Published : Jul-2018
No. of Pages : 143
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 $0.7 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 $5.5 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 $5 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 $5.5 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 $4.6 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
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
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
