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- In March 2008 Amicus Therapeutics Inc. ("Amicus") announced positive
data from its Phase 2 clinical trial for PLICERA. Results from this
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.
HGT-3510 - Pompe disease
- In June 2008 Amicus initiated Phase 2 clinical trials of HGT-3510, an
orally administered, small molecule pharmacological chaperone being
jointly developed for the treatment of Pompe disease by Shire and
Amicus. Shire has rights to HGT-3510 in markets outside the US.
HGT-1410 - Sanfilippo syndrome (Mucopolysaccharidosis IIIA)
- On May 22, 2008 orphan drug designation was granted by the FDA for
HGT-1410, an enzyme replacement therapy being developed for the
treatment of Sanfilippo syndrome, a lysosomal storage disorder.
Pre-clinical development for this product is continuing.
Business Highlights
A new listed holding company for the Shire group
- On May 23, 2008 Shire Limited, a public company with its primary
listing on the London Stock Exchange (secondary listing on NASDAQ),
incorporated in Jersey and tax resident in the Republic of Ireland,
became the holding company of the Shire group, pursuant to a scheme of
arrangement under Sections 895 to 899 of the United Kingdom Companies
Act 2006 (the "Scheme"). The Scheme was approved by the High Court of
England and Wales and the shareholders of Shire plc, the former holding
company of the Shire group. The introduction of a new holding company
tax resident in Ireland, is designed to help protect Shire's tax
position.
- Immediately prior to the Schem
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