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Corcept Preclinical Trials Show Corlux® Prevents Weight Gain Associated with Use of Olanzapine, the Active Ingredient in Zyprexa®

Corcept Therapeutics, Incorporated (NASDAQ: CORT) today announced results from two preclinical studies evaluating whether CORLUX® can (i) induce weight loss following olanzapine (the active ingredient in Zyprexa®) induced weight gain and (ii) prevent the weight gain induced by olanzapine. These studies were conducted in a rat model of olanzapine induced weight gain. The studies show that CORLUX has the potential to both reduce the weight gain caused by olanzapine and to prevent the weight gain caused by the initiation of treatment with olanzapine.

"We are encouraged by these preclinical results", said Dr. Robert L. Roe, M.D., President of Corcept. "The use of GRII antagonists to prevent the weight gain commonly associated with the use of many antipsychotic drugs could be of great benefit to the millions of people currently taking these medications. Because findings in animal studies do not always translate into human experience, we look forward to testing our hypothesis in patients".

In the first study, four groups (n = 12 per group) of rats were allowed to eat a normal diet for eight weeks. Three of these groups were dosed orally with olanzapine for the eight weeks of the study. The fourth group received placebo for the eight weeks. At Day 35 the three groups receiving olanzapine had gained a statistically significant amount of weight compared to the group receiving placebo. The three olanzapine groups then began to receive daily oral doses of CORLUX through Day 56. Each group was assigned a different dose. The rats receiving the combination of olanzapine and CORLUX lost a statistically significant amount of weight from day 35 to day 42. At each assessment point between day 42 and day 56, there was no statistically significant difference in weight between the rats receiving the combination of olanzapine and CORLUX and the rats in the control group. In addition, the rats that received the combination of olanzapine and CORLUX developed no more abdominal fat than the control group.

In the second study four groups (n = 12 per group) of rats were allowed to eat a normal diet and were dosed orally with olanzapine for the three weeks of the study. Three of these groups were also dosed orally with CORLUX, each group receiving a different dose level. The fourth group was dosed with placebo in addition to olanzapine. At Day 21, the three groups dosed with the combination of olanzapine and CORLUX had gained significantly less weight compared to the group fed olanzapine plus placebo. In addition, the groups that received olanzapine and CORLUX developed significantly less abdominal fat than the group that received olanzapine plus placebo.

The labels of the following atypical antipsychotic class drugs contain a warning for hyperglycemia and diabetes mellitus, both associated with the weight gain seen in many patents taking these drugs:

Abilify® (aripiprazole, Bristol Myers Squibb and Otsuka American Pharmaceutical)
Clozaril® (clozapine, Novartis)
Geodon® (ziprasidone, Pfizer)
Risperdal® (risperidone, Janssen)
Seroquel® (quetiapine, AstraZeneca)
Zyprexa® (olanzapine, Eli Lilly).

Despite their side effect profile, atypical antipsychotic medications are widely prescribed throughout the world because of their efficacy.

Corcept's primary activity continues to be the development of CORLUX, for the treatment of the psychotic symptoms of psychotic major depression (PMD). Other metabolic and psychiatric diseases may be effectively treated by GR-II antagonists like CORLUX and the company has developed an extensive intellectual property portfolio to cover the treatment of these diseases, including the prevention of weight gain caused by the use of antipsychotic medications. Corcept is also conducting a Phase II clinical trial of CORLUX as a cognitive enhancer in early Alzheimer's disease. The company has also discovered and filed patents for GR-II specific compounds that do not block the progesterone receptor. "Eventually, we hope to test and develop our new GR-II compounds in a wide variety of disorders," said Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer.

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 PMD. 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. For additional information about the company, please visit

Statements made in this news release other than statements of historical fact are forward-looking statements, including, for example, statements relating to our preclinical and clinical development programs, and the expected timing of the initiation or results of our clinical trials. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that 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, cost, rate of spending, completion or success of clinical trials; there can be no assurance that the results of clinical trials will be consistent with preclinical studies; there can be no assurance that results obtained with olanzapine can be replicated with any other drug; there can be no assurance with respect to the regulatory process or regulatory approvals; and there can be no assurance with respect to commercial success. These and other 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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