Corcept Therapeutics Inc.'s (CORT - Free Report) key objective in 2014 is the successful commercialization of its only approved product, Korlym.
Corcept launched Korlym in the U.S in Apr 2012. Korlym is approved in the U.S. and the EU as a once-daily oral medication for the treatment of hyperglycemia secondary to hypercortisolism in adults suffering from endogenous Cushing’s syndrome, who have type II diabetes or glucose intolerance.
We remind investors that Corcept enjoys orphan drug designation for Korlym from the U.S. Food and Drug Administration (FDA) for the approved indication.
Corcept recently announced plans to extend its development program for glucocorticoid receptor (GR) antagonists, including Korlym, into oncology. The company plans to expand its development program based on encouraging early clinical and pre-clinical data from leading academic institutions including the University of Chicago.
The data shows the efficacy of cortisol, a glucocorticoid stress hormone, and its receptors in chemotherapy resistance, particularly for women suffering from relapsed, metastatic triple-negative breast cancer (TNBC), a form of the disease with a poor prognosis.
We note that Corcept has licensed patent rights from the University of Chicago's Center for Technology Development & Ventures, for the use of GR antagonists in combination with chemotherapy in the treatment of estrogen-receptor-negative breast cancer, a form of cancer that includes TNBC.
Based on positive data from the studies conducted by the University of Chicago, Corcept has filed an investigational new drug (IND) application with the FDA. Corcept also plans to conduct its own multi-center, phase I clinical study of Korlym in combination with Eisai Co., Ltd.'s (ESALY - Free Report) Halaven.
We are encouraged by the company’s efforts to commercialize Korlym and develop it for additional indications.
Corcept currently carries a Zacks Rank #3 (Hold). Right now, Shire (SHPG - Free Report) and Forest Laboratories look attractive. Both carry a Zacks Rank #1 (Strong Buy).