Korlym
In 2012, Corcept launched the prescription medicine Korlym, a cortisol receptor blocker to control hyperglycemia (high blood sugar) in adult patients with endogenous Cushing's syndrome who have type 2 diabetes or glucose intolerance and have failed surgery or are not candidates for surgery.[10] Korlym was the first FDA-approved oral therapy for the treatment of such patients.[11] Since Korlym was an orphan drug—i.e., one developed specifically to treat a rare medical condition—Corcept received seven years of exclusive marketing rights, as well as tax credits for clinical trial costs, marketing application filing fee waivers, and assistance from the FDA in the drug development process.[12] In 2013, Corcept reported $19.7 million in federal tax credits. Corcept's marketing exclusivity for Korlym ended on February 17, 2019.[12] As of 2018, Korlym is Corcept's only product and treats about 1,000 patients annually in the U.S.[13]
Korlym's active ingredient is mifepristone, also known as RU-486, which is a medication typically used in combination with misoprostol to bring about an abortion.[14] Developed in France in 1980,[15] mifepristone was approved by the FDA in 2000 for abortion in the U.S.[16] Since then,[13] mifepristone has been marketed by Danco Laboratories, a private pharmaceutical distributor, under the brand name Mifeprex, and is Danco's only product.[17]
In 2018, Kaiser Health News reported that the difference in price between Danco's Mifeprex and Corcept's Korlym "is striking, even though the ingredients are the same: One 200-milligram pill to prompt an abortion costs about $80. In contrast, a 300-milligram pill prescribed for Cushing's runs about $550 before discounts. Patients wanting an abortion take only one pill. People with Cushing's often take up to three pills a day for months or years."[13] While the price of Mifeprex has remained stable, the price for Korlym has increased nearly 150 percent over the past six years, rising to an average yearly cost per patient of $180,000.[13] "We have an expensive drug," said Corcept's CEO Joseph K. Belanoff, MD.[3] "There's no getting around that."[13]
In 2017, Corcept's revenue nearly doubled to $159.2 million, and executives expect to reach $275 million to $300 million in 2018. In January 2018, Corcept's stock price rose 27.4 percent. Executives say revenue from Korlym, which cost about $300 million to develop, has paid for development of new drugs. By December 2016, Corcept had discovered three structurally distinct series of selective cortisol modulators that, unlike mifepristone, do not terminate pregnancy.[4] In March 2018, Corcept reported an encouraging phase II clinical trial update on relacorilant, a possible successor to Korlym that could treat Cushing's syndrome without the side effects of endometrial thickening and vaginal bleeding experienced by some women.[13]
Warning. Since each tablet for oral use contains 300 mg of mifepristone,[18] Korlym should never be taken by women who are pregnant or who might become pregnant. Taking Korlym during pregnancy will result in the loss of a pregnancy.[19]
