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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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