Aldurazyme granted EU marketing approval

The EC has granted marketing authorisation for Aldurazyme (laronidase), the first specific treatment approved in the EU for mucopolysaccharidosis I (MPS I). Aldurazyme was developed by BioMarin and Genzyme under a joint venture agreement that assigns commercial manufacturing responsibilities to BioMarin and worldwide sales and marketing responsibilities to Genzyme.

Aldurazyme will be manufactured at BioMarin's plant in Novato, California, which has sufficient capacity to launch the product and to meet worldwide commercial demand. Bulk enzyme will be sent to Genzyme's manufacturing facility in Allston, Massachusetts, US, or to a third-party facility for the final filling and finishing process. Genzyme's manufacturing facility in Haverhill, UK, will be responsible for import and batch release in the European Economic Area.

Genzyme will launch Aldurazyme in the EU on a country-by-country basis. As the first orphan drug approved for MPS I in the EU, Aldurazyme has been granted 10 years of market exclusivity. The drug was approved in the US on 30 April, 2003, and patients began to receive therapy in mid-May. Applications to market Aldurazyme are also pending in Israel, Canada, New Zealand and Australia, and the companies expect a regulatory response in these countries in late 2003 or early 2004.