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Corcept Therapeutics - What's Ahead?

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The regulatory decision on a new drug for Cushing's syndrome is just a few days away. Cushing's syndrome is a hormonal disorder caused by high levels of cortisol and is characterized by diabetes, high blood pressure, upper body obesity, thinner arms and legs. So, which is the drug and the company expecting the FDA decision?

Read on to find more...

Cushing's syndrome is most frequently seen in adults between the ages of 20 to 50 and is often treated by surgery, radiation, chemotherapy or the use of drugs which inhibit cortisol production. However, there are no approved drugs for the treatment of Cushing's syndrome.

Cushing's syndrome is more common in women than in men. An estimated 20,000 patients in the U.S. have Cushing's syndrome.

At the altar awaiting the FDA decision is Korlym, developed by pharmaceutical company Corcept Therapeutics Inc. (CORT).

Korlym contains the active ingredient Mifepristone, which blocks cortisol receptor GR-II, potentially blocking the harmful effects of excess cortisol. Mifepristone is approved for use in a physician's office as a single dose in combination with the drug Misoprostol for the termination of early pregnancy in women with a confirmed uterine pregnancy of accurately predicted duration. In the U.S., Mifepristone is available to eligible patients with Cushing's syndrome through a compassionate use program, also known as an Expanded Access Program.

Korlym is designated as an orphan drug for the treatment of endogenous Cushing's syndrome in the U.S. and European Union.

Corcept submitted the New Drug Application for Korlym, formerly referred to as Corlux, on April 15, 2011. The NDA for Korlym was accepted by the FDA last June and has a decision date set for February 17, 2012.

In clinical trials, Korlym has shown to significantly improve blood glucose levels, blood pressure and to decrease body weight and waist circumference - all key manifestations of Cushing's Syndrome, according to Corcept.

One specific cause of Cushing's Syndrome is Cushing's disease, when the pituitary gland makes too much Adrenocorticotropic hormone, which in turn elevates cortisol. Swiss drug maker Novartis AG (NVS) is developing a drug - Signifor, for Cushing's disease. On January 20, 2012, Signifor won the European Committee's backing to treat patients with Cushing's disease.

Another potential indication for which Korlym is being evaluated is psychotic depression.

Psychotic depression, a serious disorder characterized by severe depression accompanied by delusions, hallucinations or both, affects about three million people annually in the U.S.

Corcept has completed three phase III trials to evaluate the safety and efficacy of Korlym for the treatment of the psychotic features of psychotic depression.

The results of three of the phase III studies reported in 2006 and 2007 were not statistically superior over placebo. However, not having lost hope on the efficacy of Korlym in treating psychotic depression, Corcept commenced a fourth phase III trial, dubbed Study 14 for treatment of psychotic depression in March 2008. About 450 patients are expected to be enrolled in the study. The trial is currently recruiting participants and completion of the study is expected in April 2013.

Korlym has secured fast track status for the treatment of the psychotic features of psychotic depression.

Also in the pipeline is CORT 108297, which is also a GR-II antagonist, being evaluated as a potential treatment for addressing weight gain. CORT 108297 is under phase 1b/2a multi-dose safety and proof of concept studies.

A quick look at the company's balance sheet...

Corcept is a development stage company and has incurred significant losses since its inception. As of September 30, 2011, the company had an accumulated deficit of $198.6 million. The company has no marketed drug and did not recognize any revenue during any period in 2011 or 2010.

In the third quarter ended September 30, 2011, Corcept's net loss narrowed to $6.43 million or $0.08 per share from $7.10 million or $0.10 per share in the year-ago quarter. The company ended the quarter with cash balance of $45.9 million, expected to be sufficient to fund its operations through the end of 2012.

Founded in 1998, the company went public in April 2004 offering its shares at $12 each. Shares of Corcept Therapeutics have thus far hit a 52-week low of $2.51 and a 52-week high of $5.07. The stock gained 1.15% on Thursday to close the day's trading at $3.53.

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