Orphan drug status provides for a period of marketing exclusivity, certain tax benefits, and an exemption from certain fees upon submission of a new drug application.
Loretta Itri, president of pharmaceutical development and chief medical officer, said: “The clinical development plan for tesetaxel includes an early determination of its activity in melanoma. Prototype taxanes such as paclitaxel have activity in melanoma and have comprised a standard of care in currently ongoing Phase III studies.
“We plan to leverage our extensive knowledge gained from late-stage trials of Genasense in melanoma, as well as our worldwide relationships with clinical experts in this disease, to accelerate the tesetaxel program.”