Intercept Receives Complete Response Letter from FDA for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH
22 Junho 2023 - 6:45PM
Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical
company focused on the development and commercialization of novel
therapeutics to treat rare and serious liver diseases, today
announced that the U.S. Food and Drug Administration (FDA) has
issued a Complete Response Letter (CRL) in response to the
Company’s New Drug Application (NDA) for obeticholic acid (OCA) for
the treatment of pre-cirrhotic fibrosis due to nonalcoholic
steatohepatitis (NASH).
The FDA indicated in the CRL that it has completed its review of
the NDA and determined that it cannot be approved in its present
form. Based on the content of the CRL, any resubmission of an NDA
for OCA in NASH would require, at a minimum, successful completion
of the long-term outcomes phase of the REGENERATE study. As a
result of the CRL, Intercept has decided to discontinue all
NASH-related investment, restructure the Company’s operations to
strengthen its focus on rare and serious liver diseases, and drive
an accelerated path to profitability beginning in 2024.
“While this is clearly not the outcome that we have worked
toward, I’m proud of the impact that Intercept has made to move the
science of NASH forward and bring the field closer to a treatment
option,” said Jerry Durso, President and Chief Executive Officer of
Intercept. “Intercept thanks the scientists, clinicians and
patients whose contributions to the clinical development of OCA in
NASH have significantly advanced the understanding of this deadly
disease.”
Durso continued, “We believe that taking decisive action to
reshape Intercept will improve our long-term ability to grow our
business, innovate for patients, and create value for shareholders.
We remain committed to the liver community and will continue to
advance our leadership in rare and serious liver diseases where
Intercept has deep expertise and a recognized dedication to
therapeutic innovation.”
Conference Call on Friday, June 23, 2023, at 8:30 a.m.
ETThe Company will host a conference call on Friday, June
23, 2023, at 8:30 a.m. ET to address the restructuring and provide
updated financial guidance. The conference call will be available
via a listen-only webcast on the investor page of the Company’s
website at http://ir.interceptpharma.com. Participants who wish to
ask a question may register here to receive dial-in numbers and a
unique pin to join the call. A replay of the call will be available
on the Intercept website shortly following the completion of the
call and will be available for one year.
About InterceptIntercept is a biopharmaceutical
company focused on the development and commercialization of novel
therapeutics to treat rare and serious liver diseases, including
primary biliary cholangitis (PBC) and severe alcohol-associated
hepatitis (sAH). For more information, please visit
www.interceptpharma.com or connect with the Company on Twitter and
LinkedIn.
Forward-Looking StatementsThis news release
contains forward-looking statements (“FLS”), including regarding a
planned corporate restructuring, corporate strategy and priorities,
corporate financial performance and profitability, and timing of
profitability. Important factors could cause actual results to
differ materially from the FLS. For example, we may be less
effective than expected in implementing strategic changes,
restructuring and clinical trial wind-down may be slower and have
greater costs than expected, and we may fail to achieve
profitability due to lower revenues or higher expenses than
expected.
ContactsFor more information about Intercept,
please contact:
For investors:Nareg Sagherian, Executive Director, Global
Investor Relationsinvestors@interceptpharma.com
For media:Karen Preble, Executive Director, Global Corporate
Communicationsmedia@interceptpharma.com
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