Japan's MHLW OKs Shire's Elaprase

UK drugmaker Shire says that Japan's Ministry of Health, Labor and Welfare has approved its product Elaprase (idursulfase) for the treatment of Hunter syndrome. The decision means that the drug, a human enzyme replacement therapy, has gained regulatory clearance in 34 countries worldwide since the US Food and Drug Administration first approved it last year (Marketletter July 31, 2006).

Shire president Sylvie Gregoire said that the decision is another step towards making the drug available to Hunter syndrome patients worldwide. She added that the firm greatly appreciated the commitment of Japanese patients to the drug, some of whom temporarily moved to the USA to participate in its clinical trial program.

Japanese sale and distribution of Eleprase will be carried out by US biotechnology major Genzyme, under a pre-existing agreement between the two firms (Marketletters passim). Under the terms of the deal, Genzyme will make a $3.0 million payment as a result of MHLW approval, and is set to pay a further $4.0 million when reimbursement is secured. Additionally, the US company will record net sales of the product in the region, allocating approximately one third of the generated revenue to Shire.