Autism - Pipeline Review - H1 2014





 Published: March 2014 | Pages: 148 | Format: PDF 

 Summary 

 Global Markets Direct’s, ‘Autism - Pipeline Review, H1 2014’, provides an overview of the Autism’s therapeutic pipeline. 

 This report provides comprehensive information on the therapeutic development for Autism, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Autism and special features on late-stage and discontinued projects. 

 Global Markets Direct’s 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, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct’s team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. 

 The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. 

 Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. 

 Scope 

 

  •  The report provides a snapshot of the global therapeutic landscape of Autism 
  •  The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities  
  •  The report reviews key players involved in the therapeutics development for Autism and enlists all their major and minor projects 
  •  The report summarizes all the dormant and discontinued pipeline projects  
  •  A review of the Autism products under development by companies and universities/research institutes based on information derived from company and industry-specific sources 
  •  Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages 
  •  A detailed assessment of monotherapy and combination therapy pipeline projects 
  •  Coverage of the Autism pipeline on the basis of target, MoA, route of administration and molecule type 
  •  Latest news and deals relating related to pipeline products 

 

 Reasons to buy 

 

  •  Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies 
  •  Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage 
  •  Develop strategic initiatives by understanding the focus areas of leading companies 
  •  Identify and understand important and diverse types of therapeutics under development for Autism 
  •  Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline 
  •  Devise corrective measures for pipeline projects by understanding Autism pipeline depth and focus of Indication therapeutics 
  •  Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope 
  •  Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline 

 

 Table of Contents 

 Introduction 10 

 Global Markets Direct Report Coverage 10 

 Autism Overview 11 

 Therapeutics Development 12 

 Pipeline Products for Autism - Overview 12 

 Pipeline Products for Autism - Comparative Analysis 13 

 Autism - Therapeutics under Development by Companies 14 

 Autism - Therapeutics under Investigation by Universities/Institutes 17 

 Autism - Pipeline Products Glance 19 

 Late Stage Products 19 

 Clinical Stage Products 20 

 Early Stage Products 21 

 Unknown Stage Products 22 

 Autism - Products under Development by Companies 23 

 Autism - Products under Investigation by Universities/Institutes 25 

 Autism - Companies Involved in Therapeutics Development 26 

 F. Hoffmann-La Roche Ltd. 26 

 Dainippon Sumitomo Pharma Co., Ltd. 27 

 Novartis AG 28 

 Merz Pharma GmbH & Co. KgaA 29 

 Teva Pharmaceutical Industries Limited 30 

 Avanir Pharmaceuticals, Inc. 31 

 Snowdon Inc. 32 

 Curemark, LLC 33 

 Coronado Biosciences, Inc. 34 

 Omeros Corporation 35 

 Intra-Cellular Therapies, Inc. 36 

 Cellceutix Corporation 37 

 Heptares Therapeutics Ltd. 38 

 Otsuka Holdings Co., Ltd. 39 

 Reviva Pharmaceuticals Inc. 40 

 Naurex, Inc. 41 

 Nectid, Inc. 42 

 Mnemosyne Pharmaceuticals, Inc. 43 

 BioCrea GmbH 44 

 Saniona AB 45 

 Confluence Pharmaceuticals LLC 46 

 Autism - Therapeutics Assessment 47 

 Assessment by Monotherapy Products 47 

 Assessment by Combination Products 48 

 Assessment by Target 49 

 Assessment by Mechanism of Action 52 

 Assessment by Route of Administration 55 

 Assessment by Molecule Type 57 

 Drug Profiles 59 

 CM-AT - Drug Profile 59 

 Product Description 59 

 Mechanism of Action 59 

 R&D Progress 59 

 lurasidone hydrochloride - Drug Profile 60 

 Product Description 60 

 Mechanism of Action 60 

 R&D Progress 60 

 aripiprazole - Drug Profile 62 

 Product Description 62 

 Mechanism of Action 62 

 R&D Progress 62 

 cycloserine - Drug Profile 65 

 Product Description 65 

 Mechanism of Action 65 

 R&D Progress 65 

 fluoxetine - Drug Profile 66 

 Product Description 66 

 Mechanism of Action 66 

 R&D Progress 66 

 oxytocin - Drug Profile 68 

 Product Description 68 

 Mechanism of Action 68 

 R&D Progress 68 

 oxytocin - Drug Profile 70 

 Product Description 70 

 Mechanism of Action 70 

 R&D Progress 70 

 memantine hydrochloride - Drug Profile 71 

 Product Description 71 

 Mechanism of Action 71 

 R&D Progress 71 

 TSO - Drug Profile 73 

 Product Description 73 

 Mechanism of Action 73 

 R&D Progress 73 

 pioglitazone hydrochloride - Drug Profile 75 

 Product Description 75 

 Mechanism of Action 75 

 R&D Progress 75 

 oxytocin - Drug Profile 76 

 Product Description 76 

 Mechanism of Action 76 

 R&D Progress 76 

 oxytocin - Drug Profile 78 

 Product Description 78 

 Mechanism of Action 78 

 R&D Progress 78 

 (dextromethorphan hydrobromide + quinidine sulfate) - Drug Profile 79 

 Product Description 79 

 Mechanism of Action 79 

 R&D Progress 79 

 oxytocin - Drug Profile 81 

 Product Description 81 

 Mechanism of Action 81 

 R&D Progress 81 

 oxytocin - Drug Profile 83 

 Product Description 83 

 Mechanism of Action 83 

 R&D Progress 83 

 RG-7314 - Drug Profile 85 

 Product Description 85 

 Mechanism of Action 85 

 R&D Progress 85 

 fluoxetine - Drug Profile 86 

 Product Description 86 

 Mechanism of Action 86 

 R&D Progress 86 

 fluoxetine - Drug Profile 88 

 Product Description 88 

 Mechanism of Action 88 

 R&D Progress 88 

 argipressin tannate - Drug Profile 89 

 Product Description 89 

 Mechanism of Action 89 

 R&D Progress 89 

 NU-211-01 + NC-215-01 - Drug Profile 90 

 Product Description 90 

 Mechanism of Action 90 

 R&D Progress 90 

 Autologous Hematopoietic Stem Cells - Drug Profile 91 

 Product Description 91 

 Mechanism of Action 91 

 R&D Progress 91 

 glatiramer acetate - Drug Profile 93 

 Product Description 93 

 Mechanism of Action 93 

 R&D Progress 93 

 ITI-007 - Drug Profile 95 

 Product Description 95 

 Mechanism of Action 95 

 R&D Progress 95 

 Stem Cell Therapy for Central Nervous System Disorders - Drug Profile 97 

 Product Description 97 

 Mechanism of Action 97 

 R&D Progress 97 

 KM-391 - Drug Profile 98 

 Product Description 98 

 Mechanism of Action 98 

 R&D Progress 98 

 Program For Neurological Disorders - Drug Profile 100 

 Product Description 100 

 Mechanism of Action 100 

 R&D Progress 100 

 STX-110 - Drug Profile 101 

 Product Description 101 

 Mechanism of Action 101 

 R&D Progress 101 

 CN-2097 - Drug Profile 102 

 Product Description 102 

 Mechanism of Action 102 

 R&D Progress 102 

 acamprosate calcium - Drug Profile 103 

 Product Description 103 

 Mechanism of Action 103 

 R&D Progress 103 

 Small Molecules to Inhibit PI3K for Autism and Fragile X Syndrome - Drug Profile 104 

 Product Description 104 

 Mechanism of Action 104 

 R&D Progress 104 

 Small Molecule Targeting mGluR5 - Drug Profile 105 

 Product Description 105 

 Mechanism of Action 105 

 R&D Progress 105 

 NR-2A Modulators - Drug Profile 106 

 Product Description 106 

 Mechanism of Action 106 

 R&D Progress 106 

 Autism Program - Drug Profile 107 

 Product Description 107 

 Mechanism of Action 107 

 R&D Progress 107 

 Small Molecule Targeting GPR63 for Autism - Drug Profile 108 

 Product Description 108 

 Mechanism of Action 108 

 R&D Progress 108 

 NRX-20xx - Drug Profile 109 

 Product Description 109 

 Mechanism of Action 109 

 R&D Progress 109 

 Drug Targeting GABA Alpha 4 Delta Receptor for Autism and Sleep Disorders - Drug Profile 110 

 Product Description 110 

 Mechanism of Action 110 

 R&D Progress 110 

 Small Molecules to Positively Modulate GABAA Receptor for Epilepsy and Autism - Drug Profile 111 

 Product Description 111 

 Mechanism of Action 111 

 R&D Progress 111 

 Drugs for Autism - Drug Profile 112 

 Product Description 112 

 Mechanism of Action 112 

 R&D Progress 112 

 RP-5063 - Drug Profile 113 

 Product Description 113 

 Mechanism of Action 113 

 R&D Progress 113 

 NRT-34 - Drug Profile 114 

 Product Description 114 

 Mechanism of Action 114 

 R&D Progress 114 

 carbetocin - Drug Profile 115 

 Product Description 115 

 Mechanism of Action 115 

 R&D Progress 115 

 oxytocin - Drug Profile 116 

 Product Description 116 

 Mechanism of Action 116 

 R&D Progress 116 

 Autism - Recent Pipeline Updates 117 

 Autism - Dormant Projects 139 

 Autism - Discontinued Products 140 

 Autism - Product Development Milestones 141 

 Featured News & Press Releases 141 

 Dec 12, 2013: Coronado Biosciences Announces Presentation of Interim Data From Autism Study at Neuropsychopharmacology Meeting 141 

 Nov 14, 2013: Stanford drug trial seeks participants with autism spectrum disorder 141 

 Nov 04, 2013: Curemark Begins NDA Submission for CM-AT Autism Treatment 142 

 Sep 06, 2013: Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Wockhardt 142 

 Sep 03, 2013: Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Actavis 143 

 Aug 14, 2013: Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Sandoz 143 

 May 01, 2013: Seaside Therapeutics To Announce Results From Phase IIb Clinical Trial Of Arbaclofen In Autism Spectrum Disorder 144 

 Apr 23, 2013: Curemark Announces Positive Pre-NDA Meeting With FDA For New Drug Application For CM-AT For Autism 144 

 Dec 03, 2012: Autism Speaks Awards $2m To DELSIA For Partnership With Seaside Therapeutics To Develop Autism Treatments 145 

 Nov 12, 2012: Coronado Biosciences Announces Initiation Of Investigator-initiated Study Evaluating TSO In Autism Spectrum Disorders 145 

 Appendix 147 

 Methodology 147 

 Coverage 147 

 Secondary Research 147 

 Primary Research 147 

 Expert Panel Validation 147 

 Contact Us 148 

 Disclaimer 148 

  

 List of Tables 

 Number of Products under Development for Autism, H1 2014 12 

 Number of Products under Development for Autism - Comparative Analysis, H1 2014 13 

 Number of Products under Development by Companies, H1 2014 15 

 Number of Products under Development by Companies, H1 2014 (Contd..1) 16 

 Number of Products under Investigation by Universities/Institutes, H1 2014 18 

 Comparative Analysis by Late Stage Development, H1 2014 19 

 Comparative Analysis by Clinical Stage Development, H1 2014 20 

 Comparative Analysis by Early Stage Development, H1 2014 21 

 Comparative Analysis by Unknown Stage Development, H1 2014 22 

 Products under Development by Companies, H1 2014 23 

 Products under Development by Companies, H1 2014 (Contd..1) 24 

 Products under Investigation by Universities/Institutes, H1 2014 25 

 Autism - Pipeline by F. Hoffmann-La Roche Ltd., H1 2014 26 

 Autism - Pipeline by Dainippon Sumitomo Pharma Co., Ltd., H1 2014 27 

 Autism - Pipeline by Novartis AG, H1 2014 28 

 Autism - Pipeline by Merz Pharma GmbH & Co. KgaA, H1 2014 29 

 Autism - Pipeline by Teva Pharmaceutical Industries Limited, H1 2014 30 

 Autism - Pipeline by Avanir Pharmaceuticals, Inc., H1 2014 31 

 Autism - Pipeline by Snowdon Inc., H1 2014 32 

 Autism - Pipeline by Curemark, LLC, H1 2014 33 

 Autism - Pipeline by Coronado Biosciences, Inc., H1 2014 34 

 Autism - Pipeline by Omeros Corporation, H1 2014 35 

 Autism - Pipeline by Intra-Cellular Therapies, Inc., H1 2014 36 

 Autism - Pipeline by Cellceutix Corporation, H1 2014 37 

 Autism - Pipeline by Heptares Therapeutics Ltd., H1 2014 38 

 Autism - Pipeline by Otsuka Holdings Co., Ltd., H1 2014 39 

 Autism - Pipeline by Reviva Pharmaceuticals Inc., H1 2014 40 

 Autism - Pipeline by Naurex, Inc., H1 2014 41 

 Autism - Pipeline by Nectid, Inc., H1 2014 42 

 Autism - Pipeline by Mnemosyne Pharmaceuticals, Inc., H1 2014 43 

 Autism - Pipeline by BioCrea GmbH, H1 2014 44 

 Autism - Pipeline by Saniona AB, H1 2014 45 

 Autism - Pipeline by Confluence Pharmaceuticals LLC, H1 2014 46 

 Assessment by Monotherapy Products, H1 2014 47 

 Assessment by Combination Products, H1 2014 48 

 Number of Products by Stage and Target, H1 2014 51 

 Number of Products by Stage and Mechanism of Action, H1 2014 54 

 Number of Products by Stage and Route of Administration, H1 2014 56 

 Number of Products by Stage and Molecule Type, H1 2014 58 

 Autism Therapeutics - Recent Pipeline Updates, H1 2014 117 

 Autism - Dormant Projects, H1 2014 139 

 Autism - Discontinued Products, H1 2014 140 

  

 List of Figures 

 Number of Products under Development for Autism, H1 2014 12 

 Number of Products under Development for Autism - Comparative Analysis, H1 2014 13 

 Number of Products under Development by Companies, H1 2014 14 

 Number of Products under Investigation by Universities/Institutes, H1 2014 17 

 Comparative Analysis by Late Stage Development, H1 2014 19 

 Comparative Analysis by Clinical Stage Development, H1 2014 20 

 Comparative Analysis by Early Stage Products, H1 2014 21 

 Assessment by Monotherapy Products, H1 2014 47 

 Assessment by Combination Products, H1 2014 48 

 Number of Products by Top 10 Target, H1 2014 49 

 Number of Products by Stage and Top 10 Target, H1 2014 50 

 Number of Products by Top 10 Mechanism of Action, H1 2014 52 

 Number of Products by Stage and Top 10 Mechanism of Action, H1 2014 53 

 Number of Products by Top 10 Route of Administration, H1 2014 55 

 Number of Products by Stage and Top 10 Route of Administration, H1 2014 56 

 Number of Products by Top 10 Molecule Type, H1 2014 57 

 Number of Products by Stage and Top 10 Molecule Type, H1 2014 58