Page 1 of 5
`
`EX-99 2 corcepttherapeuticsincorpora.htm CORCEPT THERAPEUTICS PRESS RELEASE
`
`Corcept Therapeutics Incorporated Announces FDA Approval of Korlym(TM) (Mifepristone):
`First and Only Approved Medication for Cushing's Syndrome Patients
`
`MENLO PARK, CA -- (Marketwire - February 17, 2012) - Corcept Therapeutics Incorporated
`(NASDAQ: CORT) announced today that the U.S. Food and Drug Administration (FDA) has
`approved Korlym™ (mifepristone 300 mg tablets) as a once-daily oral medicine to control
`hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome
`who have diabetes mellitus type 2 or glucose intolerance and have failed surgery or are not candidates
`for surgery.
`
`"We appreciate the FDA's diligent attention to our NDA and its grant of approval on the PDUFA
`date," said Joseph K. Belanoff, M.D., the company's Chief Executive Officer. "We plan to make
`Korlym available to patients by May 1 through a distribution system designed to support both patients
`and prescribers."
`
`Corcept will be the sole marketer of Korlym. "A relatively small number of endocrinologists regularly
`treat patients with Cushing's syndrome," added Dr. Belanoff. "These doctors can be reached without a
`large sales and marketing infrastructure." The company has begun hiring Medical Science Liaisons to
`inform practitioners about the drug, which will be dispensed by the leading specialty pharmacy
`company CuraScript SP, a subsidiary of Express Scripts.
`
`"Korlym is a significant advance in the treatment of patients suffering from the debilitating symptoms
`of Cushing's syndrome," said Robert L. Roe, M.D., Corcept's President. "For the first time, these
`patients have access to an approved therapy when surgery has failed or is not an option."
`
`Korlym clinical trial investigator Amir Hamrahian, M.D., Department of Endocrinology, Diabetes and
`Metabolism at the Cleveland Clinic said, "There are not many effective treatment options for patients
`with Cushing's syndrome. Although surgery is standard first line treatment for the disease, it is not
`always successful and not all patients are candidates. As part of the clinical trial, I have used Korlym
`successfully and my patients continue to do well on the medicine. I'm excited to be able to continue
`using Korlym in these patients and others who need it. This medicine's approval gives me a much
`needed tool to better treat patients."
`
`Dr. Hamrahian's comments were seconded by Maureen V., a patient in Corcept's Phase 3 clinical trial:
`"I had pituitary surgery to treat my Cushing's syndrome. Unfortunately, my surgery wasn't successful.
`I was lucky to get into the study and get Korlym treatment. I have been taking the medicine
`successfully for over a year, and I am extremely happy that it was approved by the FDA. Now I know
`I'll be able to keep taking it. It has made a big difference in my life."
`
`Clinical Trial Results Supporting FDA Approval
`The clinical data supporting the FDA approval of Korlym resulted from an uncontrolled, open-label,
`multi-center, 24-week phase III study of 50 patients who had endogenous Cushing's syndrome and
`were either not eligible for or had relapsed from surgery and were either glucose intolerant (29
`patients) or had hypertension (21 patients). Within the glucose intolerant group, 60 percent of patients
`had a greater than 25 percent reduction from baseline in the area under the curve in the oral glucose
`tolerance test. In this group, mean hemoglobin A1C (HbA1C) was reduced from 7.4 percent to 6.3
`percent. All 14 patients with above-normal HbA1C levels at baseline experienced reductions. Eight of
`
`https://www.sec.gov/Archives/edgar/data/1088856/000110262412000138/corcepttherapeut...
`
`4/25/2019
`
`1
`
`TEVA1043
`
`

`

`Page 2 of 5
`
`these 14 normalized their HbA1C. Antidiabetic medications were reduced in seven of the 15 patients
`with diabetes mellitus type 2 and remained constant in the others.
`
`Patients who responded to therapy were allowed enrollment in an extension trial. Eighty-eight percent
`of the patients who completed the trial chose to do so.
`
`A peer-reviewed analysis of the study results will soon be published in a leading journal.
`
`Patients in the study started Korlym treatment on a dose of 300 mg administered once daily. Their
`dose was then titrated to maximum clinical effect. As indicated in the medicine's label, physicians
`prescribing Korlym may determine the appropriate dose for each patient by assessing tolerability and
`degree of improvement in Cushing's syndrome manifestations. In the first six weeks, these
`manifestations may include changes in glucose control, anti-diabetic medication requirements, insulin
`levels and psychiatric symptoms. After two months, assessment may also be based on improvements
`in cushingoid appearance, acne, hirsutism, striae, decreased body weight, along with further changes
`in glucose control.
`
`About Korlym™ (mifepristone 300 mg tablets)
`Korlym is a once-daily oral medication that blocks the glucocorticoid receptor type II (GR-II) to
`which cortisol normally binds. By blocking this receptor, Korlym inhibits the effects of excess
`cortisol in Cushing's syndrome patients.
`
`The FDA has designated Korlym as an Orphan Drug for treatment of the clinical manifestations of
`endogenous Cushing's syndrome. Orphan Drug designation is a special status designed to encourage
`the development of medicines for rare diseases and conditions. Because Korlym is an Orphan Drug,
`Corcept will have marketing exclusivity consistent with the FDA's designation until February 2019.
`
`About Cushing's Syndrome
`Endogenous Cushing's syndrome is a rare and life-threatening endocrine disorder that results from
`long-term exposure to excess levels of the hormone cortisol. This excess is caused by tumors that
`usually occur in the pituitary or adrenal glands that over-produce, or prompt the over-production of,
`cortisol.
`
`Although cortisol at normal levels is essential to health, in excess it causes a variety of problems,
`including hyperglycemia, upper body obesity, a rounded face, stretch marks on the skin, an
`accumulation of fat on the back, thin and easily bruised skin, muscle weakness, bone weakness,
`persistent infections, high blood pressure, fatigue, irritability, anxiety, psychosis and depression.
`Women may have menstrual irregularities and facial hair growth, while men may have decreased
`fertility or erectile dysfunction. More than 70 percent of Cushing's syndrome patients suffer from
`glucose intolerance or diabetes.
`
`The treatment of an endogenous Cushing's syndrome patient depends on the cause. The first-line
`approach is surgery to remove the tumor. If surgery is not successful or is not an option, radiation may
`be used, but that therapy can take up to ten years to achieve full effect. Surgery and radiation are
`successful in only approximately one-half of all cases.
`
`If left untreated, Cushing's syndrome has a five-year mortality rate of 50 percent.
`
`An orphan disease, Cushing's syndrome occurs in about 20,000 people in the United States, mostly
`women between the ages of 20 and 50.
`
`https://www.sec.gov/Archives/edgar/data/1088856/000110262412000138/corcepttherapeut...
`
`4/25/2019
`
`2
`
`

`

`Page 3 of 5
`
`Conference Call Information
`Corcept will hold a conference call on Tuesday, February 21, 2012 at 9:00 a.m. Eastern Time (6:00
`a.m. Pacific Time) to discuss this announcement. To participate in the live call please dial 1-800-264-
`7882 from the United States or +1-847-413-3708 internationally. The pass code is 31838602. Please
`dial in approximately 10 minutes before the start of the call.
`
`A replay of the conference call will be available through March 6, 2012 at 1-888-843-7419 from the
`United States and +1-630-652-3042 internationally. The pass code is 31838602.
`
`IMPORTANT SAFETY INFORMATION
`
`WARNING: TERMINATION OF PREGNANCY
`
`See full prescribing information for complete boxed warning.
`
`Mifepristone has potent antiprogestational effects and will result in the termination of pregnancy.
`Pregnancy must therefore be excluded before the initiation of treatment with Korlym, or if treatment
`is interrupted for more than 14 days in females of reproductive potential.
`
`Contraindications
`
`• Pregnancy
`• Use of simvastatin or lovastatin and CYP 3A substrates with narrow therapeutic range
`• Concurrent long-term corticosteroid use
`• Women with history of unexplained vaginal bleeding
`• Women with endometrial hyperplasia with atypia or endometrial carcinoma
`
`Warnings and Precautions
`
`• Adrenal insufficiency: Patients should be closely monitored for signs and symptoms of adrenal
`insufficiency.
`• Hypokalemia: Hypokalemia should be corrected prior to treatment and monitored for during
`treatment.
`• Vaginal bleeding and endometrial changes: Women may experience endometrial thickening or
`unexpected vaginal bleeding. Use with caution if patient also has a hemorrhagic disorder or is
`on anti-coagulant therapy.
`• QT interval prolongation: Avoid use with QT interval-prolonging drugs, or in patients with
`potassium channel variants resulting in a long QT interval.
`• Use of Strong CYP3A Inhibitors: Concomitant use can increase mifepristone plasma levels
`significantly. Use only when necessary and limit mifepristone dose to 300 mg.
`
`Adverse Reactions
`
`Most common adverse reactions in Cushing's syndrome (≥ 20%): nausea, fatigue, headache,
`decreased blood potassium, arthralgia, vomiting, peripheral edema, hypertension, dizziness, decreased
`appetite, endometrial hypertrophy.
`
`To report suspected adverse reactions, contact Corcept Therapeutics at 1-855-844-3270 or FDA
`at 1-800-FDA-1088 or www.fda.gov/medwatch.
`
`Drug Interactions
`
`https://www.sec.gov/Archives/edgar/data/1088856/000110262412000138/corcepttherapeut...
`
`4/25/2019
`
`3
`
`

`

`Page 4 of 5
`
`• Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest
`dose when used with Korlym.
`• CYP3A inhibitors: Caution should be used when Korlym is used with strong CYP3A inhibitors.
`Limit mifepristone dose to 300 mg per day when used with strong CYP3A inhibitors.
`• CYP3A inducers: Do not use Korlym with CYP3A inducers.
`• Drugs metabolized by CYP2C8/2C9: Use the lowest dose of CYP2C8/2C9 substrates when
`used with Korlym.
`• Drugs metabolized by CYP2B6: Use of Korlym should be done with caution with bupropion
`and efavirenz.
`• Hormonal contraceptives: Do not use with Korlym.
`
`Use in Specific Populations
`
`• Nursing mothers: Discontinue drug or discontinue nursing.
`
`Please see the accompanying full Prescribing Information including boxed warning at
`www.corcept.com/prescribinginfo.pdf
`
`Please see the accompanying Medication Guide at www.corcept.com/medicationguide.pdf
`
`About Corcept Therapeutics Incorporated
`Corcept is a pharmaceutical company engaged in the discovery, development and commercialization
`of drugs for the treatment of severe metabolic and psychiatric disorders. Korlym, a first generation
`GR-II antagonist, is the company's first FDA-approved medication. The company has a portfolio of
`new selective GR-II antagonists that block the effects of cortisol but not progesterone. Corcept also
`owns an extensive intellectual property portfolio covering the use of GR-II antagonists, including
`mifepristone, in the treatment of a wide variety of psychiatric and metabolic disorders. The company
`also holds composition of matter patents for its selective GR-II antagonists.
`
`Statements made in this news release, other than statements of historical fact, are forward-looking
`statements. Forward-looking statements are subject to a number of known and unknown risks and
`uncertainties that might cause actual results to differ materially from those expressed or implied by
`such statements. For example, there can be no assurances that clinical results will be predictive of
`real-world use, or regarding the pace of Korlym's acceptance by physicians and patients, the
`reimbursement decisions of government or private insurance payers, the effects of rapid technological
`change and competition, the protections afforded by Korlym's Orphan Drug Designation or by
`Corcept's other intellectual property rights, and the cost, pace and success of Corcept's other product
`development efforts. These and other risks are set forth in the Company's SEC filings, all of which are
`available from our website (www.corcept.com) or from the SEC's website (www.sec.gov). We
`disclaim any intention or duty to update any forward-looking statement made in this news release.
`Investor Contact:
`Charles Robb
`Chief Financial Officer
`Corcept Therapeutics Incorporated
`650-688-8783
`Media Contact:
`Alissa Maupin
`Communications Strategies, Inc.
`973-635-6669
`
`https://www.sec.gov/Archives/edgar/data/1088856/000110262412000138/corcepttherapeut...
`
`4/25/2019
`
`4
`
`

`

`Page 5 of 5
`
`https://www.sec.gov/Archives/edgar/data/1088856/000110262412000138/corcepttherapeut...
`
`4/25/2019
`
`5
`
`