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Shire Receives 2010 Corporate Award From the National Organization for Rare Disorders (NORD) for the Development of VPRIV (velaglucerase alfa for Injection)
Date:5/19/2010

y other marketed ERT for Type 1 Gaucher disease.

VPRIV was approved by the Food and Drug Administration (FDA) on February 26, 2010, as a long-term treatment for adult and pediatric patients with Type 1 Gaucher disease. It has also been granted accelerated assessment by the European Medicines Agency (EMA) in the European Union (EU). Shire expects to launch VPRIV in the EU in the second half of 2010, and in other countries beginning in 2011.

"It is a tremendous honor to be recognized by NORD," said Sylvie Gregoire, President of Shire HGT. "This award embodies the spirit of our organization-every employee at Shire is dedicated to developing and bringing forward new products, services and support offerings which can make a positive impact on patients' daily lives. We look forward to collaborating with NORD on many other important initiatives in the future."

Important Safety Information for VPRIV

The most serious adverse reactions seen with VPRIV were hypersensitivity reactions. Infusion-related reactions were the most commonly observed adverse reactions in patients treated with VPRIV in clinical studies. The most commonly observed symptoms of infusion-related reactions were: headache, dizziness, low or high blood pressure, nausea, tiredness and weakness, and fever. Generally the infusion-related reactions were mild and, in treatment-naive patients, onset occurred mostly during the first 6 months of treatment and tended to occur less frequently with time. Adverse reactions more commonly seen in pediatric patients compared to those observed in adult patients (>10% difference) include rash, upper respiratory tract infection, prolonged activated partial thromboplastin time, and fever.

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SOURCE Shire plc
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