Corcept Therapeutics Incorporated, a pharmaceutical company, engages in the discovery, development, and commercialization of drugs for the treatment of severe metabolic, oncologic and psychiatric disorders associated with the steroid hormone cortisol. The company is developing mifepristone - a potent glucocorticoid receptor (GR) antagonist that modulates the activity of cortisol - for the treatment of serious illnesses. It has also discovered three series of proprietary, next-generation selective GR antagonists. The company is conducting a Phase 1/2 trial of mifepristone (Korlym’s active ingredient) in combination with the chemotherapy drug eribulin (Halaven) to treat patients with GR-positive triple-negative breast cancer – a form of cancer with a particularly poor prognosis. Cushing’s Syndrome The United States Food and Drug Administration (FDA) approved Korlym (mifepristone) 300 mg Tablets as a once-daily oral medication for the treatment of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. The FDA approval means that the company could market the drug for the approved indication in the United States. Triple-Negative Breast Cancer In 2014, the company began a Phase 1/2 study of Korlym in combination with eribulin in the treatment of triple-negative breast cancer. The company developed a proprietary diagnostic test for identifying GR-positive tumors, using a laboratory that meets Clinical Laboratory Improvement Amendments federal regulatory standards. In January 2015, the company completed the dose-finding portion of its Phase 1/2 study. CORT125134 and Other Next-Generation Selective GR Antagonists In 2014, the company commenced enrollment in a Phase 1 clinical study with CORT125134. This study would assess the safety, tolerability and pharmacokinetics of CORT125134 in healthy human volunteers. Research and Development For the year ended December 31, 2014, the company incurred $18.4 million of research and development expenses. Manufacturing Korlym The company has a manufacturing agreement with one contract manufacturer, Produits Chimiques Auxiliaires et de Synthese SA (PCAS), to produce the active pharmaceutical ingredient (API) for Korlym. The FDA approved the company’s commercial use of material produced by PCAS as part of its NDA submission for Korlym. Competition The company competes with Novartis. Intellectual Property Oncology: Under an agreement with University of Chicago, the company has licensed exclusive rights to U.S. Patent No. 8,710,035 “Methods and Compositions Related to Glucocorticoid Receptor Antagonists and Breast Cancer. Proprietary GR Antagonists: The company owns issued U.S. patents for the use of GR antagonists in the treatment of mild cognitive impairment, the treatment of weight gain following treatment with antipsychotic medication, the prevention and treatment of stress disorders, improving the therapeutic response to ECT, the treatment of delirium, the treatment of catatonia, the treatment of gastroesophageal reflux disease, the treatment of migraine headaches, the treatment of psychosis with Interferon-Alpha therapy, the treatment of neurological damage in premature infants, the treatment of diseases using combination steroid and GR antagonist therapy and for inhibiting cognitive deterioration in adults with Down’s Syndrome. It also owns a method of use patent for optimizing mifepristone levels in plasma serum in patients suffering from mental disorders. The expiration dates of these patents and their foreign counterparts range from 2020 to 2034. In addition, the company has three U.S. method-of-use applications covering certain GR antagonists, including the treatment of patients suffering from mental disorders by optimizing mifepristone absorption; muscular dystrophy; and amyotrophic lateral sclerosis. The approximate expiration dates of the patents that could issue from these applications and their foreign counterparts range from 2029 to 2032. The company has eight U.S. composition of matter patents containing claims relating to three distinct series of novel selective GR antagonists. The expiration dates of these patents and their foreign counterparts range from 2026 to 2033. License Agreements Under its exclusive license agreement with Stanford University to patents covering the use of mifepristone to treat the psychotic features of psychotic depression, early dementia and cocaine-induced psychosis, the company is required to make milestone payments and pay royalties to Stanford University on sales of products commercialized under any of the above patents. In 2013, the company licensed from the University of Chicago exclusive rights to the University’s U.S. Patent No. 8,710,035 Methods and Compositions Related to Glucocorticoid Receptor Antagonists and Breast Cancer. Government Regulation The company received Orphan Drug designation for Korlym for the treatment of endogenous Cushing’s syndrome in both the United States and the European Union. History Corcept Therapeutics Incorporated was founded in 1998. The company was incorporated in the state of Delaware in 1998.
corcept therapeutics inc
149 Commonwealth Drive
Menlo Park, CA 94025
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