Shire plc: Excellent Performance Across All Areas of the Business and Accelerating New Product Sales Drive Revenue Gro...(ican Federal Commission for the Protecti...)

- In October 2007 ELAPRASE was launched in Japan, with sales and distribution managed by Genzyme Corporation. Shire's gross profit on the arrangement equates to an effective royalty of approximately 25% to 30%, but revenues will be recorded within product sales.

- REPLAGAL(R) - Fabry disease.

- REPLAGAL is now approved in 41 countries and sales for 2007 were up 22% to $143.9 million (2006: $117.7 million).

- In February 2007 REPLAGAL was launched in Japan through Shire's partner Dainippon Sumitomo Pharma Co., Ltd. Similar to ELAPRASE, Shire will record revenues within product sales.

Pipeline Highlights

Shire has expanded its product pipeline by in-licensing the following drug compounds and technologies in 2007:

- JUVISTA(R)

- In August 2007 Shire acquired exclusive rights to develop and commercialize JUVISTA worldwide (with the exception of EU member states) from Renovo Limited ("Renovo"). JUVISTA, which is being investigated for the prevention and reduction of scarring in connection with surgery, is in late Phase 2 development.

- Seven Phase 2 efficacy trials for JUVISTA have now been reported of which six demonstrated statistically significant efficacy. Phase 2 clinical trials in multiple other surgery types are ongoing and are expected to report during 2008 and 2009.

- Pharmacological chaperone compounds for Lysosomal Storage Disorders ("LSDs") - In November 2007 Shire in-licensed from Amicus Therapeutics, Inc. ("Amicus") the rights to three compounds in markets outside the US:

- AMIGAL(TM) for Fabry disease (Phase 2) received orphan drug designation by the EMEA, which may provide it with up to ten years market exclusivity in the EU;

- PLICERA(TM) for Gaucher disease (Phase 2) rec
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