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Publication of Shire plc's Annual Report 2008
Date:3/25/2009

Leukodystrophy, ('GLD'))

In November 2008 Shire announced that an enzyme replacement therapy was being developed for the treatment of Krabbe disease. This program is in early development and preclinical studies.

Pharmacological Chaperone Technology

In November 2007 Shire entered into a license agreement with Amicus under which it received the rights to three compounds, PLICERA, AMIGAL and AT2220, in markets outside the US.

PLICERA (HGT-3410 for the treatment of Gaucher disease)

PLICERA is an orally-administered, small molecule pharmacological chaperone that is being developed for the treatment of Gaucher disease. PLICERA has received orphan drug designation by the European Medicines Agency ('EMEA'),which may provide it with up to ten years market exclusivity in the EU.

In March 2008 Amicus announced positive data from its Phase 2 clinical trial. Results from the Phase 2 trial support the previously reported interim findings that PLICERA was generally safe and well tolerated at all doses and increased target enzyme activity levels in a majority of patients. Shire has rights to PLICERA in markets outside the US.

AMIGAL (HGT-3310 for the treatment Fabry disease)

AMIGAL is an orally-administered, small molecule pharmacological chaperone being developed for the treatment of Fabry disease. AMIGAL has received orphan drug designation by the EMEA, which may provide it with up to ten years market exclusivity in the EU.

Amicus met with the FDA to discuss the AMIGAL development program in June 2008, and discussions are ongoing. Discussions are also ongoing with the EMEA. A final decision on the global development strategy will follow the conclusion of the discussions with both agencies. Shire has rights to AMIGAL in markets outside the US.

HGT-3510 for the treatment of Pompe disease

HGT-3510 is an orally-a
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Prepared by multi-temperature ethanol fractionation with extensive charcoal treatment and dialysis.• Assay: ≥ 95 % (HPCE)• pH ~5.2 (10 mg/mL in 0.15 M NaCl)...
Special grade: for electrophoresis...
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