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Shire Announces Approval of ELAPRASE(R) (idursulfase) in Brazil
Date:5/26/2008

ients beyond palliative care, and provide specific treatment for Hunter syndrome."

Since its U.S. approval in July 2006, ELAPRASE has been approved for marketing and commercial distribution in several countries around the world, most recently in Mexico and Russia.

[1] Caggeso, Mike. "Outlook 2008: The Latin American Economy is 'Muy Caliente'", Money Morning. January 8, 2008 <http://www.moneymorning.com/2008/01/08/outlook-2008-the-latin-american-eco no my-is-muy-caliente%C2%A0/> (Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field. Remove the space if one exists.)

Notes to editors

About ELAPRASE(R)

ELAPRASE is a purified form of the lysosomal enzyme iduronate-2-sulfatase and is produced by recombinant DNA technology in a human cell line. ELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II.) ELAPRASE has been shown to improve walking capacity in these patients.

Safety Considerations

Some patients in the clinical trials experienced life-threatening immediate allergic reactions to ELAPRASE (idursulfase) infusion. Patients who have experienced severe allergic reactions may experience another allergic reaction approximately 24 hours after the initial reaction and may require prolonged observation. Patients with compromised respiratory function or acute respiratory disease may have a higher risk of life-threatening reactions to ELAPRASE infusion and require additional monitoring.

Life-threatening allergic reactions have been seen in some patients during ELAPRASE infusions. Reactions included difficulty breathing, lack of oxygen, seizure or loss of consciousness, hives, and/or swelling of the throat or tongue. Patients received an antihistamine to reverse the allergic reaction or corticosteroid to decre
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