Behavioral Disorders Drug Development Pipeline Review, 2017

This report provides an overview of the behavioral disorders pipeline landscape. The report provides comprehensive information on the therapeutics under development and key players involved in therapeutic development for autism, obsessive-compulsive disorder and attention deficit hyperactivity disorder and features dormant and discontinued projects.

Autism, also known as complex developmental disability, is a neurodevelopment disorder characterized by social interaction, verbal and nonverbal communication and repetitive behaviors. Risk factors include child’s sex, family history, fragile X syndrome, Tourette syndrome and epilepsy.

Obsessive-compulsive disorder (OCD) is characterized by unreasonable thoughts and fears (obsessions) that lead to do repetitive behaviors (compulsions). Symptoms include having repeated thoughts or images about many different things, such as fear of germs, dirt, or intruders, acts of violence, hurting loved ones, doing the same rituals over and over such as washing hands, locking and unlocking doors, counting, keeping unneeded items, or repeating the same steps again and again.

Finally, attention deficit hyperactivity disorder (ADHD) is a group of behavioral symptoms that include inattentiveness, hyperactivity and impulsiveness. Symptoms of ADHD include disorganized work habits, procrastination and inability to sustain attention on tasks or activities.

The size of these pipelines ranges from 8 products in obsessive-compulsive disorder to 58 products in attention deficit hyperactivity disorder. Across all three of these indications, transporters and receptors of neurotransmitters such as dopamine, glutamine and serotonin, plus G protein-coupled receptors and ion channels, are the most common targets, closely reflecting the current treatment landscape of these diseases.

Scope

– Which companies are the most active within the pipeline for behavioral disorder therapeutics?

– Which pharmaceutical approaches are the most prominent at each stage of the pipeline and within each indication?

– To what extent do universities and institutions play a role within this pipeline, compared to pharmaceutical companies?

– What are the most important R&D milestones and data publications to have happened in the field of behavioral disorders?

Reasons to buy

- Understand the overall pipeline, with an at-a-glance overview of all products in therapeutic development for each indication

- Assess the products in development in granular detail, with an up-to-date overview of each individual pipeline program in each indication, and a comprehensive picture of recent updates and milestones for each

- Analyze the companies, institutions and universities currently operating in the pipeline, and the products being fielded by each of these

- Understand the composition of the pipeline in terms of molecule type, molecular target, mechanism of action and route of administration

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 5

1.2 List of Figures 7

2 Introduction 8

2.1 Behavioral Disorders Report Coverage 8

2.2 Autism - Overview 8

2.3 Obsessive-Compulsive Disorder - Overview 8

2.4 Attention Deficit Hyperactivity Disorder (ADHD) - Overview 8

3 Therapeutics Development 9

3.1 Autism 9

3.2 Obsessive-Compulsive Disorder 17

3.3 Attention Deficit Hyperactivity Disorder (ADHD) 20

4 Therapeutics Assessment 29

4.1 Autism 29

4.2 Obsessive-Compulsive Disorder 36

4.3 Attention Deficit Hyperactivity Disorder (ADHD) 41

5 Companies Involved in Therapeutics Development 49

5.1 Autism 49

5.2 Obsessive-Compulsive Disorder 62

5.3 Attention Deficit Hyperactivity Disorder (ADHD) 64

6 Dormant Projects 80

6.1 Autism 80

6.2 Obsessive-Compulsive Disorder 82

6.3 Attention Deficit Hyperactivity Disorder (ADHD) 83

7 Discontinued Products 87

7.1 Autism 87

7.2 Obsessive-Compulsive Disorder 87

7.3 Attention Deficit Hyperactivity Disorder (ADHD) 88

8 Product Development Milestones 89

8.1 Autism 89

8.2 Obsessive-Compulsive Disorder 98

8.3 Attention Deficit Hyperactivity Disorder (ADHD) 99

9 Appendix 112

9.1 Methodology 112

9.2 Coverage 112

9.3 Secondary Research 112

9.4 Primary Research 112

9.5 Expert Panel Validation 112

9.6 Contact Us 113

9.7 Disclaimer 113

List of Tables

1.1 List of Tables

Table 1: Number of Products under Development for Autism 9

Table 2: Number of Products under Development by Companies, Autism 11

Table 3: Number of Products under Development by Universities/Institutes, Autism 13

Table 4: Products under Development by Companies, Autism 14

Table 5: Products under Development by Universities/Institutes, Autism 16

Table 6: Number of Products under Development for Obsessive-Compulsive Disorder 17

Table 7: Number of Products under Development by Companies, Obsessive-Compulsive Disorder 18

Table 8: Products under Development by Companies, Obsessive-Compulsive Disorder 19

Table 9: Number of Products under Development for Attention Deficit Hyperactivity Disorder (ADHD) 20

Table 10: Number of Products under Development by Companies, Attention Deficit Hyperactivity Disorder (ADHD) 22

Table 11: Number of Products under Development by Universities/Institutes, Attention Deficit Hyperactivity Disorder (ADHD) 24

Table 12: Products under Development by Companies, Attention Deficit Hyperactivity Disorder (ADHD) 25

Table 13: Products under Development by Universities/Institutes, Attention Deficit Hyperactivity Disorder (ADHD) 28

Table 14: Number of Products by Stage and Target, Autism 30

Table 15: Number of Products by Stage and Mechanism of Action, Autism 32

Table 16: Number of Products by Stage and Route of Administration, Autism 34

Table 17: Number of Products by Stage and Molecule Type, Autism 36

Table 18: Number of Products by Stage and Target, Obsessive-Compulsive Disorder 37

Table 19: Number of Products by Stage and Mechanism of Action, Obsessive-Compulsive Disorder 39

Table 20: Number of Products by Stage and Route of Administration, Obsessive-Compulsive Disorder 39

Table 21: Number of Products by Stage and Molecule Type, Obsessive-Compulsive Disorder 40

Table 22: Number of Products by Stage and Target, Attention Deficit Hyperactivity Disorder (ADHD) 42

Table 23: Number of Products by Stage and Mechanism of Action, Attention Deficit Hyperactivity Disorder (ADHD) 44

Table 24: Number of Products by Stage and Route of Administration, Attention Deficit Hyperactivity Disorder (ADHD) 46

Table 25: Number of Products by Stage and Molecule Type, Attention Deficit Hyperactivity Disorder (ADHD) 48

Table 26: Autism – Pipeline by 4D Pharma PLC 49

Table 27: Autism – Pipeline by Addex Therapeutics Ltd 49

Table 28: Autism – Pipeline by Aequus Pharmaceuticals Inc 50

Table 29: Autism – Pipeline by Aevi Genomic Medicine Inc 50

Table 30: Autism – Pipeline by AgeneBio Inc 51

Table 31: Autism – Pipeline by Anima Biotech Ltd 51

Table 32: Autism – Pipeline by APeT Holding BV 52

Table 33: Autism – Pipeline by BioCrea GmbH 52

Table 34: Autism – Pipeline by BioHealthonomics Inc 53

Table 35: Autism – Pipeline by BrainStorm Cell Therapeutics Inc 53

Table 36: Autism – Pipeline by Confluence Pharmaceuticals LLC 54

Table 37: Autism – Pipeline by Coronis NeuroSciences Ltd 54

Table 38: Autism – Pipeline by Curemark LLC 55

Table 39: Autism – Pipeline by DRI Biosciences Corp 55

Table 40: Autism – Pipeline by F. Hoffmann-La Roche Ltd 56

Table 41: Autism – Pipeline by GW Pharmaceuticals Plc 56

Table 42: Autism – Pipeline by Heptares Therapeutics Ltd 57

Table 43: Autism – Pipeline by Immuron Ltd 57

Table 44: Autism – Pipeline by Intra-Cellular Therapies Inc 58

Table 45: Autism – Pipeline by Leading BioSciences Inc 58

Table 46: Autism – Pipeline by MedDay SA 59

Table 47: Autism – Pipeline by Omeros Corp 59

Table 48: Autism – Pipeline by OptiNose US Inc 60

Table 49: Autism – Pipeline by Ovensa Inc 60

Table 50: Autism – Pipeline by Q BioMed Inc 61

Table 51: Autism – Pipeline by Sumitomo Dainippon Pharma Co Ltd 61

Table 52: Obsessive-Compulsive Disorder – Pipeline by AbbVie Inc 62

Table 53: Obsessive-Compulsive Disorder – Pipeline by Addex Therapeutics Ltd 63

Table 54: Obsessive-Compulsive Disorder – Pipeline by Amorsa Therapeutics Inc 63

Table 55: Obsessive-Compulsive Disorder – Pipeline by Omeros Corp 64

Table 56: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by 4P-Pharma SAS 64

Table 57: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Aevi Genomic Medicine Inc 64

Table 58: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Alcobra Ltd 65

Table 59: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Amarantus Bioscience Holdings Inc 65

Table 60: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by APeT Holding BV 66

Table 61: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by BCWorld Pharm Co Ltd 66

Table 62: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by BioHealthonomics Inc 67

Table 63: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Cingulate Therapeutics LLC 67

Table 64: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Collegium Pharmaceutical Inc 68

Table 65: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Curemark LLC 68

Table 66: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by DURECT Corp 69

Table 67: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Eli Lilly and Company 70

Table 68: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by H. Lundbeck A/S 70

Table 69: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Heptares Therapeutics Ltd 71

Table 70: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Highland Therapeutics Inc 71

Table 71: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by KemPharm Inc 71

Table 72: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Luc Therapeutics Inc 72

Table 73: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Merck & Co Inc 72

Table 74: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Neos Therapeutics Inc 73

Table 75: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by NeuroDerm Ltd 73

Table 76: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Novartis AG 74

Table 77: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Noven Pharmaceuticals Inc 74

Table 78: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Otsuka Pharmaceutical Co Ltd 75

Table 79: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by P2D Bioscience 75

Table 80: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Reviva Pharmaceuticals Inc 76

Table 81: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Shire Plc 76

Table 82: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by SK Biopharmaceuticals Co Ltd 77

Table 83: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Sunovion Pharmaceuticals Inc 77

Table 84: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Supernus Pharmaceuticals Inc 78

Table 85: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Taisho Pharmaceutical Holdings Co Ltd 79

Table 86: Attention Deficit Hyperactivity Disorder (ADHD) – Pipeline by Tris Pharma Inc 79

Table 87: Autism – Dormant Projects 80

Table 88: Obsessive-Compulsive Disorder – Dormant Projects 82

Table 89: Attention Deficit Hyperactivity Disorder (ADHD) – Dormant Projects 83

Table 90: Autism – Discontinued Products 87

Table 91: Obsessive-Compulsive Disorder – Discontinued Products 87

Table 92: Attention Deficit Hyperactivity Disorder (ADHD) – Discontinued Products 88

List of Figures

1.2 List of Figures

Figure 1: Number of Products under Development for Autism 9

Figure 2: Number of Products under Development by Companies, Autism 10

Figure 3: Number of Products under Development by Universities/Institutes, Autism 13

Figure 4: Number of Products under Development for Obsessive-Compulsive Disorder 17

Figure 5: Number of Products under Development by Companies, Obsessive-Compulsive Disorder 18

Figure 6: Number of Products under Development for Attention Deficit Hyperactivity Disorder (ADHD) 20

Figure 7: Number of Products under Development by Companies, Attention Deficit Hyperactivity Disorder (ADHD) 21

Figure 8: Number of Products under Development by Universities/Institutes, Attention Deficit Hyperactivity Disorder (ADHD) 24

Figure 9: Number of Products by Top 10 Targets, Autism 29

Figure 10: Number of Products by Stage and Top 10 Targets, Autism 29

Figure 11: Number of Products by Top 10 Mechanism of Actions, Autism 31

Figure 12: Number of Products by Stage and Top 10 Mechanism of Actions, Autism 31

Figure 13: Number of Products by Routes of Administration, Autism 33

Figure 14: Number of Products by Stage and Routes of Administration, Autism 33

Figure 15: Number of Products by Molecule Types, Autism 35

Figure 16: Number of Products by Stage and Molecule Types, Autism 35

Figure 17: Number of Products by Targets, Obsessive-Compulsive Disorder 36

Figure 18: Number of Products by Stage and Targets, Obsessive-Compulsive Disorder 37

Figure 19: Number of Products by Mechanism of Actions, Obsessive-Compulsive Disorder 38

Figure 20: Number of Products by Stage and Mechanism of Actions, Obsessive-Compulsive Disorder 38

Figure 21: Number of Products by Stage and Routes of Administration, Obsessive-Compulsive Disorder 39

Figure 22: Number of Products by Stage and Molecule Types, Obsessive-Compulsive Disorder 40

Figure 23: Number of Products by Top 10 Targets, Attention Deficit Hyperactivity Disorder (ADHD) 41

Figure 24: Number of Products by Stage and Top 10 Targets, Attention Deficit Hyperactivity Disorder (ADHD) 41

Figure 25: Number of Products by Top 10 Mechanism of Actions, Attention Deficit Hyperactivity Disorder (ADHD) 43

Figure 26: Number of Products by Stage and Top 10 Mechanism of Actions, Attention Deficit Hyperactivity Disorder (ADHD) 43

Figure 27: Number of Products by Routes of Administration, Attention Deficit Hyperactivity Disorder (ADHD) 45

Figure 28: Number of Products by Stage and Routes of Administration, Attention Deficit Hyperactivity Disorder (ADHD) 46

Figure 29: Number of Products by Molecule Types, Attention Deficit Hyperactivity Disorder (ADHD) 47

Figure 30: Number of Products by Stage and Molecule Types, Attention Deficit Hyperactivity Disorder (ADHD) 47

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