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Shire's New Product Portfolio Delivers Strong Quarterly Performance


Pipeline Highlights


- Jerini received a not approvable letter for FIRAZYR for use in the US

from the US Food and Drug Administration ("FDA") in April 2008, and

plans to provide a complete response by the end of the year.

JUVISTA(R) - Improvement of scar appearance

- Renovo Limited ("Renovo") intends to initiate its first pivotal

European Phase 3 trial in scar revision in the fourth quarter of 2008

in support of Renovo's filing of a European regulatory dossier. If the

outcome from Renovo's multi centre, EU Phase 3 study is suitably

positive, the data will be used to inform the strategy and design of

Shire's US development plan and to strengthen the chances of regulatory

and commercial success in the US.

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

- Shire has an ongoing enzyme replacement therapy program for the

treatment of MLD, which is a lysosomal storage disorder that results

from a deficiency in the enzyme arylsulfatase-A ("ASA"). METAZYM, a

clinical candidate ASA acquired from Zymenex in the second quarter of

2008, has completed a Phase 1b clinical trial in 12 MLD 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 as soon as possible

following discussions with regulatory authorities in Q4 2008.

Business Highlights

Acquisition of Jerini

- During Q3 2008 Shire acquired a majority voting interest in Jerini and

published an Offer Document in respect of acquiring the remaining

shares in Jerini that it did not already own. By September 30, 2008

Shire had acquired over 90% of the shares in Jerini and now owns

approximately 93% of the shares. The acquisition has

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

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