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News Article

Viragen Puts its Eggs in Transgenic Basket

The chairman, CEO and president of Viragen, Gerald Smith, has written to the company's shareholders to explain how Viragen will use transgenic chickens to produce pharmaceuticals.

The chairman, CEO and president of Viragen, Gerald Smith, has written to the company's shareholders to explain how Viragen will use transgenic chickens to produce pharmaceuticals. Viragen is focussed on the development of human monoclonal antibodies, protein-based drugs, which need to be produced in very large quantities. 

In December 2000, Viragen and the Roslin Institute (UK) announced that Roslin's underlying patents and exclusive global rights had been assigned to Viragen to commercialize the avian transgenic technology. Viragen is now collaborating with experts such as Ian Wilmut, renowned for cloning Dolly the Sheep, and Helen Sang whose work produced the world's first transgenic chicken and is considered the world's avian transgenic expert.

Viragen views the eggs of transgenic chickens as a cheaper, easier and quicker manufacturing production method than the expression of recombinant proteins in the milk of cows, sheep or rabbits. The first protein-based drugs to be manufactured via the Roslin/Viragen collaboration in the whites of chicken eggs are expected to be produced by mid-2002 or possibly sooner. A full flock of transgenic chickens could be producing impressive quantities of drugs very quickly by biotech standards, sometimes as short as six months from the founder chicken's birth.

One possible hold up, according to Viragen, is that it is impossible to predict whether the US Food and Drug Administration (FDA) or other international regulatory agencies will approve submissions for proteins produced in eggs. Studies have shown that the two different manufacturing methods, customary and avian technology, produce exactly the same molecule. Once approved by the FDA, biotech and pharmaceutical companies will have access to Viragen's avian production alternative.

Viragen is aiming to be used by pharmaceutical companies as a Contract Manufacturing Organization (CMO) to produce large quantities of protein drugs for use in phase III clinical trials. Such CMOs can often command significant upfront fees, royalties (which would continue through commercialization) and, in some cases, certain equities in the customer's company. Viragen also believes that its avian production technology will become an important alternative manufacturing platform technology capable of producing the huge quantities required for commercialization of approved drugs. The company believes that it has the opportunity to emerge as such a CMO with unique competitive advantages.

At the current stage of development of the transgenic technology it is envisaged that only one drug would be produced in each egg, although eventually the technology promises to be able to produce other complex proteins. Public controversy surrounding cloning does not affect the avian project. Viragen's chickens will not be eaten and there will always be one or more back-up flocks some located in different countries just in case of disease.

Viragen's avian production scenario begins with a "founder hen" which, as an embryo, has had the targeted gene transferred. It is the first hen to produce the drug in the albumen of its eggs. The eggs are hatched into chickens, which also produce the drug in their egg whites. A flock containing large numbers of chickens are then bred or perhaps even cloned. The crude drug is removed from the eggs laid by the transgenic flock and then purified. Viragen's team is considered to be expert in protein purification. According to Viragen, other companies are attempting to produce drugs in transgenic chicken albumen but, without access to significant patents, the company views their chances of success as low.

Contact: Mel Rothberg, Executive Vice President, Viragen, Inc., 865 SW 78th Avenue, Suite 100, Plantation, FL 33324, USA.
Tel: +1 (954) 233 8746

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