05.07.10
Aeterna Zentaris Inc. has received orphan drug designation from the FDA for AEZS-108, a doxorubicin targeted conjugate compound for the treatment of ovarian cancer. AEZS-108 is currently in a Phase II trial in advanced ovarian and endometrial cancer.
Orphan drug designation is granted to new drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides a seven-year period of marketing exclusivity if approved, or if it demonstrates superior safety and efficacy versus another drug for the same indication.
Juergen Engel, Ph.D., president and chief executive officer of Aeterna Zentaris said, "We are very pleased with AEZS-108 gaining orphan-drug designation for ovarian cancer from the FDA as it would provide it with extra market exclusivity protection. We look forward to reporting the final results from our ongoing European Phase II study in ovarian and endometrial cancer, later this year."
Orphan drug designation is granted to new drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides a seven-year period of marketing exclusivity if approved, or if it demonstrates superior safety and efficacy versus another drug for the same indication.
Juergen Engel, Ph.D., president and chief executive officer of Aeterna Zentaris said, "We are very pleased with AEZS-108 gaining orphan-drug designation for ovarian cancer from the FDA as it would provide it with extra market exclusivity protection. We look forward to reporting the final results from our ongoing European Phase II study in ovarian and endometrial cancer, later this year."
