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Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials
Date:9/1/2009

parisons of increases in platelet counts, decreases in organ volumes, and surrogate markers of Gaucher disease.

In this study of enzyme replacement naive patients, velaglucerase alfa demonstrated robust clinical efficacy that was comparable to imiglucerase in all endpoints.

Study 034 was a 12-month switch study in 40 clinically stable Type 1 Gaucher patients aged two years and older who had been receiving treatment with imiglucerase at doses ranging between 15 U/kg and 60 U/kg every other week for a minimum of 30 consecutive months. This study assessed the safety of patients switched from imiglucerase to velaglucerase alfa administered at the same number of units as their imiglucerase dose. In this study, hemoglobin concentrations, platelet counts, and organ volumes were sustained through 12-months of velaglucerase alfa treatment, and the therapy was generally well-tolerated.

In all three studies, most adverse events were mild to moderate in intensity. Most of the drug-related adverse events were reported in association with velaglucerase alfa infusions, all of which resolved without sequelae.

The development of antibodies to velaglucerase alfa was rare in all three studies, occurring in approximately 1% of patients treated.

The specific data from all three trials will be presented at future scientific meetings.

Background on Gaucher disease

Gaucher disease is an autosomal recessive disorder caused by mutations in the GBA gene which results in a deficiency of the lysosomal enzyme beta-glucocerebrosidase. This enzymatic deficiency causes an accumulation of glucocerebroside, primarily in macrophages. In this lysosomal storage disorder (LSD), clinical features are reflective of the distribution of Gaucher cells in the liver, spleen, bone marrow, skeleton, and lungs. The accumulation of glucocerebrosidase in the liver and spleen leads to organomegaly.
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