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Cystic Fibrosis-Pipeline Review, H1 2015

Cystic Fibrosis-Pipeline Review, H1 2015


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Executive Summary

Cystic Fibrosis-Pipeline Review, H1 2015

Summary

Global Markets Direct's, 'Cystic Fibrosis-Pipeline Review, H1 2015', provides an overview of the Cystic Fibrosis's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Cystic Fibrosis, 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 Cystic Fibrosis and special features on late-stage 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, 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 Cystic Fibrosis

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 Cystic Fibrosis and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Cystic Fibrosis 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 Cystic Fibrosis 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 Cystic Fibrosis

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

Devise corrective measures for pipeline projects by understanding Cystic Fibrosis 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

Table of Contents

Table of Contents 2

List of Tables 7

List of Figures 9

Introduction 10

Global Markets Direct Report Coverage 10

Cystic Fibrosis Overview 11

Therapeutics Development 12

Pipeline Products for Cystic Fibrosis-Overview 12

Pipeline Products for Cystic Fibrosis-Comparative Analysis 13

Cystic Fibrosis-Therapeutics under Development by Companies 14

Cystic Fibrosis-Therapeutics under Investigation by Universities/Institutes 20

Cystic Fibrosis-Pipeline Products Glance 22

Late Stage Products 22

Clinical Stage Products 23

Early Stage Products 24

Unknown Stage Products 25

Cystic Fibrosis-Products under Development by Companies 26

Cystic Fibrosis-Products under Investigation by Universities/Institutes 32

Cystic Fibrosis-Companies Involved in Therapeutics Development 33

Actelion Ltd 33

Alaxia SAS 34

AlgiPharma AS 35

Arcturus Therapeutics, Inc 36

Bayer AG 37

Beech Tree Labs, Inc. 38

Carolus Therapeutics, Inc. 39

Celsus Therapeutics Plc 40

Celtaxsys, Inc. 41

Chiesi Farmaceutici SpA 42

Cilian AG 43

Concert Pharmaceuticals, Inc. 44

Corbus pharmaceuticals, Inc. 45

Cubist Pharmaceuticals, Inc. 46

DiscoveryBiomed, Inc. 47

Errant Gene Therapeutics, LLC 48

Galapagos NV 49

GlaxoSmithKline plc 50

Grifols, S.A. 51

Invion Limited 52

InvivoGen Therapeutics 53

JHL Biotech, Inc. 54

Kamada Ltd. 55

Lamellar Biomedical Ltd 56

Laurent Pharmaceuticals Inc. 57

Microbion Corporation 58

Mucokinetica Ltd. 59

N30 Pharmaceuticals 60

NanoBio Corporation 61

Nostrum Pharmaceuticals, LLC 62

Novabiotics Ltd 63

Novartis AG 64

Ockham Biotech Limited 65

OSE Pharma SA 66

Parion Sciences, Inc. 67

Pfizer Inc. 68

Pharmaxis Limited 69

Polyphor Ltd. 70

Progenra, Inc. 71

ProQR Therapeutics N.V. 72

Protalix BioTherapeutics, Inc. 73

PTC Therapeutics, Inc. 74

Pulmatrix, Inc. 75

Reata Pharmaceuticals, Inc. 76

ReveraGen BioPharma, Inc. 77

Serendex Pharmaceuticals A/S 78

Shire Plc 79

Synovo GmbH 80

Verona Pharma Plc 81

Vertex Pharmaceuticals Incorporated 82

Xenetic Biosciences plc 83

Cystic Fibrosis-Therapeutics Assessment 84

Assessment by Monotherapy Products 84

Assessment by Combination Products 85

Assessment by Target 86

Assessment by Mechanism of Action 89

Assessment by Route of Administration 92

Assessment by Molecule Type 94

Drug Profiles 96

(fosfomycin + tobramycin)-Drug Profile 96

alpha-1 proteinase inhibitor (human) second generation-Drug Profile 97

ALX-009-Drug Profile 100

Anti-Microbial Drug for Cystic Fibrosis-Drug Profile 101

ataluren-Drug Profile 102

BTL-na-Drug Profile 105

CFX-1-Drug Profile 106

CSY-0073-Drug Profile 107

CT-2009-Drug Profile 108

CTX-4430-Drug Profile 109

cysteamine-Drug Profile 110

D-Ivacaftor-Drug Profile 112

dapsone-Drug Profile 113

Deoxyribonuclease II to Inhibit DNA Synthesis for Cystic Fibrosis-Drug Profile 114

dornase alfa biosimilar-Drug Profile 115

Drug for Cystic Fibrosis-Drug Profile 116

Drug to Activate Kir 4.2 for Cystic Fibrosis-Drug Profile 117

Drugs for COPD and Cystic Fibrosis-Drug Profile 118

Drugs for Cystic Fibrosis Lung Infections-Drug Profile 119

EBX-001-Drug Profile 120

FDL-169-Drug Profile 121

fenretinide-Drug Profile 122

fosfomycin-Drug Profile 123

Gene Therapy to Activate CFTR for Cystic Fibrosis-Drug Profile 124

Gene Therapy to Activate CFTR for Cystic Fibrosis-Drug Profile 125

GLPG-1837-Drug Profile 126

GSK-2225745-Drug Profile 128

Heparin-Drug Profile 129

JBT-101-Drug Profile 130

levofloxacin-Drug Profile 131

LMS-611-Drug Profile 132

lumacaftor-Drug Profile 133

LUNAR-CF-Drug Profile 136

mannitol-Drug Profile 137

miglustat-Drug Profile 140

MKA-104-Drug Profile 142

molgramostim-Drug Profile 143

N-1785-Drug Profile 145

N-1861-Drug Profile 146

N-6022-Drug Profile 147

N-91115-Drug Profile 148

N-91138-Drug Profile 149

N-91169-Drug Profile 150

nadolol-Drug Profile 151

NB-401-Drug Profile 153

Next Generation Correctors-Drug Profile 154

nitric oxide-Drug Profile 155

nitric oxide-Drug Profile 156

Oligomer G for Cystic Fibrosis-Drug Profile 157

Oligonucleotide to Activate CFTR for Cystic Fibrosis-Drug Profile 159

ORP-100-Drug Profile 160

P-1037-Drug Profile 161

Peptide to Block ENaC for Cystic Fibrosis and Hypertension-Drug Profile 162

POL-6014-Drug Profile 163

PRX-110-Drug Profile 165

pseudomonas aeruginosa vaccine-Drug Profile 166

PulmoXen-Drug Profile 167

PUR-118-Drug Profile 168

PUR-1900-Drug Profile 169

PUR-2000-Drug Profile 170

PXS-4728A-Drug Profile 171

QBW-251-Drug Profile 172

QR-010-Drug Profile 173

Recombinant A1PI-Drug Profile 174

Recombinant Enzyme for Cystic Fibrosis-Drug Profile 176

Recombinant Enzyme for Farber Disease and Cystic Fibrosis-Drug Profile 177

Recombinant Human Follistatin-Drug Profile 178

Recombinant Protein for Infectious Diseases and Respiratory Disorders-Drug Profile 179

riociguat-Drug Profile 180

RPL-554-Drug Profile 182

Small Molecule for Cystic Fibrosis-Drug Profile 185

Small Molecule for Pneumonia, COPD, Cystic Fibrosis and Pulmonary Tuberculosis-Drug Profile 186

Small Molecule to Activate CFTR Protein for Cystic Fibrosis-Drug Profile 187

Small Molecule to Activate Nrf2 for Cystic Fibrosis-Drug Profile 188

Small Molecule to Inhibit EnaC and CFTR for Cystic Fibrosis, Diarrhea and Autosomal Dominant Polycystic Kidney Disease-Drug Profile 189

Small Molecule to Inhibit HDAC for Cystic Fibrosis and COPD-Drug Profile 190

Small Molecules for Bacterial Infections, Oncology and Cystic Fibrosis-Drug Profile 191

Small Molecules for Cystic Fibrosis-Drug Profile 192

Small Molecules to Activate CFTR for Cystic Fibrosis-Drug Profile 193

Small Molecules to Activate CFTR for Cystic Fibrosis-Drug Profile 194

Small Molecules to Agonize PPAR-Gamma for COPD and Cystic Fibrosis-Drug Profile 195

Small Molecules to Inhibit Lethal Factor for Anthrax and Cystic Fibrosis-Drug Profile 196

Small Molecules to Inhibit USP8 for Cystic Fibrosis-Drug Profile 197

solithromycin-Drug Profile 198

SP-14-Drug Profile 200

SP-9-Drug Profile 201

tritoqualine-Drug Profile 202

VBP-15-Drug Profile 203

VRT-325-Drug Profile 205

VX-661-Drug Profile 206

Cystic Fibrosis-Recent Pipeline Updates 207

Cystic Fibrosis-Dormant Projects 246

Cystic Fibrosis-Discontinued Products 252

Cystic Fibrosis-Product Development Milestones 253

Featured News & Press Releases 253

Appendix 260

Methodology 260

Coverage 260

Secondary Research 260

Primary Research 260

Expert Panel Validation 260

Contact Us 260

Disclaimer 261

List of Tables

Number of Products under Development for Cystic Fibrosis, H1 2015 18

Number of Products under Development for Cystic Fibrosis-Comparative Analysis, H1 2015 19

Number of Products under Development by Companies, H1 2015 21

Number of Products under Development by Companies, H1 2015 (Contd..1) 22

Number of Products under Development by Companies, H1 2015 (Contd..2) 23

Number of Products under Development by Companies, H1 2015 (Contd..3) 24

Number of Products under Development by Companies, H1 2015 (Contd..4) 25

Number of Products under Investigation by Universities/Institutes, H1 2015 27

Comparative Analysis by Late Stage Development, H1 2015 28

Comparative Analysis by Clinical Stage Development, H1 2015 29

Comparative Analysis by Early Stage Development, H1 2015 30

Comparative Analysis by Unknown Stage Development, H1 2015 31

Products under Development by Companies, H1 2015 32

Products under Development by Companies, H1 2015 (Contd..1) 33

Products under Development by Companies, H1 2015 (Contd..2) 34

Products under Development by Companies, H1 2015 (Contd..3) 35

Products under Development by Companies, H1 2015 (Contd..4) 36

Products under Development by Companies, H1 2015 (Contd..5) 37

Products under Investigation by Universities/Institutes, H1 2015 38

Cystic Fibrosis-Pipeline by Actelion Ltd, H1 2015 39

Cystic Fibrosis-Pipeline by Alaxia SAS, H1 2015 40

Cystic Fibrosis-Pipeline by AlgiPharma AS, H1 2015 41

Cystic Fibrosis-Pipeline by Arcturus Therapeutics, Inc, H1 2015 42

Cystic Fibrosis-Pipeline by Bayer AG, H1 2015 43

Cystic Fibrosis-Pipeline by Beech Tree Labs, Inc., H1 2015 44

Cystic Fibrosis-Pipeline by Carolus Therapeutics, Inc., H1 2015 45

Cystic Fibrosis-Pipeline by Celsus Therapeutics Plc, H1 2015 46

Cystic Fibrosis-Pipeline by Celtaxsys, Inc., H1 2015 47

Cystic Fibrosis-Pipeline by Chiesi Farmaceutici SpA, H1 2015 48

Cystic Fibrosis-Pipeline by Cilian AG, H1 2015 49

Cystic Fibrosis-Pipeline by Concert Pharmaceuticals, Inc., H1 2015 50

Cystic Fibrosis-Pipeline by Corbus pharmaceuticals, Inc., H1 2015 51

Cystic Fibrosis-Pipeline by Cubist Pharmaceuticals, Inc., H1 2015 52

Cystic Fibrosis-Pipeline by DiscoveryBiomed, Inc., H1 2015 53

Cystic Fibrosis-Pipeline by Errant Gene Therapeutics, LLC, H1 2015 54

Cystic Fibrosis-Pipeline by Galapagos NV, H1 2015 55

Cystic Fibrosis-Pipeline by GlaxoSmithKline plc, H1 2015 56

Cystic Fibrosis-Pipeline by Grifols, S.A., H1 2015 57

Cystic Fibrosis-Pipeline by Invion Limited, H1 2015 58

Cystic Fibrosis-Pipeline by InvivoGen Therapeutics, H1 2015 59

Cystic Fibrosis-Pipeline by JHL Biotech, Inc., H1 2015 60

Cystic Fibrosis-Pipeline by Kamada Ltd., H1 2015 61

Cystic Fibrosis-Pipeline by Lamellar Biomedical Ltd, H1 2015 62

Cystic Fibrosis-Pipeline by Laurent Pharmaceuticals Inc., H1 2015 63

Cystic Fibrosis-Pipeline by Microbion Corporation, H1 2015 64

Cystic Fibrosis-Pipeline by Mucokinetica Ltd., H1 2015 65

Cystic Fibrosis-Pipeline by N30 Pharmaceuticals, H1 2015 66

Cystic Fibrosis-Pipeline by NanoBio Corporation, H1 2015 67

Cystic Fibrosis-Pipeline by Nostrum Pharmaceuticals, LLC, H1 2015 68

Cystic Fibrosis-Pipeline by Novabiotics Ltd, H1 2015 69

Cystic Fibrosis-Pipeline by Novartis AG, H1 2015 70

Cystic Fibrosis-Pipeline by Ockham Biotech Limited, H1 2015 71

Cystic Fibrosis-Pipeline by OSE Pharma SA, H1 2015 72

Cystic Fibrosis-Pipeline by Parion Sciences, Inc., H1 2015 73

Cystic Fibrosis-Pipeline by Pfizer Inc., H1 2015 74

Cystic Fibrosis-Pipeline by Pharmaxis Limited, H1 2015 75

Cystic Fibrosis-Pipeline by Polyphor Ltd., H1 2015 76

Cystic Fibrosis-Pipeline by Progenra, Inc., H1 2015 77

Cystic Fibrosis-Pipeline by ProQR Therapeutics N.V., H1 2015 78

Cystic Fibrosis-Pipeline by Protalix BioTherapeutics, Inc., H1 2015 79

Cystic Fibrosis-Pipeline by PTC Therapeutics, Inc., H1 2015 80

Cystic Fibrosis-Pipeline by Pulmatrix, Inc., H1 2015 81

Cystic Fibrosis-Pipeline by Reata Pharmaceuticals, Inc., H1 2015 82

Cystic Fibrosis-Pipeline by ReveraGen BioPharma, Inc., H1 2015 83

Cystic Fibrosis-Pipeline by Serendex Pharmaceuticals A/S, H1 2015 84

Cystic Fibrosis-Pipeline by Shire Plc, H1 2015 85

Cystic Fibrosis-Pipeline by Synovo GmbH, H1 2015 86

Cystic Fibrosis-Pipeline by Verona Pharma Plc, H1 2015 87

Cystic Fibrosis-Pipeline by Vertex Pharmaceuticals Incorporated, H1 2015 88

Cystic Fibrosis-Pipeline by Xenetic Biosciences plc, H1 2015 89

Assessment by Monotherapy Products, H1 2015 90

Assessment by Combination Products, H1 2015 91

Number of Products by Stage and Target, H1 2015 93

Number of Products by Stage and Mechanism of Action, H1 2015 96

Number of Products by Stage and Route of Administration, H1 2015 99

Number of Products by Stage and Molecule Type, H1 2015 101

Cystic Fibrosis Therapeutics-Recent Pipeline Updates, H1 2015 213

Cystic Fibrosis-Dormant Projects, H1 2015 252

Cystic Fibrosis-Dormant Projects (Contd..1), H1 2015 253

Cystic Fibrosis-Dormant Projects (Contd..2), H1 2015 254

Cystic Fibrosis-Dormant Projects (Contd..3), H1 2015 255

Cystic Fibrosis-Dormant Projects (Contd..4), H1 2015 256

Cystic Fibrosis-Dormant Projects (Contd..5), H1 2015 257

Cystic Fibrosis-Discontinued Products, H1 2015 258

List of Figures

Number of Products under Development for Cystic Fibrosis, H1 2015 18

Number of Products under Development for Cystic Fibrosis-Comparative Analysis, H1 2015 19

Number of Products under Development by Companies, H1 2015 20

Number of Products under Investigation by Universities/Institutes, H1 2015 26

Comparative Analysis by Late Stage Development, H1 2015 28

Comparative Analysis by Clinical Stage Development, H1 2015 29

Comparative Analysis by Early Stage Products, H1 2015 30

Assessment by Monotherapy Products, H1 2015 90

Number of Products by Top 10 Targets, H1 2015 92

Number of Products by Stage and Top 10 Targets, H1 2015 92

Number of Products by Top 10 Mechanism of Actions, H1 2015 95

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 95

Number of Products by Top 10 Routes of Administration, H1 2015 98

Number of Products by Stage and Top 10 Routes of Administration, H1 2015 99

Number of Products by Top 10 Molecule Types, H1 2015 100

Number of Products by Stage and Top 10 Molecule Types, H1 2015 101

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Actelion Ltd

Alaxia SAS

AlgiPharma AS

Arcturus Therapeutics, Inc

Bayer AG

Beech Tree Labs, Inc.

Carolus Therapeutics, Inc.

Celsus Therapeutics Plc

Celtaxsys, Inc.

Chiesi Farmaceutici SpA

Cilian AG

Concert Pharmaceuticals, Inc.

Corbus pharmaceuticals, Inc.

Cubist Pharmaceuticals, Inc.

DiscoveryBiomed, Inc.

Errant Gene Therapeutics, LLC

Galapagos NV

GlaxoSmithKline plc

Grifols, S.A.

Invion Limited

InvivoGen Therapeutics

JHL Biotech, Inc.

Kamada Ltd.

Lamellar Biomedical Ltd

Laurent Pharmaceuticals Inc.

Microbion Corporation

Mucokinetica Ltd.

N30 Pharmaceuticals

NanoBio Corporation

Nostrum Pharmaceuticals, LLC

Novabiotics Ltd

Novartis AG

Ockham Biotech Limited

OSE Pharma SA

Parion Sciences, Inc.

Pfizer Inc.

Pharmaxis Limited

Polyphor Ltd.

Progenra, Inc.

ProQR Therapeutics N.V.

Protalix BioTherapeutics, Inc.

PTC Therapeutics, Inc.

Pulmatrix, Inc.

Reata Pharmaceuticals, Inc.

ReveraGen BioPharma, Inc.

Serendex Pharmaceuticals A/S

Shire Plc

Synovo GmbH

Verona Pharma Plc

Vertex Pharmaceuticals Incorporated

Xenetic Biosciences plc

Cystic Fibrosis Therapeutic Products under Development, Key Players in Cystic Fibrosis Therapeutics, Cystic Fibrosis Pipeline Overview, Cystic Fibrosis Pipeline, Cystic Fibrosis Pipeline Assessment


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