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European Commission approves Firazyr

German pharmaceutical company, Jerini, has been granted marketing approval by the European Commission for their hereditary angioedema drug, Firazyr
German pharmaceutical company, Jerini, has been granted marketing approval by the European Commission for their hereditary angioedema (HAE) drug, Firazyr.

The approval allows Jerini to market Firazyr in all 27 EU countries ñ the first HAE drug to receive EU-wide approval.

HAE is a debilitating and potentially life-threatening genetic disease causing unpredictable, recurring swelling attacks. While swellings in the hands, feet and face can be disfiguring, swellings in the larynx constrict the airways and can be life-threatening.

Firazyr works by blocking the B2 receptor as an antagonist to a hormone that has been shown to be elevated in HAE patients. Firazyr has been granted orphan drug status for the treatment of angioedema by the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA).

Earlier this month, Jerini entered into a partnership, which included a voluntary public takeover bid, with Shire Ltd. The deal is expected to be complete by the end of Q3 2008.

Sylvie Gregoire, president of Shire Human Genetic Therapies (HGT) business said: "We are very pleased that European approval has been granted to Jerini today. This is an important step in bringing this first-in-class orphan treatment to patients who suffer from HAE attacks. We look forward to the completion of our transaction with Jerini which will enable us to work together and ultimately build Firazyr into a global gold standard treatment."

15th July 2008

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