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Corcept May Have Hit Pay Dirt

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After failing to show a statistically significant effect for treating the psychotic features of psychotic depression in three individual clinical trials, Corcept Therapeutics (Nasdaq: CORT  ) finally found something that its drug candidate, Corlux, is good at: treating Cushing's syndrome.

Cushing's is a rare, complex disease with no current treatments, so the Food and Drug Administration allowed the company to run a trial without a control group and said Corlux had to show a 20% response rate to gain approval.

Corlux crushed that number.

In one measure of its effectiveness, 60% of the glucose-intolerant patients responded to the medication. In the group that had hypertension -- high blood pressure -- 43% of the patients responded.

Corcept plans to apply to the FDA in the first quarter of next year. It's in a race against Novartis (NYSE: NVS  ) , which presented positive data for its Cushing's syndrome drug, SOM230, earlier this year.

Given the small number of patients who have Cushing's syndrome, Corcept plans to sell the drug itself inside the U.S. But it's looking for a partner outside the U.S. There are plenty of options for potential partners, given pharma's increased interest in orphan drugs.GlaxoSmithKline (NYSE: GSK  ) launched a new unit in February to treat rare diseases. And Pfizer (NYSE: PFE  ) has shown interest as well, having purchased FoldRx and licensed Protalix BioTherapeutics' (AMEX: PLX  ) Gaucher's disease drug.

It wouldn't surprise me if those talks turn toward an outright acquisition. Corcept doesn't have much of a pipeline beyond Corlux, and at a market cap of less than $300 million, a pharmaceutical company may be able to use synergies to its advantage and net more from Corlux than Corcept ever could.

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Pfizer is a Motley Fool Inside Value pick. GlaxoSmithKline and Novartis are Motley Fool Global Gains selections. The Fool owns shares of and has written covered calls on GlaxoSmithKline. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.


Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On December 24, 2010, at 5:15 PM, justonecomment wrote:

    Thanks for the article. I feel the article is silent on two issues: (1) the broader marketplace for the Corcept platform; and (2) how Corlux will compare with Novatis SOM230. The potential value of the Corcept platform is for mitigation of antipsychotic induced weight gain. This is why Lilly and other are so interested in the company. The potential capabilities of the platform can be seen in the endpoints chosen and successfully achieved in the latest Phase III test albeit for Cushings. The company bet the ranch on reducing the AUC for glucose. Only time, the FDA and published data will tell us how the 40% of Corcept patients who did not achieve at least a 5% reduction in glucose AUC compare with the 40% of SOM230 patients who were hyperglycemic. My gut is that the Corcept percentage of hyperglycemic patients is much lower than 40%.

    I own a small amount of Corcept.

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