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Narcolepsy - Pipeline Review, H2 2015 Is Released

Press Release   •   Jan 30, 2016 12:42 IST

Narcolepsy - Pipeline Review, H2 2015 Summary Global Markets Direct s, Narcolepsy - Pipeline Review, H2 2015, provides an overview of the Narcolepsys therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Narcolepsy, 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 Narcolepsy and special features on late-stage and discontinued projects. Global Markets Directs 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, 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 Narcolepsy - 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 Narcolepsy and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Narcolepsy 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 Narcolepsy 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 Narcolepsy - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - 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.

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Table of Contents

Introduction 6

Global Markets Direct Report Coverage 6

Narcolepsy Overview 7

Therapeutics Development 8

Pipeline Products for Narcolepsy - Overview 8

Pipeline Products for Narcolepsy - Comparative Analysis 9

Narcolepsy - Therapeutics under Development by Companies 10

Narcolepsy - Therapeutics under Investigation by Universities/Institutes 11

Narcolepsy - Pipeline Products Glance 12

Late Stage Products 12

Clinical Stage Products 13

Early Stage Products 14

Narcolepsy - Products under Development by Companies 15

Narcolepsy - Products under Investigation by Universities/Institutes 16

Narcolepsy - Companies Involved in Therapeutics Development 17

Bioprojet SCR 17

Evotec AG 18

Flamel Technologies S.A. 19

Grupo Ferrer Internacional, S.A. 20

Jazz Pharmaceuticals Plc 21

Sanofi 22

SK Biopharmaceuticals Co., Ltd. 23

Taisho Pharmaceutical Holdings Co., Ltd. 24

Theranexus SAS 25

Narcolepsy - Therapeutics Assessment 26

Assessment by Monotherapy Products 26

Assessment by Combination Products 27

Assessment by Target 28

Assessment by Mechanism of Action 30

Assessment by Route of Administration 32

Assessment by Molecule Type 33

Drug Profiles 34

(modafinil + THN-02) - Drug Profile 34

Product Description 34

Mechanism of Action 34

R&D Progress 34

arbaclofen - Drug Profile 36

Product Description 36

Mechanism of Action 36

R&D Progress 36

BTD-001 - Drug Profile 37

Product Description 37

Mechanism of Action 37

R&D Progress 37

Drugs to Agonize Orexin Receptor for Narcolepsy - Drug Profile 39

Product Description 39

Mechanism of Action 39

R&D Progress 39

EVT-501 - 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

pitolisant - Drug Profile 42

Product Description 42

Mechanism of Action 42

R&D Progress 42

SAR-110068 - Drug Profile 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

SKL-N05 - Drug Profile 45

Product Description 45

Mechanism of Action 45

R&D Progress 45

Small Molecules to Agonize Orexin Receptor 2 for Insomnia - Drug Profile 47

Product Description 47

Mechanism of Action 47

R&D Progress 47

Small Molecules to Agonize Orexin Receptor for Narcolepsy and EDS - Drug Profile 48

Product Description 48

Mechanism of Action 48

R&D Progress 48

Small Molecules to Inhibit Dopamine Transporter for CNS and Metabolic Disorders - Drug Profile 49

Product Description 49

Mechanism of Action 49

R&D Progress 49

sodium oxybate - Drug Profile 50

Product Description 50

Mechanism of Action 50

R&D Progress 50

sodium oxybate - Drug Profile 52

Product Description 52

Mechanism of Action 52

R&D Progress 52

TS-091 - Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

Narcolepsy - Recent Pipeline Updates 54

Narcolepsy - Dormant Projects 58

Narcolepsy - Discontinued Products 59

Narcolepsy - Product Development Milestones 60

Featured News & Press Releases 60

Nov 20, 2015: Narcolepsy treatment recommended for approval 60

Jul 15, 2015: Theranexus Success of phase 1 trial on the safety of a new treatment of narcolepsy and launch of efficacy studies 60

Jun 04, 2015: Jazz Pharmaceuticals to Present Abstracts from Ongoing Evaluations of Xyrem(sodium oxybate) at SLEEP 2015 61

May 07, 2015: Jazz Pharmaceuticals and Concert Pharmaceuticals Provide JZP-386 Program Update 62

Dec 19, 2014: Flamel Technologies Announces Positive Results of a Second Clinical Trial with Micropump Sodium Oxybate 62

Dec 09, 2014: Jazz Pharmaceuticals and Concert Pharmaceuticals Provide JZP-386 Program Update 63

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 64

Jul 21, 2014: Jazz Pharmaceuticals and Concert Pharmaceuticals Provide a Phase 1 Clinical Trial Update on JZP-386 64

Jun 02, 2014: Jazz Pharmaceuticals Presents JZP-110 Phase 2b Data for the Treatment of EDS Symptoms In Adults With Narcolepsy 65

May 27, 2014: Jazz Pharmaceuticals to Present Data On Compound In Sleep Pipeline During APSS Annual SLEEP Meeting 66

Appendix 67

Methodology 67

Coverage 67

Secondary Research 67

Primary Research 67

Expert Panel Validation 67

Contact Us 67

Disclaimer 68

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