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Further Upgrade to 2007 Financial Guidance Based on Strong Revenue Growth; VYVANSE Demand on Track
Date:11/1/2007

e 2 clinical studies.

On August 15, 2007, following the expiry of the Hart-Scott-Rodino waiting period, Shire's agreement with Renovo became effective. Under the terms of this agreement, Shire has exclusive rights to commercialize JUVISTA worldwide (with the exception of EU member states). Shire paid Renovo a $75 million up-front payment in respect of the license (expensed during this quarter as R&D) and made a $50 million equity investment in Renovo (at a subscription price of GBP2 per ordinary share, representing approximately 6.5% of Renovo's share capital). Shire's future financial obligations under the agreement are geared to the successful development and commercialization of JUVISTA.

VYVANSE - ADHD

During Q3 2007, the FDA accepted the filing of a supplemental New Drug Application for VYVANSE for the treatment of ADHD in adults. The Prescriptions Drug User Fee Act action date ("PDUFA date") is April 28, 2008. On October 25, 2007 Shire released results from the Phase 3 clinical trials in adults. In this double-blind, placebo-controlled, four-week study with dose escalations in 414 adults aged 18 to 55 years, treatment with VYVANSE at all doses studied (30 mg, 50 mg, 70 mg) was significantly more effective than placebo.

Shire is expecting a decision from the FDA on the approvability of VYVANSE intermediate strength products in the pediatric indication by the PDUFA date, December 15, 2007. If approved, this would make 20mg, 40mg and 60mg product available, which are designed to increase the flexibility of the dosing of VYVANSE for the pediatric indication in the US.

SPD493 (formerly known as Valrocemide)

Following preclinical evaluation, Shire intends to study SPD493 in a number of Central Nervous Systems disorders, and Phase 1 clinical trials started in October 2007.

Q3 2007 Unaudited Results

Q3 2007 Q3 2006

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SOURCE Shire plc
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