Ursolic Acid

- Synergizing the bio and food business competencies to target the global market for food & nutritional ingredient solutions SEOUL, South Korea, Feb. 14, 2023 /PRNewswire/ -- CJ Food&Nutrition Tech (CJ FNT), a newly established business unit within South Korea-based food & bio company CJ CheilJedang, targets the global food & nutrition market initially focusing on the United States. The business unit officially announced the launch of 'CJ FNT' brand globally on February 14. Accordingly, the food and nutrition ingredients product portfolio such as 'TasteNrich®,' 'FlavorNrich™,' and 'AMINATURE®' will be sold under the CJ FNT brand. Continue Reading [Image] CJ FNT’s business structure CJ FNT was established at the end of 2022 by combining CJ's food ingredients and nutritional solutions business, as well as the addition of future growth businesses such as alternative proteins and cultured proteins. This new organization aims to meet the growing needs of the wellness category and lead innovations in the global food & nutrition market by synergizing the top-notch business capabilities of CJ BIO and CJ FOODS. CJ FNT plans to become a 'total solutions provider' in the food & nutritional sector by 2025. To this end, it will quickly build up business competencies by securing a competitive edge in raw material and R&D, and by making strategic investments including M&A. Looking ahead, CJ FNT will be focusing on developing next-generation ingredients and expanding the business, leveraging the organizational functions of its former predecessor – Human Nutrition & Health Business Division of CJ BIO. As global consumer interest in health continues to grow amid the COVID-19 pandemic, the market for healthy food ingredients & solutions is expected to grow from about $560 billion in 2021 to about $704 billion in 2025. In this category, CJ FNT has successfully grown 'TasteNrich®,' a clean-label vegetable fermented seasoning blend, into a large-scale product with annual sales of $40 million in just two years after its launch. The BU also launched the world's first non-electrolytic functional amino acid cysteine product 'FlavorNrich™.' With such a strong business performance model, CJ FNT will continue to introduce brand-new ingredients & solutions that will replace additives used to enhance the taste, aroma, texture and shelf life of food. *Clean label: A term referring to food or food ingredients with characteristics such as additive-free, non-GMO, non-allergic, and natural ingredients. It has recently emerged as an important value in the global food market. In the Nutritional Solutions business segment, CJ FNT is developing the 'customized solution' business (for both corporate and individual customers) to meet the diversified consumer needs for nutrition and health. The functional nutrition market, which includes fortified foods, healthy functional foods and workout supplements, is expected to reach about $490 billion in 2025. To win in this market, companies need to have the whole package from R&D-based raw material development to customized manufacturing/formulation technology as well as having the ability to create finished products. CJ FNT plans to be vertically integrated throughout the whole value chain. This includes strategic investment in new technologies such as BIO foundry & top of the line contract development manufacturing company (CDMO). In December of 2022, CJ FNT signed an exclusive license agreement to use ursolic acid technology with Emmyon, Inc., a US-based biotechnology startup, targeting the global nutrition market. In collaboration with Emmyon, Inc., CJ FNT will develop the nutritional raw materials that will help prevent muscle loss. CJ FNT will also provide a 'total solution' which will include manufacturing insights and raw material application technologies to health functional food manufacturers. "CJ FNT is a young organization that combines CJ BIO's advanced R&D technologies with CJ FOODS' market insights and know-hows," said an official from CJ FNT, "We will become a total solution provider in the global food & nutrition market by establishing core business competencies in the early stage." About CJ Food&Nutrition Tech (CJ FNT) CJ FNT, a business unit of CJ CheilJedang, is a part of CJ Group, South Korea's preeminent company in the fields of Food & Food Service, Bio & Pharma, Entertainment & Media, and Retail & Logistics. CJ FNT is a leading supplier of fermentation-based bio-products such as an extensive line of 'AMINATURE®' amino acids for human nutrition at its multi-national manufacturing facilities worldwide. SOURCE CJ Food&Nutrition Tech

MORRISTOWN, N.J., Dec. 08, 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, is pleased to share that The American Journal of Pathology has published results of a new study evaluating the link between cholestatic liver disease and cognitive impairment in mouse and human cell models. The study, which is the first to explore drug-based treatment response for cholestatic-related cognitive impairment, also evaluated the impact of anti-cholestatic therapies ursodeoxycholic acid (UDCA), obeticholic acid (OCA) and bezafibrate on their potential to reverse cognitive impairment and found that only OCA demonstrated potential efficacy. “Patients with liver disease at any stage often experience disruptive cognitive problems, such as difficulty concentrating and short-term memory loss, which can greatly impact quality of life,” said co-lead investigators Fiona Oakley, PhD, and David E.J. Jones, MD, PhD, Newcastle University. “We conducted this research to better understand the mechanisms behind these cognitive symptoms and to equip us with information to find effective treatment options to improve patients’ lives.” The study assessed mice that were made cholestatic by bile duct ligation (BDL) with cognitive impairment of the type seen in human cholestatic patients and typically associated with significant brain changes including loss of blood brain barrier integrity, abnormalities in hippocampal function and senescence (deterioration usually associated with aging) of neurons. UDCA, bezafibrate and OCA, three therapies that are commonly used in the clinical setting for patients with primary biliary cholangitis (PBC), were initiated in these cognitively impaired mice. Only treatment with OCA – a potent farnesoid X receptor (FXR) agonist and approved second-line therapy for PBC – significantly reduced short-term memory abnormalities. These effects of OCA on cognition were confirmed in a separate validation cohort of mice, conducted by a different observer. In pathological evaluations, researchers found that FXR expression, the receptor targeted by OCA, was significantly lower in BDL mice vs. controls but returned to near normal levels with OCA therapy. Further, OCA metabolites were found in the bile, serum and brain of OCA-treated BDL mice, leading researchers to hypothesize that OCA could directly act on cell populations within the brain. OCA therapy also ameliorated cholestasis-induced hepatocyte senescence, which is commonly seen in cholestatic livers in animal models as well as PBC patients, and is considered a predictor of disease progression. An additional analysis of a human neural stem cell (hNSC) culture model, undertaken to explore translation into the human disease setting, showed that cholestatic serum induced senescence in human neurons and that the effect was again reversed by OCA but not by UDCA or bezafibrate. "We are encouraged by these positive findings, which show that OCA may improve cognitive impairment and neuronal senescence in animal and in vitro models of human disease," said M. Michelle Berrey, MD, MPH, President, Research & Development and Chief Medical Officer of Intercept. “We are excited about the potential of OCA to alleviate neurocognitive symptoms and to improve quality of life in patients living with PBC.” 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), nonalcoholic steatohepatitis (NASH) and severe alcohol-associated hepatitis (sAH). For more information, please visit www.interceptpharma.com or connect with the Company on Twitter and LinkedIn. About Primary Biliary Cholangitis Primary biliary cholangitis (PBC) is a rare, progressive and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent (approximately 1 in 10,000) in women over the age of 40. PBC causes bile acid to build up in the liver, resulting in inflammation and scarring (fibrosis), which, if left untreated, can lead to cirrhosis, a liver transplant, or death. About Ocaliva® (obeticholic acid) OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC). without cirrhosis orwith compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). 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. IMPORTANT SAFETY INFORMATION WARNING: HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY BILIARY CHOLANGITIS PATIENTS WITH CIRRHOSIS Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in primary biliary cholangitis (PBC) patients with either compensated or decompensated cirrhosis.OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension.Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension, or experience clinically significant hepatic adverse reactions while on treatment. Contraindications OCALIVA is contraindicated in patients with: decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation eventcompensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia)complete biliary obstruction Warnings and Precautions Hepatic Decompensation and Failure in PBC Patients with Cirrhosis 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. 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. 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. Hepatotoxicity was observed in the OCALIVA clinical trials. A dose-response relationship was observed for the occurrence of hepatic adverse reactions including jaundice, worsening ascites, and primary biliary cholangitis flare with dosages of OCALIVA of 10 mg once daily to 50 mg once daily (up to 5-times the highest recommended dosage), as early as one month after starting treatment with OCALIVA in two 3-month, placebo-controlled clinical trials in patients with primarily early stage PBC. Routinely monitor patients for progression of PBC, including hepatic adverse reactions, with laboratory and clinical assessments to determine whether drug discontinuation is needed. Closely monitor patients with compensated cirrhosis, concomitant hepatic disease (e.g., autoimmune hepatitis, alcoholic liver disease), and/or with severe intercurrent illness for new evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), or increases above the upper limit of normal in total bilirubin, direct bilirubin, or prothrombin time to determine whether drug discontinuation is needed. Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation (e.g., ascites, jaundice, variceal bleeding, hepatic encephalopathy), have compensated cirrhosis and develop evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), experience clinically significant hepatic adverse reactions, or develop complete biliary obstruction. If severe intercurrent illness occurs, interrupt treatment with OCALIVA and monitor the patient’s liver function. After resolution of the intercurrent illness, consider the potential risks and benefits of restarting OCALIVA treatment. Severe PruritusSevere 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. 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. Consider clinical evaluation of patients with new onset or worsening severe pruritus. Management strategies include the addition of bile acid binding resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing. Reduction in HDL-CPatients with PBC generally exhibit hyperlipidemia characterized by a significant elevation in total cholesterol primarily due to increased levels of high-density lipoprotein-cholesterol (HDL-C). Dose-dependent reductions from baseline in mean HDL-C levels were observed at 2 weeks in OCALIVA-treated patients, 20% and 9% in the 10 mg and titration arms, respectively, compared to 2% in the placebo arm. Monitor patients for changes in serum lipid levels during treatment. 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. Adverse ReactionsThe most common adverse reactions (≥5%) are: pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema. Drug Interactions Bile Acid Binding ResinsBile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the absorption, systemic exposure, and efficacy of OCALIVA. If taking a bile acid binding resin, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid binding resin, or at as great an interval as possible.WarfarinThe International Normalized Ratio (INR) decreased following coadministration of warfarin and OCALIVA. Monitor INR and adjust the dose of warfarin, as needed, to maintain the target INR range when co-administering OCALIVA and warfarin.CYP1A2 Substrates with Narrow Therapeutic IndexObeticholic acid may increase the exposure to concomitant drugs that are CYP1A2 substrates. Therapeutic monitoring of CYP1A2 substrates with a narrow therapeutic index (e.g., theophylline and tizanidine) is recommended when co-administered with OCALIVA.Inhibitors of Bile Salt Efflux PumpAvoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine. 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. If concomitant use is deemed necessary, monitor serum transaminases and bilirubin. Please click here for Full Prescribing Information, including Boxed WARNING.To report SUSPECTED ADVERSE REACTIONS, contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Forward-Looking Statements This press release contains forward-looking statements (“FLS”), including regarding our product pipeline, our clinical studies, and our research and development (“R&D”) plans. Important factors could cause actual results to differ materially from the FLS. For example, our clinical studies could be delayed, not reach enrollment targets, have methodological problems, or indicate that a studied drug is not effective, safe, or tolerable. As a result, our pipeline, studies, and R&D initiatives could be unsuccessful. CONTACT For more information about Intercept, please contact: For investors:Nareg Sagherian, Executive Director, Global Investor Relationsinvestors@interceptpharma.com For media:Karen Preble, Executive Director, Global Corporate Communicationsmedia@interceptpharma.com