SHIRE RECEIVES POSITIVE EUROPEAN OPINION FOR HUNTER SYNDROME DRUG

Shire has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of Elaprase for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II). Approval is expected early in 2007 and will result in unified labeling that will be valid in the 25 member states of the EU as well as in Iceland and Norway.

Hunter syndrome is a very rare, life-threatening genetic condition that affects mostly males and results from the absence or deficiency of the lysosomal enzyme iduronate-2-sulfatase.

Elaprase was approved earlier this year by the FDA, and early access has been granted to patients with Hunter syndrome in a number of European countries including Italy, Germany, Spain, France, Sweden, Denmark and Norway. Demand from patients' families and healthcare providers has been high, and some patients have already been given the treatment in these countries.

The product, which is delivered via weekly infusions, replaces the missing enzyme. The data supporting the license application come from the single largest, longest and most comprehensive pivotal study of any lysosomal storage disease to date, according to Shire.

Elaprase is a purified form of the lysosomal enzyme iduronate-2-sulfatase and is produced by recombinant DNA technology in a human cell line.