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VGNI NEWS - Viragen, Inc.
(Amex: VRA) and its majority-owned subsidiary, Viragen International, Inc.
(OTC Bulletin Board: VGNI), today announced that the Swedish Medical Products
Agency (MPA) approved Multiferon(R) (multi-subtype, natural human alpha
interferon) for the first-line adjuvant treatment of high-risk (Stages IIb-
III) malignant melanoma following dacarbazine (DTIC) after surgical removal of
tumors. Viragen will officially launch this new malignant melanoma indication
this month.
"We have long been dedicated to the positioning of Multiferon(R) as a
leading therapy for certain cancers, and this approval validates our many
years of hard work devoted to providing new hope for patients for the
treatment of malignant melanoma," stated Orjan Norberg, Managing Director of
ViraNative AB, the Viragen subsidiary, which manufactures Multiferon(R) in
Umea, Sweden. "We are extremely proud that long-term studies have supported
the use of Multiferon(R) in this cancer indication, and that our product has
been shown to provide significant survival benefits, while also being well
tolerated."
Approval for Multiferon(R) in sequential combination with DTIC was granted
based on clinical trial data that demonstrated a statistically significant
advantage over untreated controls in terms of survival-without-distant-
metastasis and overall survival.
The current approved therapy for high-risk malignant melanoma in Sweden
may include recombinant alpha interferon, following resection, for up to
18 months, sometimes in a high-dose regimen. By comparison, two doses of
dacarbazine followed by low-dose Multiferon(R) for six months represents a
significant reduction in total treatment time and cost.
Viragen's President and CEO, Charles A. Rice, commented, "We will now
collaborate with the MPA and EU regulatory authorities to initiate the process
for seeking broader European approvals through the Mutual Recognition
Procedure. As we adapt our marketing activities in Sweden to immediately
generate new sales of Multiferon(R), we will also provide support to our
global license partners to expand this approval of Multiferon(R) in our
international markets. In coordination with our expert Melanoma Advisory
Board, we have initiated the process to conduct a post-marketing supporting
clinical trial with Multiferon(R) on a pan-European basis. The trial is
scheduled to include up to 1,000 patients in multiple centers across Europe
and is expected to build additional clinical evidence of the value of
Multiferon(R) in cancer therapy."
According to Cancer Research UK, Sweden reports the highest per capita
incidence of malignant melanoma in men in Europe and the third highest
incidence in women. (Based on 2002 Data)
Sequential DTIC/Multiferon(R) Therapy for High-Risk Malignant Melanoma:
Following resection, patients receive two doses of dacarbazine, followed
by a 6-month regimen of Multiferon(R) at three doses per week (3 MIU) by
subcutaneous injection.
About Malignant Melanoma:
Skin cancer is the most common type of cancer, accounting for more than
50% of all cancers. Melanoma accounts for approximately 4% of skin cancer
cases, but causes 79% of skin cancer deaths. About 132,000 people worldwide
are diagnosed with melanoma each year, and more than 37,000 die from the
disease annually. According to Decision Resources, current pharmaceutical
therapies are extremely toxic and ineffective in the majority of patients, and
they predict that any emerging therapy that can bring modest improvements in
overall survival and tolerability will revolutionize the treatment of
malignant melanoma.
Decision Resources reports that the current worldwide melanoma
therapeutics market is estimated at $437 million and is expected to exceed
$1.1 billion worldwide by 2013. The European market is estimated to be
approximately one-third of this total.
About Alpha Interferon:
The majority of marketed alpha interferons are single-subtype recombinant
interferons. Therapy resistance is not unusual with recombinant interferons
as a significant percentage of patients fail to respond or are unable to
tolerate the adverse side effects commonly associated with high dosing, as is
sometimes prescribed for melanoma treatment.
About Multiferon(R):
Multiferon(R) is a highly purified, multi-subtype, natural human alpha
interferon. Marketed as "The natural choice(TM)", it is approved for sale in
ten international markets (non-U.S.) for the first-line or rescue therapy for
a broad range of infectious diseases and cancers. For more information,
visit: http://www.Multiferon.com
About Viragen, Inc.:
With global operations in the U.S., Scotland and Sweden, Viragen is a
biotechnology company engaged in the research, development, manufacture and
commercialization of pharmaceutical proteins for the treatment of viral
diseases and cancers. Our product portfolio includes: Multiferon(R) (multi-
subtype, natural human alpha interferon) targeting a broad range of infectious
and malignant diseases; and humanized monoclonal antibodies targeting specific
antigens over-expressed on many types of cancers. We are also pioneering the
development of Avian Transgenic Technology, with the renowned Roslin
Institute, as a revolutionary manufacturing platform for the large-scale,
efficient and economical production of human therapeutic proteins and
antibodies.
For more information, please visit: http://www.Viragen.com

Viragen, Inc. Corporate Contact:
Douglas Calder, Director of Communications
Phone: [phone]; Fax: [phone]
E-mail: [e-mail]