models
suggest that in the absence of any control measures (eg,
vaccination), a "medium-level" pandemic in the U.S. could cause 89
- 207,000 deaths, 314 - 734,000 hospitalizations, 18 - 42 million
outpatient visits, and another 20 - 47 million people being sick.
Between 15% and 35% of the U.S. population could be affected by an
influenza pandemic, and the economic impact could range between
$71.3 and $166.5 billion. About West Nile Virus Virtually unknown
in the U.S. prior to 1999, the West Nile virus is now permanently
established throughout the U.S. and Canada. According to the CDC,
in 1 of 150 infected with West Nile, encephalitis and meningitis
will occur, characterized by polio-like symptoms. Live, attenuated
virus vaccines being developed by potential competitors have a
small, but real risk of causing severe, encephalitic West Nile
disease. Hawaii Biotech's approach has been to utilize genetically
engineered viral proteins that cannot cause disease, conferring a
substantial safety advantage. Estimates of U.S. market size for a
West Nile Virus Vaccine are between $200 and 500 million, annually.
Unlike most human viral diseases, West Nile causes both disease and
death in animals. In a well-validated animal model of human West
Nile disease, the company's West Nile vaccine conferred 100%
protection from viral challenge vs. 77% mortality in controls.
Forward-Looking Statements Statements contained in this press
release that are not historical information are forward-looking
statements as contemplated by the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements are subject to
risks and uncertainties that could cause actual results to differ
materially from those projected or implied. Such potential risks
and uncertainties relate, but are not limited, to the results of
clinical trials, product demand and market acceptance, the impact
of competitive products and pricing, effectiveness and pace of
current and future product development, and regulatory approval.
More detailed information on these and additional factors that
could affect Avantogen's business, prospects and operating and
financial results are described in Avantogen's annual reports filed
or to be filed with the Australian Stock Exchange. Avantogen urges
all interested parties to read these reports to gain a better
understanding of the many business and other risks that the company
faces. For further information visit www.avantogen.com The
historical results achieved by the company are not necessarily
indicative of its future prospects. The company undertakes no
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
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