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Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
Date:7/6/2009

LEXINGTON, Massachusetts, July 6 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher Disease patients, it has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher Disease.

If approved by the FDA, the treatment protocol would allow physicians to treat Gaucher Disease patients with velaglucerase alfa ahead of commercial availability in the US. Under the conditions of the treatment protocol, Shire would provide velaglucerase alfa free of charge initially, in order to provide access to patients as quickly as possible.

Velaglucerase alfa is made with Shire's proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and carries a human glycosylation pattern.

Shire has sufficient supply of velaglucerase alfa to meet anticipated patient demand.

Shire is working with the FDA to file a New Drug Application (NDA) for velaglucerase alfa as early as possible.

Shire will provide further updates when available via press releases and/or its website (http://www.shire.com) on its progress with its discussions with the FDA and other regulatory bodies about the development of velaglucerase alfa as an alternative choice for Gaucher Disease patients.

Background on Gaucher Disease

Gaucher Disease is an autosomal recessive disease and the most prevalent Lysosomal Storage Disorder (LSD), with an incidence of about 1 in 20,000 live births. Despite the fact that Gaucher Disease consists of a p
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SOURCE Shire Plc
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