>> Pharming Seeks EU Approval for Rabbit-Derived Drug
By Harro ten Wolde
AMSTERDAM, July 21 (Reuters) - Dutch biotechnology firm Pharming <PHAR.AS> has applied for European approval of its rabbit-derived drug rhC1INH, which could be the second medicine from a genetically engineered animal to get to market.
Shares in the company jumped as much as 9 percent on Friday on the news.[Shares are currently up 7%, giving Pharming a market cap of about $310M.]
Pharming is seeking permission from the European Medicines Agency (EMEA) to market the product, which is purified from the milk of transgenic rabbits, as a treatment for acute attacks of hereditary angioedema.
The submission follows last month's decision by the EMEA to recommend approval of GTC Biotherapeutics Inc's < GTCB > goat-derived drug ATryn for people with a rare inherited disease that leads to blood clotting.
ATryn had initially been rejected by European experts but the EMEA finally gave it a green light on June 2, providing a boost for the emerging field of "pharming", in which medicines are produced in animals or plants.
Pharming said it anticipated responding to questions from the agency and coordinating inspections in 2006 regarding its product recombinant human C1 inhibitor (rhC1INH).
The filing marks the last phase in bringing the product to market but a Pharming spokeswoman said she could not give a timeframe for the process. "We simply do not know how long it will take the EMEA to make a decision," she said.
Analyst Mark van de Geest at Rabo Securities calculated that the drug's potential annual sales in Europe would be at least 125 million euros ($158 million), assuming a market share of more than 50 percent.
…Hereditary angioedema is a genetic disorder caused by a shortage of C1 inhibitor activity, which is characterised by acute attacks of painful swelling of soft tissues, including the skin, the intestine and the mouth and throat.
Approximately one in every 30,000 people suffer from the condition and they have an average of seven acute attacks per year, Pharming said.
The company said it expects to provide further information on rhC1INH "at an appropriate time and in a manner which reflects the ongoing interactions with EMEA for approval of the product".
Pharming also plans to file for market approval for the C1 inhibitor with the U.S. Food and Drug Administration.
"We believe that both agencies will deliver their positive opinion on rhC1INH this full year," AEK analyst Bernd Hilhorst said in a note. AEK is market maker in Pharming shares and is obliged to take positions in the stock, it noted.
Pharming has secured the commercial production of rhC1INH through a collaboration with Akzo Nobel's <AKZO.AS> subsidiary Diosynth. <<
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