| • | | Speculators wrongly claim that Korlym is unreasonably costly. |
In fact, we charge for Korlym no more than what we must for a drug for a rare disorder that we developed over many years, at great expense and risk. Even then, Korlym is less expensive than many other orphan drugs. More importantly, we never deny Korlym for financial reasons. And we direct our profits first to the development of our next-generation medications, which we hope will provide treatments for serious oncologic, metabolic and psychiatric disorders.http://www.corcept.com
Detailed Discussion
Background. Corcept was founded in 1998 by Stanford Medical School professors who believed that modulating the effects of the stress hormone cortisol might provide a treatment for a wide variety of serious disorders. At that time, the only drug known to bind to the cortisol receptor was mifepristone, which had been approved in the United States for the termination of pregnancy.
Proving that mifepristone (and cortisol modulation more generally) could be an effective therapy was a long, expensive and challenging task. We began in 1998 by studying mifepristone in the treatment of psychotic major depression, a deadly psychiatric illness. Although our Phase 2 trials provided promising results, our three Phase 3 trials failed to meet their primary endpoints. In 2014, we discontinued the program. All of the results of these studies have been published in peer-reviewed journals.4,5,6,7,8
Our accumulated deficit at that point was more than $300 million, mostly due to spending on research and development.
Fortunately, by the time our psychotic depression programs ended, another of our development programs had succeeded. In 2012, the FDA had approved mifepristone (our product, Korlym®) for the treatment of a rare, deadly disease known as Cushing’s syndrome. We had begun thepre-clinical and clinical research necessary to support Korlym’s approval for this use in 2008.
What is Cushing’s syndrome?Cushing’s syndrome is caused by a tumor that either produces excess cortisol or causes the body to produce excess cortisol. Because there are receptors for cortisol in nearly every tissue type, excess cortisol activity makes patients sick in many ways. Symptoms include diabetes, high blood pressure, obesity, fat around the neck, thinning arms and legs, weak muscles and severe fatigue. Irritability, anxiety, cognitive disturbances and depression are common.
Cushing’s syndrome is deadly. Untreated patients have an average lifespan of4-5 years.
Why did the FDA approve Korlym?The FDA approved Korlym because our pivotal trial in patients with Cushing’s syndrome (known as “SEISMIC”) had demonstrated that Korlym was safe and effective for its approved use. You can read Korlym’sFDA-approved label atwww.Korlym.com.
4 | C. DeBattista et al., Biol Psychiatry, 2006 |
5 | C.M. Blasey et al., Contemporary Clinical Trials, 2009 |
6 | C.M. Blasey et al., Journal of Clinical Psychopharmacology, 2011 |
7 | C.M. Blasey et al., Current Psychiatry Reviews, 2013 |
8 | T.S. Block et al., Biol Psychiatry, 2018 |
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