Shire plc (SHPGY) Venvanse Accepted for Review by MHRA, U.K.

Shire plc (Nasdaq: SHPGY), reports the acceptance for review of their once-daily ADHD medicinal product Venvanse (lisdexamfetamine dimesylate) by the Medicines Healthcare products Regulatory Agency (MHRA), UK. The MHRA have agreed to act as the Reference Member State for this Decentralised Procedure (DCP) which will initially include eight European countries.This application follows the successful completion of the European Phase 3 study of Venvanse in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) last year.

VENVANSE® is the first long-acting prodrug stimulant and is currently commercialized in the US, and Canada for the treatment of ADHD in children, adolescents and adults (under the tradename VYVANSE) and in Brazil for the treatment of ADHD in children (under the trade name VENVANSE).

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