Endocyte, Inc. (ECYT - Free Report) provided an update on pending EU conditional marketing authorization applications (MAA) for vintafolide, etarfolatide and intravenous (IV) folic acid. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently confirmed questions to be addressed by Endocyte regarding these applications.
The company’s management expects the questions to be addressed in the first quarter of 2014. Following a successful response, the committee is expected to give its opinion in a meeting in the following month.
Endocyte had submitted an MAA seeking approval for vintafolide for platinum-resistant ovarian cancer in 2012. The company is also seeking EU approval for a folate-targeted molecular imaging agent, etarfolatide. These applications are supported by four clinical studies: a phase I study in solid tumors, two single agent and single-arm phase II studies in ovarian cancer and non-small cell lung cancer (NSCLC) and phase II PRECEDENT trial.
The applications for conditional marketing authorization were accepted by the EMA in Nov 2012, for vintafolide for the treatment of platinum-resistant ovarian cancer and etarfolatide and folic acid for patient selection.
We note that Endocyte and Merck & Co. Inc. (MRK - Free Report) had entered into a partnership in Apr 2012, wherein Endocyte granted Merck an exclusive license to develop, manufacture and commercialize vintafolide outside the U.S.
Endocyte expects interim results from phase III PROCEED study in the second quarter of 2014. Endocyte completed enrollment in the phase IIb TARGET study of vintafolide in NSCLC patients. Top-line data from the study is expected in the first quarter of 2014.
Endocyte and Merck will initiate a phase II randomized trial on vintafolide in folate receptor-positive triple negative breast cancer in the first half of 2014.
For its folate-targeted tubulysin therapeutic, EC1456, an investigational new drug application was accepted by the U.S. Food and Drug Administration (FDA) in Sep 2013. Endocyte dosed its first patient in a phase I study evaluating EC1456, for the treatment of advanced solid tumors in Dec 2013.
We expect investor focus on updates on the two candidates - vintafolide and etarfolatide. Endocyte carries a Zacks Rank #1 (Strong Buy). Other players in the pharma industry sharing the Zacks Rank #1 include Actelion Ltd. (ALIOF - Free Report) and Lannett Co. Inc. (LCI - Free Report) .