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Mexico Expands Approval For Viragen's Natural Interferon Allows Drug To Be Marketed For The Treatment Of Hepatitis C And Certain Cancers
PLANTATION, Fla., May 29, 2003 /PRNewswire-FirstCall via COMTEX/ -- Viragen,
Inc. (Amex: VRA) and its majority-owned subsidiary, Viragen International, Inc.
(OTC Bulletin Board: VGNI) today announced the approval of an application
submitted to Mexican regulatory authorities to expand the use of the natural
human alpha interferon drug, Multiferon(TM).
The Mexican regulatory authorities approved an application filed by Viragen's
strategic partner, Laboratorios Pisa, a leading Mexican pharmaceutical company,
to expand the use of Multiferon. This broadened approval extends use of the drug
to include the treatment of patients afflicted with any and all diseases in
which patients show an initial response to recombinant (synthetic) alpha
interferon followed by treatment failure, probably due to the formation of
neutralizing antibodies. Multiferon had previously been approved in Mexico for
the treatment of patients with hairy cell leukemia (HCL) or chronic myelogenous
leukemia (CML) who failed or relapsed to recombinant interferon regimens.
Multiferon is primarily being marketed for the treatment of hepatitis C and
certain cancers.
According to Viragen's Executive Vice President, Mr. Mel Rothberg, "This
expanded approval allows us to market Multiferon in Mexico for the treatment of
serious diseases such as hepatitis C and many cancers. Our Marketing team has
been working closely with Laboratorios Pisa in Mexico to identify those
physicians and patients who are most anxious to initiate a natural interferon
therapy."
"Based on the marketing initiatives that we are conducting with Viragen and the
initial positive feedback that we are receiving from physicians, we are now
anticipating higher sales figures for Multiferon than we had originally
expected," stated Pisa's General Director, Mr. Alfonso Alvarez. "Launching any
new pharmaceutical product can be a challenging endeavor, but we are very
excited about the growth prospects for natural interferon to treat a variety of
viral and malignant diseases."
Multiferon(TM) -- The Natural Choice:
Multiferon is a highly purified, multi-subtype, natural human alpha interferon
derived from human white blood cells and is approved in Sweden and Mexico for
the second-line treatment of any and all diseases in which patients show an
initial response to recombinant (synthetic) alpha interferon followed by
treatment failure, probably due to the formation of neutralizing antibodies.
Viragen's natural interferon is also approved for sale in the following
countries as a second-line therapy for the treatment of Hairy Cell Leukemia
(HCL) and Chronic Myelogenous Leukemia (CML): Czech Republic, Egypt, Hong Kong,
Indonesia, Myanmar, South Africa and Thailand. Work is ongoing to expand the
approved indications in these countries.
Regulatory approval processes are also underway in a number of other South
American, Middle East and Far East territories.
The Interferon Market:
The majority of alpha interferons that are marketed are single-subtype
recombinant interferons. Therapy resistance is not unusual with recombinant
interferons with a significant percentage of patients failing to respond to
standard therapy. In some instances, recombinant interferon is rejected by the
patient's immune system, usually caused by the formation of neutralizing
antibodies which may lead to a loss of clinical efficacy. Also, many patients
cannot tolerate the adverse side effects sometimes associated with recombinant
therapy. High doses of recombinant interferon may cause serious, even life-
threatening side effects. Viragen has observed that in many cases, especially
when higher dosages are required, its natural interferon appears to offer
substantial advantages to recombinant interferon regimens. The annual global
interferon market is estimated to exceed $3 billion.
About Viragen, Inc.
Viragen is a biotechnology company specializing in the research, development and
commercialization of natural and recombinant protein-based drugs designed to
treat a broad range of viral and malignant diseases. These protein-based drugs
include human natural alpha interferon, monoclonal antibodies, peptide drugs and
therapeutic vaccines. Viragen's strategy also includes the development of Avian
Transgenic Technology for the large-scale, cost-effective biomanufacturing of
human therapeutic protein drugs, such as monoclonal antibodies.
Viragen is publicly traded on the American Stock Exchange (VRA). Viragen's
majority owned subsidiary, Viragen International, Inc., is publicly traded on
the Over-The-Counter Bulletin Board (VGNI). Viragen's key partners and licensors
include: Roslin Institute, Memorial Sloan-Kettering Cancer Center, National
Institutes of Health, Cancer Research UK, University of Nottingham (U.K.),
University of Miami, America's Blood Centers and the German Red Cross.
For more information, please visit our Web site at: www.Viragen.com
Viragen, Inc. Corporate Contact:
Douglas Calder, Director of Communications
Phone: (954) 233-8746; Fax: (954) 233-1414
E-mail: dcalder@viragen.com
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 and/or
commercial results could be affected by, among other things, uncertainties
relating to clinical trials and product development; availability of future
financing; 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. Forward-looking
statements speak only as to the date they are made. The Company does not
undertake to update forward-looking statements to reflect circumstances or
events that occur after the date the forward-looking statements are made.
SOURCE Viragen, Inc.
CONTACT: Douglas Calder, Director of Communications, Viragen, Inc.,
+1-954-233-8746, or fax, +1-954-233-1414, or dcalder@viragen.com
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