We would like to take this opportunity to provide an important update to the global Pompe Community.
In the early stages of development of Myozyme® (alglucosidase alfa), Genzyme initiated manufacturing at a small scale, and has since scaled-up the process to produce larger quantities of product for commercial use worldwide. The bioreactors in which alglucosidase alfa has been produced over the course of time have steadily grown in size to the 2000 liter (L) scale that currently produces Myozyme for worldwide use. This incremental scale-up is standard manufacturing practice for any biological drug development process. Due to the rapidly growing number of patients with Pompe disease receiving treatment, worldwide demand for Myozyme has continuously increased since it was launched in April 2006. Anticipating a higher long-term demand, Genzyme started to develop an even larger production facility of 4000 L bioreactors for Myozyme approximately five years ago at a manufacturing facility located in Belgium. Genzyme has submitted an application seeking approval to produce Myozyme at the 4000 L scale to the European Medicines Agency (EMEA), the regulatory authority that assesses whether a drug is efficacious and safe in the European Union. Under the standard 60-day review process we would expect approval in April 2009 at the earliest. Genzyme has requested an expedited review of its application from the EMEA Committee for Medicinal Products for Human Use (CHMP). Ultimately, Genzyme plans to apply for 4000 L approval with regulatory agencies throughout the world to be the main supplysource of Myozyme in its effort to assure a sustainable supply for the Pompe Community.