EC145 regulatory update

Endocyte announced a new timeline for seeking conditional approval in the EU of cancer compound EC145 and diagnostic imaging agent EC20. Endocyte also said the European Commission granted Orphan Drug designation for the products. In 3Q12, the company plans to submit an MAA for EC145 to treat folate-receptor positive, platinum-resistant ovarian cancer and an MAA for EC20 to identify patients that overexpress folate.

Endocyte had planned to submit applications in 1Q12 but in December said it may need to delay the submissions after EMA expressed concern about the confirmatory Phase III PROCEED trial of EC145, which was on hold due to a shortage of Doxil doxorubicin. In February, FDA approved the importation of foreign supplies of Doxil. As a result, Endocyte expects enrollment in PROCEED to resume next quarter. ...