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 based on discussions earlier this week, the U.S.
Food and Drug Administration (FDA) has notified Intercept that its
tentatively scheduled June 9, 2020 advisory committee meeting
(AdCom) relating to the company’s new drug application (NDA) for
obeticholic acid (OCA) for the treatment of liver fibrosis due to
nonalcoholic steatohepatitis (NASH) has been postponed. The
postponement will accommodate the review of additional data
requested by the FDA that the company intends to submit within the
next week. The FDA has indicated that it will reach out to
Intercept in the near future with a new proposed AdCom date.
Intercept now anticipates that the FDA’s review of its NDA will
extend beyond the Prescription Drug User Fee Act (PDUFA) target
action date of June 26, 2020.
“While this delay was unanticipated, following our most recent
dialogue with the FDA we believe that the additional data being
submitted will be important in facilitating a more informed
discussion at the AdCom,” said Mark Pruzanski, M.D., President and
Chief Executive Officer of Intercept. “We remain confident in our
NDA submission and look forward to continuing to work with the FDA
to bring the first treatment to patients with advanced fibrosis due
to NASH.”
Intercept previously announced the FDA’s acceptance of the NDA
and granting of priority review. OCA has received Breakthrough
Therapy designation from the FDA for the treatment of NASH patients
with liver fibrosis.
About Liver Fibrosis due to NASH
Nonalcoholic steatohepatitis (NASH) is a serious progressive
liver disease caused by excessive fat accumulation in the liver
that induces chronic inflammation, resulting in progressive
fibrosis (scarring) that can lead to cirrhosis, eventual liver
failure, cancer and death. Advanced fibrosis is associated with a
substantially higher risk of liver-related morbidity and mortality
in patients with NASH. In the United States, NASH is currently the
second leading cause for liver transplantation overall, and in
females, the leading cause. NASH is anticipated to become the
leading indication for liver transplantation
in Europe within the next decade. There are currently no
medications approved for the treatment of NASH.
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
Statements
This press release contains forward-looking statements,
including, but not limited to, statements regarding the progress,
timing and results of our clinical trials, including 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 or any other indications in addition to PBC, the timing and
potential commercial success of OCA and any other product
candidates we may develop and 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: the impact of COVID-19, including any
impact on our net sales, non-GAAP adjusted operating expenses 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; 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; 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 timely and cost-effectively file for and obtain
regulatory approval of our product candidates, including the
regulatory approval of our New Drug Application for liver fibrosis
due to NASH; any advisory committee recommendation that our
product candidates, including OCA for liver fibrosis due to NASH,
should not be approved or approved only under certain conditions;
any 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; 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 timely and 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, 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
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.
Contact
For more information about Intercept, please contact:
Lisa DeFrancesco+1-646-565-4833investors@interceptpharma.com
Christopher Frates+1-646-757-2371media@interceptpharma.com
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