ELAPRASE® for the treatment of Hunter syndrome approved by the European Commission

11 Jan 2007 - Basingstoke, UK and Cambridge, MA U.S. - 11 January 2007 - Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces today that the European Commission has granted a marketing authorisation for the use of ELAPRASE® (idursulfase) for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II or MPS II).1 ELAPRASE is the first and only enzyme replacement therapy for people suffering from Hunter syndrome and it was launched in the U.S. in July 2006. Pricing and reimbursement procedures are already underway for ELAPRASE in many European countries and it will be launched across the majority of European countries in 2007.

More than 200 patients currently receive ELAPRASE therapy -- just over 100 in countries across Europe through pre-approval access programmes and just over 100 in the U.S. It is estimated that there are around 2,000 Hunter syndrome patients worldwide in countries where reimbursement is possible and approximately 400 patients have been diagnosed with this condition in Europe so far.

Says Matthew Emmens, Chief Executive Officer of Shire: “We are very pleased with this next step in the global development of ELAPRASE. Hunter syndrome is a rare and devastating condition. The availability of this treatment will potentially have a huge impact on patients’ lives.”

ELAPRASE is a purified form of the lysosomal enzyme iduronate-2-sulfatase (I2S) and is produced by recombinant DNA technology in a human cell line. ELAPRASE, delivered by weekly infusions, replaces the deficient or missing enzyme that Hunter syndrome patients fail to produce in sufficient quantities.2-5

Hunter syndrome is a very rare, progressive and life threatening condition, which primarily affects males. It is one of several hereditary metabolic diseases, known collectively as lysosomal storage disorders. Individuals with Hunter syndrome lack the enzyme I2S which is essential in the continuous process of breaking down and recycling of complex carbohydrates called glycosaminoglycans (GAG). Life expectancy for severely affected patients is only 10-20 years.6

Marketing authorisation for ELAPRASE® follows the positive opinion issued by The Committee for Medicinal Products for Human Use (CHMP) in October 2006.

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For further information please contact:

Investor Relations
Cléa Rosenfeld (Rest of the World) +44 1256 894 160
Brian Piper (North America) +1 484 595 8252
Media
Jessica Mann (Rest of the World) +44 1256 894 280
Matthew Cabrey (North America) +1 484 595 8248

 

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