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Corcept Therapeutics presents results of clinical study at the 59th Annual Society of Biological Psychiatry Conference

Corcept Therapeutics Incorporated (NASDAQ: CORT) today announced that Dr. Joseph Belanoff, Corcept's chief executive officer, presented the results of the Corcept '03 clinical study investigating the use of its lead drug, CORLUX™ (mifepristone) for the treatment of psychotic features of psychotic major depression (PMD) at the Biological Psychiatry Conference in New York City on May 1. The results of this study demonstrated with statistical significance that more patients treated with CORLUX achieved a rapid and sustained reduction of the psychotic features of PMD than did patients treated with placebo.

The '03 study was a multi-center, randomized, placebo controlled study that evaluated 600 mg of CORLUX administered once daily over a period of seven days in patients with PMD. Patients were not allowed to receive any antipsychotic or antidepressant medication for at least seven days prior to or during administration of the study drug. The study randomized 221 patients on a one-to-one basis to receive either CORLUX or placebo.

The '03 study showed that patients who received CORLUX were more likely than patients who received placebo to achieve a rapid and sustained reduction in psychosis as measured by a 30% reduction in the BPRS (Brief Psychiatric Rating Scale) at day 7 sustained to day 28. This difference was statistically significant (p value < .05). The BPRS is an 18-item rating instrument used to assess psychopathology.

Additionally, the '03 study showed with statistical significance that patients receiving CORLUX were more likely than patients receiving placebo to achieve a 50% reduction in the BPRS positive symptom subscale (PSS) at day 7 sustained to day 28. The PSS is a validated instrument containing the four items in the BPRS that more specifically measure psychosis. The subgroup of patients who were the most symptomatic (score = 12 on the BPRS PSS) and who received CORLUX separated with even greater statistical significance from those who received placebo.

The results of the '03 study also indicated that CORLUX was well tolerated as demonstrated by the finding that there was no statistically significant difference in adverse events observed between the CORLUX group and the placebo group.

"We are pleased with the results of this study because a seven day course of treatment with CORLUX appeared to produce a substantial and sustained reduction in psychotic symptoms in patients with PMD" said Dr. Belanoff. "Currently, the most effective treatment for PMD is electroconvulsive therapy (ECT), often referred to as electric shock therapy. The vast majority of patients with PMD choose not to have this therapy. Instead patients often opt for a combination of antidepressant and antipsychotic medications, which are slow acting and have many significant side effects."

"Given the results of our '03 study, we expect to begin pivotal Phase III trials very soon. These studies are designed to replicate the results of the '03 study. Upon successful completion of these trials, we expect to submit an NDA to the FDA. Because of the serious nature of PMD and the lack of approved drugs for the disorder, the FDA has granted a Fast Track designation for CORLUX for the treatment of the psychotic features of PMD," continued Dr. Belanoff.

About Psychotic Major Depression (PMD)
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 candidate, CORLUX, is currently in Phase III clinical trials for the treatment of the psychotic features of psychotic major depression. CORLUX is an oral medication being developed for patients with PMD to be administered once a day in a controlled setting, such as a hospital or physician's office. CORLUX is a potent GR-II antagonist that appears to mitigate the effects of the elevated and abnormal release patterns of cortisol in PMD patients. Corcept is also conducting a clinical trial to evaluate the safety and efficacy of our drug in improving cognition in patients with mild to moderate Alzheimer's disease.

The scientific information discussed in this news release is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for mifepristone. The product is not approved for the investigational uses discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the product for these uses. Only the FDA can determine whether the product is safe and effective for these uses.

This press release contains forward-looking statements that are based on management's current expectations. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statement we make. There are significant risks and uncertainties in our pharmaceutical research and development, including risks relating to the commencement and success of our pivotal clinical trials, risks relating to the receipt of necessary clinical and manufacturing regulatory approvals, and risks relating to successful product commercialization. These and other risks are described in greater detail in the "Risk Factors" section of the final prospectus relating to our initial public offering, filed with the SEC. We do not assume any obligation to update any forward-looking statements.


CONTACT:
Fred Kurland
Chief Financial Officer
Corcept Therapeutics
650-327-3270
ir@corcept.com
www.corcept.com

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