Sleep Apnea - Pipeline Review, H2 2016

Global Markets Direct’s, ‘Sleep Apnea - Pipeline Review, H2 2016’, provides an overview of the Sleep Apnea pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Sleep Apnea, 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 Sleep Apnea 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 Sleep Apnea

The report reviews pipeline therapeutics for Sleep Apnea 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 Sleep Apnea therapeutics and enlists all their major and minor projects

The report assesses Sleep Apnea 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 Sleep Apnea

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 Sleep Apnea

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 Sleep Apnea 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

Galleon Pharmaceuticals

RespireRx Pharmaceuticals Inc.

SK Biopharmaceuticals Co., Ltd.

Vivus, Inc.

Galleon Pharmaceuticals

RespireRx Pharmaceuticals Inc.

SK Biopharmaceuticals Co., Ltd.

Vivus, Inc.

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 4

List of Figures 4

Introduction 5

Global Markets Direct Report Coverage 5

Sleep Apnea ...

Table of Contents

Table of Contents 2

List of Tables 4

List of Figures 4

Introduction 5

Global Markets Direct Report Coverage 5

Sleep Apnea Overview 6

Therapeutics Development 7

Pipeline Products for Sleep Apnea - Overview 7

Pipeline Products for Sleep Apnea - Comparative Analysis 8

Sleep Apnea - Therapeutics under Development by Companies 9

Sleep Apnea - Therapeutics under Investigation by Universities/Institutes 10

Sleep Apnea - Pipeline Products Glance 11

Late Stage Products 11

Clinical Stage Products 12

Early Stage Products 13

Sleep Apnea - Products under Development by Companies 14

Sleep Apnea - Products under Investigation by Universities/Institutes 15

Sleep Apnea - Companies Involved in Therapeutics Development 16

Galleon Pharmaceuticals 16

RespireRx Pharmaceuticals Inc. 17

SK Biopharmaceuticals Co., Ltd. 18

Vivus, Inc. 19

Sleep Apnea - Therapeutics Assessment 20

Assessment by Monotherapy Products 20

Assessment by Combination Products 21

Assessment by Target 22

Assessment by Mechanism of Action 24

Assessment by Route of Administration 26

Assessment by Molecule Type 27

Drug Profiles 28

(phentermine + topiramate) ER - Drug Profile 28

Product Description 28

Mechanism Of Action 28

R&D Progress 28

CX-1739 - Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

dronabinol - Drug Profile 38

Product Description 38

Mechanism Of Action 38

R&D Progress 38

GAL-475 - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

GAL-475 Backups - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

SKL-N05 - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

Small Molecule for Sleep Apnea - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

Sleep Apnea - Dormant Projects 46

Sleep Apnea - Discontinued Products 47

Sleep Apnea - Product Development Milestones 48

Featured News & Press Releases 48

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 48

Feb 29, 2016: RespireRx Pharmaceuticals Announces Removal of FDA Clinical Hold on CX1739 and Initiation of Phase IIA Clinical Trial by March 31, 2016 49

Jun 08, 2015: Jazz Pharmaceuticals Announces First Patients Enrolled in Phase 3 Clinical Development Program Evaluating JZP-110 as a Potential Treatment of EDS Associated with Narcolepsy or with OSA 49

May 14, 2015: VIVUS Announces Scientific Presentations 50

May 04, 2015: Cortex Pharmaceuticals Announces Publication of Research Results on the Use of Ampakines CX1739 in the Treatment of Respiratory Disorders 51

May 04, 2015: Cortex Pharmaceuticals Announces Publication of Research Results on the Use of Ampakines CX1739 in the Treatment of Respiratory Disorders 52

May 15, 2014: VIVUS Announces Qsymia Presentation at the American Association of Clinical Endocrinologists 52

Jul 01, 2013: VIVUS Announces Initial Availability of Qsymia Through Certified Retail Pharmacies 53

Nov 12, 2012: Study Finds Significant Improvements In Patients With Obstructive Sleep Apnea Treated With Phentermine And Topiramate Extended-Release Capsules 54

Jan 09, 2012: VIVUS Provides Update On Regulatory Status Of Qnexa 55

Nov 03, 2011: FDA Accepts New Drug Application Filing For Qnexa 55

Apr 26, 2011: Cortex Receives US Patent For Lead AMPAKINE Molecule CX1739 56

Feb 02, 2011: Cortex’s Ampakine CX1739 Improves Respiratory Parameters In Obstructive Sleep Apnea Patients 56

Jan 07, 2010: VIVUS Announces Positive Results From Phase II Study Of Qnexa In Obstructive Sleep Apnea 57

Appendix 59

Methodology 59

Coverage 59

Secondary Research 59

Primary Research 59

Expert Panel Validation 59

Contact Us 59

Disclaimer 60

List of Tables

List of Tables

Number of Products under Development for Sleep Apnea, H2 2016 7

Number of Products under Development for Sleep Apnea - Comparative Analysis, ...

List of Tables

Number of Products under Development for Sleep Apnea, H2 2016 7

Number of Products under Development for Sleep Apnea - Comparative Analysis, H2 2016 8

Number of Products under Development by Companies, H2 2016 9

Number of Products under Investigation by Universities/Institutes, H2 2016 10

Comparative Analysis by Late Stage Development, H2 2016 11

Comparative Analysis by Clinical Stage Development, H2 2016 12

Comparative Analysis by Early Stage Development, H2 2016 13

Products under Development by Companies, H2 2016 14

Products under Investigation by Universities/Institutes, H2 2016 15

Sleep Apnea - Pipeline by Galleon Pharmaceuticals, H2 2016 16

Sleep Apnea - Pipeline by RespireRx Pharmaceuticals Inc., H2 2016 17

Sleep Apnea - Pipeline by SK Biopharmaceuticals Co., Ltd., H2 2016 18

Sleep Apnea - Pipeline by Vivus, Inc., H2 2016 19

Assessment by Monotherapy Products, H2 2016 20

Assessment by Combination Products, H2 2016 21

Number of Products by Stage and Target, H2 2016 23

Number of Products by Stage and Mechanism of Action, H2 2016 25

Number of Products by Stage and Route of Administration, H2 2016 26

Number of Products by Stage and Molecule Type, H2 2016 27

Sleep Apnea - Dormant Projects, H2 2016 46

Sleep Apnea - Discontinued Products, H2 2016 47

List of Figures

List of Figures

Number of Products under Development for Sleep Apnea, H2 2016 7

Number of Products under Development for Sleep Apnea - Comparative Analysis, ...

List of Figures

Number of Products under Development for Sleep Apnea, H2 2016 7

Number of Products under Development for Sleep Apnea - Comparative Analysis, H2 2016 8

Number of Products under Development by Companies, H2 2016 9

Comparative Analysis by Early Stage Products, H2 2016 13

Assessment by Monotherapy Products, H2 2016 20

Number of Products by Top 10 Targets, H2 2016 22

Number of Products by Stage and Top 10 Targets, H2 2016 22

Number of Products by Top 10 Mechanism of Actions, H2 2016 24

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 24

Number of Products by Stage and Routes of Administration, H2 2016 26

Number of Products by Stage and Molecule Types, H2 2016 27

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