Hepatitis, Alcoholic

Partnership agreement will be the first-ever co-marketing and sales collaboration for the ALZET Osmotic Pumps Portfolio and Associated Product Line in the U.S. and Canada Both companies will jointly market and commercialize the ALZET product line to customers over a multi-year period CUPERTINO, Calif. , March 4, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX), today announced that it has entered into a co-marketing and collaboration agreement with Charles River Laboratories for the ALZET® Osmotic Pumps Portfolio and Associated Product Line in the U.S. and Canada. Charles River is a highly respected, global provider of drug discovery and non-clinical development solutions. Charles River Research Models & Services (RMS) sales and marketing teams will collaborate with DURECT to jointly market and commercialize the ALZET product line to existing and new customers in the pharmaceutical industry and academic laboratories over a multi-year period. Charles River RMS will provide dedicated marketing resources and collaborate with DURECT to develop and roll out a broad range of sales and marketing initiatives for ALZET. DURECT will remain responsible for manufacturing, marketing support, order fulfillment and customer billing. "The DURECT and Charles River RMS teams are excited by this synergistic commercial partnership," said James E. Brown, D.V.M., President and CEO of DURECT. "Both teams look forward to collaborating to broaden awareness, promote and expand ALZET sales across the U.S. and Canada." About ALZET Osmotic Pumps The ALZET product line consists of miniature implantable pumps and a range of accessories for experimental research in mice, rats, and other laboratory animals. ALZET pumps continuously deliver drugs, hormones, and other test agents at controlled rates for durations ranging from 1 day to 6 weeks. They eliminate the need for external connections, frequent handling, or repeated dosing. The wide use and broad application of the ALZET product line is evidenced by more than 22,000 references in the scientific literature. ALZET pumps are neither approved nor intended for human use. For more information about the ALZET product line, please visit . About DURECT Corporation DURECT is a late-stage biopharmaceutical company pioneering the development of epigenetic therapies that target dysregulated DNA methylation to transform the treatment of serious and life-threatening conditions, including acute organ injury and cancer. Larsucosterol, DURECT's lead drug candidate, binds to and inhibits the activity of DNA methyltransferases (DNMTs), epigenetic enzymes that are elevated and associated with hypermethylation found in alcohol-associated hepatitis (AH) patients. Larsucosterol is in clinical development for the potential treatment of AH, for which FDA has granted a Fast Track Designation. In addition, POSIMIR® (bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER® platform technology, is FDA-approved and is exclusively licensed to Innocoll Pharmaceuticals for sale and distribution in the United States. For more information about DURECT, please visit and follow us on X (formerly Twitter) at . DURECT Forward-Looking Statements This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: the potential for larsucosterol to demonstrate a reduction in mortality or liver transplant in patients with AH and to save lives, our plans to meet with the FDA to review the results of AHFIRM trial and the Phase 3 registration trial design in the first quarter of 2024, the potential FDA or other regulatory approval of larsucosterol for the treatment of AH, the commercialization of POSIMIR by Innocoll, the potential to develop larsucosterol for AH, NASH or other indications, and the potential benefits, if any, of our product candidates. Actual results may differ materially from those contained in the forward-looking statements contained in this press release, and reported results should not be considered as an indication of future performance. The potential risks and uncertainties that could cause actual results to differ from those projected include, among other things, the risk that future clinical trials of larsucosterol do not confirm the results from subset analyses of the AHFIRM trial, including geographic or other segmentation, or of earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of larsucosterol in a statistically significant manner, the risk that the FDA or other government agencies may require additional clinical trials for larsucosterol before approving it for the treatment of AH, risks that Innocoll may not commercialize POSIMIR successfully, and risks related to the sufficiency of our cash resources, our anticipated capital requirements, our need or desire for additional financing, our ability to meet the minimum bid price for continued listing on Nasdaq, our ability to obtain capital to fund our operations and expenses and our ability to continue to operate as a going concern. Further information regarding these and other risks is included in DURECT's most recent Securities and Exchange Commission (SEC) filings, including its annual report on Form 10-K for the year ended December 31, 2022 and quarterly report on Form 10-Q for the quarter ended September 30, 2023, when filed, under the heading "Risk Factors." These reports are available on our website under the "Investors" tab and on the SEC's website at . All information provided in this press release and in the attachments is based on information available to DURECT as of the date hereof, and DURECT assumes no obligation to update this information as a result of future events or developments, except as required by law. NOTE: POSIMIR® is a trademark of Innocoll Pharmaceuticals, Ltd. in the U.S. and a trademark of DURECT Corporation outside of the U.S. SABER® is a trademark of DURECT Corporation. Other referenced trademarks belong to their respective owners. Larsucosterol is an investigational drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication. SOURCE DURECT Corporation

sNDA intended to satisfy post-marketing requirements to confirm a clinical benefit in patients with PBC Precedent-setting submission includes data from post-marketing studies COBALT and Study 401 as well as real-world evidence from a claims database and patient registries FDA has assigned a PDUFA target action date of October 15, 2024 MORRISTOWN, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Ocaliva for the treatment of individuals with primary biliary cholangitis (PBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024. In this communication, the agency informed Intercept that they are planning to hold an Advisory Committee meeting to discuss the application. “The sNDA data submission asserted that, with more than seven years on the market and more than 40,000 patient-years of post-marketing experience in PBC, Ocaliva is the only second-line therapy that has multiple published analyses of registry data and real-world evidence showing significant effect on transplant-free and decompensation-free survival in people living with PBC,” said Paul Nitschmann, M.D., Senior Vice President of Regulatory Affairs at Intercept. “We are pleased that the FDA has filed the submission and look forward to continued, constructive interactions with the agency, including discussing our precedent-setting application during the forthcoming Advisory Committee meeting.” Ocaliva received accelerated approval in 2016 and is indicated for the treatment of adult patients living with primary biliary cholangitis (PBC) without cirrhosis or with 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. The precedent-setting sNDA for Ocaliva is intended to satisfy the post-marketing requirements to confirm a clinical benefit in patients with PBC. The sNDA is supported by data from the Company’s post-marketing requirement studies COBALT and Study 401 as well as real-world evidence from a U.S. claims database and international PBC patient registries. Intercept and Alfasigma remain committed to supporting people living with PBC and look forward to advancing discussions with the agency. 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 or with 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 event compensated 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 Pruritus 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. 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-C Patients 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 Reactions The 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 Resins Bile 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. Warfarin The 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 Index Obeticholic 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 Pump Avoid 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 . About Intercept Intercept is a biopharmaceutical company and a wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, including primary biliary cholangitis (PBC) and severe alcohol-associated hepatitis (sAH). Intercept owns the commercial rights to Ocaliva in the U.S. market. For more information, please visit or connect with the Company on LinkedIn, Threads, and X (formerly Twitter). Contact For more information about Intercept, please contact: For media: media@interceptpharma.com

DUBLIN, Feb. 12, 2024 /PRNewswire/ -- The "Liver Disease Therapeutics - Global Market Insights, Competitive Landscape, and Market Forecast - 2028" report has been added to ResearchAndMarkets.com's offering. The increased consumption of alcohol across the world is expected to drive the growth of the peptide therapeutics market. For instance, as per the data provided by the Organization for Economic Co-operation and Development (OECD) 2023, Germany witnessed 10.6 litres/per capita consumption of alcohol among people aged 15 and above in 2019 and France reported 10.4 litres/per capita consumption of alcohol in 2020 by people aged 15 and above. The above-mentioned source further mentioned about 9.7 litres/per capita and 7.9 litres/per capita alcohol consumption among individuals aged 15 and above in the United Kingdom and South Korea respectively in 2020. Latvia reported the highest consumption in 2019 (12.9 litres), followed by the Czech Republic, Austria, France, Hungary, Lithuania and Slovenia, all with over 11 litres per person. Alcoholic fatty liver disease, alcoholic hepatitis, and cirrhosis are some of the major liver diseases resulting from the misuse of alcohol. Depending upon the severity of the liver damage and considering other factors such as age, weight, and others healthcare professionals may prescribe a range of liver disease therapeutics thereby driving the market growth. However, stringent regulatory approval processes and side effects associated with various liver disease therapeutics may restrict the growth of the overall liver disease therapeutics market. Liver Disease Therapeutics Market Segment Analysis: In the application segment of the liver disease therapeutics market, the anti-viral drugs category amassed a significant revenue share in 2022. This can be ascribed to the high incidence of virus-infected liver diseases, including hepatitis, and the efficacy of antiviral treatment for their treatment and management. Because chronic hepatitis B virus (HBV) infection can lead to cirrhosis and hepatocellular carcinoma (HCC), which raise mortality and morbidity rates in people, it continues to be a major global public health concern. Antiviral drugs are a type of medicine used to treat hepatitis. These are frequently used to prevent the hepatitis B virus and its long-term side effects, such as liver damage and impairment. They function by reducing the body's concentration of HBV (hepatitis B virus) and the chance of developing cirrhosis and hepatocellular carcinoma. Some of the FDA-approved drugs include Mavyret, Zepatier, and Vosevi. Being safe and effective these drugs have been widely used for many years for patients with signs and symptoms of moderate-to-severe liver impairment or other serious liver problems. Therefore, owing to the above-mentioned factors, the anti-viral category is expected to register significant growth, thereby driving the growth of the overall liver disease therapeutics market during the forecast period. North America is expected to dominate the overall Liver Disease Therapeutics Market: Among all the regions, North America accounted for the largest share of the liver disease therapeutics market in the year 2022. Owing to the significance of key growth factors such as the changes in lifestyles, like drinking more alcohol and eating less healthily, have also made liver disease more common. Over the next few years, the regional market is expected to grow because patients are becoming more aware of their health and because new products are being made to meet unmet medical needs. According to the National Institute on Alcohol Abuse and Alcoholism 2023, in the United States around 29.5 million people aged between 12 and older (10.5% in this age group) had Alcohol Use Disorder (AUD) in 2022. This included 17.4 million males aged 12 and older (12.6% in this age group) and 12.2 million females aged 12 and older (8.5% in this age group). About 753,000 US adolescents having their aged between 12 and 17 had AUD in 2022. Coupled with the factors mentioned above, the growing awareness of liver disease among US citizens as a result of the rise in the number of initiatives and programs by government and non-government organizations in the region is also going to assist in the market growth of liver disease therapeutics. For example, a national public health campaign named Think Liver Think LifeT by the American Liver Foundation aims to ensure every American understands their risk for liver disease, receives the appropriate screening and care coordination and feels well-informed and supported throughout their liver journey. Such initiatives assist people to receive proper diagnosis as well as treatment in the form of liver disease therapeutics for faster recovery. Thus, the above-mentioned factors are likely to propel the growth of the liver disease therapeutics market in the region during the forecast period from 2023-2028. Key Takeaways from the Liver Disease Therapeutics Market Report Study Market size analysis for current liver disease therapeutics market size (2022), and market forecast for 5 years (2023-2028) Top key product/services/technology developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years Key companies dominating the global liver disease therapeutics market. Various opportunities available for the other competitors in the liver disease therapeutics market space. What were the top-performing segments in 2022? How these segments will perform in 2028? Which are the top-performing regions and countries in the current liver disease therapeutics market scenario? Which are the regions and countries where companies should have concentrated on opportunities for liver disease therapeutics market growth in the coming future? Key Topics Covered: 1. Liver Disease Therapeutics Market Report Introduction 2. Liver Disease Therapeutics Market Executive Summary 2.1. Scope of the Study 2.2. Market at Glance 2.3. Competitive Assessment 3. Regulatory Analysis 3.1. The United States 3.2. Europe 3.3. Japan 3.4. China 4. Liver Disease Therapeutics Market Key Factors Analysis 4.1. Liver Disease Therapeutics Market Drivers 4.2. Liver Disease Therapeutics Market Restraints and Challenges 4.3. Liver Disease Therapeutics Market Opportunities 5. Liver Disease Therapeutics Market Porter's Five Forces Analysis 5.1. Bargaining Power of Suppliers 5.2. Bargaining Power of Consumers 5.3. Threat of New Entrants 5.4. Threat of Substitutes 5.5. Competitive Rivalry 6. Liver Disease Therapeutics Market Layout 6.1. By Treatment Type 6.1.1. Anti-Viral Drugs 6.1.2. Targeted Therapy 6.1.3. Immunosuppressant Drugs 6.1.4. Chemotherapy Drugs 6.1.5. Immunoglobulins 6.1.6. Vaccines 6.1.7. Others 6.2. By Geography 7. Liver Disease Therapeutics Market Company and Product Profiles AbbVie Inc. GSK F.Hoffmann-La Roche Ltd. Bristol-Myers Squibb Company Abbott Gilead Sciences, Inc. Astellas Pharma Inc. Merck & Co., Inc. Alnylam Pharmaceuticals, Inc. Sanofi GSK For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets