Pharmion submits thalidomide to EMEA

Nasdaq-listed Pharmion Corp has submitted a marketing authorization application with the European Medicines Agency (EMEA) for thalidomide as a therapy of untreated multiple myeloma. The submission includes details of the Pharmion Risk Management Program as a condition of supply following potential approval.

Philippe Moreau, professor of clinical hematology at Nantes Faculty of Medicine, France, said that, in a study he carried out together with colleagues, thalidomide showed significant benefit when added to the standard-of-care in untreated elderly patients with MM. "Based on these data, and particularly the unprecedented 21-month survival advantage demonstrated for the thalidomide arm, we believe that thalidomide, melphalan and prednisone should rapidly become the reference therapy for this patient population. We hope the EMEA acts urgently to approve this very critical therapy," he added.

Thalidomide Pharmion has been designated as an Orphan Medicinal Product in the European Union for MM which, if approved, entitles the drug to 10 years of market exclusivity for the approved indications. The application is based upon a clinical data package comprised of four studies in more than 1,400 patients, Pharmion noted.