Zeyzelf (rivastigmine twice weekly) / Luye Group, Esteve, GeneScience - LARVOL DELTA

Luye Pharma's Rivastigmine Twice Weekly Transdermal Patch Approved for Marketing in Japan for the Treatment of Alzheimer's Dementia (PRNewswire) - "Luye Pharma Group today announced that marketing approval for its innovative formulation Rivastigmine Twice Weekly Transdermal Patch has been granted by the Japanese Ministry of Health, Labour and Welfare as a new drug, indicated for suppression of progression of dementia symptoms in mild to moderate Alzheimer's disease. The product is to be marketed as Rivaluen LA Patch 25.92mg/51.84mg. It is the first extended-release Rivastigmine transdermal formulation approved for marketing in the country....This approval is based on the positive results of a Phase Ⅲ clinical trial conducted in Japan for patients with Alzheimer's type dementia which met the primary efficacy endpoint."

Japan approval • Alzheimer's Disease

Efficacy of Pharmacotherapies in Improving Cognitive Function in Vascular Dementia: A Network Meta-analysis of Randomized Controlled Trials (AAN 2024) - "Compared to placebo, the ADAS-Cog scores improved significantly with Cerebrolysin (MD, -6.20; 95%CI, -6.39 to -6.01) and Rivastigmine (MD, -1.10; 95%CI, -1.16 to -1.04) in the overall network analysis. Cerebrolysin demonstrates significant enhancement in cognitive function in vascular dementia, as assessed by the ADAS-Cog score. Rivastigmine also shows improvement. Additionally, Donepezil and Memantine demonstrate cognitive benefits, as measured by MMSE."

Retrospective data • Alzheimer's Disease • CNS Disorders • Dementia

Luye Pharma Grants Myung In Pharm Exclusive Rights to Commercialize Rivastigmine Twice Weekly Transdermal Patch in South Korea (AsiaOne) - "Luye Pharma Group has entered into an agreement with Myung In Pharm, granting the latter the exclusive rights to commercialize Rivastigmine Twice Weekly Transdermal Patch in South Korea. Developed by Luye Pharma, this drug is used to treat mild to moderate dementia associated with Alzheimer's disease (AD). "

Licensing / partnership • Alzheimer's Disease • CNS Disorders

China’s Luye Pharma partners with Korea-based Myung In Pharm to improve Alzheimer’s related dementia treatment (Biospectrumasia) - "China-based Luye Pharma Group has entered into an agreement with South Korea's Myung In Pharm, granting the latter the exclusive rights to commercialise Rivastigmine Twice Weekly Transdermal Patch in South Korea. Developed by Luye Pharma, this drug is used to treat mild to moderate dementia associated with Alzheimer's disease (AD)."

Licensing / partnership • Alzheimer's Disease • CNS Disorders • Dementia

Rivastigmine Bioequivalence Trial With Multiple Application of Transdermal Patches (13.3mg/24h) (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Luye Pharma Group Ltd. | Recruiting ➔ Completed | Trial primary completion date: Oct 2023 ➔ Jul 2023

Trial completion • Trial primary completion date

NEW DEVELOPMENT IN THE TREATMENT OF ALZHEIMER’S DISEASE (PharmiWeb) - "A new development in the treatment of Alzheimer’s disease is now available that can help reduce symptoms and lessen the care burden for patients and their caregivers. Zeyzelf® twice weekly rivastigmine transdermal patch is for the symptomatic treatment of mild to moderately severe Alzheimer’s dementia and it is the first ever patch to be launched in the UK that does not need daily application."

Launch Europe • Alzheimer's Disease • CNS Disorders

Rivastigmine Bioequivalence Trial With Multiple Application of Transdermal Patches (13.3mg/24h) (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Luye Pharma Group Ltd.

New P1 trial

Comparative Bioavailability study of a Novel Multi-day Patch Formulation of Rivastigmine (twice weekly) with Exelon® Transdermal Patch (daily). A randomized clinical trial. (PubMed, Curr Alzheimer Res) - P1 | "Bioequivalence was demonstrated between RID-TDS mg twice a week and Exelon® once a day in SS. Patch adhesion favored RID-TDS despite the longer dosing interval. Both products were well tolerated."

Clinical • Alzheimer's Disease • CNS Disorders • Dementia

Luye Pharma Grants Exeltis Exclusive Commercialization Rights to Its Innovative Alzheimer's Disease Treatment Rivastigmine Multi-Day Transdermal Patch in Mexico and Poland (PRNewswire) - “Luye Pharma Group (Luye Pharma) today announced that its subsidiary Luye Pharma Switzerland AG has entered into agreements with Exeltis Pharma México, S.A. de C.V and Exeltis Pharmaceuticals Holding, S.L (Exeltis), under which the company grants Exeltis exclusive rights to commercialize Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD) in Mexico and Poland. Rivastigmine MD is a twice-weekly innovative patch formulation of Rivastigmine for the treatment of mild to moderate dementia associated with Alzheimer's disease.”

Licensing / partnership • Alzheimer's Disease • CNS Disorders

Luye Pharma : Grants Gensci Exclusive Commercialization Rights of Rivastigmine Transdermal Patches on China’s Mainland (Market Screener) - "Luye Pharma will receive an upfront payment of RMB 70 million, and the total payment of this agreement is up to RMB 216 million....Luye Pharma Group (Luye Pharma) today announced that its subsidiary Luye Pharma Switzerland AG has entered into an agreement with Changchun GeneScience Pharmaceutical Co., Ltd. (Gensci), under which the company grants Gensci the exclusive, non-transferable, sub-licensable and perpetual commercialization rights of Rivastigmine Single-Day Transdermal Patch (Rivastigmine SD) and Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD) on the Chinese mainland."

Licensing / partnership • CNS Disorders • Dementia

Luye Pharma Grants Zambon Exclusive Commercialization Rights to Its Innovative Alzheimer's Disease Treatment Rivastigmine Multi-Day Transdermal Patch in Switzerland (Yahoo Finance) - “Luye Pharma Group…announced that its subsidiary Luye Pharma Switzerland AG has entered into an agreement with Zambon Switzerland (Zambon), under which the company grants Zambon exclusive rights to commercialize Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD) in Switzerland….The drug was developed by Luye Pharma on its proprietary transdermal patch platform and has received marketing authorization for several European countries. Luye Pharma will apply for marketing authorization for the drug in Switzerland….Luye Pharma is accelerating the development and commercialization of Rivastigmine MD in major global markets including Europe, Japan and China.”

Licensing / partnership • Alzheimer's Disease • CNS Disorders

Luye Pharma's Innovative Alzheimer's Disease Therapy Rivastigmine Multi-Day Transdermal Patch Receives Marketing Approval in the UK (PRNewswire) - “Luye Pharma Group today announced that marketing approval for its innovative formulation Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD) has been granted by the UK's Medicines and Healthcare Products Regulatory Agency, for the treatment of mild to moderate dementia associated with Alzheimer's disease…Luye Pharma is accelerating the development and commercialization of Rivastigmine Multi-Day Transdermal Patch in major global markets including Europe, Japan and China….In China, the product has received approval from the Centre for Drug Evaluation of China's National Medical Products Administration to commence clinical trials. Going forward, Luye Pharma has plans to accelerate the marketing of Rivastigmine MD in a number of developing countries and emerging markets around the world.”

European regulatory • Alzheimer's Disease • CNS Disorders

Luye Pharma enters into an agreement with ESTEVE to commercialize an Alzheimer’s Disease Multi-Day Treatment Patch in Spain (PRNewswire) - “Luye Pharma Switzerland AG…and Esteve Pharmaceuticals…announced today that they have entered into an agreement under which ESTEVE receives exclusive rights to commercialize the Rivastigmine Multi-Day Transdermal Patch in Spain. Developed by Luye Pharma, this new drug is used to treat mild to moderate dementia associated with Alzheimer's disease and has recently been granted marketing authorization in Spain. This product represents an important strategic addition to ESTEVE's central nervous system (CNS) portfolio...The product will be registered in major global markets, including Europe, Japan, and China….In September 2020, the product was approved by the Center for Drug Evaluation of China's National Medical Products Administration to initiate clinical trials in that country….This treatment is soon to start phase III clinical trials in Japan.”

Licensing / partnership • New P3 trial • Alzheimer's Disease • CNS Disorders

Luye Pharma's innovative multi-day transdermal patch treatment for Alzheimer's disease with rivastigmine can now benefit from marketing authorization in several EU countries [Google translation] (PRNewswire) - "Luye Pharma Group today announced successful decentralized registration procedures (PEDs) for its rivastigmine multi-day transdermal patch (Rivastigmine MD). At the end of the procedure of May 21, 2021, the medicinal product is now eligible for marketing authorization by the various Member States of the European Union involved in developing countries."

European regulatory • Alzheimer's Disease • CNS Disorders

Italfarmaco Group Enters Into an Agreement with Luye Pharma to Commercialize Alzheimer’s Disease Treatment Rivastigmine Multi-Day Transdermal Patch in Four European Countries (BioSpace) - "Italfarmaco Group (Italfarmaco) and Luye Pharma Switzerland AG...announced today that they have entered into an agreement under which Italfarmaco receives exclusive rights to commercialize Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD) in four European countries....used to treat mild to moderate dementia associated with Alzheimer's disease and is currently in the final registration phase of marketing approval in Europe....In Germany, Italy, Portugal and Greece. Italfarmaco will also have a preferred right to market Rivastigmine MD in Chile and Vietnam. Italfarmaco will make an upfront payment to Luye Pharma upon the signing of the agreement as well as additional payments when certain sales milestones are achieved. Luye Pharma is also eligible to receive royalties from Italfarmaco."

Licensing / partnership • Alzheimer's Disease • CNS Disorders

Luye Pharma (02186) A new drug for Alzheimer's disease entered clinical practice in China and entered the marketing application stage in Europe [Google translation] (Eastmoney.com) - "The drug by the German sub-company drug delivery technology platform for the development of transdermal Luye Pharma AG, after its listing application has been Germany, Britain, Spain, Italy, Portugal, Luxembourg, Greece seven European countries formally accepted, the review of related work It is already underway."

European regulatory • Alzheimer's Disease • CNS Disorders

Luye Pharma (02186.HK): Lissmin transdermal patch (multi-day patch) approved for clinical trials in China [Google translation] (jrj.com) - "Luye Pharmaceutical...announced that the group’s new drug Lismin transdermal patch (multi-day patch) (LY03013) for the treatment of senile dementia has been approved by the Chinese National Drug Administration The Agency's Center for Drug Evaluation ('CDE') approved the start of clinical trials."

New trial • Non-US regulatory • Alzheimer's Disease • CNS Disorders

Luye Pharma's Innovative Formulation LY03013 Soon to Begin Clinical Trials in China, Helping Alzheimer’s patients achieve more stable outcomes (Luye Pharma Press Release) - "Luye Pharma Group announced today that the Investigational New Drug application for Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD, LY03013) has been formally accepted by the Center for Drug Evaluation of the National Medical Products Administration in China."

New trial • Alzheimer's Disease • CNS Disorders

Luye Pharma's rivastigmine transdermal patch receives market approval in China (Luye Pharma Press Release) - "Luye Pharma Group announced today that one of its key central nervous system (CNS) products, Rivastigmine Transdermal Patch, has been approved by the National Medical Products Administration in China. It is the first transdermal patch product approved for marketing under China CDE’s quality and efficacy consistency evaluation."

Non-US regulatory • Alzheimer's Disease • CNS Disorders

Luye Pharma (02186.HK): Lisi's transdermal patch was approved by the State Food and Drug Administration for listing [Google translation] (Sina Corp) - "Luye Pharma (02186.HK) announced that the group's drug Leith's Ming Transdermal Patch (Jing Siming®) has been approved by the State Drug Administration of the People's Republic of China to be listed as the first in terms of quality and efficacy The consistency evaluation review requires approval of the marketed transdermal patch product."

Non-US regulatory • Alzheimer's Disease • CNS Disorders

Brief-Luye Pharma says MAA for rivastigmine MD accepted for review by EU authorities (Reuters) - "MARKETING AUTHORIZATION APPLICATION FOR RIVASTIGMINE MD TO TREAT ALZHEIMER'S ACCEPTED FOR REVIEW BY EU COMPETENT AUTHORITIES."

European regulatory • Alzheimer's Disease • CNS Disorders

Luye Pharma continues to deliver strong growth in 2019 (PRNewswire) - "In terms of drug candidates developed by the Novel Drug Delivery Systems platform, the high dosage strength (13.3mp/24h) Rivastigmine Once-A-Day Transdermal Patch has received market authorization in Germany...The Rivastigmine Multi-Day Transdermal Patch has completed a pivotal study in Germany and the Rivastigmine Once-A-Day Transdermal Patch is soon to be approved for launch in China."

European regulatory • Non-US regulatory • Trial completion

Rivastigmine Bioequivalence Trial With Multiple Application of Transdermal Patches (9.5mg/24h) (clinicaltrials.gov) - P1; N=58; Completed; Sponsor: SocraTec R&D GmbH; Recruiting ➔ Completed

Clinical • Trial completion

Comparative Effectiveness and Safety of Cognitive Enhancers for Treating Alzheimer's Disease: Systematic Review and Network Metaanalysis. (PubMed, J Am Geriatr Soc) - "An exhaustive review of the literature involving 142 studies demonstrated that cognitive enhancers in general have minimal effects on cognition according to minimal clinically important difference and global ratings. The drugs appear safe, but this must be interpreted cautiously because trial participants may have less comorbidity and fewer adverse effects than those treated with these drugs in clinical practice."

HEOR • Journal • Retrospective data • Review