Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a
biopharmaceutical company focused on the development and
commercialization of novel therapeutics to treat progressive
non-viral liver diseases, today announced that multiple obeticholic
acid, INT-767 and preclinical research abstracts will be presented
at the International Liver Congress 2017, the 52nd Annual Meeting
of the European Association for the Study of the Liver (EASL), in
Amsterdam, the Netherlands, from April 19-23, 2017.
“As our first International Liver Congress following the
marketing authorization of Ocaliva for PBC, this represents an
important and exciting milestone for our team,” said David Shapiro,
M.D., Intercept's Chief Medical Officer. “The presentations at this
year’s meeting provide new insights into Ocaliva’s potential
effects on long term risk in PBC patients, as well as preclinical
findings on the drug’s potential impact on cognitive impairment in
cholestatic liver disease. Additionally, we will be presenting new
preclinical research indicating that activation of the farnesoid X
receptor by both steroidal and non-steroidal agonists may cause an
increase in LDL-cholesterol.”
EASL attendees can visit Intercept at booth 127 (primary booth)
and 187 (Medical Affairs booth) throughout the meeting.
Presentations at the International Liver Congress include:
Clinical Poster Presentations
“Effect of obeticholic acid treatment in patients with
primary biliary cholangitis on categorical shifts in GLOBE score”
(Abstract LBP-527)Maren H. Harms, Willem J. Lammers,
Bettina E. Hansen, Marlyn Mayo, Albert Parés, Elizabeth Smoot
Malecha, Richard Pencek, Leigh MacConell
“Risk reduction with obeticholic acid in patients not
achieving the POISE primary endpoint” (Abstract
SAT-378)Maren Harms, Marco Carbone, Bettina Hansen, George
Mells, Richard Pencek, Elizabeth Smoot Malecha, Leigh MacConell
Preclinical Poster Presentations
“Effects of obeticholic acid and INT-767: a
comparison of hepatic and ileal drug concentration and gene
expression” (Abstract FRI-355)Jonathan Roth, Michael
Feigh, Sanne Veidal, Kristoffer Rigbolt, Jacob Jelsing, Niels
Vrang, Weslyn Friley, Mark Young
“Obeticholic acid improves histological, biochemical and
gene expression profiles in Gubra AMLN mice with biopsy-confirmed
NASH” (Abstract FRI-356)Jonathan Roth, Michael Feigh,
Sanne Veidal, Kristoffer Rigbolt, Mark Young
“Obeticholic acid therapy improves
cognitive decline in cholestatic liver disease” (Abstract
FRI-396)Ben Millar, Claire Richardson, Kat McKay,
Alexandros Pechlivanis, Barbara Innes, John Kirby, David Jones,
Elaine Holmes, Fiona Oakley
“Activation of FXR by steroidal or non-steroidal
agonists causes an increase in LDL-cholesterol in mice with
humanized chimeric liver” (Abstract SAT-363)Xueqing Liu,
Jingwen Liu, Bin Dong, Jonathan Roth, Mark Young
“Evidence of FXR activation with obeticholic acid in an
in vitro intestinal model” (Abstract SAT-420)Yuanyuan
Zhang, Carl LaCerte, Kenneth R. Brouwer, Jonathan P. Jackson,
Sanjay Kansra, Jeffrey E. Edwards
A full list of sessions at EASL 2017, including symposia,
relating to obeticholic acid is available on the International
Liver Congress website.
About Primary Biliary CholangitisPrimary
biliary cholangitis (PBC) is a rare, autoimmune cholestatic liver
disease that puts patients at risk for life-threatening
complications. PBC is primarily a disease of women, afflicting
approximately one in 1,000 women over the age of 40. If left
untreated, survival of PBC patients is significantly worse than the
general population.
About Ocaliva® (obeticholic acid)Ocaliva
(obeticholic acid) is a potent and highly selective agonist of the
farnesoid X receptor (FXR), a nuclear receptor expressed in the
liver and intestine. FXR is a key regulator of bile acid,
inflammatory, fibrotic and metabolic pathways.
In December 2016, Ocaliva received conditional marketing
authorization in Europe for the treatment of PBC in combination
with ursodeoxycholic acid (UDCA) in adults with an inadequate
response to UDCA or as monotherapy in adults unable to tolerate
UDCA, conditional to the company providing further data
post-approval to confirm benefit. In May 2016, the U.S. Food and
Drug Administration granted accelerated approval to Ocaliva for the
treatment of PBC. For full prescribing information in the U.S.,
visit Ocaliva.com.
EU IMPORTANT SAFETY INFORMATION
Contraindications
Hypersensitivity to the active substance or to any of the
excipients and complete biliary obstruction.Warnings and
Precautions
Elevations in alanine amino transferase (ALT) and aspartate
aminotransferase (AST) have been observed in patients taking
obeticholic acid. Clinical signs and symptoms of hepatic
decompensation have also been observed. These events have occurred
as early as within the first month of treatment. Liver-related
adverse events have primarily been observed at doses higher than
the maximum recommended dose of 10 mg once daily. Patients should
be monitored during treatment with Ocaliva for elevations in liver
biochemical tests and for the development of liver-related adverse
events. Dosage adjustments are needed for patients with moderate
(Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic
impairment.
Severe pruritus was reported in 23% of patients treated in the
Ocaliva 10 mg arm, 19% of patients in the Ocaliva titration arm and
7% of patients in the placebo arms. The median time to onset of
severe pruritus was 11, 158 and 75 days for patients in the Ocaliva
10 mg, Ocaliva titration and placebo arms, respectively. Management
strategies include the addition of bile acid binding resins or
antihistamines, dose reduction, reduced dosing frequency and/or
temporary dose interruption.
Adverse Reactions
The most commonly reported adverse reactions were pruritus (63%)
and fatigue (22%). Other common adverse reactions observed in
clinical trials (> 5%) were abdominal pain and discomfort, rash,
oropharyngeal pain, dizziness, constipation, arthralgia, thyroid
function abnormality and eczema.
Drug Interaction
Bile acid binding resins such as cholestyramine, colestipol or
colesevelam adsorb and reduce bile acid absorption and may reduce
efficacy of obeticholic acid. When concomitant bile acid binding
resins are administered, obeticholic acid should be taken at least
4-6 hours before or 4-6 hours after taking a bile acid binding
resin, or at as great an interval as possible.
For detailed safety information for Ocaliva (obeticholic acid) 5
mg and 10 mg tablets including posology and method of
administration, special warnings, drug interactions and adverse
drug reactions, please see the European Summary of Product
Characteristics.
About InterceptIntercept 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), nonalcoholic
steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and
biliary atresia. Founded in 2002 in New York, Intercept now has
operations in the United States, Europe and Canada. Intercept’s
International headquarters are located in London. For more
information about Intercept, please visit
www.interceptpharma.com.
Safe Harbor StatementsThis press release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including, but
not limited to, statements regarding the clinical relevance and
utility of the data on OCA and INT-767 to be presented at EASL, the
continued development of OCA, INT-767 and Intercept's other product
candidates, and our strategic directives under the caption "About
Intercept." These "forward-looking statements" are based on
management's current expectations of future events and are subject
to a number of important risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. These risks
and uncertainties include, but are not limited to: Intercept's
ability to successfully commercialize Ocaliva in PBC, and
Intercept's ability to maintain its regulatory approval in
jurisdictions in which Ocaliva is approved for use in PBC; the
initiation, cost, timing, progress and results of Intercept's
development activities, preclinical studies and clinical trials,
including Intercept's development program in NASH; the timing of
and Intercept's ability to obtain and maintain regulatory approval
of OCA in PBC in countries outside the ones in which it is approved
and in indications other than PBC and any other product candidates
it may develop such as INT-767; conditions that may be imposed by
regulatory authorities on Intercept's marketing approvals for its
products and product candidates such as the need for clinical
outcomes data (and not just results based on achievement of a
surrogate endpoint), and any related restrictions, limitations,
and/or warnings in the label of any approved products and product
candidates; Intercept's plans to research, develop and
commercialize its product candidates; Intercept's ability to obtain
and maintain intellectual property protection for its products and
product candidates; Intercept's ability to successfully
commercialize OCA in indications other than PBC and its other
product candidates; the size and growth of the markets for
Intercept's products and product candidates and its ability to
serve those markets; the rate and degree of market acceptance of
any of Intercept's products, which may be affected by the
reimbursement that it may receive for its products from payors; the
success of competing drugs that are or become available; the
election by Intercept's collaborators to pursue research,
development and commercialization activities; Intercept's ability
to attract collaborators with development, regulatory and
commercialization expertise; regulatory developments in the United
States and other countries; the performance of third-party
suppliers and manufacturers; Intercept's need for and ability to
obtain additional financing; Intercept's estimates regarding
expenses, future revenues and capital requirements and the accuracy
thereof; Intercept's use of cash, short-term investments and the
proceeds from the offering; Intercept's ability to attract and
retain key scientific or management personnel; and other factors
discussed under the heading "Risk Factors" contained in our annual
report on Form 10-K for the year ended December 31, 2016 filed on
March 1, 2017 as well as any updates to these risk factors filed
from time to time in our other filings with the Securities and
Exchange Commission. All information in this press release is as of
the date of the release, and Intercept undertakes no duty to update
this information unless required by law.
Contact
For more information about Intercept Pharmaceuticals, please contact:
Mark Vignola
+1-646-747-1000
investors@interceptpharma.com
Christopher Frates
+1-646-757-2371
media@interceptpharma.com
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