Bronchiectasis - Pipeline Review, H2 2012

Global Markets Direct, September 2012, Pages: 71

Bronchiectasis – Pipeline Review, H2 2012

Summary

Global Markets Direct’s, 'Bronchiectasis - Pipeline Review, H2 2012', provides an overview of the indication’s therapeutic pipeline. This report provides information on the therapeutic development for Bronchiectasis, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Bronchiectasis. Bronchiectasis - Pipeline Review, Half Year 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.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

Scope

- A snapshot of the global therapeutic scenario for Bronchiectasis.
- A review of the Bronchiectasis products under development by companies and universities/research institutes based on information derived from company and industry-specific sources.
- Coverage of products based on various stages of development ranging from discovery till registration stages.
- A feature on pipeline projects on the basis of monotherapy and combined therapeutics.
- Coverage of the Bronchiectasis pipeline on the basis of route of administration and molecule type.
- Key discontinued pipeline projects.
- Latest news and deals relating to the products.

Reasons to buy

- Identify and understand important and diverse types of therapeutics under development for Bronchiectasis.
- Identify emerging players with potentially strong product portfolio and design effective counter-strategies to gain competitive advantage.
- Plan mergers and acquisitions effectively by identifying players of the most promising pipeline.
- 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.

2
List of Tables 5
List of Figures 5
Introduction 6
REPORT COVERAGE 6
Bronchiectasis Overview 7
Therapeutics Development 8
An Overview of Pipeline Products for Bronchiectasis 8
Bronchiectasis Therapeutics under Development by Companies 10
Late Stage Products 12
Comparative Analysis 12
Mid Clinical Stage Products 13
Comparative Analysis 13
Early Clinical Stage Products 14
Comparative Analysis 14
Pre-Clinical Stage Products 15
Comparative Analysis 15
Bronchiectasis Therapeutics – Products under Development by Companies 16
Companies Involved in Bronchiectasis Therapeutics Development 17
Aradigm Corporation 17
AstraZeneca PLC 18
Gilead Sciences, Inc. 19
Discovery Laboratories, Inc. 20
Bayer AG 21
Pharmaxis Ltd. 22
RegeneRx Biopharmaceuticals, Inc. 23
Kamada Ltd. 24
Aridis Pharmaceuticals LLC 25
Nostrum Pharmaceuticals, LLC 26
NexBio, Inc. 27
Clarassance, Inc. 28
Bronchiectasis – Therapeutics Assessment 29
Assessment by Monotherapy Products 29
Assessment by Route of Administration 30
Assessment by Molecule Type 32
Drug Profiles 34
aztreonam - Drug Profile 34
Product Description 34
Mechanism of Action 34
R&D Progress 34
ciprofloxacin - Drug Profile 36
Product Description 36
Mechanism of Action 36
R&D Progress 36
ciprofloxacin - Drug Profile 38
Product Description 38
Mechanism of Action 38
R&D Progress 38
liposomal ciprofloxacin - Drug Profile 40
Product Description 40
Mechanism of Action 40
R&D Progress 40
Fludase - Drug Profile 42
Product Description 42
Mechanism of Action 42
R&D Progress 42
RGN-457 - Drug Profile 44
Product Description 44
Mechanism of Action 44
R&D Progress 44
AZD-5069 - Drug Profile 45
Product Description 45
Mechanism of Action 45
R&D Progress 45
mannitol - Drug Profile 46
Product Description 46
Mechanism of Action 46
R&D Progress 46
gallium nitrate - Drug Profile 48
Product Description 48
Mechanism of Action 48
R&D Progress 48
AAT Inhaled - Drug Profile 49
Product Description 49
Mechanism of Action 49
R&D Progress 49
CG-459 - Drug Profile 51
Product Description 51
Mechanism of Action 51
R&D Progress 51
Inhaled Dapsone - Drug Profile 52
Product Description 52
Mechanism of Action 52
R&D Progress 52
Bronchiectasis Therapeutics – Drug Profile Updates 53
Bronchiectasis Therapeutics – Discontinued Products 61
Bronchiectasis Therapeutics - Dormant Products 62
Bronchiectasis – Product Development Milestones 63
Featured News & Press Releases 63
Aug 23, 2012: Bayer HealthCare Initiates Phase III Study Of Ciprofloxacin Dry Powder For Inhalation To Treat Non-Cystic Fibrosis Bronchiectasis 63
Mar 12, 2012: Aradigm Receives FDA Clearance For Phase III Clinical Trial Of Pulmaquin In Patients With Non-Cystic Fibrosis Bronchiectasis 63
Feb 21, 2012: Aradigm Receives US Patent Covering Its Lead Preparation Pulmaquin 64
Dec 13, 2011: Pharmaxis Announces Phase III Study Results Of Bronchitol For Treatment Of Bronchiectasis 65
Dec 07, 2011: Aradigm Announces Issuance Of Its First US Patent Covering Inhaled Ciprofloxacin Formulations 65
Dec 07, 2011: Aradigm Selects Pulmaquin For Phase III Development 66
Sep 21, 2011: Aradigm To Present Additional Analyses Of Clinical Results From ORBIT-1 And ORBIT-2 Trials Of Inhaled Ciprofloxacin At ERS 2011 Annual Congress 66
Jun 16, 2011: Aradigm Reports Successful ORBIT-1 Bronchiectasis Study With Inhaled Liposomal Ciprofloxacin 67
Jun 06, 2011: Aradigm Receives FDA Orphan Drug Designation For Ciprofloxacin For Inhalation In Bronchiectasis 68
May 17, 2011: Bayer Presents Positive Data From Phase II Study Of Ciprofloxacin DPI In Patients With Non-Cystic Fibrosis Bronchiectasis At ATS Annual Meeting 68
Appendix 70
Methodology 70
Coverage 70
Secondary Research 70
Primary Research 70
Expert Panel Validation 70
Contact Us 71
Disclaimer 71

List of Tables
Number of Products Under Development for Bronchiectasis, H2 2012 8
Products under Development for Bronchiectasis – Comparative Analysis, H2 2012 9
Number of Products under Development by Companies, H2 2012 11
Comparative Analysis by Late Stage Development, H2 2012 12
Comparative Analysis by Mid Clinical Stage Development, H2 2012 13
Comparative Analysis by Early Clinical Stage Development, H2 2012 14
Comparative Analysis by Pre-Clinical Stage Development, H2 2012 15
Products under Development by Companies, H2 2012 16
Aradigm Corporation, H2 2012 17
AstraZeneca PLC, H2 2012 18
Gilead Sciences, Inc., H2 2012 19
Discovery Laboratories, Inc., H2 2012 20
Bayer AG, H2 2012 21
Pharmaxis Ltd., H2 2012 22
RegeneRx Biopharmaceuticals, Inc., H2 2012 23
Kamada Ltd., H2 2012 24
Aridis Pharmaceuticals LLC, H2 2012 25
Nostrum Pharmaceuticals, LLC, H2 2012 26
NexBio, Inc., H2 2012 27
Clarassance, Inc., H2 2012 28
Assessment by Monotherapy Products, H2 2012 29
Assessment by Stage and Route of Administration, H2 2012 31
Assessment by Stage and Molecule Type, H2 2012 33
Bronchiectasis Therapeutics – Drug Profile Updates 53
Bronchiectasis Therapeutics – Discontinued Products 61
Bronchiectasis Therapeutics – Dormant Products 62

List of Figures
Number of Products under Development for Bronchiectasis, H2 2012 8
Products under Development for Bronchiectasis – Comparative Analysis, H2 2012 9
Products under Development by Companies, H2 2012 10
Late Stage Products, H2 2012 12
Mid Clinical Stage Products, H2 2012 13
Early Clinical Stage Products, H2 2012 14
Pre-Clinical Stage Products, H2 2012 15
Assessment by Monotherapy Products, H2 2012 29
Assessment by Route of Administration, H2 2012 30
Assessment by Stage and Route of Administration, H2 2012 31
Assessment by Molecule Type, H2 2012 32
Assessment by Stage and Molecule Type, H2 2012 33

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