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Shire Receives CHMP Positive Opinion for VPRIV(TM) (velaglucerase alfa) for the Treatment of Type 1 Gaucher Disease in the European Union
Date:6/25/2010

"A positive opinion for VPRIV in the EU, earlier than expected, is very good news, particularly as we have been working with physicians in 22 countries for almost a year to treat patients with type 1 Gaucher disease through early access programs," said Sylvie Gregoire, President, Shire Human Genetic Therapies. "We look forward to our ongoing collaboration with these physicians and the Gaucher community at large as we enter the final stages of the approval process in Europe."

In addition to the CHMP positive opinion, VPRIV has received orphan drug designation from the Committee for Orphan Medical Products.

With the accelerated adoption of VPRIV worldwide, and the earlier than anticipated US approval and EU positive opinion, Shire expects continued high demand for the therapy. As a result of this, the company is now implementing a program with physicians and patients to monitor and manage requests from new patients carefully in order to ensure long-term, uninterrupted treatment with VPRIV.

Shire's VPRIV clinical development program represents the largest and most comprehensive clinical data set supporting registration for an ERT for Type 1 Gaucher disease to date.

About VPRIV(TM)

VPRIV is made using Shire's gene-activation technology, in a human cell line. The glucocerebrosidase enzyme produced has the exact human amino acid sequence and has a human glycosylation pattern.

VPRIV was approved by the U.S. Food and Drug Administration on February 26, 2010. For full US prescribing information see

SOURCE Shire plc
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