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Inhalable Drug Delivery - Medical Devices Pipeline Assessment, 2018

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Inhalable Drug Delivery-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Inhalable Drug Delivery-Medical Devices Pipeline Assessment, 2018" provides an overview of Inhalable Drug Delivery currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Inhalable Drug Delivery pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

- Extensive coverage of the Inhalable Drug Delivery under development

- The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities

- The report reviews the major players involved in the development of Inhalable Drug Delivery and list all their pipeline projects

- The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage

- The report provides key clinical trial data of ongoing trials specific to pipeline products

- Recent developments in the segment / industry.

Reasons to buy

The report enables you to-

- Formulate significant competitor information, analysis, and insights to improve 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 Inhalable Drug Delivery under development

- Develop market-entry and market expansion strategies

- Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline

- In-depth analysis of the product's current stage of development, territory and estimated launch date.

READ MORE

Table Of Content

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 8

2 Introduction 9

2.1 Inhalable Drug Delivery Overview 9

3 Products under Development 10

3.1 Inhalable Drug Delivery-Pipeline Products by Stage of Development 10

3.2 Inhalable Drug Delivery-Pipeline Products by Segment 11

3.3 Inhalable Drug Delivery-Pipeline Products by Territory 12

3.4 Inhalable Drug Delivery-Pipeline Products by Regulatory Path 13

3.5 Inhalable Drug Delivery-Pipeline Products by Estimated Approval Date 14

3.6 Inhalable Drug Delivery-Ongoing Clinical Trials 15

4 Inhalable Drug Delivery-Pipeline Products under Development by Companies 16

4.1 Inhalable Drug Delivery Companies-Pipeline Products by Stage of Development 16

4.2 Inhalable Drug Delivery-Pipeline Products by Stage of Development 17

5 Inhalable Drug Delivery Companies and Product Overview 18

5.1 Acorda Therapeutics Inc Company Overview 18

5.1.1 Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 18

5.2 Amphastar Pharmaceuticals Inc Company Overview 19

5.2.1 Amphastar Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 19

5.3 Baxter International Inc Company Overview 20

5.3.1 Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 20

5.4 Bellerophon Therapeutics Inc Company Overview 21

5.4.1 Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 21

5.5 Breath Therapeutics Holding BV Company Overview 29

5.5.1 Breath Therapeutics Holding BV Pipeline Products & Ongoing Clinical Trials Overview 29

5.6 Canigma A.L LTD Company Overview 30

5.6.1 Canigma A.L LTD Pipeline Products & Ongoing Clinical Trials Overview 30

5.7 Edixomed Ltd Company Overview 31

5.7.1 Edixomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 31

5.8 iDTx Systems, Inc. Company Overview 33

5.8.1 iDTx Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

5.9 Impel NeuroPharma Inc Company Overview 34

5.9.1 Impel NeuroPharma Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.10 Kanabo Research Ltd Company Overview 35

5.10.1 Kanabo Research Ltd Pipeline Products & Ongoing Clinical Trials Overview 35

5.11 Medical Developments International Ltd Company Overview 36

5.11.1 Medical Developments International Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

5.12 Medspray BV Company Overview 39

5.12.1 Medspray BV Pipeline Products & Ongoing Clinical Trials Overview 39

5.13 NeuroproteXeon Inc Company Overview 41

5.13.1 NeuroproteXeon Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.14 Next Safety, Inc. Company Overview 44

5.14.1 Next Safety, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44

5.15 Nobilis Therapeutics Inc Company Overview 45

5.15.1 Nobilis Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 45

5.16 Sandoz International GmbH Company Overview 46

5.16.1 Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 46

5.17 SmartAir Medical Company Overview 47

5.17.1 SmartAir Medical Pipeline Products & Ongoing Clinical Trials Overview 47

5.18 Syqe Medical Company Overview 48

5.18.1 Syqe Medical Pipeline Products & Ongoing Clinical Trials Overview 48

5.19 Texas Tech University Health Sciences Center Company Overview 49

5.19.1 Texas Tech University Health Sciences Center Pipeline Products & Ongoing Clinical Trials Overview 49

5.20 University of Texas Health Science Center at Houston Company Overview 50

5.20.1 University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 50

5.21 Vectura Group Plc Company Overview 51

5.21.1 Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 51

5.22 Vero Biotech LLC Company Overview 56

5.22.1 Vero Biotech LLC Pipeline Products & Ongoing Clinical Trials Overview 56

5.23 Windtree Therapeutics Inc Company Overview 58

5.23.1 Windtree Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 58

6 Inhalable Drug Delivery- Recent Developments 63

6.1 Jun 01, 2018: Vectura Group Appoints Anne Whitaker As Non-Executive Director 63

6.2 May 22, 2018: Windtree Receives USD0.7 Million SBIR Grant in Continuing Support of the AEROSURF Phase 2b Clinical Trial Completion 63

6.3 May 21, 2018: Baxter Highlights Business Strategies and Innovation at 2018 Investor Conference 64

6.4 May 17, 2018: Catalent Completes USD5.5 Million Phased Clinical Storage Expansion At Kansas City Campus 65

6.5 May 16, 2018: Bellerophon to Present Positive Results from Phase 2 Study of INOpulse for Treatment of Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease at the American Thoracic Society 114th International Conference 66

6.6 May 16, 2018: EyePoint Pharmaceuticals Announces Appointment of Leonard Blum as Executive Vice President and General Manager, U.S. 67

6.7 May 10, 2018: Bellerophon Provides Business Update and Reports First Quarter 2018 Financial Results 68

6.8 May 09, 2018: European Distribution Partnership between NeuroproteXeon and Linde 69

6.9 May 08, 2018: Bellerophon Reaches Agreement with FDA on Study Design of Phase 2b Trial of INOpulse for Treatment of Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease 69

6.10 May 08, 2018: Inhalation Sciences' new CEO Lena Heffler: science, sales, win-win 70

6.11 May 08, 2018: EyePoint Pharmaceuticals Reports Fiscal Third Quarter 2018 Results 71

6.12 May 01, 2018: Catalent Reports Third Quarter Fiscal 2018 Results 72

6.13 Apr 26, 2018: Baxter Reports First-Quarter 2018 Results And Increases Financial Outlook For Full-Year 2018 75

6.14 Apr 26, 2018: Catalent Announces Organizational Restructuring To Support Customer Demand For Fast, Integrated Biologics Development 77

6.15 Apr 26, 2018: Consort Medical: Director Declaration 78

6.16 Apr 24, 2018: Medical Developments International Announces the Approval of Penthrox in Finland 78

6.17 Apr 24, 2018: Catalent To Invest USD5 Million At Somerset Site To Create New Drug Development And Modified Release Center Of Excellence 78

6.18 Apr 20, 2018: Vectura Announces Senior Management Change 79

6.19 Apr 20, 2018: Vectura Group: Directorate Change-Chief Financial Officer 79

6.20 Apr 19, 2018: Inhalation Sciences Names Lena Heffler As CEO 80

6.21 Apr 12, 2018: Catalent Completes USD5.5 Million Expansion at Philadelphia Facility 80

6.22 Apr 10, 2018: Penthrox is approved in Canada 80

6.23 Apr 05, 2018: Penthrox Approved In Germany 81

6.24 Apr 05, 2018: TRELEGY ELLIPTA Approved In Canada As The First Single Inhaler Triple Therapy For The Treatment Of Appropriate Patients With COPD 82

6.25 Mar 27, 2018: Penthrox Approved In Sweden, Norway, Poland And Croatia 82

6.26 Mar 23, 2018: Aradigm Reports Fourth Quarter 2017 And Full Year Financial Results 82

6.27 Mar 21, 2018: Vectura Group: 2017 Preliminary Results 84

6.28 Mar 21, 2018: Vectura Group: 2017 Preliminary Results-Performance in-line with expectations, with strong in-market growth from key inhaled products 85

6.29 Mar 15, 2018: Bellerophon Reports Fourth Quarter and Full-Year 2017 Financial Results 86

6.30 Mar 14, 2018: The Israeli Ministry of Health has Approved Kanabo Research's Medical Cannabis Vaporizer as a Medical Device 88

6.31 Feb 28, 2018: Catalent Completes USD4.6 Million Expansion at Singapore Facility 89

6.32 Feb 23, 2018: Nobilis Therapeutics Presents Its PTSD Clinical Development Program To The US Congress 89

6.33 Feb 20, 2018: Catalent Announces Changes to its Board of Directors 90

6.34 Feb 19, 2018: Penthrox : First order received for Austria 91

6.35 Feb 19, 2018: Penthrox Approved in Estonia 91

6.36 Feb 09, 2018: Aradigm Announces Personnel Changes 92

6.37 Feb 07, 2018: Impel NeuroPharma Announces Positive Results of Phase 1 Clinical Trial of INP104 for Treatment of Acute Migraine Headache 92

6.38 Feb 07, 2018: pSivida Reports Second Quarter FY2018 Results; Continues to Achieve Milestones and Timelines 93

6.39 Feb 05, 2018: Catalent Reports Second Quarter Fiscal 2018 Financial Results 94

6.40 Feb 01, 2018: Medical Developments International: Penthrox approved in Slovakia 98

6.41 Feb 01, 2018: Baxter Reports 2017 Fourth-Quarter and Full-Year Results 98

6.42 Jan 29, 2018: Bellerophon Therapeutics Announces Enrollment Exceeds 100 Patients in Phase 3 INOvation-1 Study Evaluating INOpulse for Treatment of Pulmonary Arterial Hypertension 101

6.43 Jan 18, 2018: Inhalation Sciences announces new recruitment and reorganization 102

6.44 Jan 03, 2018: Bellerophon Announces First Patient Enrolled in Phase 2b Study Evaluating INOpulse for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease 102

7 Appendix 140

7.1 Methodology 140

7.2 About GlobalData 143

7.3 Contact Us 143

7.4 Disclaimer 143


List Of Figure

1.2 List of Figures

Figure 1: Inhalable Drug Delivery-Pipeline Products by Stage of Development 10

Figure 2: Inhalable Drug Delivery-Pipeline Products by Segment 11

Figure 3: Inhalable Drug Delivery-Pipeline Products by Territory 12

Figure 4: Inhalable Drug Delivery-Pipeline Products by Regulatory Path 13

Figure 5: Inhalable Drug Delivery-Pipeline Products by Estimated Approval Date 14

Figure 6: Inhalable Drug Delivery-Ongoing Clinical Trials 15


List Of Table

1.1 List of Tables

Table 1: Inhalable Drug Delivery-Pipeline Products by Stage of Development 10

Table 2: Inhalable Drug Delivery-Pipeline Products by Segment 11

Table 3: Inhalable Drug Delivery-Pipeline Products by Territory 12

Table 4: Inhalable Drug Delivery-Pipeline Products by Regulatory Path 13

Table 5: Inhalable Drug Delivery-Pipeline Products by Estimated Approval Date 14

Table 6: Inhalable Drug Delivery-Ongoing Clinical Trials 15

Table 7: Inhalable Drug Delivery Companies-Pipeline Products by Stage of Development 16

Table 8: Inhalable Drug Delivery-Pipeline Products by Stage of Development 17

Table 9: Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 18

Table 10: Drug Delivery Device-Neonatal Respiratory Distress Syndrome (RDS)-Product Status 18

Table 11: Drug Delivery Device-Neonatal Respiratory Distress Syndrome (RDS)-Product Description 18

Table 12: Amphastar Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 19

Table 13: Primatene Mist-New Version-Product Status 19

Table 14: Primatene Mist-New Version-Product Description 19

Table 15: Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 20

Table 16: ProMaxx Microsphere-Product Status 20

Table 17: ProMaxx Microsphere-Product Description 20

Table 18: Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 21

Table 19: INOpulse-Product Status 21

Table 20: INOpulse-Product Description 22

Table 21: INOpulse-PH-COPD-Product Status 22

Table 22: INOpulse-PH-COPD-Product Description 22

Table 23: INOpulse-PH-ILD-Product Status 23

Table 24: INOpulse-PH-ILD-Product Description 23

Table 25: Bellerophon Therapeutics Inc-Ongoing Clinical Trials Overview 24

Table 26: INOpulse-A Phase 3, Placebo Controlled, Double-blind, Randomized, Clinical Study to Determine Efficacy, Safety, and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Symptomatic Subjects with PAH (Part 1 and Part 2) 25

Table 27: INOpulse-A Phase IIb Study of INOpulse in the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD) 25

Table 28: INOpulse-An Open-label Long-term Safety Study of Inhaled Nitric Oxide (iNO) for PAH 25

Table 29: INOpulse-INOvation-2 Clinical Study of INOpulse Device 26

Table 30: INOpulse-PH-COPD-Phase IIb Clinical Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects in Treatment of Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease (PH-COPD) 27

Table 31: INOpulse-PH-ILD-A Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) in Subjects with Pulmonary Hypertension Associated with Pulmonary Fibrosis on Long Term Oxygen Therapy (Part 1 and Part 2) 28

Table 32: Breath Therapeutics Holding BV Pipeline Products & Ongoing Clinical Trials Overview 29

Table 33: Lung-Targeted BOS Device-Product Status 29

Table 34: Lung-Targeted BOS Device-Product Description 29

Table 35: Canigma A.L LTD Pipeline Products & Ongoing Clinical Trials Overview 30

Table 36: Vaporiser Device-Product Status 30

Table 37: Vaporiser Device-Product Description 30

Table 38: Edixomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 31

Table 39: NOx System-Cystic Fibrosis-Product Status 31

Table 40: NOx System-Cystic Fibrosis-Product Description 31

Table 41: NOx System-VAP-Product Status 31

Table 42: NOx System-VAP-Product Description 32

Table 43: iDTx Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

Table 44: GoPilot-Product Status 33

Table 45: GoPilot-Product Description 33

Table 46: Impel NeuroPharma Inc Pipeline Products & Ongoing Clinical Trials Overview 34

Table 47: POD Device-Product Status 34

Table 48: POD Device-Product Description 34

Table 49: Kanabo Research Ltd Pipeline Products & Ongoing Clinical Trials Overview 35

Table 50: VapePod-Product Status 35

Table 51: VapePod-Product Description 35

Table 52: Medical Developments International Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

Table 53: Penthrox Inhaler-Paediatric-Product Status 36

Table 54: Penthrox Inhaler-Paediatric-Product Description 36

Table 55: Medical Developments International Ltd-Ongoing Clinical Trials Overview 37

Table 56: Penthrox Inhaler-Paediatric-A Randomized, Double-blind, Multicenter, Placebo Controlled Study to Evaluate the Safety and Efficacy of Methoxyflurane (PENTHROX) for the Treatment of Acute Pain in Children and Adolescents from 6 to Less Than 18 Years of Age (Presenting to an Emergency Department with Minor Trauma) 38

Table 57: Medspray BV Pipeline Products & Ongoing Clinical Trials Overview 39

Table 58: Device 0075-Product Status 39

Table 59: Device 0075-Product Description 39

Table 60: Product 0070-Product Status 40

Table 61: Product 0070-Product Description 40

Table 62: Product 0077-Product Status 40

Table 63: Product 0077-Product Description 40

Table 64: NeuroproteXeon Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Table 65: Xenon Inhalation Device-Product Status 41

Table 66: Xenon Inhalation Device-Product Description 41

Table 67: NeuroproteXeon Inc-Ongoing Clinical Trials Overview 42

Table 68: Xenon Inhalation Device-XePOHCAS-Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome 43

Table 69: Next Safety, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44

Table 70: Pulmonary Drug Delivery Device-Product Status 44

Table 71: Pulmonary Drug Delivery Device-Product Description 44

Table 72: Nobilis Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 45

Table 73: Zephyrus-Product Status 45

Table 74: Zephyrus-Product Description 45

Table 75: Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 46

Table 76: FreePath Drug Delivery System-Product Status 46

Table 77: FreePath Drug Delivery System-Product Description 46

Table 78: SmartAir Medical Pipeline Products & Ongoing Clinical Trials Overview 47

Table 79: SmartAir DDM-Product Status 47

Table 80: SmartAir DDM-Product Description 47

Table 81: Syqe Medical Pipeline Products & Ongoing Clinical Trials Overview 48

Table 82: Syqe Inhaler-Product Status 48

Table 83: Syqe Inhaler-Product Description 48

Table 84: Texas Tech University Health Sciences Center Pipeline Products & Ongoing Clinical Trials Overview 49

Table 85: Inhalable Nanoparticle System-Product Status 49

Table 86: Inhalable Nanoparticle System-Product Description 49

Table 87: University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 50

Table 88: Pedinap-Product Status 50

Table 89: Pedinap-Product Description 50

Table 90: Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 51

Table 91: VR475 Combination Device-Product Status 51

Table 92: VR475 Combination Device-Product Description 51

Table 93: VR647-Product Status 52

Table 94: VR647-Product Description 52

Table 95: Vectura Group Plc-Ongoing Clinical Trials Overview 53

Table 96: VR647-A Phase I Clinical Study of VR-647 54

Table 97: VR647-A Phase I Clinical Study of VR-647 in Adult Asthma Subjects 54

Table 98: VR647-A Single-dose, Open-label, Randomized, Incomplete Block Design Trial to Characterize the Pharmacokinetics of VR647 Inhalation Suspension Delivered by the VR647 Inhalation System and Single Doses of Budesonide Delivered by a Conventional Jet Nebulizer in Pediatric Subjects Aged 4 to 8 Years with Wheezing, Reactive Airway Disease or Mild Asthma 54

Table 99: VR647-Phase II Pharmacokinetic Study of VR-647 in Children 55

Table 100: VR647-Phase III Study of VR-647 55

Table 101: Vero Biotech LLC Pipeline Products & Ongoing Clinical Trials Overview 56

Table 102: GeNOsyl Acute DS-Product Status 56

Table 103: GeNOsyl Acute DS-Product Description 56

Table 104: GeNOSYL Nitrosyl Delivery Platform-Ambulatory System-Product Status 57

Table 105: GeNOSYL Nitrosyl Delivery Platform-Ambulatory System-Product Description 57

Table 106: Windtree Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 58

Table 107: Aerosol Drug Delivery Device-Acute Lung Injury-Product Status 58

Table 108: Aerosol Drug Delivery Device-Acute Lung Injury-Product Description 58

Table 109: AEROSURF-Product Status 59

Table 110: AEROSURF-Product Description 59

Table 111: Capillary Aerosol Generator (CAG)-Product Status 59

Table 112: Capillary Aerosol Generator (CAG)-Product Description 60

Table 113: Windtree Therapeutics Inc-Ongoing Clinical Trials Overview 61

Table 114: AEROSURF-A Multinational, Multicenter, Masked, Randomized, Controlled Study to Assess the Safety and Efficacy of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age with Respiratory Distress Syndrome 62

Table 119: Glossary 142

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Products and Companies


Companies

Acorda Therapeutics Inc

Amphastar Pharmaceuticals Inc

Baxter International Inc

Bellerophon Therapeutics Inc

Breath Therapeutics Holding BV

Canigma A.L LTD

Edixomed Ltd

iDTx Systems, Inc.

Impel NeuroPharma Inc

Kanabo Research Ltd

Medical Developments International Ltd

Medspray BV

NeuroproteXeon Inc

Next Safety, Inc.

Nobilis Therapeutics Inc

Sandoz International GmbH

SmartAir Medical

Syqe Medical

Texas Tech University Health Sciences Center

University of Texas Health Science Center at Houston

Vectura Group Plc

Vero Biotech LLC

Windtree Therapeutics Inc

Company Profile

Company Profile Title

Inhalable Drug Delivery-Medical Devices Pipeline Assessment, 2018

Summary

GlobalData's Medical Devices sector report, Inhalable Drug Delivery-Medical Devices Pipeline Assessment, 2018" provides an overview of Inhalable Drug Delivery currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Inhalable Drug Delivery pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

- Extensive coverage of the Inhalable Drug Delivery under development

- The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities

- The report reviews the major players involved in the development of Inhalable Drug Delivery and list all their pipeline projects

- The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage

- The report provides key clinical trial data of ongoing trials specific to pipeline products

- Recent developments in the segment / industry.

Reasons to buy

The report enables you to-

- Formulate significant competitor information, analysis, and insights to improve 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 Inhalable Drug Delivery under development

- Develop market-entry and market expansion strategies

- Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline

- In-depth analysis of the product's current stage of development, territory and estimated launch date.

READ MORE

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 8

2 Introduction 9

2.1 Inhalable Drug Delivery Overview 9

3 Products under Development 10

3.1 Inhalable Drug Delivery-Pipeline Products by Stage of Development 10

3.2 Inhalable Drug Delivery-Pipeline Products by Segment 11

3.3 Inhalable Drug Delivery-Pipeline Products by Territory 12

3.4 Inhalable Drug Delivery-Pipeline Products by Regulatory Path 13

3.5 Inhalable Drug Delivery-Pipeline Products by Estimated Approval Date 14

3.6 Inhalable Drug Delivery-Ongoing Clinical Trials 15

4 Inhalable Drug Delivery-Pipeline Products under Development by Companies 16

4.1 Inhalable Drug Delivery Companies-Pipeline Products by Stage of Development 16

4.2 Inhalable Drug Delivery-Pipeline Products by Stage of Development 17

5 Inhalable Drug Delivery Companies and Product Overview 18

5.1 Acorda Therapeutics Inc Company Overview 18

5.1.1 Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 18

5.2 Amphastar Pharmaceuticals Inc Company Overview 19

5.2.1 Amphastar Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 19

5.3 Baxter International Inc Company Overview 20

5.3.1 Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 20

5.4 Bellerophon Therapeutics Inc Company Overview 21

5.4.1 Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 21

5.5 Breath Therapeutics Holding BV Company Overview 29

5.5.1 Breath Therapeutics Holding BV Pipeline Products & Ongoing Clinical Trials Overview 29

5.6 Canigma A.L LTD Company Overview 30

5.6.1 Canigma A.L LTD Pipeline Products & Ongoing Clinical Trials Overview 30

5.7 Edixomed Ltd Company Overview 31

5.7.1 Edixomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 31

5.8 iDTx Systems, Inc. Company Overview 33

5.8.1 iDTx Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

5.9 Impel NeuroPharma Inc Company Overview 34

5.9.1 Impel NeuroPharma Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.10 Kanabo Research Ltd Company Overview 35

5.10.1 Kanabo Research Ltd Pipeline Products & Ongoing Clinical Trials Overview 35

5.11 Medical Developments International Ltd Company Overview 36

5.11.1 Medical Developments International Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

5.12 Medspray BV Company Overview 39

5.12.1 Medspray BV Pipeline Products & Ongoing Clinical Trials Overview 39

5.13 NeuroproteXeon Inc Company Overview 41

5.13.1 NeuroproteXeon Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.14 Next Safety, Inc. Company Overview 44

5.14.1 Next Safety, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44

5.15 Nobilis Therapeutics Inc Company Overview 45

5.15.1 Nobilis Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 45

5.16 Sandoz International GmbH Company Overview 46

5.16.1 Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 46

5.17 SmartAir Medical Company Overview 47

5.17.1 SmartAir Medical Pipeline Products & Ongoing Clinical Trials Overview 47

5.18 Syqe Medical Company Overview 48

5.18.1 Syqe Medical Pipeline Products & Ongoing Clinical Trials Overview 48

5.19 Texas Tech University Health Sciences Center Company Overview 49

5.19.1 Texas Tech University Health Sciences Center Pipeline Products & Ongoing Clinical Trials Overview 49

5.20 University of Texas Health Science Center at Houston Company Overview 50

5.20.1 University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 50

5.21 Vectura Group Plc Company Overview 51

5.21.1 Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 51

5.22 Vero Biotech LLC Company Overview 56

5.22.1 Vero Biotech LLC Pipeline Products & Ongoing Clinical Trials Overview 56

5.23 Windtree Therapeutics Inc Company Overview 58

5.23.1 Windtree Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 58

6 Inhalable Drug Delivery- Recent Developments 63

6.1 Jun 01, 2018: Vectura Group Appoints Anne Whitaker As Non-Executive Director 63

6.2 May 22, 2018: Windtree Receives USD0.7 Million SBIR Grant in Continuing Support of the AEROSURF Phase 2b Clinical Trial Completion 63

6.3 May 21, 2018: Baxter Highlights Business Strategies and Innovation at 2018 Investor Conference 64

6.4 May 17, 2018: Catalent Completes USD5.5 Million Phased Clinical Storage Expansion At Kansas City Campus 65

6.5 May 16, 2018: Bellerophon to Present Positive Results from Phase 2 Study of INOpulse for Treatment of Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease at the American Thoracic Society 114th International Conference 66

6.6 May 16, 2018: EyePoint Pharmaceuticals Announces Appointment of Leonard Blum as Executive Vice President and General Manager, U.S. 67

6.7 May 10, 2018: Bellerophon Provides Business Update and Reports First Quarter 2018 Financial Results 68

6.8 May 09, 2018: European Distribution Partnership between NeuroproteXeon and Linde 69

6.9 May 08, 2018: Bellerophon Reaches Agreement with FDA on Study Design of Phase 2b Trial of INOpulse for Treatment of Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease 69

6.10 May 08, 2018: Inhalation Sciences' new CEO Lena Heffler: science, sales, win-win 70

6.11 May 08, 2018: EyePoint Pharmaceuticals Reports Fiscal Third Quarter 2018 Results 71

6.12 May 01, 2018: Catalent Reports Third Quarter Fiscal 2018 Results 72

6.13 Apr 26, 2018: Baxter Reports First-Quarter 2018 Results And Increases Financial Outlook For Full-Year 2018 75

6.14 Apr 26, 2018: Catalent Announces Organizational Restructuring To Support Customer Demand For Fast, Integrated Biologics Development 77

6.15 Apr 26, 2018: Consort Medical: Director Declaration 78

6.16 Apr 24, 2018: Medical Developments International Announces the Approval of Penthrox in Finland 78

6.17 Apr 24, 2018: Catalent To Invest USD5 Million At Somerset Site To Create New Drug Development And Modified Release Center Of Excellence 78

6.18 Apr 20, 2018: Vectura Announces Senior Management Change 79

6.19 Apr 20, 2018: Vectura Group: Directorate Change-Chief Financial Officer 79

6.20 Apr 19, 2018: Inhalation Sciences Names Lena Heffler As CEO 80

6.21 Apr 12, 2018: Catalent Completes USD5.5 Million Expansion at Philadelphia Facility 80

6.22 Apr 10, 2018: Penthrox is approved in Canada 80

6.23 Apr 05, 2018: Penthrox Approved In Germany 81

6.24 Apr 05, 2018: TRELEGY ELLIPTA Approved In Canada As The First Single Inhaler Triple Therapy For The Treatment Of Appropriate Patients With COPD 82

6.25 Mar 27, 2018: Penthrox Approved In Sweden, Norway, Poland And Croatia 82

6.26 Mar 23, 2018: Aradigm Reports Fourth Quarter 2017 And Full Year Financial Results 82

6.27 Mar 21, 2018: Vectura Group: 2017 Preliminary Results 84

6.28 Mar 21, 2018: Vectura Group: 2017 Preliminary Results-Performance in-line with expectations, with strong in-market growth from key inhaled products 85

6.29 Mar 15, 2018: Bellerophon Reports Fourth Quarter and Full-Year 2017 Financial Results 86

6.30 Mar 14, 2018: The Israeli Ministry of Health has Approved Kanabo Research's Medical Cannabis Vaporizer as a Medical Device 88

6.31 Feb 28, 2018: Catalent Completes USD4.6 Million Expansion at Singapore Facility 89

6.32 Feb 23, 2018: Nobilis Therapeutics Presents Its PTSD Clinical Development Program To The US Congress 89

6.33 Feb 20, 2018: Catalent Announces Changes to its Board of Directors 90

6.34 Feb 19, 2018: Penthrox : First order received for Austria 91

6.35 Feb 19, 2018: Penthrox Approved in Estonia 91

6.36 Feb 09, 2018: Aradigm Announces Personnel Changes 92

6.37 Feb 07, 2018: Impel NeuroPharma Announces Positive Results of Phase 1 Clinical Trial of INP104 for Treatment of Acute Migraine Headache 92

6.38 Feb 07, 2018: pSivida Reports Second Quarter FY2018 Results; Continues to Achieve Milestones and Timelines 93

6.39 Feb 05, 2018: Catalent Reports Second Quarter Fiscal 2018 Financial Results 94

6.40 Feb 01, 2018: Medical Developments International: Penthrox approved in Slovakia 98

6.41 Feb 01, 2018: Baxter Reports 2017 Fourth-Quarter and Full-Year Results 98

6.42 Jan 29, 2018: Bellerophon Therapeutics Announces Enrollment Exceeds 100 Patients in Phase 3 INOvation-1 Study Evaluating INOpulse for Treatment of Pulmonary Arterial Hypertension 101

6.43 Jan 18, 2018: Inhalation Sciences announces new recruitment and reorganization 102

6.44 Jan 03, 2018: Bellerophon Announces First Patient Enrolled in Phase 2b Study Evaluating INOpulse for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease 102

7 Appendix 140

7.1 Methodology 140

7.2 About GlobalData 143

7.3 Contact Us 143

7.4 Disclaimer 143


List Of Figure

1.2 List of Figures

Figure 1: Inhalable Drug Delivery-Pipeline Products by Stage of Development 10

Figure 2: Inhalable Drug Delivery-Pipeline Products by Segment 11

Figure 3: Inhalable Drug Delivery-Pipeline Products by Territory 12

Figure 4: Inhalable Drug Delivery-Pipeline Products by Regulatory Path 13

Figure 5: Inhalable Drug Delivery-Pipeline Products by Estimated Approval Date 14

Figure 6: Inhalable Drug Delivery-Ongoing Clinical Trials 15


List Of Table

1.1 List of Tables

Table 1: Inhalable Drug Delivery-Pipeline Products by Stage of Development 10

Table 2: Inhalable Drug Delivery-Pipeline Products by Segment 11

Table 3: Inhalable Drug Delivery-Pipeline Products by Territory 12

Table 4: Inhalable Drug Delivery-Pipeline Products by Regulatory Path 13

Table 5: Inhalable Drug Delivery-Pipeline Products by Estimated Approval Date 14

Table 6: Inhalable Drug Delivery-Ongoing Clinical Trials 15

Table 7: Inhalable Drug Delivery Companies-Pipeline Products by Stage of Development 16

Table 8: Inhalable Drug Delivery-Pipeline Products by Stage of Development 17

Table 9: Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 18

Table 10: Drug Delivery Device-Neonatal Respiratory Distress Syndrome (RDS)-Product Status 18

Table 11: Drug Delivery Device-Neonatal Respiratory Distress Syndrome (RDS)-Product Description 18

Table 12: Amphastar Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 19

Table 13: Primatene Mist-New Version-Product Status 19

Table 14: Primatene Mist-New Version-Product Description 19

Table 15: Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 20

Table 16: ProMaxx Microsphere-Product Status 20

Table 17: ProMaxx Microsphere-Product Description 20

Table 18: Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 21

Table 19: INOpulse-Product Status 21

Table 20: INOpulse-Product Description 22

Table 21: INOpulse-PH-COPD-Product Status 22

Table 22: INOpulse-PH-COPD-Product Description 22

Table 23: INOpulse-PH-ILD-Product Status 23

Table 24: INOpulse-PH-ILD-Product Description 23

Table 25: Bellerophon Therapeutics Inc-Ongoing Clinical Trials Overview 24

Table 26: INOpulse-A Phase 3, Placebo Controlled, Double-blind, Randomized, Clinical Study to Determine Efficacy, Safety, and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Symptomatic Subjects with PAH (Part 1 and Part 2) 25

Table 27: INOpulse-A Phase IIb Study of INOpulse in the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD) 25

Table 28: INOpulse-An Open-label Long-term Safety Study of Inhaled Nitric Oxide (iNO) for PAH 25

Table 29: INOpulse-INOvation-2 Clinical Study of INOpulse Device 26

Table 30: INOpulse-PH-COPD-Phase IIb Clinical Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects in Treatment of Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease (PH-COPD) 27

Table 31: INOpulse-PH-ILD-A Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) in Subjects with Pulmonary Hypertension Associated with Pulmonary Fibrosis on Long Term Oxygen Therapy (Part 1 and Part 2) 28

Table 32: Breath Therapeutics Holding BV Pipeline Products & Ongoing Clinical Trials Overview 29

Table 33: Lung-Targeted BOS Device-Product Status 29

Table 34: Lung-Targeted BOS Device-Product Description 29

Table 35: Canigma A.L LTD Pipeline Products & Ongoing Clinical Trials Overview 30

Table 36: Vaporiser Device-Product Status 30

Table 37: Vaporiser Device-Product Description 30

Table 38: Edixomed Ltd Pipeline Products & Ongoing Clinical Trials Overview 31

Table 39: NOx System-Cystic Fibrosis-Product Status 31

Table 40: NOx System-Cystic Fibrosis-Product Description 31

Table 41: NOx System-VAP-Product Status 31

Table 42: NOx System-VAP-Product Description 32

Table 43: iDTx Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

Table 44: GoPilot-Product Status 33

Table 45: GoPilot-Product Description 33

Table 46: Impel NeuroPharma Inc Pipeline Products & Ongoing Clinical Trials Overview 34

Table 47: POD Device-Product Status 34

Table 48: POD Device-Product Description 34

Table 49: Kanabo Research Ltd Pipeline Products & Ongoing Clinical Trials Overview 35

Table 50: VapePod-Product Status 35

Table 51: VapePod-Product Description 35

Table 52: Medical Developments International Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

Table 53: Penthrox Inhaler-Paediatric-Product Status 36

Table 54: Penthrox Inhaler-Paediatric-Product Description 36

Table 55: Medical Developments International Ltd-Ongoing Clinical Trials Overview 37

Table 56: Penthrox Inhaler-Paediatric-A Randomized, Double-blind, Multicenter, Placebo Controlled Study to Evaluate the Safety and Efficacy of Methoxyflurane (PENTHROX) for the Treatment of Acute Pain in Children and Adolescents from 6 to Less Than 18 Years of Age (Presenting to an Emergency Department with Minor Trauma) 38

Table 57: Medspray BV Pipeline Products & Ongoing Clinical Trials Overview 39

Table 58: Device 0075-Product Status 39

Table 59: Device 0075-Product Description 39

Table 60: Product 0070-Product Status 40

Table 61: Product 0070-Product Description 40

Table 62: Product 0077-Product Status 40

Table 63: Product 0077-Product Description 40

Table 64: NeuroproteXeon Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Table 65: Xenon Inhalation Device-Product Status 41

Table 66: Xenon Inhalation Device-Product Description 41

Table 67: NeuroproteXeon Inc-Ongoing Clinical Trials Overview 42

Table 68: Xenon Inhalation Device-XePOHCAS-Xenon by Inhalation for Post Out of Hospital Cardiac Arrest Syndrome 43

Table 69: Next Safety, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44

Table 70: Pulmonary Drug Delivery Device-Product Status 44

Table 71: Pulmonary Drug Delivery Device-Product Description 44

Table 72: Nobilis Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 45

Table 73: Zephyrus-Product Status 45

Table 74: Zephyrus-Product Description 45

Table 75: Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 46

Table 76: FreePath Drug Delivery System-Product Status 46

Table 77: FreePath Drug Delivery System-Product Description 46

Table 78: SmartAir Medical Pipeline Products & Ongoing Clinical Trials Overview 47

Table 79: SmartAir DDM-Product Status 47

Table 80: SmartAir DDM-Product Description 47

Table 81: Syqe Medical Pipeline Products & Ongoing Clinical Trials Overview 48

Table 82: Syqe Inhaler-Product Status 48

Table 83: Syqe Inhaler-Product Description 48

Table 84: Texas Tech University Health Sciences Center Pipeline Products & Ongoing Clinical Trials Overview 49

Table 85: Inhalable Nanoparticle System-Product Status 49

Table 86: Inhalable Nanoparticle System-Product Description 49

Table 87: University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 50

Table 88: Pedinap-Product Status 50

Table 89: Pedinap-Product Description 50

Table 90: Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 51

Table 91: VR475 Combination Device-Product Status 51

Table 92: VR475 Combination Device-Product Description 51

Table 93: VR647-Product Status 52

Table 94: VR647-Product Description 52

Table 95: Vectura Group Plc-Ongoing Clinical Trials Overview 53

Table 96: VR647-A Phase I Clinical Study of VR-647 54

Table 97: VR647-A Phase I Clinical Study of VR-647 in Adult Asthma Subjects 54

Table 98: VR647-A Single-dose, Open-label, Randomized, Incomplete Block Design Trial to Characterize the Pharmacokinetics of VR647 Inhalation Suspension Delivered by the VR647 Inhalation System and Single Doses of Budesonide Delivered by a Conventional Jet Nebulizer in Pediatric Subjects Aged 4 to 8 Years with Wheezing, Reactive Airway Disease or Mild Asthma 54

Table 99: VR647-Phase II Pharmacokinetic Study of VR-647 in Children 55

Table 100: VR647-Phase III Study of VR-647 55

Table 101: Vero Biotech LLC Pipeline Products & Ongoing Clinical Trials Overview 56

Table 102: GeNOsyl Acute DS-Product Status 56

Table 103: GeNOsyl Acute DS-Product Description 56

Table 104: GeNOSYL Nitrosyl Delivery Platform-Ambulatory System-Product Status 57

Table 105: GeNOSYL Nitrosyl Delivery Platform-Ambulatory System-Product Description 57

Table 106: Windtree Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 58

Table 107: Aerosol Drug Delivery Device-Acute Lung Injury-Product Status 58

Table 108: Aerosol Drug Delivery Device-Acute Lung Injury-Product Description 58

Table 109: AEROSURF-Product Status 59

Table 110: AEROSURF-Product Description 59

Table 111: Capillary Aerosol Generator (CAG)-Product Status 59

Table 112: Capillary Aerosol Generator (CAG)-Product Description 60

Table 113: Windtree Therapeutics Inc-Ongoing Clinical Trials Overview 61

Table 114: AEROSURF-A Multinational, Multicenter, Masked, Randomized, Controlled Study to Assess the Safety and Efficacy of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age with Respiratory Distress Syndrome 62

Table 119: Glossary 142

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Companies

Acorda Therapeutics Inc

Amphastar Pharmaceuticals Inc

Baxter International Inc

Bellerophon Therapeutics Inc

Breath Therapeutics Holding BV

Canigma A.L LTD

Edixomed Ltd

iDTx Systems, Inc.

Impel NeuroPharma Inc

Kanabo Research Ltd

Medical Developments International Ltd

Medspray BV

NeuroproteXeon Inc

Next Safety, Inc.

Nobilis Therapeutics Inc

Sandoz International GmbH

SmartAir Medical

Syqe Medical

Texas Tech University Health Sciences Center

University of Texas Health Science Center at Houston

Vectura Group Plc

Vero Biotech LLC

Windtree Therapeutics Inc