FIRAZYR - HAE
- 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.
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|
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