Narcolepsy - Pipeline Review, H2 2015 Is Released

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
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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
4

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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