Lundbeck has launched ATryn in the USA, an anti-clotting treatment which is the first drug to be approved across the Atlantic that has been manufactured using transgenic animals.
The product, which is marketed by the Danish drugmaker and manufactured by GTC Biotherapeutics, was approved by the US Food and Drug Administration in February for the prevention of peri-operative and peri-partum thromboembolic events in patients with hereditary antithrombin deficiency. The rare but potentially fatal blood clotting disorder affects one in 2,000 to one in 5,000 people and by the age of 50, approximately 50 percent of people with HAD will have experienced a venous thromboembolic events.
ATryn is made by processing the human antithrombin protein from the milk of a select herd of transgenic goats. The process involves scientists inserting DNA for the HAP into a single-celled goat embryo, which is implanted into a surrogate doe. The resulting transgenic offspring are able to produce high levels of human antithrombin in their milk and this is collected and purified from the milk to produce ATryn. The product is administered by intravenous infusion.
Jeffrey Aronin, chief executive of Lundbeck’s US operations, said that ATryn offers an alternative to human plasma-derived antithrombin and the company “is well- positioned to ensure a safe and reliable supply for those who need it, when they need it”. GTC, which will receive $1 million from Lundbeck for its initial inventory of ATryn, has estimated that the product could generate $40-$50 million in annual sales in the USA in its first five years on the market.
Meantime Lundbeck has once again been mentioned as a possible bidder for Elan Corp, a rumour which has helped push the Irish drugmaker’s shares up over 15% in the past couple of days.
