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Corcept Therapeutics commences second pivotal Phase III clinical trial of Corlux™

Corcept Therapeutics Incorporated, (NASDAQ: CORT), a pharmaceutical company, today announced the commencement of its second pivotal Phase III clinical trial, known as Corcept 06, evaluating CORLUX™ (mifepristone) for the treatment of the psychotic features of Psychotic Major Depression (PMD). Corcept anticipates having initial results from both the first and second pivotal studies available in the first half of 2006. CORLUX has been granted Fast Track designation for this indication.

"We are on track with our development plans for CORLUX," said Joseph K. Belanoff, M.D., Corcept's chief executive officer. "PMD is a disorder that affects approximately three million people in the United States each year and for which there are no FDA-approved treatments. Through our studies, we will investigate whether CORLUX will provide rapid and sustained relief from the psychotic symptoms of this crippling illness."

"The 06 study is the second of our pivotal studies to commence in the United States and like the 07 study which began to enroll patients in September is being conducted according to a Special Protocol Assessment agreement with the FDA, said Robert L. Roe, M.D., Corcept's President. "Our highly experienced in-house clinical development team has forged strong relationships with our contract research organizations to help ensure that these studies are conducted according to the rigorous standards required for registration."

Corcept 06 Study Details
Corcept 06 will enroll approximately 440 patients at about 30 sites in the United States in a randomized, double-blind, placebo-controlled trial of CORLUX. The primary endpoint is the proportion of patients with at least a 50% improvement in the Brief Psychiatric Rating Scale Positive Symptom Subscale (BPRS PSS) at both Day 7 and Day 56. The BPRS is an 18-item rating instrument used to assess psychopathology and the PSS includes the four items in the BPRS that specifically measure psychosis. BPRS assessments will be conducted at baseline and Days, 7, 14, 28, 42 and 56. Patients must have at least mild psychotic symptoms (BPRS PSS greater than or equal to 12) to enter the studies and will be hospitalized if clinically necessary.

Patients will be evenly distributed among three active dose groups (300 mg, 600 mg and 1200 mg) or a placebo group with patients receiving once daily dosing for a period of seven days. All patients in the study must be off any antidepressant and antipsychotic medication for at least one week before the seven day treatment period and will receive antidepressant therapy starting on Day 1 through Day 56. As with Corcept 07, treatment with antipsychotic medications or electroconvulsive therapy will not be allowed at any time during this study.

About Psychotic Major Depression
PMD is a serious psychiatric disorder that affects approximately three million people annually in the United States. It is more prevalent than either schizophrenia or manic depressive illness. The disorder is characterized by severe depression accompanied by delusions, hallucinations or both. People with PMD are approximately 70 times more likely to commit suicide than the general population and often require lengthy and expensive hospital stays. There is no FDA-approved treatment for PMD.

About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company engaged in the development of drugs for the treatment of severe psychiatric and neurological diseases. Corcept's lead product, CORLUX™, is currently in Phase III clinical trials for the treatment of the psychotic features of psychotic major depression. The drug is administered orally to PMD patients once per day for seven days. CORLUX, a potent GR-II antagonist, appears to mitigate the effects of the elevated and abnormal release patterns of cortisol seen in PMD. Corcept is also conducting a clinical trial to evaluate the safety and efficacy of our product in improving cognition in patients with mild to moderate Alzheimer's disease. For additional information about the company, please visit

Forward Looking Statements
Statements made in this news release, other than statements of historical fact, are forward-looking statements, including, for example, statements relating to our PMD clinical development program, FDA agreements and the timing of the start and completion of pivotal Phase III trials. Forward-looking statements are subject to a number of known and unknown risks and uncertainties which might cause actual results to differ materially from those expressed or implied by such statements. For example, there can be no assurances with respect to the commencement, efficacy, safety, completion or success of clinical trials, there can be no assurances with respect to the regulatory process or regulatory approvals, there can be no assurances with respect to commercial success, and financial projections and trial timetables may not be accurate. Risk factors are set forth in the Company's SEC filings, all of which are available from our website ( or from the SEC's website ( We disclaim any intention or duty to update any forward-looking statement made in this news release.

Fred Kurland
Chief Financial Officer
Corcept Therapeutics

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