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Shire Presents Positive New Data at the 60th Annual American Society of Human Genetics (ASHG) for Patients with Type 1 Gaucher Disease
Date:11/4/2010

CAMBRIDGE, Mass., Nov. 4, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today presented positive new data from a Phase III clinical trial (study 039) designed to evaluate the efficacy of VPRIV® (velaglucerase alfa for injection) compared with imiglucerase in patients with type 1 Gaucher disease at the 2010 Annual American Society of Human Genetics (ASHG) in Washington, D.C. The study met its primary endpoint and adds to the growing body of clinical evidence which supports the use of VPRIV in patients who have transitioned from imiglucerase or who are treatment-naive. 

In the 039 (head-to-head) study, adult and pediatric patients with type 1 Gaucher disease were included in a 9-month, global, randomized, double-blind, non-inferiority study comparing VPRIV with imiglucerase in treatment-naive patients aged >/= 2 years, with anemia and either thrombocytopenia or organomegaly. Patients were randomized in a 1:1 ratio to receive either VPRIV or imiglucerase at a dose of 60U/kg via continuous infusion over one hour every other week for 39 weeks (total of 20 infusions per patient). 35 patients in 9 countries were randomized and 34 received the study drug (intent-to-treat [ITT] population was 17 in both the VPRIV and imiglucerase groups). The per-protocol (PP) analysis included 15 patients in each group. Baseline clinical characteristics were generally similar between the 2 groups, although hemoglobin concentrations appeared slightly higher in the VPRIV group.

After 9 months of treatment, hemoglobin concentration improved in both groups. The estimated mean treatment difference for hemoglobin concentration from baseline between patients treated with VPRIV and imiglucerase was 0.14 and 0.16 g/dL in the ITT and PP populations, respectively, with a lower bound of the 97.5% one-sided confidence inte
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