The company now expects the primary biliary cholangitis (PBC) drug will make between $340 million . Contact your prescriber immediately if you develop any symptoms, which may be signs of worsening liver injury or development of advanced cirrhosis. Before taking OCALIVA, tell your healthcare provider about all of your medical conditions, including ifyou: Tell your healthcare provider about all the medicines you take, including prescription and overthecounter medicines, vitamins, and herbal supplements. Therapeutic monitoring of CYP1A2 substrates with a narrow therapeutic index (e.g., theophylline and tizanidine) is recommended when co-administered with OCALIVA. Mechanism of Action OCALIVA is a potent activator of FXR, a receptor that plays a critical role in bile acid homeostasis. OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal The Intercept/Almac partnership began in 2013, with Almac's Pharmaceutical Development teams supporting the early-phase development of various dosage forms of Ocaliva. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. However, we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. The content on this site may not apply to nonU.S. Monitor patients for changes in serum lipid levels during treatment. Intercept Pharmaceuticals . OCALIVA can affect the way certain medicines work. compensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), CYP1A2 Substrates with Narrow Therapeutic Index. Financial Ratios. Intercept Pharma ( NASDAQ: ICPT) is trading ~12% higher after the company raised Ocaliva adjusted net sales guidance and posted a 16% rise in quarterly profit, helped by strong sale of . For more information, please visitwww.interceptpharma.comor connect with the company on Twitter and LinkedIn. A year after the FDA handed Intercept Pharmaceuticals a disappointing ruling for its potential nonalcoholic steatohepatitis (NASH) medicine, the company thinks it's found a detouras long as its sa Stomacharea pain; nausea, vomiting, or diarrhea; loss of appetite or weight loss; new or worsening fatigue; weakness; fever and chills; lightheadedness; less frequenturination. There may be additional risks that we do not presently know, or that we currently believe are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. 11 DESCRIPTION. Following new data, Intercept to re-file NDA for obeticholic acid. U.S. Ocaliva net sales of $77.6 million; 16.4% growth over the prior year quarter. A marketing authorization application for Ocaliva for the treatment of PBC was accepted by the European Medicines Authority (EMA) in June 2015 and is currently under review. This site is intended for US healthcare professionals only. Consider clinical evaluation of patients with new onset or worsening severe pruritus. Intercept Pharmaceuticals Inc has said it entered into a settlement agreement with Dr Reddy's Laboratories resolving the previously disclosed patent litigation . Intercept Pharmaceuticals sold the international rights to its liver-disease treatment, Ocaliva, for up to $450 million on Thursday, and ICPT stock soared.. X. RBC Capital Markets analyst Brian . AASLD, American Association for the Study of Liver Diseases; ACG, American College of Gastroenterology; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid. Some of these cases occurred in patients with decompensated cirrhosis when they were treated with higher than the recommended dosage for that patient population; however, cases of hepatic decompensation and failure have continued to be reported in patients with decompensated cirrhosis even when they received the recommended dosage. have a complete blockage of the bile ducts in your liver orgallbladder. Copyright 2022 ETHealthworld.com. In approving OCA, Health Canada issued a notice of compliance with conditions (NOC/c) pending results of trials to verify the clinical benefit of OCA. Routinely monitor patients for progression of PBC, including hepatic adverse reactions, with laboratory and clinical assessments to determine whether drug discontinuation is needed. are pregnant or plan to become pregnant. Cautionary Note Regarding Forward-Looking Statements. Severe pruritus was defined as intense or widespread itching, interfering with activities of daily living, or causing severe sleep disturbance, or intolerable discomfort, and typically requiring medical interventions. An improvement in survival or disease-related symptoms has not been established. Consider clinical evaluation of patients with new onset or worsening severe pruritus. Lammers WJ, van Buuren HR, Hirschfield GM, et al; on behalf of the Global PBC Study Group. . By adding OCALIVA, youre doing everything you can to lower ALP (alkalinephosphatase). Intercept Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Business Update. Concomitant medications that inhibit canalicular membrane bile acid transporters such as the BSEP may exacerbate accumulation of conjugated bile salts including taurine conjugate of obeticholic acid in the liver and result in clinical symptoms. Advanced cirrhosis is defined as cirrhosis with current or prior evidence of hepatic decompensation (e.g., encephalopathy, coagulopathy) or portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia). morristown, n.j., may 05, 2022 (globe newswire) -- 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 it has entered into an agreement to sell to advanz pharma, a pharmaceutical company with Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. nov 1 (reuters) - intercept pharmaceuticals inc icpt.o: intercept pharmaceuticals reports third quarter 2022 financial results and provides business update. In addition, Intercept increased its full-year 2022 guidance for adjusted net sales of Ocaliva. Intercept, founded in 2002 and headquartered in New York City, focuses on the treatment of progressive non-viral liver diseases. 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). FDAalso revised the Boxed Warning, our most prominent warning, to include this information along with related warnings about this risk. Agreement includes rights for Advanz to commercialize orphan drug Ocaliva for PBC outside the U.S., as well as the transition to Advanz of the international commercial and medical infrastructure of Intercept, Additionally, Intercept will receive royalties on any future ex-U.S. net sales of obeticholic acid in NASH, Intercept to discuss further details during Q1 2022 earnings call on Friday, May 6th at 8:30 a.m. While black box warnings on new drugs typically scare off investors, shares in Intercept . 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility . It can also be used as monotherapy for patients who cannot tolerate UDCA.1. We do not review or control the content of external websites, and this hyperlink does not constitute an endorsement of the sitescontent. In medical terminology, foetus-in-fetu (FIF) is a rare condition in which one malformed vertebrate foetus is enclosed within the body of its twin. US-PP-PB-1812 01/22. In addition, this press release contains statements related to 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, the review of our New Drug Application for OCA for the treatment of liver fibrosis due to NASH by the U.S. Food and Drug Administration (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 in the US and internationally, as well as our strategy, future operations, future financial position, future revenue, projected costs, financial guidance, prospects, plans and objectives. Intercept Pharmaceuticals, Inc. (ICPT) 10-Q Quarterly Report Tue Nov 01 2022; SEC Filings. Financial Stability. Intercept (ICPT) currently has only one marketed product in its portfolio, Ocaliva, for treating PBC. Pipeline - Intercept Pharmaceuticals Home > Our Research > Pipeline Our Clinical Development Program Our portfolio is based on novel scientific targets with the potential for therapeutic application across multiple liver diseases. Get a real-time Intercept Pharmaceuticals, Inc. (ICPT) stock price quote with breaking news, financials, statistics, charts and more. Hyderabad: Intercept Pharmaceuticals Inc has said it entered into a settlement agreement with Dr Reddy 's Laboratories resolving the previously disclosed patent litigation to market a generic version of Ocaliva (obeticholic acid) 5 mg and 10 mg tablets in the USA. Help patients access treatment coverage, helpful resources, and more by enrolling them in Interconnect Support Services. Severe pruritus was reported in 23% of patients in the OCALIVA 10 mg arm, 19% of patients in the OCALIVA titration arm, and 7% of patients in the placebo arm in a 12-month double-blind randomized controlled clinical trial of 216 patients. Indian drug 2DG can reduce heart damage by coronavirus, find US researchers2 hrs ago, Indian scientist gets Bailey K Ashford Medal for work in tropical medicine3 hrs ago, The unsung hero in faster holistic recovery, Technological Disruption in Indian Health & Pharma. For patients who do not respond to OCALIVA after 1 year at the highest recommended dosage that can be tolerated (maximum of 10 mg once daily), and who experience a reduction in HDL-C, weigh the potential risks against the benefits of continuing treatment. WarfarinThe International Normalized Ratio (INR) decreased following coadministration of warfarin and OCALIVA. Hepatotoxicity was observed in the OCALIVA clinical trials. Clinically important medical product safety alerts and timely information about the products you use, prescribe, or dispense every day. are breastfeeding or plan to breastfeed. q3 earnings per share view $4.61, revenue view $74.1 million -- refinitiv ibes data. If severe intercurrent illness occurs, interrupt treatment with OCALIVA and monitor the patients liver function. Intercept Pharmaceuticals, Inc. (ICPT) SEC Filing 10-Q Quarterly Report for the period ending Friday, September 30, 2022. U.S. Ocaliva net sales of $77.6 million; 16.4% growth over the prior year quarter . Ocaliva represents the company's lead product. Policy History Date Action June 2016 Addition to PA Addition of Managed PA September 2016 Annual review March 2017 Change in initiation duration from 3 months to 6 months June 2017 Annual . It is a white to off-white powder. Intercept (ICPT) Ocaliva Drives Growth, Pipeline Setbacks Hurt. Ocaliva was granted conditional approval by the European Commission in December 2016 for the treatment of PBC in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA and is currently approved in more than 40 countries worldwide. morristown, nj, june 3, 2022 - intercept pharmaceuticals, inc. (nasdaq:icpt), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral liver diseases, today announced results from two studies designed to evaluate clinical outcomes in patients with pbc on ocaliva (obeticholic acid or OCALIVA, an FXR agonist, is effective in combination with UDCA for the treatment of PBC in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. After resolution of the intercurrent illness, consider the potential risks and benefits of restarting OCALIVA treatment. The primary endpoint was a responder analysis . Please click here for Full Prescribing Information, including Boxed WARNING. Founded in 2002 in New York, Intercept has operations in the U.S., Europe, Canada and Australia. Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in PBC patients with cirrhosis, either compensated or decompensated. OCA is approved by Health Canada 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. Among post-marketing cases reporting it, median time to hepatic decompensation (e.g., new onset ascites) was 4 months for patients with compensated cirrhosis; median time to a new decompensation event (e.g., hepatic encephalopathy) was 2.5 months for patients with decompensated cirrhosis. OCALIVA full prescribing information. OCALIVA, Interconnect and their respective logos, as well as the Intercept logo, are registered trademarks of InterceptPharmaceuticals,Inc. 2022 InterceptPharmaceuticals,Inc. Allrightsreserved. We are committed to working closely with. Permanently discontinue Ocaliva in patients developing these symptoms. An improvement in survival or disease-related symptoms has not been established. Before you start OCALIVA, and during your treatment with OCALIVA, your healthcare provider will do tests to check your liver. OCALIVA activates the FXR1 to take UDCA treatment to the next level. 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