
HepaLife Enters Into Exclusive License Agreement for Development
of New Flu Vaccines.
Worldwide license agreement supported by 5 issued patents for
the development of new flu vaccines to protect against the spread
of influenza viruses among humans, including potentially the high
pathogenicity H5N1 virus.
Boston, MA - July 10, 2006 - As part of its effort to expand
its cell based research and development activities, HepaLife Technologies,
Inc. (OTCBB: HPLF) (FWB: HL1) (WKN: 500625), through a wholly owned
subsidiary, today announced that it has entered into an exclusive
worldwide license agreement with Michigan State University (MSU)
for the development of new cell-culture based flu vaccines to protect
against the spread of influenza viruses among humans, including potentially
the high pathogenicity H5N1 virus.
The license agreement gives HepaLife exclusive rights to five issued
patents, including US patent 5,989,805 ("Immortal Avian Cell
Line To Grow Avian and Animal Viruses To Produce Vaccines"),
US patent 5,827,738, US patent 5,833,980, US patent 5,866,117 and
US patent 5,874,303. Under the terms of the agreement, HepaLife agreed
to pay MSU undisclosed milestone payments and royalty payments based
on future sales.
"As evidenced by the recent deaths in Indonesia, which appeared
to be the first example of the highly virulent avian flu transferring
from one human to another, the threat of the avian flu mutating into
a strain that could cause a pandemic is very real," states Mr.
Harmel S. Rayat, President and CEO of HepaLife Technologies. "Since
last summer, the lethal avian influenza virus has migrated out of
southeast Asia into Europe, the Middle East and Africa. Because of
trade, smuggling and migratory birds, all potential conduits for
the H5N1 virus, many experts feel it's just a matter of time before
it arrives in North and South America."
These recent events have highlighted problems with traditional influenza
vaccine production methods, particularly the length of time to produce
a new vaccine and the amount of vaccine that can be produced on short
notice.
A successful cell-culture based avian flu vaccine has the potential
to reduce production time compared to traditional vaccine production
methods and should allow rapid expansion of vaccine production in
the face of a pandemic. Traditional production methods use embryonated
hens' eggs, which requires extensive planning for the millions of
eggs necessary in the case of exponentially increasing demand. Additionally,
risks associated with impurities in eggs (antibiotics and other viruses),
which may cause sterility problems, and allergies against egg albumin,
could be avoided.
Current vaccine production, which is based on decades old technology,
involves injecting a small amount of a targeted virus into fertilized
chicken eggs, where the virus multiplies. After the virus is harvested
from the eggs, chemicals inactivate and purify the virus, which is
then blended into a vaccine and bottled in vials. This production
method takes at least six months.
In the event of a flu pandemic, it is unlikely that current egg-based
vaccines will be produced fast enough to meet expected demand due
to the lengthy production time. Additionally, vaccines go stale quickly,
and small changes in a virus's makeup can render them useless. Transferring
production to a cell-culture based system will avoid many of these
problems and reduce lot to lot variation in vaccine efficacy and
potency.
ABOUT AVIAN FLU
The H5N1 strain of avian flu can be transmitted from birds to humans.
From 2003 to June 6, 2006 the World Health Organization has confirmed
225 human cases, including 128 deaths. There is currently no vaccine
available to protect humans from H5N1.
The Centers for Disease Control states, "There is little pre-existing
natural immunity to H5N1 infection in the human population. If these
H5N1 viruses gain the ability for efficient and sustained transmission
among humans, an influenza pandemic could result, with potentially
high rates of illness and death." In May, the White House issued
a report saying that a disease outbreak could lead to the deaths
of 200,000 to 2 million in the U.S. alone.
ABOUT HEPALIFE TECHNOLOGIES, INC.
HepaLife Technologies, Inc. (OTCBB: HPLF) (FWB: HL1) (WKN: 500625)
is a development stage biotechnology company focused on the identification,
development and eventual commercialization of cell-based technologies
and products.
Current cell-based technologies under development by HepaLife include
1) the first-of- its-kind artificial liver device, 2) proprietary
in-vitro toxicology and pre-clinical drug testing platforms, and
3) cell-culture based vaccines to protect against the spread of influenza
viruses among humans, including potentially the high pathogenicity
H5N1 virus.
For additional information, please visit hepalife.com
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