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Shire Presents Data at ACMG for Fabry and Gaucher Patients Who Switched to Replagal® (agalsidase alfa) and VPRIV® (velaglucerase alfa for injection)
Date:3/21/2011

p>"The data presented here reinforces our confidence in the treatments that Shire has developed for Fabry and Gaucher diseases. I am pleased that Shire has been able to continue supporting the Fabry and Gaucher patient communities," commented Dr. Paul M. Fernhoff, Division of Medical Genetics of the Emory University School of Medicine.

Replagal and VPRIV were developed by Shire using its proprietary gene activation technology in human cell lines. Shire has utilized this technology to manufacture enzyme replacement therapies for nearly two decades.

"We are pleased to continue our commitment to support patients and healthcare providers who are dedicated to treating rare diseases. The data presented at ACMG strengthens the body of evidence for Replagal and VPRIV as treatments that may benefit Fabry and Gaucher patients," said Sylvie Grégoire, President of Shire HGT. "Shire has invested more than $200 million on enhancing capacity and technology in order to ensure safe and consistent drug supplies, and we anticipate the first approval of the new Lexington manufacturing facility at the end of 2011."

About REPLAGAL (agalsidase alfa)

Replagal is a human form of enzyme alpha-galactosidase A (a-Gal A) manufactured in a human cell line by gene activation. 2011 marks our 15th year of clinical experience with Replagal, which is now approved in 46 countries. Over 2,300 patients are now being treated with Replagal globally. This figure represents about 70 percent of the treated Fabry patients worldwide. Replagal is not currently approved for commercial sale in the U.S.

Replagal is the only human-cell-line-derived form of enzyme replacement therapy (ERT) that is indicated for the long-term treatment of patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency).

About VPRIV (velaglucerase alfa for injection)

VPRIV was approved by the US FDA as a hydrolytic lysosomal glucocerebroside-s
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