PLANTATION, Fla., Nov. 22 /PRNewswire-FirstCall/ -- Viragen, Inc.
(Amex: VRA) and Viragen International, Inc. (OTC Bulletin Board: VGNI) today
announced the approval of Multiferon(R), natural human alpha interferon, for
sale in Bulgaria. The Bulgarian regulatory authorities approved an
application filed by Viragen's distribution partner, Arriani Pharmaceuticals
S.A., who holds the exclusive rights to distribute the drug in Greece and
designated Balkan countries.
Multiferon(R) is now approved in Bulgaria for the second-line treatment of
any and all diseases in which recombinant interferon therapy failed or the
patient was unable to tolerate the regimen, possibly due to the formation of
neutralizing antibodies. As an alternative to single-subtype, recombinant
alpha interferons, Viragen's Swedish-manufactured natural interferon is
primarily marketed for the treatment of hepatitis B, hepatitis C, chronic
myelogenous leukemia, hairy cell leukemia, renal cell carcinoma and malignant
melanoma.
"With this approval, we are now preparing to commence with our marketing
program in Bulgaria, and we anticipate placing orders in the first quarter of
2005," stated Arriani Pharmaceutical's Managing Director, CEO and Founder, Mr.
Harry C. Lambridis. "As we build our sales program in Bulgaria, we will
continue to take the measures necessary to achieve new regulatory approvals
for Multiferon(R) in Greece, Cyprus, Slovenia and Croatia for future growth."
Viragen's Executive Vice President, Operations, Mr. Mel Rothberg stated,
"This is another step in our goal to make Multiferon(R) the world's most
prescribed natural human alpha interferon and we look forward to establishing
other key partnerships with market leaders that will strengthen our global
position."
Mr. Rothberg also commented on plans to expand the drug's approved
indications in Europe, "Based on the strength of the results of our recently
reported Phase II/III malignant melanoma study, we expect to submit an
application in Sweden next month that seeks approval for Multiferon(R) as
adjuvant interferon therapy following dacarbazine after surgical removal of
the tumor. Potential first-line approval in Sweden is expected to play an
important role in our regulatory strategy to obtain broad EU approval for
Multiferon(R) - a priority goal for our business development program."
About Multiferon(R):
Multiferon(R) is a highly purified, multi-subtype, natural human alpha
interferon derived from human white blood cells and is approved in Bulgaria,
Mexico and Sweden for the second-line treatment of any and all diseases in
which patients show an initial response to recombinant alpha interferon
followed by treatment failure, possibly due to the formation of neutralizing
antibodies.
Multiferon(R) is also approved for sale in the following countries for the
treatment of a range of viral and malignant diseases: Egypt, Hong Kong,
Indonesia, Mexico, Myanmar, South Africa and Thailand. Work is ongoing to
expand the approved indications in these countries. Regulatory approval
activities are also underway in a number of other European, South American,
Middle East and Far East territories.
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 natural human alpha interferon, monoclonal
antibodies and a peptide drug. Viragen's strategy also includes the
development of Avian Transgenic Technology as a biomanufacturing platform for
the large-scale, cost-effective production of therapeutic proteins.
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, 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: http://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 announcement contains forward-looking statements that
can be identified by such terminology such as "expect", "potential",
"suggests," "may," "should," "could" 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.
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Related links:
http://www.viragen.com
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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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