Goat-derived drug cleared in Europe
Seems Europe has approved ATryn (an anticlotting drug) which is produced in the milk of genetically modified goats. GTC Biotherapeutics is the company behind this although Genyme is representing them in European regulatory issues.
Reuters: Goat-derived drug cleared in Europe
Boston Globe: GTC gets surprise boost from EU
The clinical trials in the US are almost compete and it should go to the FDA sometime in the first half on 2007. The process involves inserting a gene into the goat before they are born which causes them to produce a human protein that can be purified and tuned into an injectable drug for humans. The disease ATryn treats is fairly rare (about 60,000 cases in the US or about 1 in 5,000) and therefore an excellent candidate to be produce in animals. The economics of producing this complex of a product in a standard biotech factory would most likely be prohibitive with that few patients.
This situation, where an animal is used to produce a drug, has lead to the term “pharming” since the goats are in essence a walking, eating drug factory. It is nice to see fruits of the efforts to produce drugs in animal milk that started over 20 years ago.
Technorati Tags: pharming
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