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NEW YORK, Oct 28, 2019 (GLOBE NEWSWIRE via COMTEX) — New analyses from Phase 3 REGENERATE abstraction evaluating the furnishings of OCA on non-invasive alarmist fibrosis tests and NASH patient-reported outcomes
Five-year assay of abiding Ocaliva(R) assay in patients with PBC called for admittance in ‘Best of the Alarmist Meeting’ abstracts
NEW YORK, Oct. 28, 2019 (GLOBE NEWSWIRE) — Intercept Pharmaceuticals, Inc. ICPT, -1.02%, a biopharmaceutical aggregation focused on the development and commercialization of atypical assay to amusement accelerating non-viral alarmist diseases, today appear that assorted abstracts on obeticholic acerbic (OCA) will be presented at The Alarmist Affair [(R)] 2019, the Annual Affair of the American Affiliation for the Abstraction of Alarmist Diseases (AASLD), demography abode from November 8, 2019 through November 12, 2019 in Boston, Massachusetts. Highlights accommodate new abstracts from the acting assay of the advancing cardinal Phase 3 REGENERATE abstraction in patients with alarmist fibrosis due to nonalcoholic steatohepatitis (NASH) and a late-breaking articulate presentation evaluating the abiding adeptness of Ocaliva in patients with primary biliary cholangitis (PBC).
“With two articulate presentations in NASH, a late-breaking PBC presentation, abundant posters and an accretion anatomy of assay on OCA actuality presented by absolute investigators, this is absolutely an alive Alarmist Affair for Intercept,” said Christian Weyer, M.D., M.A.S., Intercept’s Executive Vice President, Assay & Development. “As the aboriginal Phase 3 abstraction to authenticate fibrosis advance in patients with NASH, REGENERATE continues to accommodate the medical affiliation with important insights that we accept will advice appearance the affliction alleyway for these patients. New analyses analytical the furnishings of OCA on noninvasive measures of alarmist fibrosis and patient-reported outcomes are of accurate analytic appliance because they accommodate a window into how OCA’s adeptness and tolerability will be beheld in a real-world setting.”
Select Intercept and absolute presentations at The Alarmist Affair include:
Sunday, November 10, 2019 – 8:30 a.m. ET
“Obeticholic Acerbic Assay in Patients with Nonalcoholic Steatohepatitis: A Secondary Assay of the REGENERATE Abstraction Beyond Fibrosis Stages” (Abstract # 0034) Arun J. Sanyal, Vlad Ratziu, Rohit Loomba, Mary E. Rinella, Quentin M. Anstee, Zachary D. Goodman, Pierre Bedossa, Mandana Khalili, Jerome Boursier, Laura Stinton, Giulio Marchesini, Michael E. Allison, Jacob George, Perttu Arkkila, Luna Zaru, Leigh MacConell, Reshma Shringarpure, Zobair M. Younossi
Sunday, November 10, 2019 – 10:30 a.m. ET
“The Appulse of Pruritus on Patient-Reported Outcomes (PROs) in Patients with Non-alcoholic Steatohepatitis (NASH) Treated with Obeticholic Acerbic (OCA)” (Abstract # 0056) Zobair M. Younossi, Maria Stepanova, Fatema Nader, Rohit Loomba, Quentin M. Anstee, Vlad Ratziu, Stephen A. Harrison, Arun J. Sanyal, Jacob George, Susanne Beckebaum, David W. Orr, Giuseppe Mazzella, Victor Vargas, Lise L. Gluud, Rifaat Safadi, James F. Trotter, Jaideep Behari, David A. Sheridan, Muhammad Y. Sheikh, Gail Cawkwell, Bruce Wong, Pierre Bedossa, Zachary D. Goodman, Mary E. Rinella and on account of the REGENERATE Abstraction Investigators
Late-Breaking Articulate Presentation:
Monday, November 11, 2019 – 3:45 p.m. ET
“Durable Acknowledgment in the Markers of Cholestasis Through 5 Years of Open-Label Extension Abstraction of Obeticholic Acerbic in Primary Biliary Cholangitis” (Abstract # LO6) Frederik Nevens, Mitchell L. Shiffman, Joost PH Drenth, Christopher L. Bowlus, Victor Vargas, Pietro Andreone, Karel J. Van Erpecum, Alexander Liberman, Richard Pencek, Elizabeth Smoot Malecha, Leigh MacConell, Michael H. Trauner
Friday, November 8, 2019 – 8:00 a.m. ET
“The Bread-and-butter Amount and Health Burden of Nonalcoholic Steatohepatitis in the EU5 Countries” (Abstract #0395) Philip N. Newsome, Jorn Schattenberg, Lawrence Serfaty, Alessio M. Aghemo, Salvador Augustin, Emmanuel A. Tsochatzis, Ali E. Canbay, Victor de Ledinghen, Elisabetta Bugianesi, Manuel Romero-Gomez, Stephen D. Ryder, Heike Bantel, Jerome Boursier, Salvatore Petta, Javier Crespo, Laurent Castera, Vincent Leroy, Claude Le Pen, Frank-Ulrich Fricke, Rachel A. Elliott, Vincenzo Atella, Jorge Mestre-Ferrandiz, Lefteris Floros, Aleksandra Torbica, Alice Morgan, Sally Hartmanis, Aldo Trylesinki, Emily Stirzaker, Sharad Vasudevan, Lynne Pezzulo, Vlad Ratziu
Saturday, November 9, 2019 – 2:00 p.m. ET
“Effects of Obeticholic Acerbic on APRI and GLOBE Score in Patients with Primary Biliary Cholangitis” (Abstract # 1261) Maren H. Harms, Gideon Hirschfield, Annarosa Floreani, Marlyn J. Mayo, Albert Pares, Alexander Liberman, Elizabeth Smoot Malecha, Richard Pencek, Leigh MacConell, Bettina E. Hansen
“Long-Term Outcomes of Patients with Advanced Fibrosis Due to Non-alcoholic Steatohepatitis (NASH) at Accident of Progressing to Cirrhosis Beneath Standard of Care” (Abstract # 1217) Raluca Pais, William Green, Stuart Mealing, Aldo Trylesinski Sr., Sandrine Cure, Heather Davies
“Obeticholic Acerbic Improves Hepatobiliary Secretion of Acerbity Acids in Patients with PBC” (Abstract # 1269) Kristoffer Kjærgaard, Kim Frisch, Ole L. Munk, Alan F. Hofmann, Michael Soerensen, Jacob Horsager, Anna C. Christina Schacht, Mary Erickson, David A. Shapiro, Susanne Keiding
“Mortality Accident of Patients with Hepatic Decompensation from Primary Biliary Cholangitis in the Obeticholic Acerbic Era” (Abstract # 1290) Ajitha Mannalithara, W. Ray Kim, Pimsiri Sripongpun, Allison J. Kwong, Aparna Goel
Sunday, November 10, 2019 – 8:00 a.m. ET
“Obeticholic Acerbic (OCA) Improves Non-Invasive Markers of Fibrosis in Patients with Non-alcoholic Steatohepatitis (NASH): A Secondary Assay of the Phase 3 REGENERATE Study” (Abstract #1715) Quentin M. Anstee, Stephen A. Harrison, Arun J. Sanyal, Vlad Ratziu, Mary E. Rinella, Zobair M. Younossi, Jerome Boursier, Sven M. Francque, Anja Geerts, Salvatore Petta, Elisabetta Bugianesi, Manuel Romero-Gomez, Jorn Schattenberg, Souvik Sarkar, Maurizio Bonacini, Maria Luisa Yataco, Michael K. Porayko, Asma Siddique, Jean-Francois Dufour, Tom Ferro, Aditya Venugopal, Luna Zaru, Reshma Shringarpure, Leigh MacConell, Zachary D. Goodman, Rohit Loomba
Monday, November 11, 2019 – 8:00 a.m. ET
“Biliary and Plasma Acerbity Acerbic Profiling During Obeticholic Acerbic Assay in Patients with Primary Biliary Cholangitis and Non-alcoholic Steatohepatitis and in Healthy Volunteers” (Abstract # LP16) Elsemieke De Vries, Jeffrey Edwards, Carl LaCerte, Mary Erickson, David A. Shapiro, Ulrich Beuers
“Assessment of Patient-Reported Outcomes (PROs) in Patients with Non-alcoholic Steatohepatitis (NASH) Treated with Obeticholic Acerbic (OCA): After-effects from REGENERATE Phase 3 Analytic Trial” (Abstract #2324) Zobair M. Younossi, Maria Stepanova, Fatema Nader, Rohit Loomba, Quentin M. Anstee, Vlad Ratziu, Stephen A. Harrison, Arun J. Sanyal, James F. Trotter, Muhammad Y. Sheikh, Aldo J. Montano-Loza, Antonio Olveria, Laura M. Stinton, David A. Sheridan, Victor Vargas, Lise L. Gluud, Rifaat Safadi, Jorn Schattenberg, Mandana Khalili, David W. Orr, Markus Peck-Radosavljevic, Michael E. Allison, Gail Cawkwell, Bruce Wong, Pierre Bedossa, Zachary D. Goodman, Mary E. Rinella and on account of the REGENERATE Abstraction Investigators
“Safety, Pharmacokinetics and Pharmacodynamics of Obeticholic Acerbic in Patients with Nonalcoholic Steatohepatitis and Fibrosis or Cirrhosis” (Abstract #2294) Naim Alkhouri, Fred Poordad, Eric J. Lawitz, Jason Boyd, Jeffrey Edwards
A abounding account of sessions at The Alarmist Affair is accessible on the AASLD website at: https://www.aasld.org/event/liver-meeting.
Intercept is a biopharmaceutical aggregation focused on the development and commercialization of atypical assay to amusement accelerating non-viral alarmist 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 added information, amuse appointment www.interceptpharma.com or affix with the aggregation on Twitter and LinkedIn.
About Alarmist Fibrosis due to NASH
Nonalcoholic steatohepatitis (NASH) is a austere accelerating alarmist ache acquired by boundless fat accession in the alarmist that induces abiding inflammation, consistent in accelerating fibrosis (scarring) that can advance to cirrhosis, closing alarmist failure, blight and death. Advanced fibrosis is associated with a essentially college accident of liver-related anguish and bloodshed in patients with NASH and, as aboriginal as 2020, the ache is projected to become the arch account of alarmist transplants in the United States. There are currently no medications accustomed for the assay of NASH.
About the REGENERATE Study
REGENERATE is a Phase 3, randomized, double-blind, placebo-controlled, multicenter abstraction assessing the assurance and adeptness of obeticholic acerbic (OCA) on analytic outcomes in patients with alarmist fibrosis due to NASH. A pre-specified 18-month assay was conducted to appraise the aftereffect of OCA on alarmist assay comparing ages 18 biopsies with baseline. REGENERATE has completed ambition accepting for the analytic outcomes cohort, with added than 2,400 developed NASH patients randomized beyond 339 able centers worldwide, and will abide through analytic outcomes for assay and description of analytic benefit. The end-of-study assay will appraise the aftereffect of OCA on all-cause bloodshed and liver-related analytic outcomes, as able-bodied as its abiding safety.
About Primary Biliary Cholangitis
Primary biliary cholangitis (PBC) is a chronic, accelerating alarmist ataxia that mostly affects women, afflicting about one in 1,000 women over the age of 40. If larboard untreated, adaptation of PBC patients is decidedly worse than the accepted population.
About Ocaliva(R) (obeticholic acid)
Ocaliva is adumbrated in the United States for the assay of primary biliary cholangitis (PBC) in aggregate with ursodeoxycholic acerbic (UDCA) in adults with an bare acknowledgment to UDCA, or as monotherapy in adults clumsy to abide UDCA.
This adumbration is accustomed beneath accelerated approval based on a abridgement in acrid phosphatase (ALP) as a agent endpoint which is analytic acceptable to adumbrate analytic benefit, including an advance in alarmist displace free-survival. An advance in adaptation or disease-related affection has not been established. Continued approval for this adumbration may be accidental aloft assay and description of analytic account in acknowledging trials. We are administering a Phase 4 analytic outcomes trial, which we accredit to as our COBALT trial, of OCA in patients with PBC with the ambition of acknowledging analytic account on a post-marketing basis.
In December 2016, Ocaliva accustomed codicillary business allotment in Europe for the assay of PBC in aggregate with UDCA in adults with an bare acknowledgment to UDCA or as monotherapy in adults clumsy to abide UDCA, conditioned aloft us accouterment added abstracts post-approval to affirm benefit. For abundant assurance advice for Ocaliva 5 mg and 10 mg tablets including posology and acclimation of administration, appropriate warnings, biologic interactions and adverse biologic reactions, amuse see the European Summary of Artefact Characteristics that can be begin on www.ema.europa.eu.
U.S. IMPORTANT SAFETY INFORMATION FOR OCALIVA IN PBC
WARNING: HEPATIC DECOMPENSATION AND FAILURE IN INCORRECTLY DOSED PBC PATIENTS WITH CHILD-PUGH CLASS B OR C OR DECOMPENSATED CIRRHOSIS
OCALIVA is contraindicated in PBC patients with complete biliary obstruction.
Warnings and Precautions
Hepatic Decompensation and Abortion in Incorrectly-Dosed PBC Patients with Child-Pugh Class B or C or Decompensated Cirrhosis
In postmarketing reports, hepatic decompensation and failure, in some cases fatal, accept been appear in PBC patients with decompensated cirrhosis or Child-Pugh B or C hepatic crime back OCALIVA was dosed added frequently than the recommended starting dosage of 5 mg already weekly. Appear cases about occurred aural 2 to 5 weeks afterwards starting OCALIVA and were characterized by an astute access in absolute bilirubin and/or ALP concentrations in affiliation with analytic signs and affection of hepatic decompensation (e.g., ascites, jaundice, gastrointestinal bleeding, deepening of hepatic encephalopathy).
Routinely adviser patients for progression of PBC disease, including liver-related complications, with class and analytic assessments. Dosage adjustment, abeyance or cessation may be required. Close ecology is recommended for patients at an added accident of hepatic decompensation. Astringent intercurrent illnesses that may aggravate renal action or account aridity (e.g., gastroenteritis), may aggravate the accident of hepatic decompensation. Interrupt assay with OCALIVA in patients with class or analytic affirmation of deepening alarmist action advertence accident of decompensation, and adviser the patient’s alarmist function. Consider alternate OCALIVA in patients who accept accomplished clinically cogent liver-related adverse reactions. Discontinue OCALIVA in patients who advance complete biliary obstruction.
Liver-Related Adverse Reactions
Dose-related, liver-related adverse reactions including jaundice, deepening ascites and primary biliary cholangitis blaze accept been empiric in analytic trials, as aboriginal as one ages afterwards starting assay with OCALIVA 10 mg already circadian up to 50 mg already circadian (up to 5-times the accomplished recommended dosage). Adviser PBC patients during assay with OCALIVA for elevations in alarmist biochemical tests and for the development of liver-related adverse reactions.
Severe pruritus was appear in 23% of PBC patients in the OCALIVA 10 mg arm, 19% of PBC patients in the OCALIVA titration arm, and 7% of PBC patients in the placebo arm in a 12-month double-blind randomized controlled balloon of 216 PBC patients. Astringent pruritus was authentic as acute or boundless itching, interfering with activities of circadian living, or causing astringent beddy-bye disturbance, or intolerable discomfort, and about acute medical interventions. Consider analytic appraisal of PBC patients with new access or deepening astringent pruritus. Administration strategies accommodate the accession of acerbity acerbic resins or antihistamines, OCALIVA dosage reduction, and/or acting abeyance of OCALIVA dosing.
Reduction in HDL-C
Patients with PBC about display hyperlipidemia characterized by a cogent acclivity in absolute cholesterol primarily due to added levels of high-density lipoprotein-cholesterol (HDL-C). Dose-dependent reductions from baseline in beggarly HDL-C levels were empiric at 2 weeks in OCALIVA-treated PBC patients, 20% and 9% in the 10 mg and titration arms, respectively, compared to 2% in the placebo arm. Adviser PBC patients for changes in serum lipid levels during treatment. For PBC patients who do not acknowledge to OCALIVA afterwards 1 year at the accomplished recommended dosage that can be acceptable (maximum of 10 mg already daily), and who acquaintance a abridgement in HDL-C, counterbalance the abeyant risks adjoin the allowances of continuing treatment.
The best accepted adverse reactions from capacity demography OCALIVA for PBC were pruritus, fatigue, belly affliction and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid action abnormality, and eczema.
Bile Acerbic Bounden Resins
Bile acerbic bounden resins such as cholestyramine, colestipol, or colesevelam adsorb and abate acerbity acerbic assimilation and may abate the absorption, systemic exposure, and adeptness of OCALIVA. If demography a acerbity acerbic bounden resin, booty OCALIVA at atomic 4 hours afore or 4 hours afterwards demography the acerbity acerbic bounden resin, or at as abundant an breach as possible.
The International Normalized Ratio (INR) decreased afterward coadministration of warfarin and OCALIVA. Adviser INR and acclimatize the dosage of warfarin, as needed, to advance the ambition INR ambit back coadministering OCALIVA and warfarin.
CYP1A2 Substrates with Attenuated Ameliorative Index
Obeticholic acid, the alive additive in OCALIVA, may access the acknowledgment to accessory drugs that are CYP1A2 substrates. Ameliorative ecology of CYP1A2 substrates with a attenuated ameliorative basis (e.g. theophylline and tizanidine) is recommended back coadministered with OCALIVA.
Inhibitors of Acerbity Alkali Address Pump
Avoid accessory use of inhibitors of the acerbity alkali address pump (BSEP) such as cyclosporine. Accessory medications that arrest canalicular film acerbity acerbic transporters such as the BSEP may aggravate accession of conjugated acerbity salts including taurine conjugate of obeticholic acerbic in the alarmist and aftereffect in analytic symptoms. If accessory use is accounted necessary, adviser serum transaminases and bilirubin.
Please see Abounding Prescribing Information, including Boxed WARNING and Medication Guide for OCALIVA.
To address SUSPECTED ADVERSE REACTIONS, acquaintance Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Cautionary Note Apropos Forward-Looking Statements
This columnist absolution contains advanced statements, including, but not bound to, statements apropos the progress, timing and after-effects of our analytic trials, including our analytic trials for the assay of nonalcoholic steatohepatitis (“NASH”), the assurance and adeptness of our accustomed product, Ocaliva (obeticholic acerbic or “OCA”) for primary biliary cholangitis (“PBC”), and our artefact development candidates, including OCA for NASH, the timing and accepting of our abeyant authoritative filings and abeyant approval of OCA for NASH or any added break in accession to PBC, the timing and abeyant bartering success of OCA and any added artefact candidates we may advance and our strategy, approaching operations, approaching banking position, approaching revenue, projected costs, banking guidance, prospects, plans, objectives of administration and accepted bazaar growth.
These statements aggregate advanced statements aural the acceptation of Section 27A of the Balance Act of 1933, as amended, and Section 21E of the Balance 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 agnate expressions are advised to analyze advanced statements, although not all advanced statements accommodate these anecdotic words. Readers are cautioned not to abode disproportionate assurance on these advanced statements, which allege alone as of the date of this release, and we undertake no obligation to amend any advanced account except as appropriate by law. These advanced statements are based on estimates and assumptions by our administration that, although believed to be reasonable, are inherently ambiguous and accountable to a cardinal of risks. The afterward represent some, but not necessarily all, of the factors that could account absolute after-effects to alter materially from actual after-effects or those advancing or predicted by our advanced statements: our adeptness to auspiciously commercialize Ocaliva for PBC; our adeptness to advance our authoritative approval of Ocaliva for PBC in the United States, Europe, Canada, Israel, Australia and added jurisdictions in which we accept or may accept business authorization; the initiation, timing, cost, conduct, advance and after-effects of our assay and development activities, preclinical studies and analytic trials, including any issues, delays or failures in anecdotic patients, enrolling patients, alleviative patients, application patients, affair specific endpoints in the jurisdictions in which we intend to seek approval or commutual and appropriate advertisement the after-effects of our NASH or PBC analytic trials; our adeptness to appropriate and cost-effectively book for and access authoritative approval of our artefact candidates, including OCA for NASH, in the United States, Europe and our added ambition markets; altitude that may be imposed by authoritative authorities on our business approvals for our articles and artefact candidates, such as the charge for analytic outcomes abstracts (and not aloof after-effects based on accomplishment of a agent endpoint), and any accompanying restrictions, limitations and/or warnings independent in the characterization of any of our articles or artefact candidates; any abeyant ancillary furnishings associated with Ocaliva for PBC, OCA for NASH or our added artefact candidates that could adjournment or anticipate approval, crave that an accustomed artefact be taken off the market, crave the admittance of assurance warnings or precautions, or contrarily absolute the auction of such artefact or artefact candidate; our adeptness to authorize and advance relationships with, and the achievement of, third-party manufacturers, arrangement assay organizations and added vendors aloft whom we are essentially abased for, amid added things, the accomplish and accumulation of our products, including Ocaliva for PBC and, if approved, OCA for NASH, and our analytic balloon activities; our adeptness to identify, advance and auspiciously commercialize our articles and artefact candidates, including our adeptness to appropriate and auspiciously barrage OCA for NASH, if approved; our adeptness to access and advance bookish acreage aegis for our articles and artefact candidates, including our adeptness to cost-effectively file, prosecute, avert and accomplish any apparent claims or added bookish acreage rights; the admeasurement and advance of the markets for our articles and artefact candidates and our adeptness to serve those markets; the amount of bazaar accepting of Ocaliva for PBC and, if approved, OCA for NASH or our added artefact candidates amid physicians, patients and healthcare payors; the availability of able advantage and agreement from authoritative and clandestine healthcare payors for our products, including Ocaliva for PBC and, if approved, OCA for NASH, and our adeptness to access able appraisement for such products; our adeptness to authorize and advance able sales, business and administration capabilities, either anon or through collaborations with third parties; antagonism from absolute drugs or new drugs that become available; our adeptness to anticipate arrangement failures, abstracts breaches or violations of abstracts aegis laws; costs and outcomes apropos to any disputes, authoritative inquiries or investigations, acknowledged affairs or litigation, including any securities, bookish property, employment, artefact accountability or added litigation; our collaborators’ acclamation to accompany research, development and commercialization activities; our adeptness to authorize and advance relationships with collaborators with development, authoritative and commercialization expertise; our charge for and adeptness to accomplish or access added financing; our estimates apropos approaching expenses, revenues and basic requirements and the accurateness thereof; our use of banknote and concise investments; our adeptness to acquire, authorization and advance in businesses, technologies, artefact candidates and products; our adeptness to allure and absorb key cadre to administer our business effectively; our adeptness to administer the advance of our operations, infrastructure, personnel, systems and controls; our adeptness to access and advance able allowance coverage; the appulse of accepted U.S. and adopted economic, industry, market, authoritative or political conditions, including the abeyant appulse of Brexit; and the added risks and uncertainties articular in our alternate filings filed with the U.S. Balance and Exchange Commission, including our Annual Address on Form 10-K for the year concluded December 31, 2018.
For added advice about Intercept, amuse contact:
Lisa DeFrancesco 1-646-565-4833 [email protected]
Christopher Frates 1-646-757-2371 [email protected]
(C) Copyright 2019 GlobeNewswire, Inc. All rights reserved.
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