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Press Release CONTACT: CORCEPT THERAPEUTICS RECEIVES FDA NOTIFICATION OPENING IND FOR CORLUX® FOR THE TREATMENT OF CUSHING’S SYNDROME Menlo Park, Calif., (September 11, 2007) -- Corcept Therapeutics Incorporated (NASDAQ: CORT) today announced that it has received notification from the Food and Drug Administration (FDA) that the FDA has opened the Investigational New Drug application (IND) for CORLUX for the treatment of Cushing’s Syndrome. CORLUX is a cortisol receptor (GR-II) antagonist. In July 2007, the Company announced the receipt of Orphan Drug Designation for CORLUX for the treatment of Cushing’s Syndrome. Drugs that receive Orphan Drug Designation obtain seven years of marketing exclusivity from the date of drug approval as well as tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process. In the communication regarding the opening of the IND, the FDA indicated that a single study may provide a reasonable basis for the submission of a New Drug Application (NDA) for Corlux for the treatment of Cushing’s Syndrome, which allows us to initiate the 50-patient open label study defined by the protocol submitted with the application for the IND. Corcept has begun qualifying potential sites for this study and expects to open the trial for enrollment late in the fourth quarter of 2007. Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer commented, "We are pleased that the FDA has allowed us to open our IND for CORLUX for the treatment of Cushing’s Syndrome and to initiate the Phase 3 protocol included in the IND submission. We look forward to advancing a potential treatment for this rare illness.” About Cushing’s
Syndrome About Corcept
Therapeutics Incorporated Statements made in
this news release, other than statements of historical fact, are forward-looking
statements, including, for example, statements relating to the timing
and results of the clinical trial for CORLUX for the treatment of Cushing’s
Syndrome, Corcept’s other clinical development programs, and its
spending plans. 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 with respect to the commencement,
cost, rate of spending, completion or success of clinical trials; financial
projections may not be accurate; there can be no assurances that the investigations
for future clinical trials will be completed, or that Corcept will pursue
further activities with respect to clinical development of CORLUX. These
and other risk factors 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. |