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
Email: mrothberg@viragen.com
URL: http://www.viragen.com/.