SuperGen Inc announced that its European affiliate, EuroGen Pharmaceuticals Ltd. (EuroGen), has been granted an 'orphan medical product designation' by the European Agency for the Evaluation of Medicinal Products (EMEA) for the investigational anticancer drug Orathecin that is being developed as a treatment for pancreatic cancer.

The Committee for Orphan Medicinal Products (COMP) of the EMEA found that EuroGen, as the sponsor, has established that although satisfactory methods of treatment of pancreatic cancer has been authorized in the Community, Orathecin, if approved, may be of significant benefit to those affected by pancreatic cancer.

The EMEA's 'orphan' designation promotes development of drugs to treat rare diseases or life-threatening conditions by providing marketing exclusivity to approved orphan products for 10 years following regulatory approval.

"This European orphan designation review process has helped us prepare for the full European submission, which should follow the completion of the final module of the U.S. New Drug Application (NDA)," said Dr. Joseph Rubinfeld, Chairman and Chief Executive Officer of SuperGen. "We believe that all data has been formatted to comply with both the FDA and the EMEA submission standards."

Orathecin is currently in the latter stages of a "rolling, fast-track" NDA in the United States for the treatment of pancreatic cancer that is resistant or refractory to treatment.