Neurim Pharmaceuticals Ltd

Tel Aviv, Israel

Neurim Pharmaceuticals Ltd

Tel Aviv, Israel
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This report provides an overview of the pain pipeline landscape. The report provides comprehensive information on the therapeutics under development and key players involved in therapeutic development for Osteoarthritis Pain, Migraine pain and Neuropathic Pain, therefore covering a number of the most difficult-to-treat chronic and acute pain subtypes. Osteoarthritis pain is the most common symptom associated with osteoarthritis which causes disruption of the cartilage. This further leads to rubbing of the bones against each other stimulating pain. The predisposing factors are age, joint injury, obesity and heredity. There are a total of 62 products in development for this indication, by 52 companies and two academic institutions. Key companies operating in this pipeline space include Iroko Pharmaceuticals, Aquilus Pharmaceuticals, AskAt, Astellas Pharma, Marina Biotech, Pfizer and Rottapharm Biotech. Migraine is a disorder characterized by repeated attacks of severe headache. A migraine headache causes throbbing or pulsating pain, usually on only one side of the head. These headaches are often associated with nausea, vomiting, and extreme sensitivity to light and sound. There are a total of 76 products in development for this indication, by 49 companies and five academic institutions. Key companies operating in this pipeline space include Promius Pharma (who are fielding six pipeline products), Allergan, Amgen, Eli Lilly and Company and Klaria Pharma Holding. Neuropathic pain, or neuralgia, is a condition in which the sensory system is affected. It is commonly accompanied by tissue injury, in which the nerve fibres could be damaged resulting in the generation of abnormal signals. However, it is exhibited in a range of diseases and has no specific identifiable cause. There are a total of 249 products in development for this indication, by 163 companies and 31 academic institutions. Key companies operating in this pipeline space include Anavex Life Sciences (who are fielding five pipeline products), Algiax Pharmaceuticals, AnaBios Corp and Grunenthal GmbH. The molecular targets which are being studied overlap to only a moderate extent, and generally a different set of molecular targets is being studied in each of the three indications. Generally, there is a mixture of novel and well-established molecular targets across all three areas. Within osteoarthritis pain, prostaglandin G/H synthases 1 and 2 and the nerve growth factor receptors are being studied by the most pipeline products; while the prostaglandin receptors are frequently targeted by already approved marketed products, the nerve growth factor receptors are not. In migraine, it is the 5-hydroxytryptamine (serotonin) receptors 1D and 1B which are being most frequently studied, again reflecting the composition of the market for this indication. However, the calcitonin gene related peptide and its receptor, also very frequently targeted, are not yet present in the migraine market. Finally, the favoured targets of neuropathic pain are the sodium channel protein type 9 (Nav1.9) and the mu type opioid receptor. While the latter is already heavily targeted in the pain market, the former is not. Companies Mentioned - 2-BBB Medicines BV - 4P Therapeutics LLC - AbbVie Inc - Abide Therapeutics Inc - Acadia Pharmaceuticals Inc - Achelios Therapeutics Inc - Acorda Therapeutics Inc - Addex Therapeutics Ltd - Aevi Genomic Medicine Inc - Affectis Pharmaceuticals AG - Alder Biopharmaceuticals Inc - Allergan Plc - Amgen Inc - Ampio Pharmaceuticals Inc - Amura Holdings Ltd - AnaBios Corp - Anavex Life Sciences Corp - AngioChem Inc - Antibe Therapeutics Inc - Apollo Endosurgery Inc - Aptinyx Inc - Aralez Pharmaceuticals Inc - Arena Pharmaceuticals Inc - Array BioPharma Inc - Asahi Kasei Pharma Corp - Astellas Pharma Inc - AstraZeneca Plc - Aucta Pharmaceuticals LLC - Avanir Pharmaceuticals Inc - Axsome Therapeutics Inc - BCI Pharma - BCN Peptides SA - BELLUS Health Inc - BioHealthonomics Inc - Biofrontera AG - Biogen Inc - Biomar Microbial Technologies - Bionomics Ltd - Boehringer Ingelheim GmbH - Bristol-Myers Squibb Company - CLL Pharma SA - Can-Fite BioPharma Ltd - Cara Therapeutics Inc - Cavion LLC - Celgene Corp - Cerecor Inc - Charleston Laboratories Inc - Chromocell Corp - Circuit Therapeutics Inc - Colby Pharmaceutical Company - ConSynance Therapeutics Inc - ContraVir Pharmaceuticals Inc - Corium International Inc - Crinetics Pharmaceuticals Inc - Cytogel Pharma LLC - Daewoong Pharmaceutical Co Ltd - Daiichi Sankyo Company Ltd - Develco Pharma Schweiz AG - Dompe Farmaceutici SpA - Eisai Co Ltd - Eli Lilly and Company - Elite Pharmaceuticals Inc - Endece LLC - Eupraxia Pharmaceuticals Inc - Evec Inc - Flexion Therapeutics Inc - GL Pharm Tech Corp - GW Pharmaceuticals Plc - Genecode AS - Genzyme Corp - GlaxoSmithKline Plc - Glenmark Pharmaceuticals Ltd - Glialogix Inc - Grunenthal GmbH - Hydra Biosciences Inc - Immune Pharmaceuticals Inc - Impel NeuroPharma Inc - InKemia IUCT Group SA - InMed Pharmaceuticals Inc - InStar Technologies AS - Intec Pharma ltd - Integral Molecular Inc - Intellipharmaceutics International Inc - Ionis Pharmaceuticals Inc - Iroko Pharmaceuticals LLC - JT Pharmaceuticals Inc - Jeil Pharmaceutical Co Ltd - Jiangsu Hengrui Medicine Co Ltd - Jiangsu Nhwa Pharmaceutical Corp Ltd - Johnson & Johnson - KPI Therapeutics Inc - Klaria Pharma Holding AB - Knopp Biosciences LLC - Kolon Life Science Inc - Lexicon Pharmaceuticals Inc - Lohocla Research Corp - MD Biosciences GmbH - MEDRx Co Ltd - Mapi Pharma Ltd - Marina Biotech Inc - MedImmune LLC - Medestea Research & Production SpA - Medifron DBT Co Ltd - Medy-Tox Inc - Merck & Co Inc - Mitsubishi Tanabe Pharma Corp - Monosol Rx LLC - Mundipharma International Ltd - NAL Pharmaceuticals Ltd - Nanomerics Ltd - NeurOp Inc - Neurim Pharmaceuticals Ltd - NeuroCycle Therapeutics GmbH - Neurocentrx Pharma Ltd - Newron Pharmaceuticals SpA - Nippon Chemiphar Co Ltd - NoNO Inc - Novaremed Ltd - Novartis AG - Nuvo Pharmaceuticals Inc - Omeros Corp - Ono Pharmaceutical Co Ltd - Orion Oyj - pSivida Corp - Patagonia Pharmaceuticals LLC - PeriphaGen Inc - Pfizer Inc - Pharmaleads SA - Phosphagenics Ltd - Prismic Pharmaceuticals Inc - Promius Pharma LLC - ProteoThera Inc - Purdue Pharma LP - RaQualia Pharma Inc - Re-Pharm Ltd - Reata Pharmaceuticals Inc - RedHill Biopharma Ltd - Regeneron Pharmaceuticals Inc - Relmada Therapeutics Inc - Revance Therapeutics Inc - Rottapharm Biotech Srl - SK Biopharmaceuticals Co Ltd - Saniona AB - Scilex Pharmaceuticals Inc - Shin Nippon Biomedical Laboratories Ltd - Shionogi & Co Ltd - Suda Ltd - Sunovion Pharmaceuticals Inc - Symic Biomedical Inc - Syntrix Biosystems Inc - Taiwan Liposome Company Ltd - Takeda Pharmaceutical Company Ltd - Teva Pharmaceutical Industries Ltd - TheraJect Inc - Theranexus SAS - Tonix Pharmaceuticals Holding Corp - Toray Industries Inc - Torrent Pharmaceuticals Ltd - Trevena Inc - Trigemina Inc - TrioxBio Inc - Vertex Pharmaceuticals Inc - Virobay Inc - VistaGen Therapeutics Inc - Vitality Biopharma Inc - Xenon Pharmaceuticals Inc - Yooyoung Pharm Co Ltd - Yuhan Corp - Yungjin Pharm Co Ltd - Zosano Pharma Corp - Zynerba Pharmaceuticals Inc For more information about this report visit https://www.researchandmarkets.com/research/m2lvql/pain_drug


— Global Melatonin Market Research Report 2017 presents an in-depth assessment of the Melatonin including enabling technologies, key trends, market drivers, challenges, standardization, regulatory landscape, deployment models, operator case studies, opportunities, future roadmap, value chain, ecosystem player profiles and strategies. The report also presents forecasts for Melatonin investments from 2017 till 2022. This study answers several questions for stakeholders, primarily which market segments they should focus upon during the next five years to prioritize their efforts and investments. These stakeholders include Melatonin manufacturers such as Aspen Pharmacare Holdings, Natrol, Bebida Beverage Company, Fidia Farmaceutici, Neurim Pharmaceuticals, Pulse Pharmaceuticals Pvt Ltd and Lapolla Industries. This report segments the global Melatonin market on the basis of types, Pharmaceutical Grade and Food Grade. On the basis of application, the global Melatonin market is segmented into Dietary Supplements, Medical, Food & Beverages and Others. Inquire for discount on this research at: https://www.marketinsightsreports.com/reports/080919840/global-melatonin-market-professional-survey-report-2017/discount Primary sources are mainly industry experts from core and related industries, and suppliers, manufacturers, distributors, service providers, and organizations related to all segments of the industry’s supply chain. The bottom-up approach was used to estimate the global market size of Melatonin based on end-use industry and region, in terms of value. With the data triangulation procedure and validation of data through primary interviews, the exact values of the overall parent market, and individual market sizes were determined and confirmed in this study. Geographically, this report is segmented into several key Regions, with production, consumption, revenue (million USD), and market share and growth rate of Melatonin in these regions, from 2012 to 2022 (forecast), covering North America (USA, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, Columbia etc.) and Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa). The research provides answers to the following key questions: • What will be the market size and the growth rate in 2022? • What are the key factors driving the global Melatonin market? • Who are the key market players and what are their strategies in the global Melatonin market? • Trending factors influencing the market shares of the North America, Europe, China, Japan, and Southeast Asia, India. • What are the key market trends impacting the growth of the global Melatonin market? • What trends, challenges and barriers are influencing its growth? • What are the market opportunities and threats faced by the vendors in the global Melatonin market? • What are the key outcomes of the five forces analysis of the global Melatonin market? This independent 109 pages report guarantees you will remain better informed than your competition. With over 170 tables and figures examining the Melatonin market, the report gives you a visual, one-stop breakdown of the leading products, submarkets and market leader’s market revenue forecasts as well as analysis to 2022. The report provides a basic overview of the Melatonin industry including definitions, classifications, applications and industry chain structure. And development policies and plans are discussed as well as manufacturing processes and cost structures. Then, the report focuses on global major leading industry players with information such as company profiles, product picture and specifications, sales, market share and contact information. What’s more, the Melatonin industry development trends and marketing channels are analyzed. The research includes historic data from 2012 to 2016 and forecasts until 2022 which makes the reports an invaluable resource for industry executives, marketing, sales and product managers, consultants, analysts, and other people looking for key industry data in readily accessible documents with clearly presented tables and graphs. The report will make detailed analysis mainly on above questions and in-depth research on the development environment, market size, development trend, operation situation and future development trend of Melatonin on the basis of stating current situation of the industry in 2017 so as to make comprehensive organization and judgment on the competition situation and development trend of Melatonin Market and assist manufacturers and investment organization to better grasp the development course of Melatonin Market. The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to a SWOT analysis of the key vendors. There are 15 Chapters to deeply display the global Melatonin market. Chapter 2, to analyze the top manufacturers of Grain and Seed Cleaning Equipment, with sales, revenue, and price of Grain and Seed Cleaning Equipment, in 2016 and 2017; Chapter 3, to display the competitive situation among the top manufacturers, with sales, revenue and market share in 2016 and 2017; Chapter 4, to show the global market by regions, with sales, revenue and market share of Grain and Seed Cleaning Equipment, for each region, from 2012 to 2017; Chapter 5, 6, 7,8and 9, to analyze the key regions, with sales, revenue and market share by key countries in these regions; Chapter 10and 11, to show the market by type and application, with sales market share and growth rate by type, application, from 2012 to 2017; Chapter 12, Melatonin market forecast, by regions, type and application, with sales and revenue, from 2017 to 2022; Chapter 13, 14 and 15, to describe Melatonin sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source. Order a copy of this research at https://www.marketinsightsreports.com/report/purchase/080919840?mode=su For more information, please visit https://www.marketinsightsreports.com/reports/080919840/global-melatonin-market-professional-survey-report-2017


News Article | August 16, 2017
Site: marketersmedia.com

— Global Melatonin Market Research Report 2017 presents an in-depth assessment of the Melatonin including enabling technologies, key trends, market drivers, challenges, standardization, regulatory landscape, deployment models, operator case studies, opportunities, future roadmap, value chain, ecosystem player profiles and strategies. The report also presents forecasts for Melatonin investments from 2017 till 2022. This study answers several questions for stakeholders, primarily which market segments they should focus upon during the next five years to prioritize their efforts and investments. These stakeholders include Melatonin manufacturers such as Aspen Pharmacare Holdings, Natrol, Bebida Beverage Company, Fidia Farmaceutici, Neurim Pharmaceuticals, Pulse Pharmaceuticals Pvt Ltd and Lapolla Industries. This report segments the global Melatonin market on the basis of types, Pharmaceutical Grade and Food Grade. On the basis of application, the global Melatonin market is segmented into Dietary Supplements, Medical, Food & Beverages and Others. Primary sources are mainly industry experts from core and related industries, and suppliers, manufacturers, distributors, service providers, and organizations related to all segments of the industry’s supply chain. The bottom-up approach was used to estimate the global market size of Melatonin based on end-use industry and region, in terms of value. With the data triangulation procedure and validation of data through primary interviews, the exact values of the overall parent market, and individual market sizes were determined and confirmed in this study. Geographically, this report is segmented into several key Regions, with production, consumption, revenue (million USD), and market share and growth rate of Melatonin in these regions, from 2012 to 2022 (forecast), covering North America (USA, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, Columbia etc.) and Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa). The research provides answers to the following key questions: • What will be the market size and the growth rate in 2022? • What are the key factors driving the global Melatonin market? • Who are the key market players and what are their strategies in the global Melatonin market? • Trending factors influencing the market shares of the North America, Europe, China, Japan, and Southeast Asia, India. • What are the key market trends impacting the growth of the global Melatonin market? • What trends, challenges and barriers are influencing its growth? • What are the market opportunities and threats faced by the vendors in the global Melatonin market? • What are the key outcomes of the five forces analysis of the global Melatonin market? This independent 109 pages report guarantees you will remain better informed than your competition. With over 170 tables and figures examining the Melatonin market, the report gives you a visual, one-stop breakdown of the leading products, submarkets and market leader’s market revenue forecasts as well as analysis to 2022. There are 15 Chapters to deeply display the global Melatonin market. Chapter 2, to analyze the top manufacturers of Grain and Seed Cleaning Equipment, with sales, revenue, and price of Grain and Seed Cleaning Equipment, in 2016 and 2017; Chapter 3, to display the competitive situation among the top manufacturers, with sales, revenue and market share in 2016 and 2017; Chapter 4, to show the global market by regions, with sales, revenue and market share of Grain and Seed Cleaning Equipment, for each region, from 2012 to 2017; Chapter 5, 6, 7,8and 9, to analyze the key regions, with sales, revenue and market share by key countries in these regions; Chapter 10 and 11, to show the market by type and application, with sales market share and growth rate by type, application, from 2012 to 2017; Chapter 12, Melatonin market forecast, by regions, type and application, with sales and revenue, from 2017 to 2022; Chapter 13, 14 and 15, to describe Melatonin sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source. The report provides a basic overview of the Melatonin industry including definitions, classifications, applications and industry chain structure. And development policies and plans are discussed as well as manufacturing processes and cost structures. Then, the report focuses on global major leading industry players with information such as company profiles, product picture and specifications, sales, market share and contact information. What’s more, the Melatonin industry development trends and marketing channels are analyzed. The research includes historic data from 2012 to 2016 and forecasts until 2022 which makes the reports an invaluable resource for industry executives, marketing, sales and product managers, consultants, analysts, and other people looking for key industry data in readily accessible documents with clearly presented tables and graphs. The report will make detailed analysis mainly on above questions and in-depth research on the development environment, market size, development trend, operation situation and future development trend of Melatonin on the basis of stating current situation of the industry in 2017 so as to make comprehensive organization and judgment on the competition situation and development trend of Melatonin Market and assist manufacturers and investment organization to better grasp the development course of Melatonin Market. The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to a SWOT analysis of the key vendors. Order a copy of this research at https://www.marketinsightsreports.com/report/purchase/081020713?mode=su For more information, please visit https://www.marketinsightsreports.com/reports/081020713/global-melatonin-market-professional-survey-report-2017


The report provides comprehensive information on the therapeutics under development for Visceral Pain, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Visceral Pain and features dormant and discontinued projects. The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. Complete report on Visceral Pain - Pipeline Review, H2 2016 addition with 25 market data tables and 12 figures, spread across 58 pages http://www.reportsnreports.com/reports/703650-visceral-pain-pipeline-review-h2-2016.html This report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis ADX-71441, ADX-71743, ASP-7663, CC-8464, GIC-1002, MED-1101, Monoclonal Antibody to Antagonize P2X2 and P2X3 for Visceral Pain, NEO-5937, NeuP-12, piromelatine, PR-38, RO-656570, SBFI-26, Small Molecule to Block Nav1.9 Channel for Pain, URB-937 Addex Therapeutics, Astellas Pharma Inc., Chromocell Corporation, GIcare Pharma Inc, Grunenthal GmbH, Medestea Research & Production S.p.A., Neurim Pharmaceuticals Ltd, Pfizer Inc., Inquire before buying for this http://www.reportsnreports.com/contacts/inquirybeforebuy.aspx?name=703650


News Article | November 16, 2016
Site: www.prnewswire.co.uk

ReportsnReports.com adds "Insomnia - Pipeline Review, H2 2016" to its store providing comprehensive information on the therapeutics under development for Insomnia (Respiratory), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Complete report on H2 2016 pipeline review of Insomnia with 35 market data tables and 15 figures, spread across 101 pages is available at http://www.reportsnreports.com/reports/747733-insomnia-pipeline-review-h2-2016.html . Insomnia is a sleep disorder that is characterized by difficulty falling and/or staying asleep. Symptoms include difficulty falling asleep at night, irritability, depression or anxiety, tension headaches and distress in the stomach and intestines. Risk factors include age, mental health disorder, stress and shift working. Companies discussed in this Insomnia Pipeline Review, H2 2016 report include Actelion Ltd, Alexza Pharmaceuticals, Inc., Eisai Co., Ltd., Evotec AG, Grupo Ferrer Internacional, S.A., Heptares Therapeutics Limited, Intec Pharma Ltd, Intra-Cellular Therapies, Inc., Johnson & Johnson, Leading BioSciences, Inc., Merck & Co., Inc., Neurim Pharmaceuticals Ltd, Novartis AG, Reviva Pharmaceuticals Inc., Shionogi & Co., Ltd. and Takeda Pharmaceutical Company Limited. Drug Profiles mentioned in this research are (diphenhydramine + lorazepam + zolpidem tartrate), ACT-541468, CB-2810, DORA-12, Drug for Insomnia, Drugs to Inhibit Angiotensin II Receptor Type 1 for Insomnia, EVT-201, HTL-6641, ITI-007, JNJ-42847922, JNJ-48816274, LASSBio-785, LASSBio-786, lemborexant, lorediplon, MK-8133, NEO-1940, piromelatine, ramelteon, S-117957, Small Molecule for Insomnia, Obesity and Treatment Resistant Depression, Small Molecule to Antagonize Orexin Receptor Type 1 and 2 for Insomnia, Small Molecule to Inhibit OX2R for Insomnia, Small Molecules to Activate CYP1A2 for Insomnia and Anxiety, UCM-765, zaleplon and zolpidem tartrate. The Insomnia (Central Nervous System) pipeline guide also reviews of key players involved in therapeutic development for Insomnia and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Phase III, Phase II, Phase I, Preclinical and Discovery stages are 1, 2, 9, 3, 6 and 3 respectively. Similarly, the Universities portfolio in Phase I and Preclinical stages comprises 1 and 3 molecules, respectively. Insomnia. Insomnia (Central Nervous System) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from Global Markets Direct's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. Scope of this report: The report provides a snapshot of the global therapeutic landscape of Insomnia and reviews pipeline therapeutics for Insomnia by companies and universities/research institutes based on information derived from company and industry-specific sources and key players involved Insomnia therapeutics and enlists all their major and minor projects. The research covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages. The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities and assesses Insomnia therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report summarizes all the dormant and discontinued pipeline projects with latest news related to pipeline therapeutics for Insomnia. ReportsnReports.com is your single source for all market research needs. Our database includes 500,000+ market research reports from over 100+ leading global publishers & in-depth market research studies of over 5000 micro markets. With comprehensive information about the publishers and the industries for which they publish market research reports, we help you in your purchase decision by mapping your information needs with our huge collection of reports. Connect With Us on:


News Article | November 16, 2016
Site: www.newsmaker.com.au

The report provides comprehensive information on the therapeutics under development for Insomnia, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Insomnia and features dormant and discontinued projects. The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. Complete report on Insomnia - Pipeline Review, H2 2016 addition with 35 market data tables and 15 figures, spread across 101 pages is available at http://www.reportsnreports.com/reports/747733-insomnia-pipeline-review-h2-2016.html This report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Directs proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis Actelion Ltd, Alexza Pharmaceuticals, Inc. ,Eisai Co., Ltd. ,Evotec AG ,Grupo Ferrer Internacional, S.A. Heptares Therapeutics Limited, Intec Pharma Ltd, Intra-Cellular Therapies, Inc., Johnson & Johnson Leading BioSciences, Inc., Merck & Co., Inc., Neurim Pharmaceuticals Ltd, Novartis AG, Reviva Pharmaceuticals Inc., Shionogi & Co., Ltd., Takeda Pharmaceutical Company Limited Inquire before buying http://www.reportsnreports.com/contacts/inquirybeforebuy.aspx?name=747733this is a premium report price at US$2000 for a single user PDF license).


News Article | November 2, 2016
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- Neurim Pharmaceuticals anuncia resultados de primera línea positivos del ensayo pivotal de fase III de melatonina pediátrica de liberación prolongada (PedPRM) para molestias del sueño en niños con desórdenes del espectro del autismo (ASD) Neurim Pharmaceuticals ("Neurim") ha anunciado hoy resultados de primera línea de su estudio NEU_CH_7911 de fase III. PedPRM cumplió la conclusión de eficacia primaria que demostró una mejora estadísticamente significativa en el tiempo de sueño total (TST) en comparación con el placebo. Además del TST, también se alcanzaron las conclusiones de eficacia secundarias que demostraron mejoras en el inicio y mantenimiento del sueño. Esto fue un estudio aleatorio, de doble ciego, controlado por placebo, paralelo, multicentro (UE y EE. UU.) en niños con ASD o enfermedades neurogenéticas y desórdenes del sueño. Los pacientes (125), que no habrían mostrado mejora practicando higiene del sueño, recibieron dos semana de placebo, y luego seleccionaron aleatoriamente a PedPRM (2 mg con incremento opcional a 5 mg) o placebo por la noche, durante 13 semanas.  Los pacientes que completaron el estudio recibieron PedPRM de etiqueta abierta durante 13 semanas más. La conclusión de eficacia primaria se definió como la diferencia entre PedPRM y placebo en cambio medio desde la ejecución al final del periodo de tratamiento de doble ciego, en TST reportada por los padres (sueño diario y registro de siesta). Los resultados de este estudio se presentarán en los próximos congresos médicos. "PedPRM mejoró significativamente el inicio y mantenimiento del sueño, al tiempo que mantuvo un perfil de seguridad favorable", dijo el doctor Tali Nir, DVM, vicepresidente de Asuntos Regulatorios y Clínicos de Neurim Pharmaceuticals. "Además, más allá del beneficio para el sueño del niño, hemos observados mejoras graduales en el nivel de alerta diario y funcionamiento social del niño". "No hay medicamentos para el sueño aprobados para la población pediátrica", dijo la profesora Nava Zisapel, PhD, directora científica de Neurim Pharmaceuticals. "Estamos orgullosos de llevar un tratamiento efectivo y seguro a los niños con ASD que viven con graves molestias de sueño y a sus familias". PedPRM es una fórmula adaptada a la edad diseñada para poblaciones con dificultades para tragar. Se desarrolló en respuesta a la necesidad médica no conocida en el campo del insomnio pediátrico bajo el EU-PIP (http://www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500212192.pdf) y el US-FDA IND. Los pacientes actualmente continúan en un estudio de seguimiento de etiqueta abierta de 78 semanas, evaluando la eficacia a largo plazo y la seguridad de PedPRM. Neurim sigue con los trámites regulatorios para este producto. Neurim Pharmaceuticals Ltd. (http://www.neurim.com ) es una compañía de descubrimiento y desarrollo de neurociencias. Su primer fármaco aprobado Circadin® está comercialmente disponible en más de 45 países en todo el mundo. Neurim tiene una sólida e innovadora línea de producto, orientada al insomnio, enfermedad de Alzheimer, demencia, glaucoma y dolor.


Neurim Pharmaceuticals ("Neurim") hat heute hervorragende Resultate aus der Phase III-Studie mit NEU_CH_7911 bekannt gegeben. PedPRM erreichte das primäre Wirksamkeitsziel und demonstrierte statistisch signifikante Verbesserungen der Gesamtschlafzeit im Vergleich mit Placebo. Zusätzlich zur Gesamtschlafzeit wurden auch sekundäre Wirksamkeitsziele erreicht, nämlich Verbesserungen beim Einschlafen und bei der Schlaferhaltung. Das Sicherheitsprofil war bei den mit PedPRM und mit Placebo behandelten Gruppen ähnlich. Es handelte sich um eine randomisierte, doppelblinde, Placebo-kontrollierte Parallelgruppenstudie an mehreren Zentren (EU und USA) bei Kindern mit ASD oder neurogenetischen Erkrankungen und Schlafstörungen. Die 125 Patienten, die keine Verbesserungen bei der Schlafhygiene zeigten, erhielten zwei Wochen lang Placebo und wurden sodann für PedPRM (2 mg mit optionaler Steigerung auf 5 mg) oder Placebo an den Abenden für eine Dauer von 13 Wochen randomisiert. Abschließer erhielten offenes PedPRM für weitere 13 Wochen. Das primäre Wirkungsziel wurde als Differenz zwischen PedPRM und Placebo in der mittleren Änderung vom Beginn zum Ende einer doppelblinden Behandlungsperiode definiert, wobei die Elternberichte zur Schlafdauer (täglicher Schlaf und Nickerchen) berücksichtigt wurden. Die Resultate der Studie werden bei künftigen medizinischen Konferenzen vorgestellt. "PedPRM erhöhte das Einschlafen und die Schlaferhaltung erheblich und behielt dabei ein günstiges Sicherheitsprofil", sagte Dr. Tali Nir, DVM, VP für regulatorische und klinische Beziehungen bei Neurim Pharmaceuticals. "Wichtig war neben dem Vorteil für den Schlaf der Kinder auch die beobachteten graduellen Verbesserungen bei der Wachheit der Eltern am Tage und der sozialen Funktion der Kinder." "Es gibt keine zugelassen Schlafmedikamente für die pädiatrische Population", sagte Prof. Nava Zisapel, Dr. phil. und wissenschaftliche Leiterin bei Neurim Pharmaceuticals. "Wir sind stolz darauf, Kindern mit ASD ein potenziell neues, wirksames und sicheres Medikament zu bringen, die bisher mit ihren Familien schwere Schlafstörungen erlebt haben." PedPRM ist eine an das Alter angepasste Formel für Populationen mit Schluckbeschwerden. Für den medizinisch nicht abgedeckten Bereich pädiatrischer Schlafstörungen wurde das Medikament unter EU-PIP (http://www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500212192.pdf) und US-FDA IND weiterentwickelt. Die Patienten setzen aktuell eine 78-wöchige, offene Folgestudie fort, bei der die langfristige Wirksamkeit und Sicherheit von PedPRM beurteilt wird. Neurim setzt die regulatorischen Anträge für dieses Produkt fort. Neurim Pharmaceuticals Ltd. (http://www.neurim.com ) ist ein Neurowissenschaft-Unternehmen für Medikament-Entdeckung und Entwicklung Sein zuerst zugelassenes Medikament Circadin® ist in über 45 Ländern rund um die Welt auf dem Markt. Neurim hat eine starke, innovative Produktlinie, die für Insomnie, Alzheimer-Erkrankungen, Demenz, Glaukome und Schmerzen vorgesehen sind.


Neurim Pharmaceuticals ("Neurim") announced today top-line results from its NEU_CH_7911 Phase III study. PedPRM met the primary efficacy endpoint demonstrating statistically significant improvement in total sleep time (TST) compared to placebo. In addition to TST, secondary efficacy endpoints demonstrating improvements in sleep initiation and maintenance were also met. Safety profile was similar between PedPRM and placebo-treated groups. This was a randomized, double-blind, placebo-controlled, parallel group, multi-center (EU and USA) study in children with ASD or neurogenetic diseases and sleep disorders. Patients (125), who had not shown improvement practicing sleep hygiene, received 2 weeks placebo run-in, and then randomized to PedPRM (2mg with optional increase to 5mg) or placebo in the evening, for 13 weeks. Completers received PedPRM open-label for additional 13 weeks. Primary efficacy endpoint was defined as the difference between PedPRM and placebo in mean change from run-in to the end of double-blind treatment period, in parent-reported TST (Daily Sleep and Nap Diary). Results from this study will be presented at upcoming medical congresses. "PedPRM significantly improved sleep initiation and maintenance, while maintaining a favourable safety profile" said Dr. Tali Nir, DVM, VP Regulatory and Clinical Affairs of Neurim Pharmaceuticals. "Importantly, beyond the benefit to children's sleep, we have observed gradual improvements in parents' daytime alertness and children's social functioning." "There are no approved sleep medications for the paediatric population" said Prof. Nava Zisapel, PhD, Chief Scientific Officer of Neurim Pharmaceuticals. "We are proud to bring a potentially new effective and safe treatment to children with ASD living with severe sleep disturbances and their families." PedPRM is an age-appropriate formulation designed for populations with swallowing difficulties. It was developed in response to the unmet medical need in the field of paediatric insomnia under EU-PIP (http://www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500212192.pdf) and US-FDA IND. Patients currently continue in a 78-week, open-label follow-up study, assessing long-term efficacy and safety of PedPRM. Neurim is moving forward with regulatory submissions for this product. Neurim Pharmaceuticals Ltd. (http://www.neurim.com ) is a neuroscience drug discovery and development company. Its first approved drug Circadin® is commercially available in more than 45 countries around the world. Neurim has a strong and innovative product pipeline, intended for insomnia, Alzheimer's disease, dementia, glaucoma and pain.


Neurim Pharmaceuticals (« Neurim ») a annoncé les premiers résultats de son étude de phase III NEU_CH_7911. PedPRM a satisfait au principal critère d'efficacité en démontrant une amélioration statistiquement significative du temps de sommeil (TST) par rapport au placebo. Outre le TST, des critères d'efficacité secondaires en termes d'amélioration de l'initiation et du maintien du sommeil ont également été satisfaits. PedPRM a un profil d'innocuité similaire au placebo. Cette étude randomisée multicentrique en double aveugle, contrôlée contre placebo, en groupes parallèles (États-Unis et UE) a porté sur des enfants souffrant de TSA ou de maladies neurogénétiques associés à des troubles du sommeil. Les patients (125) pour lesquels aucune amélioration n'avait été constatée après l'adoption d'une bonne hygiène du sommeil ont reçu pendant une phase initiale de 2 semaines un placebo puis, aléatoirement, de PedPRM (2 mg avec possibilité de porter la dose à 5 mg) ou un placebo en soirée pendant 13 semaines. Les non-décrocheurs ont bénéficié d'un traitement en ouvert de 13 semaines supplémentaires à base de PedPRM. Le critère d'efficacité principal a été défini comme la différence entre PedPRM et le placebo en termes de variation moyenne du TST déclaré par les parents (journal des temps de sommeil et de sieste quotidien) entre la période initiale de mise en œuvre et la fin de la période de traitement en double aveugle. Les résultats de cette étude seront présentés lors de prochains congrès médicaux. « PedPRM a sensiblement amélioré l'initiation et le maintien du sommeil tout en conservant un profil d'innocuité favorable », a déclaré le Dr Tali Nir, docteur en médecine vétérinaire, responsable du pôle Affaires cliniques et réglementaires chez Neurim Pharmaceuticals. « Il est important de souligner qu'en plus des avantages constatés en termes de sommeil chez les enfants, nous avons observé une amélioration progressive du degré de vigilance diurne des parents et du fonctionnement social des enfants. » « Il n'existe pas de médicament autorisé pour améliorer le sommeil de la population pédiatrique », a indiqué le Prof. Nava Zisapel, titulaire d'un doctorat, responsable scientifique en chef de Neurim Pharmaceuticals. « Nous sommes fiers d'offrir un traitement potentiel nouveau sûr et efficace aux enfants souffrant de TSA associés à des troubles du sommeil sévères ainsi qu'à leur famille. » PedPRM est une formulation adaptée à l'âge destinée aux populations ayant des difficultés de déglutition. Elle a été conçue pour répondre à un besoin non satisfait dans le domaine de l'insomnie pédiatrique en vertu d'une décision de modification du plan d'investigation pédiatrique prise par l'UE (http://www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500212192.pdf) et de l'autorisation d'un nouveau médicament expérimental (IND) donnée par la FDA des États-Unis. Les patients participent actuellement à une étude de suivi ouverte de 78 semaines visant à évaluer l'efficacité et l'innocuité à long terme de PedPRM. Neurim est en phase de production de documents réglementaires pour ce produit. Neurim Pharmaceuticals Ltd. (http://www.neurim.com) est une société spécialisée dans la découverte et la mise au point de médicaments en neurologie. Circadin®, son premier médicament approuvé, est commercialisé dans plus de 45 pays dans le monde. Neurim dispose d'un solide portefeuille de produits novateurs en cours de développement pour traiter l'insomnie, la maladie d'Alzheimer, la démence, le glaucome et la douleur.

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