Corcept Therapeutics Incorporated (NASDAQ:CORT) Files An 8-K Other EventsItem 8.01 Other Events
On February5, 2018, Corcept Therapeutics Incorporated (the “Company”) announced that it has received a Paragraph IV Notice Letter advising that Teva Pharmaceuticals USA, Inc. (“Teva”) submitted an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) seeking authorization from the FDA to manufacture, use or sell a generic version of KORLYM® Mifepristone Tablets, 300 mg (“KORLYM®”) in the United States.
The Notice Letter contains Paragraph IV certifications against certain of the Company’s patents related to KORLYM®, U.S. Patent No.8,921,348 (the “‘348 patent”) and U.S. Patent No.9,829,495 (the “‘495 patent,” and together with the ‘348 patent the “KORLYM® patents”), which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (referred to as the “Orange Book”). The Notice Letter alleges that the KORLYM® patents, the ‘348 patent with an expiration date in August 2028 and the ‘495 patent with an expiration date in August 2036, will not be infringed by Teva’s proposed product, are invalid and/or are unenforceable. The Company intends to vigorously defend its extensive intellectual property rights related to KORLYM®.
About Corcept Therapeutics Incorporated (NASDAQ:CORT)
Corcept Therapeutics Inc. is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic, psychiatric and oncologic disorders. The Company’s focus is on those disorders that are associated with a steroid hormone cortisol. Elevated levels and abnormal release patterns of cortisol have been implicated in a range of human disorders. The Company is developing mifepristone, a compound that modulates the effects of cortisol by acting as a competitive antagonist at the glucocorticoid receptor (GR). It has also discovered approximately three structurally distinct series of selective cortisol modulators, all of which share mifepristone’s affinity for GR but, unlike mifepristone, do not bind to the progesterone receptor, and so do not terminate pregnancy or cause other side effects associated with progesterone receptor antagonism. It has begun pre-clinical and clinical development of its lead compounds from these series.