Regulators in Europe have confirmed that Celgene has decided to withdraw its application to get marketing approval for the cancer drug satraplatin.

The European Medicines Agency says it has been formally notified by Celgene Europe of the decision taken by its Pharmion unit to withdraw the application for a centralised marketing authorisation for satraplatin 10mg and 50mg capsules. The drug, which would have had the trade name Orplatna, was expected to be used, in combination with prednisone and prednisolone, in the treatment of patients with metastatic hormonerefractory prostate cancer who have failed prior chemotherapy.

The EMEA says that in its official letter, the company claimed the withdrawal of Orplatna was based on a review by the agency’s Committee for Medicinal Products for Human Use which stated that the data provided did not allow the latter “to conclude a positive benefit-risk balance” for the drug. The application to the CHMP was submitted last June.

Pharmion bought the European rights to satraplatin from Germany’s GPC Biotech and the withdrawal of the application to the EMEA is extremely bad news for the latter firm. A year ago, GPC pulled its own marketing application in the USA for the drug after the company received a negative response from the US Food and Drug Administration’s Oncologic Drugs Advisory Committee, a decision which set off a turbulent time for the Martinsried-based group.

GPC, which was forced into a series of restructurings and has lost 80% of its workforce, is exploring various merger and acquisition opportunities. However, the withdrawal of the satraplatin application is another blow as it was eligible for royalty payments and reduces the company’s bargaining power in any merger talks.