Studie - Bronchiectasis – Pipeline Review, H1 2012

Bronchiectasis — Pipeline Review, H1 2012


Summary


Global Markets Direct’s, 'Bronchiectasis - Pipeline Review, H1 2012', provides an overview of the Bronchiectasis 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, H1 2012' 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.
- Profiles of late-stage pipeline products featuring sections on product description, mechanism of action and research & development progress.
- 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 with the most promising pipeline.
- Devise corrective measures for pipeline projects by understanding Bronchiectasis pipeline depth and focus of Bronchiectasis 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 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Bronchiectasis Overview 8

Therapeutics Development 9

An Overview of Pipeline Products for Bronchiectasis 9

Bronchiectasis Therapeutics under Development by Companies 11

Bronchiectasis Therapeutics under Investigation by Universities/Institutes 13

Late Stage Products 14

Comparative Analysis 14

Mid Clinical Stage Products 15

Comparative Analysis 15

Early Clinical Stage Products 16

Comparative Analysis 16

Pre-Clinical Stage Products 17

Comparative Analysis 17

Bronchiectasis Therapeutics — Products under Development by Companies 18

Bronchiectasis Therapeutics — Products under Investigation by Universities/Institutes 19

Companies Involved in Bronchiectasis Therapeutics Development 20

Aradigm Corporation 20

AstraZeneca PLC 21

Gilead Sciences, Inc. 22

Discovery Laboratories, Inc. 23

Bayer AG 24

Insmed Incorporated 25

Pharmaxis Ltd. 26

RegeneRx Biopharmaceuticals, Inc. 27

Kamada Ltd. 28

Aridis Pharmaceuticals LLC 29

NexBio, Inc. 30

Bronchiectasis — Therapeutics Assessment 31

Assessment by Monotherapy Products 31

Assessment by Route of Administration 32

Assessment by Molecule Type 34

Drug Profiles 36

Aztreonam - Drug Profile 36

Product Description 36

Mechanism of Action 36

R&D Progress 36

Cipro Inhale - Drug Profile 38

Product Description 38

Mechanism of Action 38

R&D Progress 38

Arikace - Drug Profile 40

Product Description 40

Mechanism of Action 40

R&D Progress 40

Pulmaquin - Drug Profile 42

Product Description 42

Mechanism of Action 42

R&D Progress 42

Fludase - Drug Profile 44

Product Description 44

Mechanism of Action 44

R&D Progress 44

RGN-457 - Drug Profile 46

Product Description 46

Mechanism of Action 46

R&D Progress 46

Aerosurf - Drug Profile 47

Product Description 47

Mechanism of Action 47

R&D Progress 47

AZD5069 - Drug Profile 49

Product Description 49

Mechanism of Action 49

R&D Progress 49

Bronchitol - Drug Profile 50

Product Description 50

Mechanism of Action 50

R&D Progress 50

Azithromycin - Drug Profile 52

Product Description 52

Mechanism of Action 52

R&D Progress 52

Panaecin - Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

Aerosolized AAT - Drug Profile 54

Product Description 54

Mechanism of Action 54

R&D Progress 54

Bronchiectasis Therapeutics — Drug Profile Updates 56

Bronchiectasis Therapeutics - Dormant Products 66

Bronchiectasis — Product Development Milestones 67

Featured News & Press Releases 67

Dec 07, 2011: Aradigm Announces Issuance Of Its First US Patent Covering Inhaled Ciprofloxacin Formulations 67

Dec 07, 2011: Aradigm Selects Pulmaquin For Phase III Development 67

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 67

Jun 16, 2011: Aradigm Reports Successful ORBIT-1 Bronchiectasis Study With Inhaled Liposomal Ciprofloxacin 68

Jun 06, 2011: Aradigm Receives FDA Orphan Drug Designation For Ciprofloxacin For Inhalation In Bronchiectasis 69

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 70

May 03, 2011: Aradigm To Present Additional ORBIT-2 Clinical Trial Results At Respiratory Drug Delivery Europe 2011 Conference 70

Apr 20, 2011: Discovery Labs’s KL4 Surfactant Aerosolization Program Data To Be Presented At Pediatric Academic Societies Annual Meeting 71

Mar 22, 2011: Aradigm Completes Enrollment In Phase IIb Study Of Inhaled Ciprofloxacin For Management Of Respiratory Infections In Bronchiectasis 72

Jan 06, 2011: Aradigm To Present Expanded Results From Successful Six-Month Phase IIb Bronchiectasis Study At Biotech Showcase 2011 72

Appendix 74

Methodology 74

Coverage 74

Secondary Research 74

Primary Research 74

Expert Panel Validation 74

Contact Us 75

Disclaimer 75





List of Tables

Number of Products Under Development for Bronchiectasis, H1 2012 9

Products under Development for Bronchiectasis — Comparative Analysis, H1 2012 10

Number of Products under Development by Companies, H1 2012 12

Number of Products under Investigation by Universities/Institutes, H1 2012 13

Comparative Analysis by Late Stage Development, H1 2012 14

Comparative Analysis by Mid Clinical Stage Development, H1 2012 15

Comparative Analysis by Early Clinical Stage Development, H1 2012 16

Comparative Analysis by Pre-Clinical Stage Development, H1 2012 17

Products under Development by Companies, H1 2012 18

Products under Investigation by Universities/Institutes, H1 2012 19

Aradigm Corporation, H1 2012 20

AstraZeneca PLC, H1 2012 21

Gilead Sciences, Inc., H1 2012 22

Discovery Laboratories, Inc., H1 2012 23

Bayer AG, H1 2012 24

Insmed Incorporated, H1 2012 25

Pharmaxis Ltd., H1 2012 26

RegeneRx Biopharmaceuticals, Inc., H1 2012 27

Kamada Ltd., H1 2012 28

Aridis Pharmaceuticals LLC, H1 2012 29

NexBio, Inc., H1 2012 30

Assessment by Monotherapy Products, H1 2012 31

Assessment by Stage and Route of Administration, H1 2012 33

Assessment by Stage and Molecule Type, H1 2012 35

Bronchiectasis Therapeutics — Drug Profile Updates 56

Bronchiectasis Therapeutics — Dormant Products 66





List of Figures

Number of Products under Development for Bronchiectasis, H1 2012 9

Products under Development for Bronchiectasis — Comparative Analysis, H1 2012 10

Products under Development by Companies, H1 2012 11

Products under Investigation by Universities/Institutes, H1 2012 13

Late Stage Products, H1 2012 14

Mid Clinical Stage Products, H1 2012 15

Early Clinical Stage Products, H1 2012 16

Pre-Clinical Stage Products, H1 2012 17

Assessment by Monotherapy Products, H1 2012 31

Assessment by Route of Administration, H1 2012 32

Assessment by Stage and Route of Administration, H1 2012 33

Assessment by Molecule Type, H1 2012 34

Assessment by Stage and Molecule Type, H1 2012 35

• Bronchopulmonary Dysplasia – Pipeline Review, H1 2013
• Bronchospasm Global Clinical Trials Review, H1, 2013
• Cystic Fibrosis – Pipeline Review, H1 2013
• Diphtheria – Pipeline Review, H1 2013
• EpiCast Report: Idiopathic Pulmonary Fibrosis - Epidemiology Forecast to 2022
• OpportunityAnalyzer: Cystic Fibrosis Therapeutics - Opportunity Analysis and Forecasts to 2017
• OpportunityAnalyzer: Idiopathic Pulmonary Fibrosis (IPF) - Opportunity Analysis and Forecasts to 2017
• Acute Respiratory Distress Syndrome – Pipeline Review, H1 2013
• Asthma – Pipeline Review, H1 2013
• Bronchiectasis – Pipeline Review, H1 2013
• Candidiasis – Pipeline Review, H1 2013
• EpiCast Report: Cystic Fibrosis - Epidemiology Forecast to 2022
• Lung Disease – Pipeline Review, H1 2013
• Nasal Congestion Global Clinical Trials Review, H1, 2013
• Perennial Allergic Rhinitis – Pipeline Review, H1 2013
• Respiratory Tract Inflammatory Disorders – Pipeline Review, H1 2013
• Allergic Rhinitis – Pipeline Review, H1 2013
• Bronchiectasis Global Clinical Trials Review, H1, 2013
• Chronic Bronchitis – Pipeline Review, H1 2013
• EpiCast Report: Pediatric Respiratory Syncytial Virus Infection and Prophylactic Populations in the US - Epidemiology Forecast to 2022