Leonard E. Warren Melanoma Foundation
Viragen launches Multiferon Sales in Mexico
PLANTATION, Fla., Feb. 18 /PRNewswire-FirstCall/ — Viragen, Inc. (Amex: VRA) today announced that the Company has initiated its Multiferon(TM) marketing and sales program in Mexico with the natural human alpha interferon drug being shipped to its distributor, Laboratorios Pisa. As part of the product’s launch, a presentation was made on February 14th at the Mexican National Oncology Congress in Veracruz that discussed the merits of Multiferon as an adjuvant treatment for malignant melanoma, a potentially lethal skin cancer.

"Our Multiferon Marketing Team has been working closely with our strategic partner, Laboratorios Pisa, to commence with our marketing and sales program in Mexico and we are pleased to report that we have shipped an initial order," stated Viragen’s Executive Vice President, Mel Rothberg. "As part of this campaign, Laboratorios Pisa sponsored a Multiferon presentation at an important Mexican National Oncology Congress sponsored by the National Cancer Institute (INCAN) that discussed the drug’s potential to treat malignant melanoma. Moving forward, we will target the treatment of a variety of viral and malignant diseases including hepatitis B, hepatitis C and certain cancers."

At a plenary session of the Mexican National Oncology Congress, Professor Orjan Strannegard from Goteborg University in Sweden made a presentation titled, "Adjuvant Treatment of Malignant Melanoma with Natural Interferon Alpha." Dr. Strannegard serves as a Director for ViraNative AB, Viragen’s Swedish interferon manufacturing subsidiary.

Dr. Strannegard made the following conclusions supporting the use of Multiferon as an adjuvant treatment for malignant melanoma:

  • Multiferon has antiviral, antiproliferative and immunological properties that are different from, and in some cases, superior to those of recombinant alpha interferons.
  • In high-risk melanoma, adjuvant treatment with dacarbazine followed by low-dose natural alpha interferon results in a highly significant beneficial effect on relapse-free survival.
  • Preliminary results indicate that the increase in relapse-free survival is followed by a substantial increase in overall survival in patients given dacarbazine and natural alpha interferon.
  • The survival advantage of dacarbazine and natural alpha interferon appears to surpass that of adjuvant treatment with high or medium doses of recombinant alpha interferon.
  • Partly because of the low doses used, natural alpha interferon is very well tolerated by patients.
  • Sequential biochemotherapy involving natural alpha interferon may be preferable to regimes where the drugs are given simultaneously to the patients.

Dr. Strannegard’s conclusions were based upon a series of studies evaluating the use of various interferons for the treatment of malignant melanoma, including a controlled Phase II/III clinical study for the adjuvant treatment of malignant melanoma with Multiferon. The results from this original 156 patient study, conducted at 20 sites in Germany, were presented at a national German oncology conference in 2003.

Dr. Jorge Yoma, Medical Director for Laboratorios Pisa, commented, "Our feedback from the Congress was very encouraging. We believe that Multiferon is the first natural human alpha interferon that can be priced competitively with recombinant versions, so we are making a very strong case supporting its use to physicians and patients seeking an alternative interferon therapy."

About Alpha Interferon:

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.

About Multiferon(TM):

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.

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, peptide drugs and therapeutic vaccines. Viragen’s strategy also includes the development of Avian Transgenic Technology for the large-scale, cost-effective manufacturing of its portfolio of protein-based drugs, as well as offering Contract Manufacturing for the biopharmaceutical industry.

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 our Web site at: http://www.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.
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