Cholelithiasis

CONSHOHOCKEN, Pa., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), today announced multiple resmetirom data presentations at the upcoming American Association for the Study of Liver Diseases (AASLD) Liver Meeting, taking place from November 15-19, 2024 in San Diego. Bill Sibold, Chief Executive Officer of Madrigal, stated, “This will be the first AASLD Liver Meeting following the approval of Rezdiffra earlier this year, and the entire NASH community feels energized with new momentum. It is an exciting moment for Madrigal and for the field as a whole. At the same time, we recognize that NASH remains the leading cause of liver transplant among women in the U.S. and second-leading cause in men, so there is an urgent need to continue advancing patient care. The Liver Meeting will provide a valuable opportunity to share the latest resmetirom clinical research, engage with healthcare providers, and reinforce Madrigal’s leadership position in NASH.” Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, added, “The eleven abstracts Madrigal will be presenting at The Liver Meeting support Rezdiffra’s position as the foundational therapy for NASH with moderate to advanced fibrosis and offer important insights into the burden of the disease on patients and the health system. We look forward to sharing two oral presentations of new results from the Phase 3 MAESTRO-NASH trial and multiple posters from our clinical development program that will help guide patient care and further NASH research.” Rezdiffra (resmetirom) is a once-daily, oral, liver-directed thyroid hormone receptor THR-β agonist designed to target key underlying causes of NASH. It is the first approved medication for the treatment of NASH. In the pivotal Phase 3 MAESTRO-NASH biopsy trial, Rezdiffra achieved both fibrosis improvement and NASH resolution primary endpoints, and 80% of patients treated with Rezdiffra 100 mg experienced improvement or stabilization of fibrosis. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials. Madrigal data presentations at AASLD The Liver Meeting, 2024 Oral presentation: “Effect of resmetirom or placebo in NASH fibrosis patients with <5% or ≥5% weight loss and/or on baseline GLP-1 therapy in the MAESTRO-NASH 52-week serial liver biopsy study” [Sunday, Nov. 17 at 9:15 a.m. PST. Presenter: Mazen Noureddin]Oral presentation: “Resmetirom effects on NASH with liver fibrosis in patients with NASH genetic risk alleles” [Sunday, Nov. 17 at 11:30 a.m. PST. Presenter: Naga Chalasani]Poster: “Resmetirom therapy of MASH-associated Child Pugh A cirrhosis reduces estimated risk for clinical outcome based on HepQuant RISK ACE model” [Presenter: Gregory Everson]Poster: “Baseline characteristics in well-compensated NASH cirrhosis patients diagnosed with or without a liver biopsy in MAESTRO-NASH-OUTCOMES, a clinical outcome Phase 3 study assessing the effect of resmetirom in well compensated NASH cirrhosis” [Presenter: Meena Bansal]Poster: “Use of non-invasive tests to diagnose and follow NASH with liver fibrosis patients treated with resmetirom” [Presenter: Naim Alkhouri]Poster: “Liver enzymes reductions from baseline over time in resmetirom treated patients in a Phase 3 study, MAESTRO-NASH” [Presenter: Seth Baum]Poster: “Validating pre-identified morphological baseline features for predicting fibrosis progression in MAESTRO-NASH” [Presenter: Jörn Schattenberg]Poster: “Impact of resmetirom on statin pharmacokinetics and safety in Phase 1 studies and MAESTRO-NASH” [Presenter: Seth Baum]Poster: “Assessment of resmetirom efficacy (80 mg vs. 100 mg) stratified by baseline body mass index and weight in patients from the MAESTRO-NASH trial” [Presenter: Mazen Noureddin]Poster: “Risk of incident extrahepatic cancers among Medicare patients with non-alcoholic steatohepatitis (NASH)” [Presenter: Robert Gish]Poster: “Current multi-dimensional view of non-alcoholic steatohepatitis (NASH)/ metabolic dysfunction-associated steatohepatitis (MASH) global epidemiological rates” [Presenter: Michael Charlton] Additionally, Madrigal will be exhibiting at booth #1239 and hosting two product theaters on Sunday and Monday, November 17 and 18, at 10:00 a.m. PST. About NASH Nonalcoholic steatohepatitis (NASH) is a more advanced form of nonalcoholic fatty liver disease (NAFLD). NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. Additionally, patients with NASH, especially those with more advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events and increased morbidity and mortality. Once patients progress to NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically. When a patient with NASH progresses to cirrhosis, their risk of liver-related mortality increases by more than 42 percent. NASH is rapidly becoming the leading cause of liver transplantation in the U.S. Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with moderate to advanced liver fibrosis. Madrigal is focusing on approximately 315,000 diagnosed patients with NASH with moderate to advanced liver fibrosis under the care of liver specialist physicians during the launch of Rezdiffra. NASH is also known as metabolic dysfunction-associated steatohepatitis (MASH). In 2023, global liver disease medical societies and patient groups came together to rename the disease, with the goal of establishing an affirmative, non-stigmatizing name and diagnosis. Nonalcoholic fatty liver disease (NAFLD) was renamed metabolic dysfunction-associated steatotic liver disease (MASLD); NASH was renamed MASH; and an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. In addition to liver disease, patients with MASH have at least one related comorbid condition (e.g., obesity, hypertension, dyslipidemia, or type 2 diabetes). About Rezdiffra What is Rezdiffra? Rezdiffra is a prescribed medicine used along with diet and exercise to treat adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver. It is not known if Rezdiffra is safe and effective in children (under 18 years old). This indication is approved based on improvement of NASH and liver scarring (fibrosis). There are ongoing studies to confirm the clinical benefit of Rezdiffra. Before you take Rezdiffra, tell your healthcare provider about all of your medical conditions, including if you: have any liver problems other than NASH.have gallbladder problems or have been told you have gallbladder problems, including gallstones.are pregnant or plan to become pregnant. It is not known if Rezdiffra will harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if Rezdiffra passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Rezdiffra. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Rezdiffra and other medicines may affect each other, causing side effects. Rezdiffra may affect the way other medicines work, and other medicines may affect how Rezdiffra works.Especially tell your healthcare provider if you take medicines that contain gemfibrozil to help lower your triglycerides, or cyclosporine to suppress your immune system, because Rezdiffra is not recommended in patients taking these medicines.Tell your healthcare provider if you are taking medicines such as clopidogrel to thin your blood or statin medicines to help lower your cholesterol.Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. What are the possible side effects of Rezdiffra? Rezdiffra may cause serious side effects, including: liver injury (hepatotoxicity). Stop taking Rezdiffra and call your healthcare provider right away if you develop the following signs or symptoms of hepatotoxicity: tiredness, nausea, vomiting, fever, rash, your skin or the white part of your eyes turns yellow (jaundice), pain or tenderness in the upper middle or upper right area of your stomach (abdomen). gallbladder problems. Gallbladder problems such as gallstones, inflammation of the gallbladder, or inflammation of the pancreas from gallstones can occur with NASH and may occur if you take Rezdiffra. Call your healthcare provider right away if you develop any signs or symptoms of these conditions including nausea, vomiting, fever, or pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back and the pain may happen with or without vomiting. The most common side effects of Rezdiffra include: diarrhea, nausea, itching, stomach (abdominal) pain, vomiting, dizziness, constipation. These are not all the possible side effects of Rezdiffra. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Madrigal at 1-800-905-0324. Please see the full Prescribing Information, including Patient Information, for Rezdiffra. About Madrigal PharmaceuticalsMadrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of NASH. For more information, visit www.madrigalpharma.com. Forward-Looking StatementsCertain statements in this press release, other than purely historical information, may constitute “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding: Rezdiffra and its expected use for treating NASH with moderate to advanced fibrosis. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Madrigal’s control, and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under the heading “Risk Factors” in Madrigal’s Annual Report on Form 10-K for the year ended December 31, 2023, and Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, and in subsequent filings made by Madrigal with the Securities and Exchange Commission from time to time. These forward-looking statements are based on Madrigal's current expectations and speak only as of the date of this press release. Except as required by law, Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Investor Contact Tina Ventura, IR@madrigalpharma.com Media ContactChristopher Frates, media@madrigalpharma.com

Terns Pharmaceuticals is making headlines with promising early results from its experimental GLP-1 obesity drug, which led to a 5.5% reduction in body weight in a small study. Positioned as a potential oral alternative to popular injectable weight loss medications like Ozempic, this new drug may soon offer another option for those seeking medical interventions for obesity. With larger trials on the horizon, the excitement around pharmaceutical treatments for weight loss continues to grow. The economic impact of weight loss medications on healthcare systems Pharmaceutical treatments like Wegovy and Ozempic have demonstrated significant potential in reducing body weight, but their high costs pose challenges for both patients and the broader healthcare system. With prices reaching up to $1,349 per month for Wegovy and around $1,000 for Ozempic, access to these medications is often restricted to those with comprehensive insurance. Even for patients with insurance, out-of-pocket costs can still amount to hundreds of dollars monthly, creating a substantial financial burden for many. presented by Health Tech What’s Keeping Healthcare CIOs Up at Night: How to Improve Patient Satisfaction by Handling Calls More Efficiently Health systems have spent billions on portals while investments in modernizing the voice channel — the dominant preference of healthcare consumers — have taken a backseat. By Stephanie Baum This cost barrier raises concerns about worsening health disparities, particularly among low-income and underserved populations. Medicaid and Medicare beneficiaries are far less likely to access these medications, as Medicare Part D typically does not cover weight-loss drugs unless the patient also has a chronic condition like heart disease. This lack of coverage leaves many patients without a traditional solution. In addition to the cost, the side effects of these drugs are another factor prompting some patients to seek alternative approaches. Common side effects of weight-loss drugs like Ozempic and Wegovy include nausea, diarrhea, and constipation, with more severe risks such as gallstones, thyroid complications, and even cancer in some cases. These potential health risks have spurred growing interest in more holistic approaches to weight management, with the U.S. alternative medicine industry experiencing significant growth — from $21.7 billion in 2013 to an estimated $30.6 billion in 2023. For employers and insurers, the rising popularity of weight-loss treatments also has financial implications. As companies consider offering coverage for these high-cost medications, they must balance short-term expenses with potential long-term savings from treating obesity-related conditions. For some organizations, incorporating more cost-effective options, such as herbal supplements, into employee benefit plans may provide a viable solution, particularly given the growing demand for natural health products. The role of herbs for weight loss presented by Sponsored Post The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani - mHUB The science behind herbal remedies for weight management is still evolving. While pharmaceutical options like Ozempic have undergone rigorous clinical trials and are backed by strong evidence, herbal alternatives lack the same level of scientific scrutiny. However, early research suggests that certain herbs may provide metabolic benefits. Adaptogens, a class of herbs gaining attention, offer a unique approach to supporting the body through stress. Adaptogens are known for their ability to help the body adapt to various stressors — be they physical, chemical, or biological. Although they are not specifically marketed as weight loss solutions, adaptogens can indirectly influence weight loss by addressing factors like hormonal imbalances and chronic stress. For example, prolonged stress triggers the production of cortisol, a hormone associated with fat accumulation, especially around the abdomen. By helping to regulate cortisol levels, adaptogens like ashwagandha, rhodiola, and holy basil promote hormonal balance, which may contribute to weight management as a secondary benefit. In addition to managing cortisol, studies suggest that adaptogens may activate genes that protect cells from damage during stress, further supporting overall bodily balance. While adaptogens are not a direct solution for weight loss, their ability to reduce stress — one of the main contributors to weight gain — makes them an intriguing part of a holistic approach to weight management. Berberine-rich herbs have also been gaining attention in the weight loss arena, often referred to as “Nature’s Ozempic” due to their potential to support metabolic health. Herbs like barberry root bark, goldenseal root, and Oregon grape root are particularly noted for their berberine content. Studies highlight berberine’s ability to activate AMP-activated protein kinase (AMPK), a key regulator of glucose metabolism and fat breakdown. Despite its nickname, berberine functions differently from medications like Ozempic, Wegovy, and Mounjaro, which are GLP-1 receptor agonists. These drugs suppress appetite by slowing digestion and increasing insulin production. In contrast, berberine activates AMP-activated protein kinase (AMPK), an enzyme that plays a crucial role in regulating energy use and fat metabolism. However, while these findings are encouraging, further research is needed to confirm berberine’s long-term efficacy and safety for weight loss. Offering choices: the compassionate approach to patient care For patients who may be unable to afford the high cost of GLP-1 obesity drugs or are worried about the side effects, it’s important for healthcare providers to offer education on herbal alternatives and consider these as part of the broader treatment conversation. While herbal options may not produce the same clinical outcomes as pharmaceuticals like Wegovy or Ozempic, they can still serve as valuable components of a comprehensive weight management strategy, particularly for those seeking more accessible or lower-cost options. By presenting herbal treatments as complementary or supportive measures, providers empower patients to make informed, individualized choices that account for both health and financial considerations. This inclusive approach ensures that patients from diverse socioeconomic backgrounds can explore effective weight management solutions, even when high-cost medications may be out of reach.

This first-to-market launch showcases Teva’s proven strengths in complex generic formulations and enhances Teva’s strategic goal of sustaining a generic powerhouse.Octreotide acetate for injectable suspension is indicated to treat acromegaly and severe diarrhea for carcinoid syndrome. PARSIPPANY, N.J., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the launch of the first and only generic version of Sandostatin®1 LAR Depot, in the United States. Octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot) is indicated to treat acromegaly and severe diarrhea for carcinoid syndrome. Please see the below for more information. “With today’s launch of octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot), Teva is providing patients a new option for this important treatment,” said Ernie Richardsen, SVP U.S. Commercial Generics.” He continued, “This first-to-market launch showcases Teva’s expertise in bringing complex generic formulations to market and demonstrates once again our ability to not only sustain a generics powerhouse, but also to bring value to patients and healthcare systems.” Sandostatin® LAR Depot had annual sales of $826 million as of July 2024, according to IQVIA data. What is octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot)?Octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot) is a prescription medication used in patients in whom initial treatment with octreotide acetate injection has been shown to be effective and tolerated for: Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy, is not an option to reduce GH and IGF-1 levels to normal.Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors. In patients with carcinoid tumors and VIP-secreting tumors, the effect of octreotide acetate injection and octreotide acetate for injectable suspension on tumor size, rate of growth and development of metastases, has not been determined. IMPORTANT SAFETY INFORMATIONWhat is the most important information I should know about octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot)? Treatment with octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot) may affect gallbladder function, with reports of gallstones resulting in complications (inflammation of the gallbladder, bile duct, and pancreas, and requiring surgical removal of the gallbladder); sugar metabolism; thyroid and heart function; and nutritional absorption, which may require monitoring by your doctor. Tell your doctor if you experience signs or symptoms of gallstones or any of their complications.Patients with carcinoid tumors and VIP-secreting tumors should adhere closely to their scheduled return visits for reinjection in order to minimize exacerbation of symptoms. Patients with acromegaly should adhere to their return visit schedule to help assure steady control of GH and IGF-1 levels.What should I tell my doctor before taking octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot)? Tell your doctor if you have a history of heart disease or are taking other medications, including cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine.What are the possible side effects of octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot)? In acromegalic patients, the most common side effects of octreotide acetate for injectable suspension include gallstones, diarrhea, abdominal pain, gas, flu-like symptoms, constipation, headache, low red blood cells, injection-site pain, gallstones, high blood pressure, dizziness and fatigue.In carcinoid tumor and VIP-secreting tumor patients, the most common side effects of octreotide acetate for injectable suspension include back pain, fatigue, headache, abdominal pain, nausea, and dizziness.These are not all of the possible side effects of octreotide acetate for injectable suspension. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see the full Prescribing Information. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: the launch and commercial success of octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot); our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; concentration of our customer base and commercial alliances among our customers; delays in launches of new generic products; our ability to develop and commercialize biopharmaceutical products; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to sustain and focus our portfolio of generics medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. 1 Sandostatin® LAR Depot is a registered trademark of Novartis AG. IR ContactsUnited StatesRan Meir(215) 591-8912 Sanjeev Sharma(973) 658 2700 PR ContactsUnited StatesKelley Dougherty(973) 658-0237 Yonatan Beker(973) 264 7378 IsraelEden Klein972 (3) 906-2645