Healthcare Industry News: metabolic disease
News Release - July 9, 2007
Corcept Therapeutics Receives Orphan Drug Designation for CORLUX(R) Treatment of Cushing's SyndromeMENLO PARK, CA--(Healthcare Sales & Marketing Network)--Jul 9, 2007 -- Corcept Therapeutics Incorporated (NasdaqCM:CORT ) today announced that it has received Orphan Drug Designation from the Food and Drug Administration (FDA) for CORLUX for the treatment of Cushing's Syndrome. CORLUX is a cortisol receptor (GR-II) antagonist.
Orphan Drug Designation is a special status granted by the FDA to encourage the development of treatments for diseases or conditions that affect fewer than 200,000 patients in the United States. Drugs that receive Orphan Drug Designation obtain seven years of marketing exclusivity from the date of drug approval as well as tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process. Corcept has not yet determined its full development plan for the use of CORLUX to treat Cushing's Syndrome but will file an IND shortly.
"We are pleased to have received the Orphan Drug Designation for CORLUX for the treatment of Cushing's Syndrome. Cushing's Syndrome can affect every organ system in the body and be lethal if not treated effectively," said Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer.
About Cushing's Syndrome
Cushing's Syndrome is a disorder caused by prolonged exposure of the body's tissues to high levels of the hormone cortisol. Sometimes called "hypercortisolism," it is relatively rare and most commonly affects adults aged 20 to 50. An estimated 10 to 15 of every one million people are affected each year. Symptoms vary, but most people have high blood sugar, high blood pressure, upper body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety and depression are common.
About Corcept Therapeutics Incorporated
Corcept Therapeutics Incorporated is a pharmaceutical company engaged in the development of drugs for the treatment of severe psychiatric and metabolic diseases. Corcept's lead product, CORLUX, is currently in Phase 3 clinical trials for the treatment of the psychotic features of psychotic depression. The drug is administered orally to psychotic depression 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 psychotic depression. In June 2007, Corcept Therapeutics announced positive results from its proof of concept study evaluating the ability of CORLUX to mitigate weight gain associated with olanzapine, a commonly used antipsychotic medication. The Company is in the process of fully evaluating all of the data from the study and considering its next steps. 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 Corcept's clinical development programs, and its spending plans. 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; financial projections may not be accurate; there can be no assurances that the investigations for future clinical trials will be completed, or that Corcept will pursue further activities with respect to clinical development of CORLUX. These and other risk factors 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.
Source: Corcept Therapeutics
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