HMGN-Huge Potential-HIV test "to neutralize the HIV virus"
...
Hemagen Announces Completion of a Revolutionary, New Diagnostic Test Developed
in
Collaboration With Noted Virologist, Professor Jean-claude Chermann, a
Co-discoverer of The HIV Virus And URRMA Biopharma, Inc.
Health Editors/Medical Writers
COLUMBIA, Md.--(BW HealthWire)--May 23, 2001--Hemagen Diagnostics,
Inc. (NASDAQ:HMGN, NASDAQ:HMGNW) a biotechnology company that
develops, manufactures and markets proprietary medical diagnostic test
kits, today reported that it has completed the development of a new
diagnostic test kit to identify individuals that have an antibody that
appears to neutralize the HIV virus and prevents the HIV from
progressing into full-blown AIDS.
The test is based on a discovery by Professor Jean-Claude Chermann
that a specific antibody appears in almost all HIV-positive
individuals who have not developed into the AIDS disease, and are
therefore considered to be long-term survivors or non-progressors.
Hemagen's diagnostic test will detect the antibody to an epitope,
called R7V, the marker believed to distinguish progressors from
non-progressors. This new diagnostic test is the result of five years
of collaboration between Professor Chermann and Hemagen.
Professor Chermann is one of the top AIDS researchers in the world
and is a co-discoverer of the HIV virus. Today, Professor Chermann
serves as the Chief Scientific Officer of URRMA Biopharma, Inc. He was
the principal investigator with the research team that first isolated
the HIV virus at the Pasteur Institute in Paris in 1983.
He was also a pioneer in the use of anti-retrovirals in the
treatment of the illness. Early on in the AIDS epidemic, Professor
Chermann's team observed that many HIV carriers never developed AIDS.
This caused him to begin to study those individuals' natural
protection mechanisms.
Subsequently, Professor Chermann led a team of scientists at
Institut National de la Sante et de la Recherche Medicale ("INSERM"),
the French National Institute of Health and Medical Research, where he
discovered that a significant number of individuals who were HIV
positive did not progress to AIDS, and contained an antibody, which is
called anti-R7V.
His studies of over 500 patients over 15 years suggest that the
anti-R7V antibodies isolated in his lab effectively neutralizes all
strains of HIV, rendering them non-infective.
Dr. Ricardo de Oliviera, M.D., Ph.D., a Founder and Director of
Hemagen and its Vice President of Research and Development, managed
this five-year developmental effort for Hemagen. Dr. de Oliveira, an
internationally renowned clinical pathologist had successfully
developed several other novel diagnostic tests for Hemagen when
Chermann approached him about this project.
Dr. de Oliveira stated that, "Evidence suggests that the results
of the Hemagen assay will help physicians determine the most
appropriate course of therapy, perhaps sparing non-progressors from
lengthy, unnecessary, and expensive treatments. With the annual cost
of treatment for AIDS in the billions, this test could have an
enormous financial impact on the course of AIDS treatment worldwide."
URRMA Biopharma, Inc., is a privately held, Canadian-based,
biotech company owned by Pharmagene, Inc., Franc-Or Resources, Dacha
Capital, Innovatech, Grand Montreal and other private investors.
URRMA has obtained an exclusive global license from INSERM, for
the use of a specific antibody (anti-R7V) in a diagnostic test and for
the eventual use of the antibody as a therapeutic and preventative
treatment for AIDS. Hemagen has an agreement with URRMA to produce
this diagnostic kit exclusively for URRMA. URRMA anticipates that the
large U.S. and European markets will generate significant revenues by
the end of 2003.
The success of this collaboration is expected to accelerate the
development of more effective vaccines and therapies for AIDS. "The
existence of anti-R7V itself", said Dr. de Oliveira, "demonstrates the
vast potential for a vaccine. After all, the natural anti-R7V, found
in non-progressors, has been protecting infected individuals for over
15 years." Professor Chermann and Dr. de Oliveira believe that it is
now time to prove that what nature has developed on its own, anti-R7V,
can now be used to protect millions of at-risk individuals around the
world.
Jerry L. Ruyan, Chairman and CEO said, "Clinical trials will
commence shortly and the fact that Professor Chermann has over 15
years worth of catalogued specimens including specimens from both
progressors and non-progressors should dramatically shorten the trial
period as the study will be retrospectively based on whether or not
patients survived. Based upon URRMA's projections, this product could
quickly become Hemagen's largest selling diagnostic test kit."
William P. Hales, President said, "We are very pleased with the
completion of this important test. This milestone is a testament to
Dr. de Oliveira's talents as a physician and scientist and Hemagen's
world-class diagnostics development capabilities. Hemagen's expertise
in developing novel diagnostic tests is evidenced by many of the
product introductions the Company has had in its autoimmune product
line and is why Hemagen was selected as a logical partner in the
development of the R7V kit."
Hemagen Diagnostics, Inc., is a biotechnology company that
develops, manufactures and, markets more than 150 FDA-cleared
proprietary medical diagnostic test kits used to aid in the diagnosis
of certain autoimmune and infectious diseases.
In the United States, the Company sells its products directly to
physicians, veterinarians, clinical laboratories and blood banks and
on a private-label basis through multinational distributors of medical
supplies. Internationally, the Company sells its products primarily
through distributors.
Hemagen also manufactures and sells the "Analyst(R)" an
FDA-cleared Clinical Chemistry Analyzer used to measure important
constituents in human and animal blood. The Company sells the
Analyst(R) both directly and through distributors servicing both
physicians' office laboratories and veterinarians offices. The company
focuses on markets that offer significant growth opportunities.
The company was incorporated in the Commonwealth of Massachusetts
in 1985 and reincorporated in the State of Delaware in 1992. Hemagen
became a publicly traded company in 1993.
Except for any historical information contained herein, the
matters discussed in this press release contain forward-looking
statements that involve risks and uncertainties, including those
described in the Company's Securities and Exchange Commission reports
and filings.
Certain Statements contained in this News Bulletin that are not
historical facts constitute forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act of 1995, and
are intended to be covered by the safe harbors created by that Act.
Reliance should not be placed on forward looking statements
because they involve unknown risks, uncertainties and other factors
which may cause actual results, performance or achievements to differ
materially from those expressed or implied. Any forward-looking
statement speaks only as of the date made.
The Company undertakes no obligation to update any forward-looking
statements to reflect events or circumstances after the date on which
they are made.
Statements concerning the establishments of reserves and
adjustments for dated and obsolete products, write-offs of goodwill,
relocation expenses, expected financial performance, on-going business
strategies and possible future action that Hemagen intends to pursue
to achieve strategic objectives constitute forward-looking
information.
The sufficiency of such charges, implementation of strategies and
the achievement of financial performance are each subject to numerous
conditions, uncertainties and risk factors.
Factors which could cause actual performance to differ materially
from these forward looking statements, include without limitation,
management's analysis of Hemagen's assets, liabilities and operations,
the failure to sell date sensitive inventory prior to its expiration,
the inability of particular products to support goodwill allocated to
them, competition, new product development by competitors which could
render particular products obsolete, the inability to develop or
acquire and successfully introduce new products or improvements of
existing product costs and difficulties in complying with laws and
regulations administered by the U. S. Food and Drug Administration and
the ability to assimilate successfully product acquisitions.
--30--KMK/ph*
CONTACT: Hemagen Diagnostics, Inc., Columbia
William P. Hales, 443/367-5500
Fax: 443/367-5527
KEYWORD: MARYLAND MASSACHUSETTS
INDUSTRY KEYWORD: BIOTECHNOLOGY MEDICAL PHARMACEUTICAL
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May-23-2001 15:41 GMT
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