UPDATE 2-Corcept hormone disorder drug meets main trial goal

Wed Dec 22, 2010 11:30am EST

* Cushing's Syndrome drug succeeds in late-stage trial

* Co plans to file NDA in Q1; Will seek priority review

* Seeks partner for the drug outside the U.S. (Adds analyst comments, updates share movement)

By Vidya L Nathan

BANGALORE, Dec 22 (Reuters) - Corcept Therapeutics Inc (CORT.O) said a late-stage trial of an experimental hormone disorder drug met its main study goal of showing statistically significant improvement in glucose tolerance and hypertension.

As initial excitement faded, shares of the Menlo Park, California-based company were trading flat at $4.17 after rising 12 percent to $4.68 on Wednesday morning on Nasdaq.

"You are talking about a company that has been anticipating the data for some time and the buying rate was generally strong in the run-up from $3, a couple of months ago to $4.50," Stifel Nicolaus & Co analyst Annabel Samimy said.

Corcept is planning to submit a marketing approval application for its product Corlux, a potential Cushing's Syndrome treatment, to U.S. regulators late in the first quarter of 2011 and would request for a priority review.

The hormone disorder, called Cushing's syndrome, is caused by unusually high levels of cortisol -- a steroid hormone produced by the adrenal gland -- in blood.

Corcept plans to market Corlux in the United States independently and seek partnership to put it in markets abroad, the company said in a call with analysts.

Corlux was granted an orphan drug designation by the U.S. Food and Drug Administration (FDA), which would give the firm a seven-year marketing exclusivity in the U.S, upon approval.

In the United States, Corcept can bill up to $300 million in peak sales of Corlux, estimates Global Hunter Securities' Kimberly Lee while Stifel Nicolaus' Samimy sees peak sales of $230 million for the region by 2015.

(Reporting by Vidya L Nathan and Esha Dey in Bangalore; Editing by Joyjeet Das)

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