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Data Presented at the European Working Group on Gaucher Disease Demonstrate Continuous Improvements in Bone Mineral Density for VPRIV(R) (Velaglucerase Alfa) Through 69 Months
Date:7/1/2010

CAMBRIDGE, Mass., July 1 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced positive data from its long-term extension to its open label Phase I/II study (TKT-025 EXT) for VPRIV® (velaglucerase alfa), the company's enzyme replacement therapy for patients with type 1 Gaucher disease.  The data were presented at the 9th Annual European Working Group on Gaucher Disease (EWGGD) in Cologne, Germany, and add to the growing body of clinical evidence which supports the safety and sustained efficacy of VPRIV.

A post-hoc analysis was undertaken of TKT-025 EXT to evaluate the achievement of long-term therapeutic goals, including improvement in bone mineral density (BMD), among all 8 type 1 treatment naive Gaucher patients who participated in TKT-025 EXT and were treated for a minimum of 48 months.  The initial dose of 60 U/kg administered intravenously every other week (EOW) was lowered in a step-wise fashion to 45 U/kg EOW and then to 30 U/kg EOW after patients achieved at least 2 of 4 predefined therapeutic goals following 1 year of treatment.  Seven of the 8 patients were maintained at the lower dose.  All of the patients achieved the therapeutic goals for hemoglobin concentrations, platelet counts, liver and spleen volumes, and improvement in BMD within 4 years of initiation of treatment with VPRIV.

A separate post-hoc analysis of the change in BMD among patients in TKT-025 EXT through 69 months was also reported.  All intent to treat (ITT) patients (n=10) had type 1 Gaucher disease-related bone issues such as osteoporosis and osteopenia at baseline.  Changes in BMD were monitored
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