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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

ents were safely transitioned to VPRIV (15-60U/kg EOW) from the same number of units of imiglucerase. Clinical measures of disease remained stable over 12 months.

TKT-034 Results Highlights Include:

  • No patients developed IgG antibodies to VPRIV, including 3 patients who tested positive for anti-imiglucerase antibodies at screening.
  • Hemoglobin concentrations, platelet counts, and liver and spleen volumes remained stable over the course of the one year study.

"We are very pleased with the opportunity to present these findings at the EWGGD, a key scientific meeting for the Gaucher community," said Ferd Massari, VP and Global Head of Clinical and Medical Affairs, Shire Human Genetic Therapies. "The data presented underscore the long term safety and efficacy of VPRIV for treatment naïve Gaucher patients, as well as for patients who switched from imiglucerase to VPRIV. Moreover, they demonstrate that VPRIV may offer benefits regarding the achievement of therapeutic goals, including improvements in bone parameters."

About VPRIV

VPRIV is Shire's enzyme replacement therapy for type 1 Gaucher disease. VPRIV is made using Shire's gene-activation technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and has a human glycosylation pattern.

VPRIV was approved by the US FDA as a long-term enzyme replacement therapy for adult and pediatric patients with type 1 Gaucher disease on February 26, 2010. On June 25, 2010, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion on the marketing authorisation for VPRIV for the treatment of type 1 Gaucher disease.


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SOURCE Shire plc
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