FDA Okays Corcept's Korlym For Cushing's Syndrome; Stock Up 57%

CorceptTherapeutics 021712

Shares of Corcept Therapeutics Inc. (CORT) soared 57 percent in extended trade Friday, after the U.S. Food and Drug Administration approved Korlym as the first therapy to treat high blood sugar in adults suffering from endogenous Cushing's syndrome.

Cushing's syndrome is a hormonal disorder caused by high levels of a steroid hormone called cortisol, and is characterized by diabetes, high blood pressure, upper body obesity, thinner arms and legs.

Korlym - mifepristone 300 mg tablets - is approved by the FDA as a once-daily oral medicine for use in patients with Cushing's syndrome who have type 2 diabetes or glucose intolerance, and are not candidates for surgery or have failed surgery.

Corcept, which will be the sole marketer of Korlym, said it plans to make the drug available to patients by May 1.

It is estimated that 20,000 patients in the U.S. have Cushing's syndrome, which is most frequently seen in adults between the ages of 20 to 50. The disorder is often treated by surgery, radiation, chemotherapy or the use of drugs which inhibit cortisol production. However, there were no FDA approved drugs to treat the disease.

According to the FDA, about 5,000 patients will be eligible for Korlym treatment, which is designated as an orphan drug in the U.S. and E.U. for the treatment of Cushing's syndrome.

Though there are no rivals for Korlym to treat Cushing's syndrome in the U.S., Swiss drug maker Novartis AG (NVS) is developing a drug - Signifor. Last month, Signifor won the European Committee's backing to treat patients suffering from the disease.

Korlym contains the active ingredient Mifepristone, which blocks cortisol receptor GR-II, potentially blocking the harmful effects of excess cortisol.

The safety and efficacy of Korlym in patients with endogenous Cushing's syndrome was assessed in a clinical trial with 50 patients. A separate open-label extension of this trial is ongoing.

In clinical trials, Korlym has shown to significantly improve blood glucose levels, blood pressure and to decrease body weight and waist circumference.

The most common side effects related to Korlym were nausea, fatigue, headache, arthralgia, vomiting, swelling of the extremities, dizziness and decreased appetite. Other effects include adrenal insufficiency, low potassium levels, vaginal bleeding and a potential for heart conduction abnormalities.

Korlym is also being evaluated as a potential indication for psychotic depression, a serious disorder characterized by severe depression accompanied by delusions, hallucinations or both. The disorder affects about three million people annually in the U.S.

Corcept has completed three phase III trials to assess the safety and efficacy of Korlym for the treatment of the psychotic features of psychotic depression, and has secured fast track status.

The FDA approval for Korlym to treat Cushing's syndrome is a boost to Corcept, a development stage company that has incurred major losses since its inception. As of September 30, 2011, Corcept had an accumulated deficit of $198.6 million. The company has had no marketed drug and did not recognize any revenue during any period in 2011 or 2010.

In the third quarter, 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 prior year.

CORT closed Friday's trade on the Nasdaq at $3.03, up $ 0.15 or 5.21%, on a volume of over 1.2 million shares. In after hours, the stock surged $1.74 or 57.43%.

For comments and feedback contact: editorial@rttnews.com

Follow RTT