The facility was acquired from Dow in 2006 and since then Alexion has worked to equip the site for production of Soliris (eculizumab), a treatment for rare blood disorder paroxysmal nocturnal hemoglobinuria.
Alexion is now nearing the end of this process and has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).
The CHMP’s positive opinion recommends the European Commission approves the site, which is expected to occur in early 2010. Gaining approval would allow Alexion to use the Rhode Island site as a second source for supplying the European Union.
To date demand for Solaris has been met through a supply contract with Lonza but Alexion has stated it wants to source the drug from multiple sites, one of which will be its Rhode Island facility if approval is gained.
As part of this effort Alexion is planning to meet the US Food and Drug Administration (FDA) to provide additional information and discuss the agency’s request for a limited number of production runs in connection with the pre-approval inspection process.
Alexion has also provided an update on a regulatory review of an external vialer previously used by the company. The authorities have permitted release of the batches of Solaris filled by the vialer, resolving the issue at no loss to Alexion.