HepaLife Technologies, Inc. (OTCBB:HPLF):
-- 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
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 US 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.
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No statement herein should be considered an offer or a
solicitation of an offer for the purchase or sale of any securities.
This release contains forward-looking statements that are based upon
current expectations or beliefs, as well as a number of assumptions
about future events. Although the Company believes that the
expectations reflected in the forward-looking statements and the
assumptions upon which they are based are reasonable, it can give no
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undue reliance on these forward-looking statements, as these
statements are subject to numerous factors and uncertainties,
including but not limited to adverse economic conditions, intense
competition, lack of meaningful research results, entry of new
competitors and products, adverse federal, state and local government
regulation, inadequate capital, unexpected costs and operating
deficits, increases in general and administrative costs, termination
of contracts or agreements, technological obsolescence of the
Company's products, technical problems with the Company's research and
products, price increases for supplies and components, litigation and
administrative proceedings involving the Company, the possible
acquisition of new businesses or technologies that result in operating
losses or that do not perform as anticipated, unanticipated losses,
the possible fluctuation and volatility of the Company's operating
results, financial condition and stock price, losses incurred in
litigating and settling cases, dilution in the Company's ownership of
its business, adverse publicity and news coverage, inability to carry
out research, development and commercialization plans, loss or
retirement of key executives and research scientists, changes in
interest rates, inflationary factors, and other specific risks. We
currently have no commercial products intended to diagnose, treat,
prevent or cure any disease. The statements contained in this press
release regarding our on going research and development and the
results attained by us to-date have not been evaluated by the Food and
Drug Administration. There can be no assurance that further research
and development, and/or whether clinical trial results, if any, will
validate and support the results of our preliminary research and
studies. Further, there can be no assurance that the necessary
regulatory approvals will be obtained or that HepaLife will be able to
develop commercially viable products on the basis of its technologies.
In addition, other factors that could cause actual results to differ
materially are discussed in the Company's most recent Form 10-Q and
Form 10-K filings with the Securities and Exchange Commission. These
reports and filings may be inspected and copied at the Public
Reference Room maintained by the U.S. Securities & Exchange Commission
at 100 F Street, N.E., Washington, D.C. 20549. You can obtain
information about operation of the Public Reference Room by calling
the U.S. Securities & Exchange Commission at 800-SEC-0330. The U.S.
Securities & Exchange Commission also maintains an Internet site that
contains reports, proxy and information statements, and other
information regarding issuers that file electronically with the U.S.
Securities & Exchange Commission at http://www.sec.gov. The Company
undertakes no obligation to publicly release the results of any
revisions to these forward looking statements that may be made to
reflect the events or circumstances after the date hereof or to
reflect the occurrence of unanticipated events.
