PLANTATION, Fla., Aug. 19 /PRNewswire-FirstCall/ -- Viragen, Inc.
(Amex: VRA) today issued a progress report updating the status of new growth
strategies for its natural human alpha interferon drug, Multiferon(TM).
Viragen previously reported promising preliminary data from a Phase II/III
clinical trial conducted in Germany that evaluated the use of Multiferon for
the treatment of malignant melanoma. "The final data collected from our
melanoma study has been delivered to an independent Contract Research
Organization for statistical determinations and we anticipate receiving the
final results in the coming weeks," stated Viragen's President and CEO,
Charles A. Rice. "If the evidence supports, we intend to submit a registration
filing with the Swedish regulatory authorities for this new indication, which
if approved, would strongly enhance our position to negotiate strategic
partnerships in Europe."
Mr. Rice also commented on current partnering initiatives: "We continue to
be engaged in active negotiations with multiple business partners for
Multiferon that have the potential to change the business of Viragen in a
significant and lasting manner. This progress has been steadily encouraging
and, subject to the result of these discussions, it appears that we are on the
verge of announcing key new agreements."
The Company also reports that it is in the final stages of negotiation
with a supplier of pre-filled syringe products, and has tentatively scheduled
validation runs in order to be prepared for registration filings early in
2005. "We expect a rapid approval of this change, hopefully in Sweden within
the second quarter of 2005, followed closely by other territories in which we
have approvals," stated Executive Vice President of Operations Mel Rothberg.
"This Project is consistent with our earlier announcement on a more aggressive
and competitive positioning of Multiferon.
"In addition, our new Ersboda Multiferon manufacturing facility's final
validation program remains on schedule. The Swedish regulatory authorities
have agreed with our validation plans and have informed us that we are not
required to have any additional inspections before we return to production in
September," Mr. Rothberg reported.
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", "will", "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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