Hanmi Pharmaceutical said that Athenex, its U.S. partner, has won orphan drug designation (ODD) for Oraxol, an oral anticancer treatment for soft tissue sarcoma, from the European Commission (EC) on Wednesday. In April last year, the U.S. Food and Drug Administration also granted the ODD status to the drug.
|Hanmi headquarters in Bangi-dong, eastern Seoul.|
Oraxol is an oral dosage form of the widely used intravenous administered tubulin-stabilizing chemotherapeutic agent paclitaxel. Hanmi licensed out the drug to Athenex in 2011.
The EC assigns an ODD status to support the development of a cure for rare diseases with an incidence of less than 5 out of 10,000. The system facilitates the development and approval of therapeutic drugs for rare or life-threatening diseases. ODD drugs receive marketing authorization process support, cost reduction, and a 10-year monopoly after obtaining authorization.
“Earlier this year, initial results from an Oraxol clinical study confirmed encouraging results, including a rapid response in difficult-to-treat angiosarcoma patients,” Athenex Chief Medical Officer Rudolf Kwan said. “We are planning to conduct a trial in Europe as soon as possible.”
Soft tissue sarcoma is a malignant tumor that occurs in the tissue that wraps and connects the organs of the body such as fat, muscles, nerves, ligaments, blood vessels, lymphatic vessels. The tumor does not affect organs or the bones.
<© Korea Biomedical Review, All rights reserved.>