Cough – Pipeline Review, H2 2016

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

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

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

The report assesses Cough 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 Cough

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 Cough

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 Cough 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

Afferent Pharmaceuticals, Inc.

Alitair Pharmaceuticals, Inc.

Alveonix AG

AstraZeneca Plc

AusBio Ltd

Charleston Laboratories, Inc.

Conrig Pharma ApS

Daewoong Pharmaceutical Co., Ltd.

GlaxoSmithKline Plc

Glenmark Pharmaceuticals Ltd.

GW Pharmaceuticals Plc

Hyundai Pharmaceutical Co., Ltd.

Johnson & Johnson

NeRRe Therapeutics Ltd

Orbis Biosciences Inc

Patara Pharma, Inc.

Pila Pharma AB

Vernalis Plc

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Cough Overview 9

Therapeutics Development 10

Pipeline Products for Cough - Overview 10

Pipeline Products for Cough - Comparative Analysis 11

Cough - Therapeutics under Development by Companies 12

Cough - Therapeutics under Investigation by Universities/Institutes 14

Cough - Pipeline Products Glance 15

Late Stage Products 15

Clinical Stage Products 16

Early Stage Products 17

Unknown Stage Products 18

Cough - Products under Development by Companies 19

Cough - Products under Investigation by Universities/Institutes 20

Cough - Companies Involved in Therapeutics Development 21

Afferent Pharmaceuticals, Inc. 21

Alitair Pharmaceuticals, Inc. 22

Alveonix AG 23

AstraZeneca Plc 24

AusBio Ltd 25

Charleston Laboratories, Inc. 26

Conrig Pharma ApS 27

Daewoong Pharmaceutical Co., Ltd. 28

GlaxoSmithKline Plc 29

Glenmark Pharmaceuticals Ltd. 30

GW Pharmaceuticals Plc 31

Hyundai Pharmaceutical Co., Ltd. 32

Johnson & Johnson 33

NeRRe Therapeutics Ltd 34

Orbis Biosciences Inc 35

Patara Pharma, Inc. 36

Pila Pharma AB 37

Vernalis Plc 38

Cough - Therapeutics Assessment 39

Assessment by Monotherapy Products 39

Assessment by Combination Products 40

Assessment by Target 41

Assessment by Mechanism of Action 43

Assessment by Route of Administration 45

Assessment by Molecule Type 47

Drug Profiles 48

Ax-8 - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

benzonatate - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

CCP-05 - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

CCP-06 - Drug Profile 51

Product Description 51

Mechanism Of Action 51

R&D Progress 51

CCP-07 - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

CCP-08 - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

CLAT-313 - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

codeine + guaifenesin - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

cromolyn sodium - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

DWJ-1340 - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

GRC-17536 - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

GSK-2339345 - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

guaifenesin + hydrocodone - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

guaifenesin ER - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

JNJ-39729209 - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

lesogaberan - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

levodropropizine CR - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

MD-990 - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

MK-7264 - Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

NEO-5937 - Drug Profile 71

Product Description 71

Mechanism Of Action 71

R&D Progress 71

orvepitant maleate - Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

S-1226 - Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

Small Molecule to Antagonize TRPA-1 for Pain And Respiratory Disorders - Drug Profile 76

Product Description 76

Mechanism Of Action 76

R&D Progress 76

Small Molecules to Agonize CB1 and CB2 for Chronic Cough and Inflammatory Skin Diseases - Drug Profile 77

Product Description 77

Mechanism Of Action 77

R&D Progress 77

ST-015 - Drug Profile 78

Product Description 78

Mechanism Of Action 78

R&D Progress 78

XEND-0501 - Drug Profile 79

Product Description 79

Mechanism Of Action 79

R&D Progress 79

Cough - Dormant Projects 81

Cough - Discontinued Products 84

Cough - Product Development Milestones 85

Featured News & Press Releases 85

Jul 08, 2016: Vernalis Announces Successful Completion of CCP-08 Pivotal Multiple-Dose Comparative Bioavailability Study 85

May 16, 2016: Afferent Pharmaceuticals Presents Updated Positive Results with AF-219 from Phase 2B Chronic Cough Study at the 2016 American Thoracic Society International Conference 85

May 03, 2016: Patara Pharma Appoints Biotechnology Industry Leader John Schmid to Board of Directors 87

Apr 25, 2016: Afferent Pharmaceuticals Announces Presentation of Chronic Cough Clinical Data at the Upcoming American Thoracic Society 2016 International Conference 88

Apr 14, 2016: Vernalis Announces Successful Completion of CCP-07 Pivotal Multiple-Dose Comparative Bioavailability Study 88

Apr 13, 2016: Vernalis Announces Successful Completion of CCP-08 Pivotal Single-Dose Comparative Bioavailability Study 88

Dec 21, 2015: Vernalis Announces Successful Completion of CCP-07 Pivotal Single-Dose Comparative Bioavailability Study 89

Oct 12, 2015: Vernalis announces start of CCP-08 12 month stability testing 89

Sep 28, 2015: Afferent Pharmaceuticals Announces Positive Results in Phase 2b Chronic Cough Trial 90

Jul 01, 2015: Spriaso Announces Approval of New Drug Application for the Long Acting Codeine Antitussive With a Popular Anti-Histamine 91

Jun 11, 2015: Vernalis announces CCP-07 starts 12 month stability testing 91

Nov 25, 2014: Afferent Clinical Data Demonstrating AF-219 Treatment Reduces Cough Frequency by 75% in Chronic Cough Is Published In The Lancet 91

Sep 09, 2014: Charleston Laboratories Announces Key Clinical Updates for Novel Drug 93

Jul 22, 2014: Third Product in Vernalis' Cough Cold Pipeline (CCP-08) Achieves Proof-of-Concept 93

Apr 29, 2014: Second Product in Vernalis’ Cough Cold Pipeline Achieves Proof-of-Concept 93

Appendix 95

Methodology 95

Coverage 95

Secondary Research 95

Primary Research 95

Expert Panel Validation 95

Contact Us 95

Disclaimer 96

List of Tables

List of Tables

Number of Products under Development for Cough, H2 2016 10

Number of Products under Development for Cough – Comparative Analysis, H2 2016 11

Number of Products under Development by Companies, H2 2016 13

Number of Products under Investigation by Universities/Institutes, H2 2016 14

Comparative Analysis by Late Stage Development, H2 2016 15

Comparative Analysis by Clinical Stage Development, H2 2016 16

Comparative Analysis by Early Stage Development, H2 2016 17

Comparative Analysis by Unknown Stage Development, H2 2016 18

Products under Development by Companies, H2 2016 19

Products under Investigation by Universities/Institutes, H2 2016 20

Cough – Pipeline by Afferent Pharmaceuticals, Inc., H2 2016 21

Cough – Pipeline by Alitair Pharmaceuticals, Inc., H2 2016 22

Cough – Pipeline by Alveonix AG, H2 2016 23

Cough – Pipeline by AstraZeneca Plc, H2 2016 24

Cough – Pipeline by AusBio Ltd, H2 2016 25

Cough – Pipeline by Charleston Laboratories, Inc., H2 2016 26

Cough – Pipeline by Conrig Pharma ApS, H2 2016 27

Cough – Pipeline by Daewoong Pharmaceutical Co., Ltd., H2 2016 28

Cough – Pipeline by GlaxoSmithKline Plc, H2 2016 29

Cough – Pipeline by Glenmark Pharmaceuticals Ltd., H2 2016 30

Cough – Pipeline by GW Pharmaceuticals Plc, H2 2016 31

Cough – Pipeline by Hyundai Pharmaceutical Co., Ltd., H2 2016 32

Cough – Pipeline by Johnson & Johnson, H2 2016 33

Cough – Pipeline by NeRRe Therapeutics Ltd, H2 2016 34

Cough – Pipeline by Orbis Biosciences Inc, H2 2016 35

Cough – Pipeline by Patara Pharma, Inc., H2 2016 36

Cough – Pipeline by Pila Pharma AB, H2 2016 37

Cough – Pipeline by Vernalis Plc, H2 2016 38

Assessment by Monotherapy Products, H2 2016 39

Assessment by Combination Products, H2 2016 40

Number of Products by Stage and Target, H2 2016 42

Number of Products by Stage and Mechanism of Action, H2 2016 44

Number of Products by Stage and Route of Administration, H2 2016 46

Number of Products by Stage and Molecule Type, H2 2016 47

Cough – Dormant Projects, H2 2016 81

Cough – Dormant Projects (Contd..1), H2 2016 82

Cough – Dormant Projects (Contd..2), H2 2016 83

Cough – Discontinued Products, H2 2016 84

List of Figures

List of Figures

Number of Products under Development for Cough, H2 2016 10

Number of Products under Development for Cough – Comparative Analysis, H2 2016 11

Number of Products under Development by Companies, H2 2016 12

Comparative Analysis by Early Stage Products, H2 2016 17

Assessment by Monotherapy Products, H2 2016 39

Number of Products by Top 10 Targets, H2 2016 41

Number of Products by Stage and Top 10 Targets, H2 2016 41

Number of Products by Top 10 Mechanism of Actions, H2 2016 43

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 43

Number of Products by Routes of Administration, H2 2016 45

Number of Products by Stage and Routes of Administration, H2 2016 45

Number of Products by Stage and Molecule Types, H2 2016 47

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