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 (OCA) abstracts, including a late-breaking poster, “Long-Term
Obeticholic Acid Treatment Associated with Reversal or
Stabilization of Fibrosis/Cirrhosis in Patients with Primary
Biliary Cholangitis,” will be presented at the International Liver
Congress™ 2018, the 53rd Annual Meeting of the European Association
for the Study of the Liver (EASL), in Paris, France, from April
11-15, 2018.
“We’re very excited to share the first biopsy-based clinical
data supporting OCA's ability to reverse or stabilize fibrosis and
cirrhosis in patients with PBC,” said Christian Weyer, M.D.,
M.A.S., Intercept's Executive Vice President of Research &
Development. “In addition to this important late-breaking poster,
the International Liver Congress will also feature new safety
analyses from the OCA clinical development program in NASH, the
first real-world OCA data from the TARGET-PBC registry, changes in
bilirubin and markers of cholestasis following long-term OCA
treatment in PBC, and OCA dose selection in pediatric patients with
biliary atresia. Finally, a preclinical oral presentation will
provide new insights into the effects of steroidal and
non-steroidal FXR agonists on cholesterol metabolism.”
Congress attendees can visit Intercept at booth 810 (primary
booth) and 430 (Medical Affairs booth) throughout the meeting.
Presentations at the International Liver Congress include:
Late-Breaking Poster Presentation
“Long-Term Obeticholic Acid Treatment Associated with
Reversal or Stabilization of Fibrosis/Cirrhosis in Patients with
Primary Biliary Cholangitis” Christopher Bowlus, Paul
Pockros, Andreas Kremer, Albert Parés, Lisa Forman, Joost Drenth,
Steve Ryder, Elizabeth Smoot Malecha, Richard Pencek, Uchenna
Iloeje, Leigh MacConell, David Shapiro, Pierre Bedossa
Oral Presentation
“Steroidal and Non-Steroidal FXR Agonists Elicit
Clinically Relevant Lipoprotein Profiles in Mice with Chimeric
Humanized Livers” Romeo Papazyan, Kristoffer Rigbolt,
Rasmus Lind, Michael Feigh, Jingwen Liu, Bin Dong, Emily M.
Plummer, Ronald D. Lewis II, Jonathan Roth, Mark Young
Clinical Poster Presentations
“Treatment with Obeticholic Acid in Patients with NASH
Does Not Show Increased Markers of Liver Toxicity Based on
Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH)”
Arun Sanyal, Paul Pockros, Amrik Shah, Reshma Shringarpure, David
Shapiro, Leigh MacConell
“Primary Biliary Cholangitis in the U.S.: Real World
Effectiveness of Obeticholic Acid in
TARGET‐PBC” Cynthia
Levy, Christopher Bowlus, Elizabeth J. Carey, George DeMuth, Karen
Deane, Marlyn J. Mayo, W. Ray Kim, Bruce R. Bacon, David Bernstein,
PJ Thuluvath, L. Michael Weiss, Uchenna Iloeje, Mary Erickson,
Marcie Strauss, Michael W. Fried
“Durable Response in the Markers of Cholestasis through
36 Months of Open-Label Extension Study of Obeticholic Acid in
Primary Biliary Cholangitis” Michael Trauner, Mitchell
Shiffman, Joost Drenth, Christopher Bowlus, Victor Vargas, Pietro
Andreone, Richard Pencek, Elizabeth Smoot Malecha, Leigh MacConell,
David Shapiro
“Change in Bilirubin with Obeticholic Acid Treatment in
Primary Biliary Cholangitis Patients with High Baseline Bilirubin:
A Retrospective Analysis of POISE, 201, and 202” Gideon M.
Hirschfield, Mitchell Shiffman, Albert Parés, Elizabeth Smoot
Malecha, Richard Pencek, Leigh MacConell, David Shapiro
“Disease Severity, Obeticholic Acid Disposition and Dose
Selection in Patients with Biliary Atresia” Jeffrey E.
Edwards, Carl LaCerte, Yuanyuan Zhang, Saul J. Karpen, Janet
Owens-Grillo, Leigh MacConell
Preclinical Poster Presentations
“Combined Administration of Obeticholic Acid and
GFT-505: Additive Histological Improvements in Mice with
Diet-induced and Biopsy-confirmed Non-alcoholic
Steatohepatitis” Jonathan Roth, Sanne Veidal, Romeo
Papazyan, Kristoffer Rigbolt, Michael Feigh, Mark Young
“Fibrosis Involves Increased Fibroblast and Hepatocyte
Collagen Species, Reflecting the Interstitial and Basement Membrane
Matrix: Restoration of the Local Tissue Milieu with FXR
Agonism” Jonathan Roth, Sanne Veidal, Romeo Papazyan,
Kristoffer Rigbolt, Michael Feigh, Morten Karsdal, Diana Leeming,
Mark Young
A full list of sessions at the International Liver Congress
2018, including symposia, relating to obeticholic acid is available
on the International Liver Congress website.
About Primary Biliary Cholangitis Primary
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
is indicated in the United States for the treatment of primary
biliary cholangitis (PBC) in combination with ursodeoxycholic acid
(UDCA) in adults with an inadequate response to UDCA, or as
monotherapy in adults unable to tolerate UDCA.
This indication is approved under accelerated approval based on
a reduction in alkaline phosphatase (ALP), as a surrogate endpoint
which is reasonably likely to predict clinical benefit, including
an improvement in liver transplant free-survival. An improvement in
survival or disease-related symptoms has not been established.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory
trials. Intercept is currently enrolling COBALT, a Phase 4 clinical
outcomes trial of Ocaliva in patients with PBC with the goal of
confirming clinical benefit on a postmarketing basis.
In December 2016, Ocaliva received conditional marketing
authorization in Europe for the treatment of PBC in combination
with 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.
Ocaliva received conditional approval from Health Canada in May
2017.
EU IMPORTANT SAFETY INFORMATION
ContraindicationsHypersensitivity to the active
substance or to any of the excipients and complete biliary
obstruction. Warnings and PrecautionsElevations 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 with
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 ReactionsThe 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 InteractionBile 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. For more information
about Intercept, please visit www.interceptpharma.com or
connect with the company
on Twitter and LinkedIn.
Forward-Looking Statements This press release
contains forward-looking statements, including, but not limited to,
statements regarding the progress, timing and results of
Intercept’s clinical trials, including its clinical trials for the
treatment of nonalcoholic steatohepatitis (“NASH”), the safety and
efficacy of Intercept’s approved product, Ocaliva (obeticholic acid
or “OCA”), the potential approval of OCA in indications other than
primary biliary cholangitis (“PBC”) and the timing and potential
commercial success of OCA and any other product candidates
Intercept may develop.
These statements constitute forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. The words
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,”
“plan,” “predict,” “project,” “target,” “potential,” “will,”
“would,” “could,” “should,” “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 Intercept undertakes no obligation to update any
forward-looking statement except as required by law. These
forward-looking statements are based on estimates and assumptions
by Intercept’s 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 Intercept’s
forward-looking statements: Intercept’s ability to successfully
commercialize Ocaliva in PBC; Intercept’s ability to maintain its
regulatory approval of Ocaliva in PBC in the United States, Europe,
Canada and other jurisdictions in which it has or may receive
marketing authorization; the initiation, cost, timing, progress and
results of Intercept’s development activities, preclinical studies
and clinical trials, including its clinical trials for the
treatment of NASH; the timing of and Intercept’s ability to obtain
regulatory approval of OCA in indications other than PBC and
regulatory approval of any other product candidates it may develop;
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 products or product candidates; Intercept’s plans to research,
develop and commercialize its products and product candidates;
Intercept’s ability to obtain and maintain intellectual property
protection for its products and product candidates; Intercept’s
ability to successfully commercialize its products and 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
received from payors; the success of competing drugs that are or
become available; regulatory developments in the United States and
other countries; the performance of Intercept’s third-party
suppliers and manufacturers; Intercept’s collaborators’ election to
pursue research, development and commercialization activities;
Intercept’s ability to attract collaborators with development,
regulatory and commercialization expertise; Intercept’s need for
and ability to obtain additional financing; Intercept’s estimates
regarding expenses, revenues and capital requirements and the
accuracy thereof; Intercept’s use of cash and short-term
investments; Intercept’s ability to attract and retain key
scientific or management personnel; and the other risks and
uncertainties identified in Intercept’s periodic filings, including
Intercept’s Annual Report on Form 10-K for the year ended December
31, 2017.
ContactFor more information about Intercept
Pharmaceuticals, please contact:
Mark
Vignola+1-646-747-1000investors@interceptpharma.com
Christopher Frates+1-646-757-2371media@interceptpharma.com
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