http://finance.individual.com/display_news.asp?doc_id=CT2001193p1460&page=news
July 12, 2001 7:01am
PLANTATION, Fla., Jul 12, 2001 /PRNewswire
via COMTEX/ -- Viragen, Inc. (Amex: VRA) and Viragen (Europe) Ltd. (OTC
Bulletin Board: VERP) today announced the signing of a Letter of Intent
to acquire BioNative AB, a privately-held Swedish biotechnology company.
The merger will create the world's most efficient, high-volume manufacturer
of highly purified alpha interferon derived from human white blood cells.
BioNative's drug has been approved by the Swedish regulatory authorities
to treat two forms of leukemia. The newly combined manufacturing facilities
would provide about 40,000 square feet of operating space with another
21,500 square feet under construction. Financial terms were not disclosed
and the final agreement will be subject to the approval of the companies'
Boards of Directors.
BioNative, founded in Umea, Sweden
in 1985, markets Alfanative(R), a natural alpha interferon which was approved
in Sweden in 1994 for the treatment of patients with hairy cell leukemia
(HCL) and chronic myelogenous leukemia (CML) who did not respond to recombinant
(synthetic) interferon regimens. Alfanative(R) is also authorized for sale
in the Czech Republic, Indonesia, Hong Kong, Burma, Thailand and as purified
bulk in Egypt with registrations pending in other countries. BioNative
has studied the product in more than 600 patients in different clinical
trials, including hepatitis C, malignant melanoma and other cancers. An
ongoing European Phase III study of adjuvant treatment of malignant melanoma
is designed to provide the data for approval of the drug as a first line
treatment. A renewal application has been submitted to the Swedish regulatory
authorities to expand its use for the treatment of patients afflicted with
any and all diseases in which the patients were or became resistant to
treatments using recombinant (synthetic) interferon, a condition probably
caused by the formation of neutralizing antibodies.
Viragen's Chairman and CEO, Mr. Gerald
Smith, stated, "With the acquisition of BioNative, its patents, skills,
production facilities and regulatory position, Viragen believes it is properly
poised to penetrate the growing multibillion-dollar interferon market.
Our organizations share complementary assets and know-how which, when combined,
should expedite our goal to become the first company ever to mass commercialize
a naturally derived interferon, upon regulatory approval, for the treatment
of hepatitis C, multiple sclerosis and as an adjuvant in certain cancers."
BioNative's Chairman of the Board,
Mr. Per-Erik Persson, added, "BioNative could hardly find a partner that
is better suited than Viragen to globally commercialize natural interferon.
Increased manufacturing capacity combined with improvements in the production
process will provide us with the platform to produce the most efficient
large-scale volumes of natural interferon ever accomplished."
Natural interferon is part of the
human immune system. It is one of the body's natural defensive responses
to foreign substances such as viruses, and is so named because it "interferes"
with viral growth. Recombinant (synthetic) interferons, which currently
dominate the interferon market, are genetically engineered and consequently
are sometimes recognized as "foreign" by the body's immune system. Recombinant
interferons usually contain only one subtype of interferon as compared
to multiple subtypes expressed from human white blood cells.
Viragen's COO, Dr. Magnus Nicolson,
explained, "Treatments with recombinant interferon therapies may cause
unfavorable immune responses in certain patients. Recombinant interferon
may cause the formation of neutralizing antibodies that reduce the effectiveness
of a particular therapy. Therefore, a percentage of patients suffering
from a range of diseases either do not respond or simply cannot tolerate
recombinant therapy. It is believed that natural interferon may be an effective
therapy in the event of failure of first line recombinant interferon regimens
either used alone or in combination with other drugs."
"Interferons are approved to treat
several chronic viral diseases such as hepatitis B & C, multiple sclerosis,
genital herpes and a variety of cancers including malignant melanoma and
different types of leukemias," said Bionative's Chief Scientist, Dr. Professor
Orjan Strannegard. "In most of these diseases, recombinant interferon products
are the treatment of choice. However, a significant percentage of these
patients may develop a resistance to treatment or cannot tolerate therapy
using genetically engineered interferon alpha. Working with Viragen, our
yields in manufacturing both crude and highly purified natural interferon
alpha should be outstanding and should provide us with the volumes necessary
to deliver a product that clinical trials prove is potentially superior
in side-effect profile and efficacy within these patient populations."
Viragen's natural interferon is currently
in Phase II European clinical trials for hepatitis C. Viragen has also
received European approval to commence human clinical trials for natural
interferon for the treatment of multiple sclerosis. A Phase II (a) multiple
sclerosis clinical trial is scheduled to begin later this year. Viragen
is also evaluating natural interferon for the treatment of genital herpes.
Viragen expects to file an Investigational New Drug Application (IND) with
the FDA to commence U.S. human clinical trials for the treatment of hepatitis
C upon completion of the acquisition of BioNative.
About Viragen, Inc.:
Viragen, Inc. researches, develops
and manufactures drugs including natural human interferon and human monoclonal
antibodies for the treatment of many life-threatening and debilitating
diseases such as hepatitis C, multiple sclerosis and cancer. In addition
to developing a portfolio of proprietary drugs, Viragen is also engaged
in the development of Avian Transgenic Technology which is designed to
deliver an efficient, cost-effective alternative to the biopharmaceutical
industry for the large-scale production of protein-based drugs.
Viragen holds the worldwide exclusive
license to commercialize Avian Transgenic Production Technology granted
by the Roslin Institute in Scotland, renowned for their creation of "Dolly
the Sheep." The Avian Project is designed to produce protein-based drugs,
including monoclonal antibodies to fight cancer, inside the eggs of transgenic
chickens. Avian Technology promises a much faster, cost-effective and virtually
unlimited production process marked by the chicken's prolific egg laying
capabilities.
Viragen's Oncology Projects include
the National Institutes of Health (NIH) granting Viragen the worldwide
exclusive rights to commercialize the human therapeutic use of a monoclonal
antibody designed to induce a wide variety of cancers to "commit suicide."
In another project, the U.K.'s Cancer Research Campaign Technology has
granted Viragen a worldwide exclusive commercial license to develop a cancer
vaccine therapy for the treatment of several oncological indications including
breast, ovarian, colorectal and certain bone cancers. Additionally, Viragen
is collaborating with Memorial Sloan-Kettering Cancer Center for the development
of a human monoclonal antibody for the treatment of melanoma and other
cancers.
The foregoing press release contains
forward-looking statements that can be identified by such terminology such
as "expects", "potential", "suggests", "may", "will", or similar expressions.
Such forward-looking statements involve known and unknown risks, uncertainties
and other factors that may cause the actual results to be materially different
from any future results, performance or achievements expressed or implied
by such statements. In particular, management's expectations regarding
future research development results could be affected by, among other things,
uncertainties relating to clinical trials and product development; unexpected
regulatory delays or government regulation generally; the Company's ability
to obtain or maintain patent and other proprietary intellectual property
protection; and competition in general.
Corporate Contacts:
Mel Rothberg,
Executive Vice President
Douglas Calder,
Director of Communications
For more information,
please visit our Web site at: WWW.VIRAGEN.COM
SOURCE Viragen, Inc.
CONTACT: Mel Rothberg,
Executive Vice President, fax, 954-233-8743, or
Copyright (C) 2001 PR Newswire
Source: PR Newswire
Viragen, Inc.:
Phone: (954)
233-8746; Fax: (954) 233-8743
E-mail: mrothberg@viragen.com
Phone: (954)
233-8746; Fax: (954) 233-1414
E-mail: dcalder@viragen.com
mrothberg@viragen.com, or Douglas Calder, Director of Communications, fax,
954-233-1414, or dcalder@viragen.com, both of Viragen, 954-233-8746
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