Narcolepsy – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Narcolepsy – Pipeline Review, H2 2016’, provides an overview of the Narcolepsy pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Narcolepsy, 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 Narcolepsy and features dormant 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, 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.

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.

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

Scope

The report provides a snapshot of the global therapeutic landscape of Narcolepsy

The report reviews pipeline therapeutics for Narcolepsy by companies and universities/research institutes based on information derived from company and industry-specific sources

The report 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

The report reviews key players involved Narcolepsy therapeutics and enlists all their major and minor projects

The report assesses Narcolepsy 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

The report reviews latest news related to pipeline therapeutics for Narcolepsy

Reasons to buy

Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of therapeutics under development for Narcolepsy

Identify potential new clients or partners in the target demographic

Develop strategic initiatives by understanding the focus areas of leading companies

Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics

Devise corrective measures for pipeline projects by understanding Narcolepsy 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

Companies mentioned

Bioprojet SCR

Evotec AG

Flamel Technologies S.A.

H.A.C. Pharma

Heptares Therapeutics Limited

Jazz Pharmaceuticals Plc

NLS Pharma Group

Ono Pharmaceutical Co., Ltd.

Sanofi

SK Biopharmaceuticals Co., Ltd.

Taisho Pharmaceutical Holdings Co., Ltd.

Theranexus SAS

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Narcolepsy Overview 8

Therapeutics Development 9

Pipeline Products for Narcolepsy - Overview 9

Pipeline Products for Narcolepsy - Comparative Analysis 10

Narcolepsy - Therapeutics under Development by Companies 11

Narcolepsy - Therapeutics under Investigation by Universities/Institutes 12

Narcolepsy - Pipeline Products Glance 13

Late Stage Products 13

Clinical Stage Products 14

Early Stage Products 15

Narcolepsy - Products under Development by Companies 16

Narcolepsy - Products under Investigation by Universities/Institutes 17

Narcolepsy - Companies Involved in Therapeutics Development 18

Bioprojet SCR 18

Evotec AG 19

Flamel Technologies S.A. 20

H.A.C. Pharma 21

Heptares Therapeutics Limited 22

Jazz Pharmaceuticals Plc 23

NLS Pharma Group 24

Ono Pharmaceutical Co., Ltd. 25

Sanofi 26

SK Biopharmaceuticals Co., Ltd. 27

Taisho Pharmaceutical Holdings Co., Ltd. 28

Theranexus SAS 29

Narcolepsy - Therapeutics Assessment 30

Assessment by Monotherapy Products 30

Assessment by Combination Products 31

Assessment by Target 32

Assessment by Mechanism of Action 34

Assessment by Route of Administration 36

Assessment by Molecule Type 37

Drug Profiles 38

(flecainide acetate + modafinil) - Drug Profile 38

Product Description 38

Mechanism Of Action 38

R&D Progress 38

arbaclofen - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

JZP-386 - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

mazindol - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

mazindol - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

NLS-3 - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

ONO-4127 - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

Pentylenetetrazol - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

pitolisant - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

SAR-110068 - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

SKL-N05 - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

Small Molecule to Agonize Orexin-2 for Narcolepsy and Sleep Disorders - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

Small Molecules to Agonize Orexin Receptor 2 for Narcolepsy - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

Small Molecules to Agonize Orexin Receptor for EDS and Narcolepsy - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

Small Molecules to Inhibit Dopamine Transporter for CNS and Metabolic Disorders - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

sodium oxybate - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

sodium oxybate - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

TS-091 - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

Narcolepsy - Dormant Projects 62

Narcolepsy - Discontinued Products 63

Narcolepsy - Product Development Milestones 64

Featured News & Press Releases 64

Oct 06, 2016: Flamel Technologies Reaches Agreement With FDA on Protocol for Phase III Pivotal Trial of FT218 64

Oct 04, 2016: Theranexus Has Obtained an Orphan Drug Designation from the FDA for THN102 in the Treatment of Narcolepsy 64

Jul 11, 2016: Mazindol Granted Orphan Drug Designation in the US & Europe for Treatment of Narcolepsy 65

Jun 14, 2016: Jazz Pharmaceuticals Presents New Data from a Human Abuse Liability Study for JZP-110, an Investigational Treatment for Excessive Sleepiness in Patients with Narcolepsy or with Obstructive Sleep Apnea, at 30th Annual SLEEP Meeting 65

May 17, 2016: Theranexus Reaches Its Primary Endpoint in the Proof of Concept Trial of THN102 in Excessive Daytime Sleepiness 66

Mar 31, 2016: Flamel Technologies Files Special Protocol Assessment for Once Nightly Sodium Oxybate 67

Mar 30, 2016: Theranexus: Preclinical Results Published in the Specialist Medical Journal Sleep 67

Nov 20, 2015: Narcolepsy treatment recommended for approval 68

Oct 19, 2015: Theranexus: Inclusion of the first subjects in the efficacy study on the treatment of sleep disorders, in partnership with the French Armed Forces Biomedical Research Institute (IRBA) 69

Jul 15, 2015: Theranexus Success of phase 1 trial on the safety of a new treatment of narcolepsy and launch of efficacy studies 69

Jun 04, 2015: Jazz Pharmaceuticals to Present Abstracts from Ongoing Evaluations of Xyrem(sodium oxybate) at SLEEP 2015 70

May 07, 2015: Jazz Pharmaceuticals and Concert Pharmaceuticals Provide JZP-386 Program Update 71

Dec 19, 2014: Flamel Technologies Announces Positive Results of a Second Clinical Trial With Micropump Sodium Oxybate 71

Dec 09, 2014: Jazz Pharmaceuticals and Concert Pharmaceuticals Provide JZP-386 Program Update 72

Dec 02, 2014: Jazz Pharmaceuticals Announces First Patients Enrolled in Phase 3 Trial of Xyrem (Sodium Oxybate) In Children And Adolescents Who Have Narcolepsy With Cataplexy 73

Appendix 74

Methodology 74

Coverage 74

Secondary Research 74

Primary Research 74

Expert Panel Validation 74

Contact Us 74

Disclaimer 75

List of Tables

List of Tables

Number of Products under Development for Narcolepsy, H2 2016 9

Number of Products under Development for Narcolepsy – Comparative Analysis, H2 2016 10

Number of Products under Development by Companies, H2 2016 11

Number of Products under Investigation by Universities/Institutes, H2 2016 12

Comparative Analysis by Late Stage Development, H2 2016 13

Comparative Analysis by Clinical Stage Development, H2 2016 14

Comparative Analysis by Early Stage Development, H2 2016 15

Products under Development by Companies, H2 2016 16

Products under Investigation by Universities/Institutes, H2 2016 17

Narcolepsy – Pipeline by Bioprojet SCR, H2 2016 18

Narcolepsy – Pipeline by Evotec AG, H2 2016 19

Narcolepsy – Pipeline by Flamel Technologies S.A., H2 2016 20

Narcolepsy – Pipeline by H.A.C. Pharma, H2 2016 21

Narcolepsy – Pipeline by Heptares Therapeutics Limited, H2 2016 22

Narcolepsy – Pipeline by Jazz Pharmaceuticals Plc, H2 2016 23

Narcolepsy – Pipeline by NLS Pharma Group, H2 2016 24

Narcolepsy – Pipeline by Ono Pharmaceutical Co., Ltd., H2 2016 25

Narcolepsy – Pipeline by Sanofi, H2 2016 26

Narcolepsy – Pipeline by SK Biopharmaceuticals Co., Ltd., H2 2016 27

Narcolepsy – Pipeline by Taisho Pharmaceutical Holdings Co., Ltd., H2 2016 28

Narcolepsy – Pipeline by Theranexus SAS, H2 2016 29

Assessment by Monotherapy Products, H2 2016 30

Assessment by Combination Products, H2 2016 31

Number of Products by Stage and Target, H2 2016 33

Number of Products by Stage and Mechanism of Action, H2 2016 35

Number of Products by Stage and Route of Administration, H2 2016 36

Number of Products by Stage and Molecule Type, H2 2016 37

Narcolepsy – Dormant Projects, H2 2016 62

Narcolepsy – Discontinued Products, H2 2016 63

List of Figures

List of Figures

Number of Products under Development for Narcolepsy, H2 2016 9

Number of Products under Development for Narcolepsy – Comparative Analysis, H2 2016 10

Number of Products under Development by Companies, H2 2016 11

Comparative Analysis by Clinical Stage Development, H2 2016 14

Comparative Analysis by Early Stage Products, H2 2016 15

Assessment by Monotherapy Products, H2 2016 30

Number of Products by Targets, H2 2016 32

Number of Products by Stage and Targets, H2 2016 32

Number of Products by Top 10 Mechanism of Actions, H2 2016 34

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 34

Number of Products by Stage and Routes of Administration, H2 2016 36

Number of Products by Stage and Molecule Types, H2 2016 37

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