Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical
company focused on the development and commercialization of novel
therapeutics to treat progressive non-viral liver diseases, today
announced that an analyst note commenting on the listing of
Intercept’s product on the U.S. Food and Drug Administration (FDA)
Adverse Event Reporting System (FAERS) website reached a conclusion
regarding the status of a newly identified safety signal (NISS) for
Ocaliva® (obeticholic acid) that the Company believes is incorrect.
The FDA provides quarterly information on newly identified
safety signals. The Company does not believe that the absence of a
listed medicine that was in one quarterly update in a subsequent
quarter necessarily indicates that the FDA has completed its
evaluation of the NISS.
As Intercept has previously communicated, the Company has
submitted a comprehensive safety assessment to the FDA and the
dialogue with the FDA regarding the Agency’s evaluation of the NISS
for Ocaliva remains ongoing.
As the Company has also previously stated, the FDA notified
Intercept in May 2020 that, in the course of its routine safety
surveillance of postmarketing data, the FDA began to evaluate a
NISS regarding liver disorder for Ocaliva which the FDA classified
as a potential risk, the lowest level of risk. Pursuant to the
FDA’s guidance, this does not mean that the FDA has concluded that
the drug has the listed risk or that the FDA has identified a
causal relationship between Ocaliva and the potential risk. The FDA
has informed the Company that the FDA’s review of the NISS is
focused on a subset of the cirrhotic, or more advanced, PBC
patients who have taken Ocaliva.
About Intercept
Intercept is a biopharmaceutical company focused on the
development and commercialization of novel therapeutics to treat
progressive non-viral liver diseases, including primary biliary
cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Founded
in 2002 in New York, Intercept has operations in the United States,
Europe and Canada. For more information, please visit
www.interceptpharma.com or connect with the company on Twitter and
LinkedIn.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements, including, but not limited to, statements regarding the
progress, timing and results of our clinical trials, including the
timeline or outcome of the U.S. Food and Drug
Administration’s (FDA) evaluation of the newly identified
safety signal, our clinical trials for the treatment of
nonalcoholic steatohepatitis (“NASH”), the safety and efficacy of
our approved product, Ocaliva (obeticholic acid or “OCA”) for
primary biliary cholangitis (“PBC”), and our product candidates,
including OCA for liver fibrosis due to NASH, the timing and
acceptance of our regulatory filings and the potential approval of
OCA for liver fibrosis due to NASH, the review of our New Drug
Application for OCA for the treatment of liver fibrosis due to NASH
by the FDA, our intent to work with the FDA to address the issues
raised in the complete response letter (CRL), the potential
commercial success of OCA, as well as our strategy, future
operations, future financial position, future revenue, projected
costs, financial guidance, prospects, plans and objectives. These
statements constitute forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. The
words “anticipate,” “believe,” “estimate,” “expect,” “intend,”
“may,” “plan,” “predict,” “project,” “target,” “potential,” “will,”
“would,” “could,” “should,” “possible,” “continue” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date of this release, and we undertake no obligation to
update any forward-looking statement except as required by law.
These forward-looking statements are based on estimates and
assumptions by our management that, although believed to be
reasonable, are inherently uncertain and subject to a number of
risks. The following represent some, but not necessarily all, of
the factors that could cause actual results to differ materially
from historical results or those anticipated or predicted by our
forward-looking statements: our ability to successfully
commercialize Ocaliva for PBC; our ability to maintain our
regulatory approval of Ocaliva for PBC in the United
States, Europe, Canada, Israel, Australia and
other jurisdictions in which we have or may receive marketing
authorization; our ability to timely and cost-effectively file for
and obtain regulatory approval of our product candidates on an
accelerated basis or at all, including OCA for liver fibrosis due
to NASH following the issuance of the CRL by the FDA; any advisory
committee recommendation or dispute resolution determination
that our product candidates, including OCA for liver fibrosis due
to NASH, should not be approved or approved only under certain
conditions; any future determination that the regulatory
applications and subsequent information we submit for our
product candidates, including OCA for liver fibrosis due to NASH,
do not contain adequate clinical or other data or meet applicable
regulatory requirements for approval; conditions that may be
imposed by regulatory authorities on our marketing approvals for
our products and product candidates, including OCA for liver
fibrosis due to NASH, such as the need for clinical outcomes data
(and not just results based on achievement of a surrogate
endpoint), any risk mitigation programs such as a REMS, and any
related restrictions, limitations and/or warnings contained in the
label of any of our products or product candidates; any potential
side effects associated with Ocaliva for PBC, OCA for liver
fibrosis due to NASH or our other product candidates that could
delay or prevent approval, require that an approved product be
taken off the market, require the inclusion of safety warnings or
precautions, or otherwise limit the sale of such product or product
candidate; the initiation, timing, cost, conduct, progress and
results of our research and development activities, preclinical
studies and clinical trials, including any issues, delays or
failures in identifying patients, enrolling patients, treating
patients, retaining patients, meeting specific endpoints in the
jurisdictions in which we intend to seek approval or completing and
timely reporting the results of our NASH or PBC clinical trials;
our ability to establish and maintain relationships with, and the
performance of, third-party manufacturers, contract research
organizations and other vendors upon whom we are substantially
dependent for, among other things, the manufacture and supply of
our products, including Ocaliva for PBC and, if approved, OCA for
liver fibrosis due to NASH, and our clinical trial activities; our
ability to identify, develop and successfully commercialize our
products and product candidates, including our ability to
successfully launch OCA for liver fibrosis due to NASH, if
approved; our ability to obtain and maintain intellectual property
protection for our products and product candidates, including our
ability to cost-effectively file, prosecute, defend and enforce any
patent claims or other intellectual property rights; the size and
growth of the markets for our products and product candidates and
our ability to serve those markets; the degree of market acceptance
of Ocaliva for PBC and, if approved, OCA for liver fibrosis due to
NASH or our other product candidates among physicians, patients and
healthcare payors; the availability of adequate coverage and
reimbursement from governmental and private healthcare payors for
our products, including Ocaliva for PBC and, if approved, OCA for
liver fibrosis due to NASH, and our ability to obtain adequate
pricing for such products; our ability to establish and maintain
effective sales, marketing and distribution capabilities, either
directly or through collaborations with third parties; competition
from existing drugs or new drugs that become available; our ability
to prevent system failures, data breaches or violations of data
protection laws; costs and outcomes relating to any disputes,
governmental inquiries or investigations, regulatory proceedings,
legal proceedings or litigation, including any securities,
intellectual property, employment, product liability or other
litigation; our collaborators’ election to pursue research,
development and commercialization activities; our ability to
establish and maintain relationships with collaborators with
development, regulatory and commercialization expertise; our need
for and ability to generate or obtain additional financing; our
estimates regarding future expenses, revenues and capital
requirements and the accuracy thereof; our use of cash and
short-term investments; our ability to acquire, license and invest
in businesses, technologies, product candidates and products; our
ability to attract and retain key personnel to manage our business
effectively; our ability to manage the growth of our operations,
infrastructure, personnel, systems and controls; our ability to
obtain and maintain adequate insurance coverage; the impact of
COVID-19, including any impact on our results of operations or
financial position, related quarantines and government actions,
delays relating to our regulatory applications, disruptions
relating to our ongoing clinical trials or involving our contract
research organizations, study sites or other clinical partners,
disruptions relating to our supply chain or involving our
third-party manufacturers, distributors or other distribution
partners, facility closures or other restrictions, and the extent
and duration thereof; the impact of general U.S. and
foreign economic, industry, market, regulatory or political
conditions, including the potential impact of Brexit; and the other
risks and uncertainties identified in our periodic filings filed
with the U.S. Securities and Exchange Commission, including
our Annual Report on Form 10-K for the year ended December 31,
2019 and our Quarterly Report on Form 10-Q for the quarter
ended September 30, 2020.
CONTACT
For more information about Intercept, please contact:
For investors:investors@interceptpharma.com
For media:media@interceptpharma.com
Source: Intercept Pharmaceuticals, Inc.
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