Annika Saarsoo Zetterstrom

Lundbeck today announced the advancement of the clinical development of amlenetug (Lu AF82422) for the treatment of MSA with the initiation of MASCOT, a randomized, double-blind, phase III trial. The trial builds on the encouraging results of the AMULET phase II trial showing consistent trend towards amlenetug slowing clinical progression in MSA patients despite the primary endpoint not meeting statistical significance and follows discussions with health authorities. “This is an important step forward in our commitment to addressing the unmet needs of patients with Multiple System Atrophy. We are hopeful about the potential of amlenetug to slow the clinical progression of this devastating disease and look forward to advancing its development through the MASCOT trial,” said Johan Luthman, EVP and Head of Research & Development at Lundbeck. Amlenetug is an investigational human monoclonal antibody (mAb) that recognizes and binds to all major forms of extracellular α-synuclein, thereby believed to prevent uptake and inhibit seeding of aggregation. Amlenetug may offer a potential treatment option that slows clinical progression for people with MSA. #clinicaltrials #MultipleSystemAtrophy #MSA #amlenetug #Lundbeck

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European regulatory authority adopts a positive opinion for an update of the Wegovy® label to reflect risk reduction of major adverse cardiovascular events Bagsværd, Denmark, 25 July 2024 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Wegovy® (semaglutide 2.4 mg) label to reflect data from the SELECT cardiovascular outcomes trial, demonstrating a risk reduction of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with established cardiovascular disease (CVD) and either overweight or obesity (initial BMI ≥27 kg/m2) without diabetes.

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🚨 Lundbeck's $2.6B Bet on Bexicaserin: Transforming Treatment for Rare Epileptic Disorders🚨 Lundbeck has announced a $2.6 billion acquisition of Longboard Pharmaceuticals, marking a significant advancement in its Focused Innovator strategy. This move brings into Lundbeck's portfolio a highly innovative, late-stage product targeting Developmental and Epileptic Encephalopathies (DEEs)—a group of over 20 rare brain disorders characterized by seizures and developmental delays. 🔬 Bexicaserin: A Potential Game-Changer for DEEs At the heart of this deal is bexicaserin, a 5-HT2C receptor superagonist. ➡️ Earlier this year, bexicaserin made headlines when it was shown to halve the number of seizures in patients with difficult-to-treat epilepsy during an early-stage trial, sending Longboard's shares soaring. ➡️ Its next-generation mechanism specifically targets 5-HT2C receptors, supporting its potential to offer a highly differentiated and best-in-class profile. 🔑✨ Key Highlights: ➡️ Phase III Trial Initiated: The global DEEp SEA Phase III trial evaluating bexicaserin for seizures associated with Dravet syndrome began in September 2024. ➡️ Blockbuster Potential: Lundbeck aims to launch bexicaserin in Q4 2028, with projected global peak sales between $1.5 billion and $2 billion. ➡️ Broad Patient Impact: The program includes patients diagnosed with Dravet syndrome, Lennox-Gastaut syndrome, and other DEE syndromes, addressing a significant unmet medical need. 💰 Strategic Acquisition Details ➡️ Transaction Value: Approximately $2.6 billion equity value and $2.5 billion net of cash (around DKK 17 billion). ➡️ Funding: The acquisition will be financed through existing cash resources and bank financing. ➡️ Enhanced Neuro-Rare Focus: This deal enhances Lundbeck’s capabilities and presence within neuro-rare conditions, complementing its existing neuroscience portfolio. 📈 Why This Matters ➡️ Addressing High Unmet Needs: DEEs have limited treatment options. Bexicaserin offers hope to patients and families affected by these debilitating conditions. ➡️ Innovative Mechanism: Its unique superagonist mechanism could set a new standard in efficacy and safety for epilepsy treatments. ➡️ Strengthening Leadership: Lundbeck solidifies its position in the CNS space, particularly in treating treatment-resistant epilepsy. 💬 Your Thoughts? What are your views on Lundbeck's bold move into rare neurological diseases? Could bexicaserin be the breakthrough patients have been waiting for?

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Open Access: Alpine altitude climate treatment improves asthma control, irrespective of biologics use. First and corresponding author: Karin Fieten Read the article here: doi.org/10.1111/all.16233 This prospective study of 375 severe asthma patients demonstrates the effectiveness of rehabilitation in the alpine climate at altitude (AACT) for the treatment of severe uncontrolled asthma, regardless of the current or past use of #biologics. Read more articles published in #Allergy on #asthma here: https://lnkd.in/dCVQJRc #Allergy_journal

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Novo Nordisk to Present Promising New Data on Sickle Cell Disease at Annual ASH Conference Novo Nordisk has announced that they will share groundbreaking data from their recent HIBISCUS phase 2 trial at this year's 66th Annual Meeting of the American Society of Hematology (ASH). The trial focused on etavopivat, a novel oral therapy currently developed for patients with Sickle Cell Disease. Preliminary results indicate that the drug can help significantly enhance patient outcomes by improving oxygen saturation and reducing VOCs — a critical need in SCD treatment. In addition to Novo Nordisk’s exploratory research into the relationship between fetal hemoglobin levels and VOC frequency, the company is pioneering innovative approaches for at-home hemoglobin monitoring via mobile app to improve quality of life for the global SCD community. At OxyDial, we're particularly excited about the advancements in the HIBISCUS trial; with SCD impacting over eight million people worldwide, these developments could mark a pivotal shift in patient care practices. The OxyDial team hopes that Novo Nordisk's continued research will lead to meaningful, transformative treatments for those battling the complexities of this challenging condition. Read more: https://lnkd.in/gpT6cx-R #NovoNordisk #SickleCellDisease #ASH2024 #MedicalInnovation

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Looking ahead to the next 5–10 years, what will be the key disruptors and/or what can be improved upon in the pharma industry? Check out the piece in The Medicine Maker for insights from Alligator Bioscience AB CEO Søren Bregenholt! 👉

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Muna Therapeutics and GSK will examine postmortem human brain samples to identify and validate new #AlzheimersDisease targets. The #partnership centers around Muna’s MiND-MAP. After targets are identified, GSK will take on preclinical, clinical, manufacturing and commercialization activities. This is the second neuroscience deal #GSK has inked within the last few weeks, following a pact with Flagship-founded Vesalius Therapetics that includes a preclinical small molecule initially targeting Parkinson’s disease. #alzheimers 

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Looking to empower your oncology trials with specialized CRO training? Our latest white paper dives into the critical role CRAs play in managing advanced oncology trials and how specialized training can help set up your trial for success. Download your copy today! https://bit.ly/48k1RHG

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Lundbeck announced that Vyepti® (eptinezumab) met the primary and all key secondary endpoints in SUNRISE, a phase III pivotal clinical trial predominantly conducted in Asia evaluating the efficacy and safety in patients with chronic migraine. Based on the trial results Lundbeck plans to initiate discussions with relevant regulatory authorities with the aim of making Vyepti available for people suffering from migraine across Asia. “Millions of people in Asia suffer from frequent and severe migraine, yet very few utilize preventive therapy due to limitations in efficacy, safety and tolerability in currently available therapies,” said Johan Luthman, EVP and Head of R&D at Lundbeck. “I am very pleased with the outcome of the SUNRISE trial as patients in Asia also deserve more from their treatments, and these data show that Vyepti could be an important advancement in meeting the significant unmet need for patients to regain control of their lives. The results of the SUNRISE trial will be pivotal for our efforts to make Vyepti available for patients in Asia suffering from severe and disabling migraine”. The observed safety profile of Vyepti in the SUNRISE trial was generally similar to placebo, with the most common treatment-emergent adverse events (TEAEs) being COVID-19 and nasopharyngitis. The safety profile and the rates of TEAEs with Vyepti were consistent with previously reported trials. 👉 Vyepti® confirms efficacy in new phase III pivotal SUNRISE trial, meeting primary endpoint with statistically significant reductions in mean monthly migraine days compared with placebo 👉 Vyepti® met all key secondary efficacy endpoints in the SUNRISE trial, and the treatment was generally well tolerated 👉 Beginning day 1 after infusion, Vyepti® lead to statistically significant reductions in the risk of experiencing migraine compared to placebo In the SUNRISE trial, Vyepti met the primary endpoint showing statistically significant reductions in monthly migraine days (MMD) as compared with placebo. From baseline (average of 17 days) over weeks 1 through 12, mean reductions in MMDs were -7.5 for 300 mg and -7.2 for 100 mg compared to -4.8 days for placebo (p<0.0001 and p<0.0001 for 300 mg and 100 mg vs placebo, respectively). In addition, significantly greater proportions of patients achieved ≥50% reduction in monthly migraine days over weeks 1-12 with Vyepti 300 mg and 100 mg compared to placebo. Also confirming previous efficacy findings with Vyepti, more patients treated with Vyepti achieved ≥75% reduction in MMDs compared to placebo, and the SUNRISE trial confirmed early onset of preventive effects with significantly lower proportion of patients experiencing migraine on the day following infusion with Vyepti compared to placebo. #clinicaltrial #migraine #eptinezumab #Vyepti #Lundbeck

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At #ADA24, Novo Nordisk highlighted data from FLOW,  the first dedicated kidney outcomes trial with glucagon-like peptide 1 (GLP-1) receptor agonist, semaglutide, for patients with Type 2 Diabetes (T2D) and Chronic Kidney Disease (CKD). Over a median follow-up of 3.4 years, semaglutide reduced the risk of kidney disease progression and kidney or cardiovascular-related death by 24%, the risk of 3P-MACE by 18%, and the risk of overall death by 20% versus placebo. Diabetes is the leading cause of kidney disease and kidney failure, with a 10-year all-cause mortality of ~30% in patients with both diseases. As patients in the trial were permitted to continue with standard care (SGLT2s, ACE/ARBs), results of the current study demonstrate that semaglutide and other incretin-based therapies may offer complementary treatment options, giving patients and physicians flexible strategies to reduce overall death and kidney disease progression. Regulatory filings based on FLOW results are anticipated in both the US and EU. Together, these findings build upon results from the SELECT  trial (that showed a 20% reduction in major cardiovascular risks in patients with overweight/obesity and comorbidities) and demonstrates the overall cardiometabolic benefits of this class of drugs.   For more information, contact Kyasha Sri Ranjan, PhD and Austin Jeffries, PhD. #NovoNordisk #EliLilly #Amgen #AstraZeneca #StructureTherapeutics #VikingTherapeutics #Pfizer #ACC24 #LifescienceDynamics

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What an interesting read on the shift from traditional patient recruitment methods in rare disease! Learn more about how to optimize patient-driven site engagement in my team member’s blog: https://bit.ly/4eHoBn4

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🌟 Novo Nordisk Partners with NanoVation Therapeutics™ 🌟 Novo Nordisk has agreed to pay NanoVation Therapeutics up to $600 million to collaborate on up to seven programs focused on targeting cells outside the liver. This partnership reflects Novo's strategic shift towards genetic medicines, expanding its pipeline beyond its traditional strengths in peptides and proteins to encompass modalities such as RNAi therapies and gene editing. 🧬 Key Highlights: → Investment Structure: Novo is paying an undisclosed upfront fee, with the total deal potentially reaching $600 million through milestone payments and research funding. → Therapeutic Focus: The partnership includes licensing NanoVation’s long-circulating lipid nanoparticle (LNP) technology for developing two base-editing therapies in rare genetic diseases, with the potential to expand to five additional targets in cardiometabolic conditions. → Technology Advantage: NanoVation’s LNP technology facilitates efficient delivery to tissues such as bone marrow, tumors, and skin, enhancing therapeutic possibilities. The decision to work on the two rare diseases first, with the option to add cardiometabolic targets later, aligns with Novo’s broader approach to exploring novel modalities. As the biotech sector pivots toward genetic medicine, this partnership signifies a major step forward in improving patient care and outcomes. 🔗 Excited to follow this collaboration’s progress and its impact. #Biotech #GeneticMedicine #Innovation #NovoNordisk #NanoVation #Cardiometabolic #RareDiseases #Partnerships

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🌟 Exciting Developments at Novo Nordisk: Innovations in Diabetes and Cardiovascular Care 🌟 This month has been significant for Novo Nordisk, showcasing groundbreaking advancements in healthcare. 🔍 Positive Outcomes in #Cardiovascular Trials Novo Nordisk announced promising results from the SOUL trial for oral semaglutide (#Rybelsus), showing a 14% reduction in major adverse cardiovascular events (MACE) for adults with type 2 diabetes. With nearly 10,000 participants, this trial sets the stage for a label expansion filing in the US and EU by the end of 2024. Talk about impactful research! 💪 💡 #Regulatory Milestone The European Medicines Agency's CHMP has also recommended approval for #Alhemo® (concizumab), potentially becoming the first once-daily subcutaneous treatment for those aged 12+ with #haemophilia A or B with inhibitors. If approved, this could significantly improve treatment options for patients facing challenges with existing therapies. 🩸 💰 Ongoing Share Repurchase Program On the financial side, Novo Nordisk has been actively engaging in a #share repurchase program, having bought back over 13 million B shares since February. This demonstrates their commitment to #shareholder value while navigating the dynamic landscape of biotech investments. 📈 These updates reflect Novo Nordisk’s dedication to pushing the boundaries of diabetes and cardiovascular care, while also driving shareholder confidence. It’s inspiring to see the company lead in both innovation and patient care. What do you think about the future of #healthcare innovation? I’d love to hear your thoughts on where the industry is headed and the role of pharmaceutical companies in shaping it! #NovoNordisk #HealthcareInnovation #DiabetesCare #CardiovascularHealth #Biotech #Pharmaceuticals

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👉 Ferring Pharmaceuticals has announced significant progress in its nadofaragene firadenovec-vncg clinical trial program, expanding its potential applications in bladder cancer and beyond. 💊 #Nadofaragene, the first FDA-approved gene therapy for high-risk BCG-unresponsive #NMIBC, is now the focus of multiple new trials:

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A nice infographic on drug development.

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🌟 Exciting News from Alligator Bioscience! 🌟 We are thrilled to announce that our Phase 2 #mitazalimab #pancreaticcancer data has been published in The Lancet Oncology, one of the world’s leading clinical oncology journals. This publication validates the quality and potential implications of our Phase 2 OPTIMIZE-1 results; results which were also presented on June 1, at the #ASCO2024 annual meeting. Comments CEO Søren Bregenholt: "“This publication in The Lancet Oncology is an important validation of the highly promising results of our OPTIMIZE-1 mitazalimab study. A substantial number of patients were either in the treatment or in the follow-up at the time of the primary analysis. Consequently, the 18-month survival follow-up data, which we expect at the end of June 2024, should provide further important insights into the potential of mitazalimab" Stay tuned for updated data with longer follow-up expected at the end of June 2024. In the meantime - check out today's press release following the post link. 👉 

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Lundbeck is enhancing its research and development in neurohormonal dysfunctions. A key part of this strategy is the development of Lu AG13909, a first-in-class monoclonal antibody (mAb) that targets the adrenocorticotropic hormone (ACTH). By binding to ACTH with high affinity, Lu AG13909 aims to reduce elevated ACTH levels, potentially providing therapeutic benefits for individuals with neurohormonal dysfunctions. In a recent development, a phase II clinical trial assessing efficacy, safety, and tolerability of Lu AG13909 as a potential treatment for Cushing’s disease, has been initiated. “We are pleased to advance this new approach to potentially treating unmet needs in Cushing’s disease, a condition that, when uncontrolled, is debilitating and increases mortality,” said Johan Luthman, EVP and Head of Research & Development at Lundbeck. With the latest initiated trial, Lundbeck is currently investigating Lu AG13909 for two conditions: Cushing’s disease and congenital adrenal hyperplasia. These ongoing clinical trials underscore Lundbeck’s commitment to innovation and expanding treatment options for people with rare neurohormonal dysfunctions. Lu AG13909: A potential treatment for people with Cushing’s disease Cushing’s disease is a serious condition caused by a pituitary adenoma leading to excessive production of ACTH, which in turn stimulates the adrenal glands to produce high levels of cortisol. This hormonal imbalance results in clinical manifestations such as weight gain, fatigue, muscle weakness, hypertension, diabetes, obesity, and can lead to early death. Lu AG13909, a potential cornerstone in the pharmacological treatment of Cushing’s disease, is an antibody designed to target ACTH with high precision thereby neutralising the actions of ACTH. Consequently, Lu AG13909 is expected to reduce pathologically elevated ACTH signaling and thus provide a therapeutic benefit to patients with Cushing’s disease. This innovative approach may be a significant step forward in managing the disease. Lu AG13909: Unveiling new possibilities for people with congenital adrenal hyperplasia Congenital adrenal hyperplasia is a rare disorder characterized by an enzyme deficiency which disrupts adrenal steroidogenesis leading to cortisol and aldosterone deficiency and consequently increased ACTH levels. The increased ACTH levels stimulate the adrenal glands, leading to adrenal hyperplasia and androgen excess, causing the clinical features of congenital adrenal hyperplasia. People with congenital adrenal hyperplasia are at risk of adrenal crisis, a life-threatening condition. The challenge lies in balancing glucocorticoid replacement therapy and controlling hyperandrogenism, with the risk of long-term consequences of glucocorticoid overtreatment. #neurohormonaldysfunctions #Cushingsdisease #mAb #ACTH #Lundbeck

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Lundbeck is set to acquire Longboard Pharmaceuticals for $2.6Bn, gaining access to bexicaserin - a selective 5-HT2C receptor agonist in development for Dravet syndrome, Lennox-Gastaut syndrome and other developmental and epileptic encephalopathies (DEEs). Bexicaserin has shown promising anti-seizure reduction in preclinical and clinical studies and is now being evaluated in a global Phase III clinical program. This strategic deal highlights increasing M&A activity in the CNS therapy area and renewed interest in serotonergic drug development. #Bexicaserin #Neuroscience #Epilepsy https://lnkd.in/e7BYFK8h

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