GTC Biotherapeutics (fka GTCB)

[DewDiligence]

The same Pharming news from Reuters:

http://investing.reuters.co.uk/news/articleinvesting.aspx?type=hotStocksNews&storyID=2007-07-13T...

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Pharming Wins Production Okay for Rabbit-Milk Drug

Fri Jul 13, 2007 9:04 AM BST

LONDON, July 13 (Reuters) - Dutch biotechnology company Pharming <PHAR.AS> has won a green light for its drugmaking facilities, boosting prospects for the group's rabbit milk-derived drug Rhucin, its most advanced product.

Shares in the group jumped 10 percent on Friday on the news that European regulators had approved its manufacturing operations as complying with the standards of good manufacturing practice (GMP) for pharmaceutical production.

"Obtaining the GMP status...is a critical step in the review and approval process of Rhucin and it is difficult to over-estimate the importance of achieving this milestone," Bruno Giannetti, Chief Operations Officer at Pharming, said in a statement.

"Our transgenic rabbit facility is the first of its kind in the world to obtain this status," he added. [Sneakily true because the word “rabbit” was included.]

Rhucin is purified from the milk of transgenic rabbits as a treatment for acute attacks of hereditary angioedema. It could be the second medicine from a genetically engineered animal to get to market.

Hereditary angioedema is a genetic disorder characterised by acute attacks of painful swelling of soft tissues, including the skin, the intestine and the mouth and throat.

Pharming said it expected an opinion on the approvability of the product from the European Medicines Agency in the second half of 2007.

GTC Biotherapeutics Inc.'s <GTCB> goat-derived drug ATryn, for a rare blood clotting disorder, became the first drug from a transgenic animal to win approval last year.
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