Press Release
Shire’s ELAPRASE® (idursulfase) Approved in Mexico for Treatment of Hunter Syndrome
Mexico is the First Latin American Country to Approve Treatment
13 Feb 2008 - Basingstoke UK and Cambridge MA, US - February 13, 2008 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, announced that ELAPRASE® (idursulfase), a human enzyme replacement therapy for the treatment of Hunter syndrome, has been approved for commercial sale by the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS). Mexico is the tenth-largest pharmaceutical market in the world1 and the first Latin American country to approve ELAPRASE.
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, developed by Shire Human Genetic Therapies (HGT), is the first and only enzyme replacement therapy approved for people suffering from Hunter syndrome. The medicine is given as a weekly infusion and is designed to replace the deficient iduronate-2-sulfatase enzyme.
“The approval of ELAPRASE in Mexico marks a significant milestone because for the first time, Hunter syndrome patients in Mexico have access to treatment,” said Sylvie Grégoire, President of Shire HGT, the Shire business unit focused on genetic diseases. “This approval also underscores our dedication and commitment to provide meaningful treatments for patients suffering from serious and often neglected diseases around the world.”
“Hunter syndrome is a devastating disease and until now, Mexican citizens had no viable treatment,” said Dr. Luis Figuera Villanueva, Title C Investigator, Division of the Genetic Center of Western Biomedical, Investigator of the IMSS and Professor of Human Genetics for the Central University of Heath Sciences, University of Guadalajara. “As a physician, it’s exciting and rewarding to now be able help these patients and their families and offer them hope for a brighter future.”
“Hunter syndrome is a devastating disease and until now, Mexican citizens had no viable treatment,” said Dr. Luis Figuera Villanueva, Title C Investigator, Division of the Genetic Center of Western Biomedical, Investigator of the IMSS and Professor of Human Genetics for the Central University of Heath Sciences, University of Guadalajara. “As a physician, it’s exciting and rewarding to now be able help these patients and their families and offer them hope for a brighter future.”
Since its U.S. approval in July 2006, ELAPRASE has been approved for marketing and commercial distribution in 37 countries worldwide including countries in Europe and Japan. Shire expects to launch the product in Mexico within the first half of 2008.
1 Epsicom Business Intelligence. (June 30, 2007) The Pharmaceutical Market: Mexico
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