Shares in UK group Shire were on the rise yesterday after regulators gave the go ahead for the company to market Elaprase for the treatment of Hunter syndrome in Mexico, marking its first Latin American approval.

Elaprase (idursulfase) is the first and only human enzyme replacement therapy approved for the treatment of Hunter syndrome - a life-threatening genetic condition caused by the absence of, or deficiency in, the lysosomal enzyme iduronate-2-sulfatase - and its approval in Mexico gives patients there a much-needed new treatment option and Shire the chance to boost sales of the treatment.

“The approval of Elaprase in Mexico marks a significant milestone because for the first time, Hunter syndrome patients in Mexico have access to treatment,” explained Sylvie Grégoire, President of Shire HGT, the Shire business unit focused on genetic diseases. “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,” added
Dr Luis Figuera Villanueva, Professor of Human Genetics for the Central University of Heath Sciences at the University of Guadalajara.

Q3 sales reach $55.1 million
Since the drug’s first approval in the USA in July 2006, Elaprase has been cleared for marketing and commercial distribution in 37 countries worldwide, with a green light in Europe in January 2007, and the therapy generated sales of $55.1 million during the third quarter of 2007.

Analysts at Collins Stewart have previously estimated that the drug will pull in peak sales of around $400 million by 2015, and $200 million by the end of this decade, given that “there is a very limited chance of any competition arriving for the drug.”

Shire estimates that there are approximately 2,000 patients worldwide afflicted with Hunter Syndrome in countries where reimbursement may be possible, and says it expects to launch the product in Mexico within the first half of 2008.