More MS news articles for July 2001

Viragen and BioNative Sign Letter of Intent; Acquisition to Create World's Largest Natural Interferon Manufacturer

July 12, 2001  7:01am
Source: PR Newswire

PLANTATION, Fla., Jul 12, 2001 /PRNewswire via COMTEX/ -- Viragen, Inc. (Amex: VRA) and Viragen (Europe) Ltd. (OTC Bulletin Board: VERP) today announced the signing of a Letter of Intent to acquire BioNative AB, a privately-held Swedish biotechnology company. The merger will create the world's most efficient, high-volume manufacturer of highly purified alpha interferon derived from human white blood cells. BioNative's drug has been approved by the Swedish regulatory authorities to treat two forms of leukemia. The newly combined manufacturing facilities would provide about 40,000 square feet of operating space with another 21,500 square feet under construction. Financial terms were not disclosed and the final agreement will be subject to the approval of the companies' Boards of Directors.

BioNative, founded in Umea, Sweden in 1985, markets Alfanative(R), a natural alpha interferon which was approved in Sweden in 1994 for the treatment of patients with hairy cell leukemia (HCL) and chronic myelogenous leukemia (CML) who did not respond to recombinant (synthetic) interferon regimens. Alfanative(R) is also authorized for sale in the Czech Republic, Indonesia, Hong Kong, Burma, Thailand and as purified bulk in Egypt with registrations pending in other countries. BioNative has studied the product in more than 600 patients in different clinical trials, including hepatitis C, malignant melanoma and other cancers. An ongoing European Phase III study of adjuvant treatment of malignant melanoma is designed to provide the data for approval of the drug as a first line treatment. A renewal application has been submitted to the Swedish regulatory authorities to expand its use for the treatment of patients afflicted with any and all diseases in which the patients were or became resistant to treatments using recombinant (synthetic) interferon, a condition probably caused by the formation of neutralizing antibodies.

Viragen's Chairman and CEO, Mr. Gerald Smith, stated, "With the acquisition of BioNative, its patents, skills, production facilities and regulatory position, Viragen believes it is properly poised to penetrate the growing multibillion-dollar interferon market. Our organizations share complementary assets and know-how which, when combined, should expedite our goal to become the first company ever to mass commercialize a naturally derived interferon, upon regulatory approval, for the treatment of hepatitis C, multiple sclerosis and as an adjuvant in certain cancers."

BioNative's Chairman of the Board, Mr. Per-Erik Persson, added, "BioNative could hardly find a partner that is better suited than Viragen to globally commercialize natural interferon. Increased manufacturing capacity combined with improvements in the production process will provide us with the platform to produce the most efficient large-scale volumes of natural interferon ever accomplished."

Natural interferon is part of the human immune system. It is one of the body's natural defensive responses to foreign substances such as viruses, and is so named because it "interferes" with viral growth. Recombinant (synthetic) interferons, which currently dominate the interferon market, are genetically engineered and consequently are sometimes recognized as "foreign" by the body's immune system. Recombinant interferons usually contain only one subtype of interferon as compared to multiple subtypes expressed from human white blood cells.

Viragen's COO, Dr. Magnus Nicolson, explained, "Treatments with recombinant interferon therapies may cause unfavorable immune responses in certain patients. Recombinant interferon may cause the formation of neutralizing antibodies that reduce the effectiveness of a particular therapy. Therefore, a percentage of patients suffering from a range of diseases either do not respond or simply cannot tolerate recombinant therapy. It is believed that natural interferon may be an effective therapy in the event of failure of first line recombinant interferon regimens either used alone or in combination with other drugs."

"Interferons are approved to treat several chronic viral diseases such as hepatitis B & C, multiple sclerosis, genital herpes and a variety of cancers including malignant melanoma and different types of leukemias," said Bionative's Chief Scientist, Dr. Professor Orjan Strannegard. "In most of these diseases, recombinant interferon products are the treatment of choice. However, a significant percentage of these patients may develop a resistance to treatment or cannot tolerate therapy using genetically engineered interferon alpha. Working with Viragen, our yields in manufacturing both crude and highly purified natural interferon alpha should be outstanding and should provide us with the volumes necessary to deliver a product that clinical trials prove is potentially superior in side-effect profile and efficacy within these patient populations."

Viragen's natural interferon is currently in Phase II European clinical trials for hepatitis C. Viragen has also received European approval to commence human clinical trials for natural interferon for the treatment of multiple sclerosis. A Phase II (a) multiple sclerosis clinical trial is scheduled to begin later this year. Viragen is also evaluating natural interferon for the treatment of genital herpes. Viragen expects to file an Investigational New Drug Application (IND) with the FDA to commence U.S. human clinical trials for the treatment of hepatitis C upon completion of the acquisition of BioNative.

About Viragen, Inc.:

Viragen, Inc. researches, develops and manufactures drugs including natural human interferon and human monoclonal antibodies for the treatment of many life-threatening and debilitating diseases such as hepatitis C, multiple sclerosis and cancer. In addition to developing a portfolio of proprietary drugs, Viragen is also engaged in the development of Avian Transgenic Technology which is designed to deliver an efficient, cost-effective alternative to the biopharmaceutical industry for the large-scale production of protein-based drugs.

Viragen holds the worldwide exclusive license to commercialize Avian Transgenic Production Technology granted by the Roslin Institute in Scotland, renowned for their creation of "Dolly the Sheep." The Avian Project is designed to produce protein-based drugs, including monoclonal antibodies to fight cancer, inside the eggs of transgenic chickens. Avian Technology promises a much faster, cost-effective and virtually unlimited production process marked by the chicken's prolific egg laying capabilities.

Viragen's Oncology Projects include the National Institutes of Health (NIH) granting Viragen the worldwide exclusive rights to commercialize the human therapeutic use of a monoclonal antibody designed to induce a wide variety of cancers to "commit suicide." In another project, the U.K.'s Cancer Research Campaign Technology has granted Viragen a worldwide exclusive commercial license to develop a cancer vaccine therapy for the treatment of several oncological indications including breast, ovarian, colorectal and certain bone cancers. Additionally, Viragen is collaborating with Memorial Sloan-Kettering Cancer Center for the development of a human monoclonal antibody for the treatment of melanoma and other cancers.

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 results could be affected by, among other things, uncertainties relating to clinical trials and product development; 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.

    Corporate Contacts:
    Viragen, Inc.:

    Mel Rothberg, Executive Vice President
    Phone: (954) 233-8746; Fax: (954) 233-8743

    Douglas Calder, Director of Communications
    Phone: (954) 233-8746; Fax: (954) 233-1414

    For more information, please visit our Web site at: WWW.VIRAGEN.COM

SOURCE Viragen, Inc.

CONTACT:    Mel Rothberg, Executive Vice President, fax, 954-233-8743, or
        , or Douglas Calder, Director of Communications, fax,
                  954-233-1414, or, both of Viragen, 954-233-8746
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