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Shire Delivers Strong Quarter: Driven by $243m of New Product Sales (+164% YOY Growth). Revenue Guidance Upgrade.
Date:7/31/2008

the

medication when compared to patients taking a placebo at all measured

time points up to 24 hours after dosing.

JUVISTA(R) - Improvement of scar appearance

- Nine Phase 2 efficacy trials for JUVISTA have now been reported of

which seven demonstrated statistically significant efficacy. Further

Phase 2 clinical trials in other surgery types are ongoing and are

expected to report during 2008 and 2009. Renovo Limited ("Renovo") is

also intending to initiate a Phase 3 trial in the second half of 2008

in support of Renovo's filing of a European regulatory dossier and has

recently announced that the European Medicines Agency ("EMEA") has

given clearance to commence Phase 3 trials. Shire is considering the

EMEA advice to Renovo and Renovo's EU Phase 3 plans and will give

guidance on the US development plan in due course.

Velaglucerase alfa - Gaucher disease

- Shire has completed enrolment in a worldwide Phase 3 clinical program

for velaglucerase alfa, an enzyme replacement therapy being developed

for the treatment of Gaucher disease. This comprehensive development

program includes the evaluation of velaglucerase alfa in naive patients

and patients previously treated with imiglucerase across three clinical

studies. It is anticipated that this development program will support

global filings in the second half of 2009.

METAZYM (HGT-1111) - Metachromatic Leukodystrophy ("MLD")

- METAZYM is being investigated for the treatment of MLD and has

completed a Phase 1b clinical trial in twelve patients in Europe and an

extension to this study is ongoing. The product has been granted orphan

drug designation in the US and in the EU. The current plan is to

initiate a Phase 2/3 clinical trial by the end of 2008. This product

will now be referred to as HGT-1111.

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SOURCE Shire Ltd
Copyright©2008 PR Newswire.
All rights reserved

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6. Shire plc: Board Changes
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