This excerpt taken from the ALXN 8-K filed Jul 25, 2007.
Soliris Commercial Update International
On June 22, 2007, Alexion announced that the European Commission granted marketing approval for Soliris for all patients with PNH. Since that time, the Company has been working on completing the reimbursement processes, which vary by country. The Company continues to sell Soliris on a named-patient basis in Europe. Alexion expects to make Soliris commercially available during the fourth quarter of this year in Germany and the United Kingdom, followed by other major European countries in 2008.
The science, clinical data and approved product label in Europe all support broad access to Soliris for the treatment of PNH. We are working with officials in major markets to secure reimbursement, and we expect initial commercial launch during the fourth quarter of this year, said David Keiser, President and Chief Operating Officer of Alexion. We continue to attract exceptional talent into the organization as we scale up our commercial operations on a country by country basis. Like the U.S., our goal in Europe is that every patient who can benefit from Soliris, will have access to Soliris.
In June 2007, Alexion was informed by the Australian regulatory authorities that it had granted priority review status for the recently submitted Soliris New Drug Application.