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Anagrelide Hydrochloride Approved by European Union

BASINGSTOKE, England, November 18/PRNewswire-FirstCall/ -- Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) today announces that it has received approval for XAGRID(R) (anagrelide hydrochloride) for second line, monotherapy treatment of essential thrombocythaemia (ET)[1] in the European Union, Iceland and Norway. Shire will commence a phased launch throughout Europe and expects the drug to be available for prescribing from the New Year.

XAGRID, as anagrelide hydrochloride, was designated as an orphan medicinal product on 29 December 2000 for the treatment of ET, thereby providing the product with up to ten years market exclusivity in Europe from the date of grant of the license.

Essential thrombocythaemia is a chronic disorder of bone marrow, which is associated with the increased production of blood platelets. Excessively high levels of platelets can result in abnormal clotting and bleeding, thereby increasing the risk of stroke and heart attack.

Shire estimates that over 40,000 patients[2] suffer from ET across the EU. There is currently no other platelet-reducing treatment approved for the treatment of ET across the whole EU.

The drug is already marketed by Shire in the US and eleven other countries under the trademarks AGRYLIN(R) or XAGRID(R). Sales of AGRYLIN in 2003 were US$132.5 million.

In addition, the product has been prescribed on a named patient basis in certain territories since 1997.

Says Matthew Emmens, Shire's Chief Executive:
"XAGRID is a unique medicine for patients suffering from essential thrombocythaemia, a condition that can have debilitating and sometimes life threatening consequences if not treated effectively. Now that XAGRID is approved, and orphan designation confirmed, we can put our full European sales and marketing effort behind its commercialisation across Europe."

Dr Claire Harrison, Consultant Haematologist at Guy's & St Thomas' Foundation Trust, London adds:
"XAGRID is platelet selective, targeting only those cells that develop into platelets; it is well tolerated by most patients and is a welcome addition to the drugs we have available to treat ET."

Source: Shire Pharmaceuticals Group

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