Corcept Therapeutics Receives Orphan Designation for Relacorilant as Treatment for Pancreatic Cancer
October 01 2018 - 7:15AM
Corcept Therapeutics Incorporated (NASDAQ: CORT), a company engaged
in the discovery, development and commercialization of drugs to
treat severe metabolic, oncologic and psychiatric disorders by
modulating the effects of the stress hormone cortisol, today
announced that the Food and Drug Administration (FDA) has granted
orphan drug status to Corcept’s selective cortisol modulator
relacorilant to treat patients with pancreatic cancer. Corcept is
conducting clinical trials of relacorilant in combination with
nab-paclitaxel (Celgene Corporation’s drug, Abraxane®) as a
treatment for pancreatic cancer and other solid tumors.
Orphan drug designation is granted by the FDA to
encourage the development of treatments for diseases that affect
fewer than 200,000 patients in the United States. Drugs that
receive orphan status obtain seven years of marketing exclusivity
from the date of drug approval, tax credits for clinical trial
costs, marketing application filing fee waivers and assistance from
the FDA in the drug development process. Receiving orphan drug
designation does not alter the standard regulatory requirements and
process for obtaining marketing approval.
"We are pleased the FDA has granted relacorilant
orphan drug status for the treatment of pancreatic cancer.
Pancreatic cancer has a poor prognosis and patients have few
treatment options,” said Joseph K. Belanoff, M.D., Corcept’s Chief
Executive Officer. “The data we have generated so far in this
indication have been very encouraging. Five of nine patients
who received the minimum therapeutic dose in our Phase 1/2 trial of
relacorilant plus nab-paclitaxel demonstrated durable disease
control. By year-end we expect to have learned enough to determine
a potential path toward a pivotal study in this indication.”
About Pancreatic
Cancer
Pancreatic cancer is the fourth leading cause of
cancer-associated mortality, with a five-year survival rate of five
percent. In the United States, an estimated 33,000 patients
are diagnosed with the disease each year.
About Corcept Therapeutics
Incorporated
Corcept is engaged in the discovery, development
and commercialization of drugs to treat severe metabolic, oncologic
and psychiatric disorders by modulating the effects of
cortisol. The company has a large portfolio of proprietary
compounds, including relacorilant, that selectively modulate the
effects of the stress hormone cortisol. It owns extensive United
States and foreign intellectual property covering the composition
of these compounds and their use to treat a wide variety of serious
disorders. Corcept offers its first FDA-approved product, Korlym®,
for the treatment of patients with Cushing’s syndrome. The company
plans to start a Phase 3 trial of relacorilant to treat patients
with Cushing’s syndrome by the end of this year.
Abraxane® is a trademark of Celgene
Corporation.
CONTACT:Charles RobbChief Financial
OfficerCorcept
Therapeutics650-688-8783crobb@corcept.comwww.corcept.com
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