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Shire plc: Continued Excellent Performance in Q3, Full Year Earnings Expectations Increased, New Value in Pipeline Emerging
Date:10/29/2010

king it available in 30 countries across Europe. - Shire has seen rapid adoption of VPRIV worldwide. There are currently over 1,000 Gaucher patients treated with VPRIV and initiation of treatment continues. Based on its current manufacturing capacity, Shire anticipates being able to accommodate approximately 200 additional Gaucher patients until the approval of the Lexington Manufacturing facility provides substantial additional capacity. Shire has an ongoing program to monitor demand and manage requests for VPRIV. Shire's priority is ensuring long-term, uninterrupted treatment of patients on therapy. FIRAZYR - for the treatment of HAE - In October 2010, Shire submitted data to support a change in the label in the EU to include the potential for self-administered subcutaneous injections of FIRAZYR in patients who are experiencing acute attacks of HAE.

Pipeline

This quarter we have made significant developments in our pipeline, including:

Collaboration with Acceleron for ActRIIB molecules - On September 9, 2010 Shire announced the expansion of its HGT pipeline through the exclusive licence, in markets outside of North America, for the ActRIIB class of molecules being developed by Acceleron. The collaboration will initially investigate ACE-031, Acceleron's lead ActRIIB drug candidate, which is currently in a Phase 2a trial for the treatment of patients with Duchenne Muscular Dystrophy. ACE-031 and other ActRIIB molecules have the potential to be used in other muscular and neuromuscular disorders with high unmet medical need. Pipeline obtained through Movetis acquisition - The acquisition of Movetis brings to Shire a promising GI pipeline, offering additional opportunities that include two projects in early clinical development and several pre-clinical leads as well as the rights to a large library of qualified lead compounds with potential for development in different GI indications. VYVANSE for the adjunctive therapy in the treatment of ina
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