Orathecin capsules granted orphan product status in Europe

Published: 12-Jun-2003

The European Agency for the Evaluation of Medicinal Products (EMEA) has granted orphan drug status to the investigational anticancer drug Orathecin that is being developed as a treatment for pancreatic cancer by California-based SuperGen and its European affiliate, EuroGen Pharmaceuticals, of Dublin.


The European Agency for the Evaluation of Medicinal Products (EMEA) has granted orphan drug status to the investigational anticancer drug Orathecin that is being developed as a treatment for pancreatic cancer by California-based SuperGen and its European affiliate, EuroGen Pharmaceuticals, of Dublin.

The Committee for Orphan Medicinal Products (COMP) of the EMEA found that Orathecin, if approved, may be of significant benefit to those affected by pancreatic cancer.

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.

Orathecin is currently in the latter stages of a "rolling, fast-track" New Drug Application (NDA) in the US for the treatment of pancreatic cancer that is resistant or refractory to treatment. According to Dr Joseph Rubinfeld, chairman and ceo of SuperGen, full European submission should follow the completion of the final module of the US NDA.

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