Shire Limited, the global specialty biopharmaceutical company, announced that Elaprase (idursulfase), a human enzyme replacement therapy for the treatment of Hunter syndrome, has been approved by the Brazilian Regulatory Agency, Agência Nacional de Vigilância Sanitária (ANVISA).

Elaprase, developed by Shire Human Genetic Therapies (HGT), a business unit of Shire focused on genetic diseases, is the first and only enzyme replacement therapy approved for people suffering from Hunter syndrome. Brazil is the largest economy in Latin America and the ninth largest in the world . With this approval, Elaprase is now cleared for marketing in two countries in the region - Brazil and Mexico.

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.

Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II), is a serious, life-threatening genetic condition mainly affecting males that results from an absence of, or deficiency in, the lysosomal enzyme iduronate-2-sulfatase. Without sufficient amounts of this enzyme, cellular waste products accumulate in tissues and organs, which then begin to malfunction, leading to severe clinical complications and early mortality. ELAPRASE, which is given as a weekly infusion, is designed to replace the deficient iduronate-2-sulfatase enzyme.

"Approval of Elaprase in Brazil further demonstrates our commitment to bringing meaningful treatments to patients across Latin America - and the world," said Sylvie Grégoire, President of Shire HGT.

"This is a tremendous milestone for the many Hunter syndrome patients in Brazil, who will now have access to treatment for this serious and life-threatening disease," said Professor Roberto Giugliani, Hospital de Clínicas de Porto Alegre. "With Elaprase, physicians will now be able to move patients beyond palliative care, and provide specific treatment for Hunter syndrome"

Since its US 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.