Corcept Therapeutics Announces Allowance of Additional Patent Covering the Use of Korlym to Treat Patients With Cushing’s Syndrome

Menlo Park, California, UNITED STATES

MENLO PARK, Calif., Dec. 13, 2018 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT) announced today that the United States Patent and Trademark Office has given notice that it will allow a patent covering the concomitant use of Korlym® and drugs from the class of medications known as strong CYP3A inhibitors to treat patients with hypercortisolism (Cushing’s syndrome).  The patent will expire in 2037.

“This patent covers an important finding of our research – that with proper dose modulation, Korlym can safely be administered in combination with medications that are strong CYP3A inhibitors,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. “Strong CYP3A inhibitors include antiviral, antibiotic, antifungal and antidepressant medications from which many patients taking Korlym could benefit.  Korlym’s label instructs doctors how to do this safely.”

Upon issuance, Corcept plans to list the patent, entitled “Concomitant Administration of Glucocorticoid Receptor Modulators and CYP3A Inhibitors” (U.S. Pat. App. 15/627,359), in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”).  Korlym is currently covered by five patents listed in the Orange Book.

About Cushing’s Syndrome

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the stress hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients being diagnosed each year. Symptoms vary, but most people experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively.

About Corcept Therapeutics Incorporated

Corcept Therapeutics is engaged in the discovery, development and commercialization of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol.  Corcept’s first approved product, Korlym, inhibits the effects of excess cortisol in patients with hypercortisolism by modulating activity at the glucocorticoid receptor, one of the two receptors to which cortisol binds. Korlym was the first FDA-approved treatment for patients with Cushing’s syndrome and the FDA has designated it as an Orphan Drug for that indication. Corcept has created a large portfolio of proprietary compounds that modulate the effects of cortisol but not progesterone. The company owns extensive United States and foreign intellectual property covering the use of cortisol modulators in the treatment of a wide variety of serious disorders. The company also holds composition of matter patents covering its selective cortisol modulators. Corcept is conducting a Phase 3 trial of its lead proprietary molecule, relacorilant, to treat patients with Cushing’s syndrome.

Forward-Looking Statements

Statements in this press release, other than statements of historical fact, are forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, are based on our current plans and expectations and are subject to risks and uncertainties that might cause actual results to differ materially from those such statements express or imply.  These risks and uncertainties include, but are not limited to, our ability to generate sufficient revenue to fund our commercial operations and development programs; the protections afforded by patents and our other intellectual property; and risks related to the development of relacorilant, including regulatory approvals, mandates, oversight and other requirements.  These and other risks are set forth in our Securities and Exchange Commission (“SEC”) filings, which are available at our website and the SEC’s website.  In this press release, forward looking statements include those regarding patent coverage for Korlym, the potential for patients receiving Korlym to benefit from the concomitant administration of one or more strong CYP3A inhibitors and our plans to list the newly allowed patent in the Orange Book.  We disclaim any intention or duty to update forward-looking statements made in this press release.

Charles Robb
Chief Financial Officer
Corcept Therapeutics