GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Pharming Denied Marketing Application for Rhucin

[I don’t consider this a reflection in any way on transgenics but rather on the strength (or weakness) of Pharming’s data package for HAE.]

http://www.reuters.com/article/rbssHealthcareNews/idUSL1366620520071213

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Thu Dec 13, 2007 12:35pm EST

AMSTERDAM, Dec 13 (Reuters) - Shares in Dutch biotechnology firm Pharming (PHAR.AS) plummeted more than 17 percent on Thursday after the firm said it had been denied a European marketing application for its key drug Rhucin.

Rhucin, derived from the milk of transgenic rabbits, treats hereditary angioedema, a genetic disorder characterised by acute attacks of painful swellings of the skin, the intestine, mouth and throat.

Analysts have said in the past Rhucin is vital to making Pharming profitable for the first time.

"Pharming understands that the Committee for Medicinal Products for Human Use (CHMP) was not reassured that there was sufficient evidence to confirm the benefits of Rhucin ... or how safe and effective the medicine is when given to a patient more than once," the company said in a statement.

Pharming said it would appeal against the decision and announce the result in the first half of 2008.

Pharming Chief Commercial Officer Rein Strijker said in a conference call the decision was "not the end of the company" and that Pharming had enough cash to last it for several years.

"In many cases, negative opinions in the past have resulted in approved products. The bad news is that it will take more time than we had hoped."

One in every 30,000 people suffers from angioedema, according to Pharming, and patients have an average of seven attacks per year.

"We remain confident that we have a very good product ... we have not seen any evidence for safety concerns in the patients we have treated. That leads us to believe that we have a product that should get marketing authorisation," Strijker said.

Pharming shares extended the days losses, and closed down 17.1 percent at 2.66 euros.

Shares rallied in August after the company said that Rhucin showed positive results in a European trial.

Pharming, which produces therapeutic proteins in milk of genetically modified animals, has no products on the market yet. It has benefited from government funding and capital from investment funds.
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