EMEA Reviews Revlimid

Celgene Corporation announced that the European Medicines Agency (EMEA) has accepted Revlimid (lenalidomide) for review. The application is based on clinical data from a Phase II trial of MDS patients.

Revlimid has been designated as an Orphan Medicinal Product in the European Union (EU) for the treatment of MDS.

Revlimid also has been designated as an Orphan Medicinal Product in the EU for treatment of multiple myeloma (MM).

Celgene expects to file its Drug Application for Revlimid in previously treated patients with relapsed/refractory MM to the FDA in 4Q 2005, and to the EMEA in 1Q 2006.