SuperGen Inc. has withdrawn its marketing authorisation application (MAA) for Orathecin (rubitecan) capsules from the European Medicines Agency (EMEA).

Orathecin is the company's investigational drug being developed for the treatment of pancreatic cancer in patients who have failed at least one prior chemotherapy regimen. SuperGen's decision is based on extensive discussions with the EMEA, states a company release.

SuperGen currently has a phase II clinical trial ongoing in the United States studying Orathecin and gemcitabine as a first-line combination therapy for advanced pancreatic cancer patients who have not undergone chemotherapy. SuperGen intends to make a decision on future development or the alternative disposition of Orathecin based on a review of the interim results of this trial, expected to occur during the first half of 2006.

Orathecin (rubitecan) capsules, an orally active camptothecin, is a topoisomerase I inhibitor that is being developed for the treatment of pancreatic cancer.

Orathecin has orphan drug status in both the US and EU. The Orathecin European filing, or marketing authorisation application, contains data from a phase III clinical programme believed to be the largest program in pancreatic cancer ever initiated worldwide, with more than 1,000 patients. Orathecin has also been evaluated in numerous other cancers and blood disorders. SuperGen originally submitted its MAA for Orathecin to the EMEA on July 1, 2004.

SuperGen is a pharmaceutical company dedicated to the acquisition, rapid development and commercialisation of therapies for solid tumours, haematological malignancies and blood disorders.