Eli Lilly and Company To Support Corcept Therapeutics Inc.'s Clinical Study Evaluating The Ability Of A GR-II Antagonist To Mitigate The Weight Gain Associated With Use Of Atypical Antipsychotic Medications

MENLO PARK, Calif., Oct. 21 /PRNewswire-FirstCall/ -- Corcept Therapeutics Incorporated today announced that it has signed an agreement with Eli Lilly and Company (Lilly) in which Lilly has agreed to support Corcept's proof of concept clinical study evaluating the ability of CORLUX(R), a GR-II antagonist, to mitigate weight gain associated with the use of olanzapine. This study will be conducted with healthy male volunteers.

Under the agreement, Lilly will supply olanzapine and pay for the study. Data resulting from the study will be shared with Lilly. Neither Lilly nor Corcept intend to commercially pursue the use of CORLUX and olanzapine in combination. The purpose of this study is to explore the mechanism of action of GR-II antagonists for mitigating weight gain associated with atypical antipsychotic medications.

Corcept previously announced results from two preclinical studies conducted in a rat model of olanzapine induced weight gain. These studies demonstrated that CORLUX's GR-II antagonist action has the potential to both reduce the weight gain associated with olanzapine and to prevent the weight gain associated with the initiation of treatment with olanzapine.

"Research into the mechanism of action of GR-II antagonists, like CORLUX, can help us better understand how to treat weight gain commonly associated with the use of many antipsychotic drugs," said Dr. Robert L. Roe, M.D., President of Corcept. "Because findings in animal studies do not always translate into human experience, we are delighted that Lilly is willing to support our further exploration of the role of GR-II antagonists in mitigating weight gain in patients taking antipsychotic medications. If results of this proof of concept study are positive, we will be encouraged to pursue this line of research with our portfolio of specific GR-II antagonists even more aggressively."


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 treated effectively with GR-II antagonists like CORLUX and the company has developed an extensive intellectual property portfolio that covers the treatment of these diseases, including the prevention of weight gain caused by the use of antipsychotic medications. 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 Dr. Joseph K. Belanoff, M.D., Corcept's CEO.


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 www.corcept.com.

Statements made in this news release other than statements of historical fact are forward-looking statements, including, for example, statements relating to conducting a clinical study with Lilly. 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 that the study will be initiated or completed, that the study will be successful, or that Corcept will decide to pursue further activities with respect to weight gain associated with olanzapine or other antipsychotic medications. Other risk factors relating to the company and its business are set forth in the company's SEC filings, all of which are available from our website (www.corcept.com) or from the SEC's website (www.sec.gov). We disclaim any intention or duty to update any forward-looking statement made in this news release.

Corcept Therapeutics Incorporated

CONTACT: Fred Kurland, Chief Financial Officer of Corcept Therapeutics,+1-650-327-3270, or IR@corcept.com

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