On June 15, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported that it has entered into an agreement with Sun Pharmaceutical Industries Limited and related entities ("Sun") resolving patent litigation related to Korlym, Corcept’s medication for the treatment of patients with Cushing’s syndrome(Press release, Corcept Therapeutics, JUN 15, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-settles-patent-litigation-sun [SID1234584024]). The litigation has been pending in the United States District Court for the District of New Jersey since 2019, shortly after Sun notified Corcept that it had submitted an Abbreviated New Drug Application (ANDA) to the United States Food and Drug Administration (FDA) seeking approval to market a generic version of Korlym.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
In connection with the settlement, Corcept has granted Sun the right to sell a generic version of Korlym in the United States beginning October 1, 2034 or earlier under circumstances customary for settlement agreements of this type.
"It is gratifying to put this lawsuit behind us," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Litigation is a costly, time-consuming diversion from our efforts to grow our Korlym business and continue the development of our increasingly mature pipeline of selective cortisol modulators – including relacorilant, our planned successor to Korlym for the treatment of patients with Cushing’s syndrome."
The settlement agreement is subject to entry by the Court of a stipulation and order of dismissal related to the litigation. As required by law, Corcept and Sun will submit the agreement to the United States Federal Trade Commission (FTC) and the United States Department of Justice (DOJ) for review. Similar patent litigation brought by Corcept against two other companies that have filed ANDAs seeking approval to market generic Korlym remains pending.
About Korlym
Korlym modulates the effect of cortisol at the glucocorticoid receptor, one of the two receptors to which cortisol binds, thereby inhibiting the effects of excess cortisol in patients with Cushing’s syndrome. Since 2012, Corcept has made Korlym available as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing’s syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for that illness.