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Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)
Date:3/16/2009

DUBLIN, March 16 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has decided to withdraw the European Marketing Authorization Application (MAA) for DAYTRANA(TM) (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). A request from European regulators to conduct an additional clinical study on DAYTRANA in a European patient population combined with the recently announced planned acquisition of the worldwide rights (excluding the US, Canada and Barbados) to EQUASYM(R) IR and XL (methylphenidate hydrochloride) for the treatment of ADHD are the basis for this decision.

The decision to withdraw the MAA does not impact Shire's commitment to DAYTRANA in the U.S. where the product has been used as a pediatric treatment for ADHD since 2006.

EQUASYM IR and XL will provide Shire with an entry to the European ADHD market upon completion of the transaction, which subject to customary completion conditions, is anticipated in Q2 2009. EQUASYM XL is approved and currently marketed for the treatment of ADHD in children over 6 years of age, and is available in 10 countries outside of the US, Canada and Barbados including Denmark, Finland, Germany, Ireland, Netherlands, Norway, Sweden, UK, Mexico and South Korea. Shire will be working to progress a number of additional planned launches for EQUASYM XL in European and ROW markets.

EQUASYM will allow Shire to build on its status as the leader in the United States ADHD market with patients and customers in Europe, and establishes a solid bridge for Shire's other ADHD treatments, including VYVANSE(TM) (lisdexamfetamine dimesylate), its flagship ADHD product, in territories outside of the United States. VYVANSE is approved in the US for the
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SOURCE Shire Plc
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