Phage Biotechnology Corp.

Products: Bio-similar Products

Interferon alpha 2b

Interferons are a family of naturally occurring small protein with molecular weights of 15,000 to 21,000 daltons that are produced and secreted by cells in response to viral infections. The addition of a polyethylene glycol (PEG) increases the molecular weight of the interferon, which slows its clearance from the body. PEG-Interferons need only be injected once a week versus 3 times a week in hepatitis C patients.

The world market for all interferon products is estimated to grow to almost $10 billion by 2010 (Recombinant Therapeutic Proteins, Datamonitor, 2004). The patent which covered the primary structure of interferon alpha 2b expired in July, 2002.

Uses of Interferon-alpha

Interferon alpha and Peg-Interferon-alpha act as broad-spectrum antiviral agents with in vitro activity against human immunodeficiency virus (HIV); human papilloma virus (causes warts); hepatitis B, C, and D viruses; herpes simplex viruses 1 and 2; and others. The biggest market for PEG-interferon is hepatitis C. Hepatitis C is one of the most prevalent worldwide public health threats, affecting as many as 10 million people in major world markets, including 4 million in the United States. Considered a 'silent epidemic' because it often takes years before an infected individual develops symptoms, hepatitis C has been estimated by the Centers for Disease Control and Prevention to contribute to the deaths of 8,000 to 10,000 Americans each year, with this toll expected to triple by 2010.

Phage Biotechnology Corporation’s interferon alpha 2b, Gentron A™, is identical to the product produced by Schering, Intron A. Extensive biochemical and biological testing of Phage’s interferon product indicate it is indistinguishable from Intron A, and thus can be considered a true generic equivalent of the Schering product. Phage’s PEG-interferon is PEGylated at a unique site, and thus, although very similar in action to Schering’s PEG-Intron, is a non-generic product.

The figure below shows the Phage process applied to the production of interferon alpha 2b and the high quality of the final product judged to be greater than 99% pure.

Production of Phage Interferon

Lane 6 in the figure above shows the final interferon protein product which is > 99% pure, and has potent biological activity in an anti-viral assay (Phage interferon bioactivity is 2.1 x 10⁸ IU/mg (IU=international units) versus the International Interferon Reference Standard which has an activity of 2 x 10⁸ IU/mg.

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