Bronchiectasis – Pipeline Review, H2 2016

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

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

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

The report assesses Bronchiectasis 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 Bronchiectasis

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 Bronchiectasis

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 Bronchiectasis 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

Alitair Pharmaceuticals, Inc.

Bayer AG

Grifols, S.A.

Insmed Incorporated

Kamada Ltd.

Polyphor Ltd.

Raptor Pharmaceutical Corp.

Recipharm AB

Savara Inc.

Vertex Pharmaceuticals Incorporated

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 5

Introduction 6

Global Markets Direct Report Coverage 6

Bronchiectasis Overview 7

Therapeutics Development 8

Pipeline Products for Bronchiectasis - Overview 8

Bronchiectasis - Therapeutics under Development by Companies 9

Bronchiectasis - Pipeline Products Glance 10

Late Stage Products 10

Clinical Stage Products 11

Early Stage Products 12

Bronchiectasis - Products under Development by Companies 13

Bronchiectasis - Companies Involved in Therapeutics Development 14

Alitair Pharmaceuticals, Inc. 14

Bayer AG 15

Grifols, S.A. 16

Insmed Incorporated 17

Kamada Ltd. 18

Polyphor Ltd. 19

Raptor Pharmaceutical Corp. 20

Recipharm AB 21

Savara Inc. 22

Vertex Pharmaceuticals Incorporated 23

Bronchiectasis - Therapeutics Assessment 24

Assessment by Monotherapy Products 24

Assessment by Target 25

Assessment by Mechanism of Action 27

Assessment by Route of Administration 29

Assessment by Molecule Type 31

Drug Profiles 33

alpha-1 proteinase inhibitor (human) second generation - Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

amikacin sulfate - Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

ARD-3150 - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

ciprofloxacin hydrochloride - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

doxofylline - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

erdosteine - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

Leukotriene-B4 - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

levofloxacin - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

POL-6014 - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

POL-7080 - Drug Profile 62

Product Description 62

Mechanism Of Action 62

R&D Progress 62

vancomycin hydrochloride - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

VX-371 - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

Bronchiectasis - Dormant Projects 68

Bronchiectasis - Discontinued Products 69

Bronchiectasis - Product Development Milestones 70

Featured News & Press Releases 70

Oct 18, 2016: Bayer to Present Data in Non-Cystic Fibrosis Bronchiectasis at the 2016 Annual Meeting of the American College of Chest Physicians 70

Sep 22, 2016: Aradigm Announces Last Patient Dosing Visit in ORBIT-3 and ORBIT-4 Phase 3 Studies of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis Patients 70

Mar 17, 2016: Aradigm Announces Decision for Centralized Review of Pulmaquin by the European Medicines Agency 71

Mar 16, 2016: Raptor Announces Qualified Infectious Disease Product Designation for MP-376, Inhaled Levofloxacin 72

Jan 05, 2016: Aradigm to Host Corporate Update Conference Call on January 6 72

Oct 13, 2015: Aradigm Completes Enrollment in the Second Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis 73

Sep 22, 2015: Aradigm Completes Enrollment in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-4) 74

Apr 16, 2015: Aradigm to Host Key Opinion Leader Breakfast and Webcast on April 23 in New York City 75

Jan 14, 2015: Aradigm Granted Key Composition of Matter Patents for Pulmaquin in Europe and Australia 76

Nov 24, 2014: FDA Grants QIDP Designation to Bayer's Ciprofloxacin Dry Powder for Inhalation 77

Sep 04, 2014: FDA Grants Fast Track Designation to Aradigm’s Pulmaquin for Non-Cystic Fibrosis Bronchiectasis 78

Jun 23, 2014: Aradigm Corporation Announces the Dosing of the First Patient in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-4) 79

Jun 03, 2014: Aradigm Receives $5 Million Milestone For Dosing of the First Patient in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis 80

May 20, 2014: FDA Grants QIDP Designation to Aradigm’s Inhaled Antibiotic 80

Apr 28, 2014: Erdosteine Received Orphan Drug Status by the FDA 81

Appendix 83

Methodology 83

Coverage 83

Secondary Research 83

Primary Research 83

Expert Panel Validation 83

Contact Us 83

Disclaimer 84

List of Tables

List of Tables

Number of Products under Development for Bronchiectasis, H2 2016 8

Number of Products under Development by Companies, H2 2016 9

Comparative Analysis by Late Stage Development, H2 2016 10

Comparative Analysis by Clinical Stage Development, H2 2016 11

Comparative Analysis by Early Stage Development, H2 2016 12

Products under Development by Companies, H2 2016 13

Bronchiectasis – Pipeline by Alitair Pharmaceuticals, Inc., H2 2016 14

Bronchiectasis – Pipeline by Bayer AG, H2 2016 15

Bronchiectasis – Pipeline by Grifols, S.A., H2 2016 16

Bronchiectasis – Pipeline by Insmed Incorporated, H2 2016 17

Bronchiectasis – Pipeline by Kamada Ltd., H2 2016 18

Bronchiectasis – Pipeline by Polyphor Ltd., H2 2016 19

Bronchiectasis – Pipeline by Raptor Pharmaceutical Corp., H2 2016 20

Bronchiectasis – Pipeline by Recipharm AB, H2 2016 21

Bronchiectasis – Pipeline by Savara Inc., H2 2016 22

Bronchiectasis – Pipeline by Vertex Pharmaceuticals Incorporated, H2 2016 23

Assessment by Monotherapy Products, H2 2016 24

Number of Products by Stage and Target, H2 2016 26

Number of Products by Stage and Mechanism of Action, H2 2016 28

Number of Products by Stage and Route of Administration, H2 2016 30

Number of Products by Stage and Molecule Type, H2 2016 32

Bronchiectasis – Dormant Projects, H2 2016 68

Bronchiectasis – Discontinued Products, H2 2016 69

List of Figures

List of Figures

Number of Products under Development for Bronchiectasis, H2 2016 8

Number of Products under Development by Companies, H2 2016 9

Comparative Analysis by Late Stage Development, H2 2016 10

Comparative Analysis by Clinical Stage Development, H2 2016 11

Assessment by Monotherapy Products, H2 2016 24

Number of Products by Top 10 Targets, H2 2016 25

Number of Products by Stage and Top 10 Targets, H2 2016 25

Number of Products by Top 10 Mechanism of Actions, H2 2016 27

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 27

Number of Products by Routes of Administration, H2 2016 29

Number of Products by Stage and Routes of Administration, H2 2016 29

Number of Products by Molecule Types, H2 2016 31

Number of Products by Stage and Molecule Types, H2 2016 31

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