Inhalers - Medical Devices Pipeline Assessment, 2018

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 8

1.2 List of Figures 11

2 Introduction 12

2.1 Inhalers Overview 12

3 Products under Development 13

3.1 Inhalers-Pipeline Products by Stage of Development 13

3.2 Inhalers-Pipeline Products by Segment 14

3.3 Inhalers-Pipeline Products by Territory 15

3.4 Inhalers-Pipeline Products by Regulatory Path 17

3.5 Inhalers-Pipeline Products by Estimated Approval Date 18

3.6 Inhalers-Ongoing Clinical Trials 19

4 Inhalers-Pipeline Products under Development by Companies 20

4.1 Inhalers Companies-Pipeline Products by Stage of Development 20

4.2 Inhalers-Pipeline Products by Stage of Development 22

5 Inhalers Companies and Product Overview 24

5.1 Acorda Therapeutics Inc Company Overview 24

5.2 Adamis Pharmaceuticals Corp Company Overview 27

5.3 Advent Pharmaceuticals Pty Ltd Company Overview 28

5.4 Aespira Ltd. Company Overview 29

5.5 AKELA Pharma Inc. (Inactive) Company Overview 30

5.6 Alexza Pharmaceuticals Inc Company Overview 31

5.7 Aradigm Corp Company Overview 33

5.8 AstraZeneca Plc Company Overview 34

5.9 Bayer AG Company Overview 35

5.10 Bellerophon Therapeutics Inc Company Overview 36

5.11 Bespak Europe Ltd Company Overview 37

5.12 Boehringer Ingelheim GmbH Company Overview 38

5.13 Circassia Pharmaceuticals Plc Company Overview 39

5.14 Drexel University Company Overview 40

5.15 FocusStart LLC Company Overview 41

5.16 GlaxoSmithKline Plc Company Overview 42

5.17 MannKind Corp Company Overview 43

5.18 Medihale Ltd (Inactive) Company Overview 45

5.19 Monash University Company Overview 46

5.20 Nanotherapeutics Inc (Inactive) Company Overview 47

5.21 Nektar Therapeutics Company Overview 49

5.22 Nicoventures Trading Ltd Company Overview 50

5.23 North Carolina State University Company Overview 51

5.24 Novartis AG Company Overview 52

5.25 OPKO Health Inc Company Overview 53

5.26 Perrigo Company Plc Company Overview 54

5.27 Pharmaxis Ltd Company Overview 55

5.28 Pneuma Respiratory Inc Company Overview 56

5.29 Resolve Digital Health Inc Company Overview 57

5.30 Respira Therapeutics Inc Company Overview 58

5.31 Sandoz International GmbH Company Overview 59

5.32 Sheffield Hallam University Company Overview 61

5.33 Sun Pharma Advanced Research Company Ltd Company Overview 62

5.34 Tetra Bio-Pharma Inc Company Overview 63

5.35 Teva Pharmaceutical Industries Ltd Company Overview 66

5.36 United Therapeutics Corp Company Overview 68

5.37 University of Kansas Company Overview 71

5.38 University of Texas Medical Branch at Galveston Company Overview 72

5.39 Uscom Ltd. Company Overview 73

5.40 Vectura Group Plc Company Overview 74

5.41 Verona Pharma Plc Company Overview 77

5.42 Virginia Commonwealth University Company Overview 78

6 Inhalers- Recent Developments 79

6.1 Jun 07, 2018: MannKind Successfully Completes Phase 1 Trial of Treprostinil Technosphere for Pulmonary Arterial Hypertension Advancing Development to Next Phase 79

6.2 Jun 01, 2018: Vectura Group Appoints Anne Whitaker As Non-Executive Director 79

6.3 May 24, 2018: Adherium Announces Appointment of David Allinson as Chief Financial Officer 80

6.4 May 21, 2018: 3M forms sustainability and product stewardship organization 80

6.5 May 17, 2018: New England Journal of Medicine publishes two trials for Symbicort as an anti-inflammatory reliever therapy as needed in mild asthma 80

6.6 May 16, 2018: Novartis announces changes to the Executive Committee 82

6.7 May 16, 2018: At the Meet Novartis Management investor event, Novartis highlights strategy to focus the company and drive sustainable growth 84

6.8 May 14, 2018: Medical Developments International: Trading Update 85

6.9 May 10, 2018: Adamis Pharmaceuticals Announces First Quarter 2018 Financial Results and Business Update 85

6.10 May 10, 2018: Nektar Therapeutics Reports Financial Results for the First Quarter of 2018 86

6.11 May 10, 2018: Bellerophon Provides Business Update and Reports First Quarter 2018 Financial Results 90

6.12 May 10, 2018: Novartis India reconstitutes Board appoints Milan Paleja as Vice Chairman Managing Director 91

6.13 May 09, 2018: 3M Announces New Leadership Appointment 91

6.14 May 09, 2018: MannKind Reports 2018 First Quarter Financial Results 92

6.15 May 09, 2018: Simon Dingemans, Chief Financial Officer, to retire from GSK 93

6.16 May 09, 2018: Savara Reports First Quarter 2018 Financial Results and Provides Business Update 93

6.17 May 08, 2018: OPKO Health Announces First Quarter 2018 Financial Results 95

6.18 May 03, 2018: Teva Reports First Quarter 2018 Financial Results 96

6.19 May 02, 2018: Novo Nordisk's operating profit decreased by 8% in Danish kroner and increased by 6% in local currencies in the first three months of 2018 102

6.20 May 01, 2018: OPKO Health Appoints Geoff Monk General Manager at BioReference Laboratories 103

6.21 Apr 30, 2018: Adherium: Appendix 4C-Quarterly cash flow report to March 31 2018 103

6.22 Apr 26, 2018: Consort Medical: Director Declaration 103

6.23 Apr 25, 2018: Novartis launches FocalView app, providing opportunity for patients to participate in ophthalmology clinical trials from home 104

6.24 Apr 25, 2018: Boehringer Ingelheim has a very successful 2017 financial year 104

6.25 Apr 24, 2018: Once-daily Trelegy Ellipta gains expanded indication in the US for the treatment of patients with COPD 105

6.26 Apr 20, 2018: Vectura Announces Senior Management Change 107

6.27 Apr 20, 2018: Vectura Group: Directorate Change-Chief Financial Officer 107

6.28 Apr 19, 2018: Boehringer Ingelheim and HealthPrize Expand Successful Digital Patient Support Program 108

6.29 Apr 19, 2018: Novartis delivered a strong first quarter and acted to become a more focused medicines company 109

6.30 Apr 19, 2018: Novartis appoints John Tsai Head of Global Drug Development and Chief Medical Officer 113

6.31 Apr 18, 2018: Landmark IMPACT study published in NEJM shows significant benefits of Trelegy Ellipta for patients with COPD 114

6.32 Apr 18, 2018: GlaxoSmithKline Names Kevin Sin as new Senior Vice President and Head of Worldwide Business Development for Research & Development 115

6.33 Apr 16, 2018: Pneuma Respiratory Appoints Rich Gimigliano As Chief Financial Officer 116

6.34 Apr 16, 2018: Cipla: US FDA conducted a routine current Good Manufacturing Practices (cGMP) audit at its Indore formulations facility 116

6.35 Apr 09, 2018: Pneuma Respiratory Appoints Dr. Steven Kesten as President and Chief Medical Officer 117

6.36 Apr 04, 2018: Tetra Bio-Pharma Initiates Enrolment of Patients in Phase 3 PPP001 Smokable Cannabis Pellet Study 117

7 Appendix 307

7.1 Methodology 307

7.2 About GlobalData 310

7.3 Contact Us 310

7.4 Disclaimer 310

List of Figure

1.2 List of Figures

Figure 1: Inhalers-Pipeline Products by Stage of Development 14

Figure 2: Inhalers-Pipeline Products by Segment 15

Figure 3: Inhalers-Pipeline Products by Territory 16

Figure 4: Inhalers-Pipeline Products by Regulatory Path 18

Figure 5: Inhalers-Pipeline Products by Estimated Approval Date 19

Figure 6: Inhalers-Ongoing Clinical Trials 20

List of Table

1.1 List of Tables

Table 1: Inhalers-Pipeline Products by Stage of Development 14

Table 2: Inhalers-Pipeline Products by Segment 15

Table 3: Inhalers-Pipeline Products by Territory 16

Table 4: Inhalers-Pipeline Products by Regulatory Path 18

Table 5: Inhalers-Pipeline Products by Estimated Approval Date 19

Table 6: Inhalers-Ongoing Clinical Trials 20

Table 7: Inhalers Companies-Pipeline Products by Stage of Development 21

Table 8: Inhalers-Pipeline Products by Stage of Development 23

Table 9: Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 25

Table 10: CVT-427 Drug Delivery Device-Product Status 25

Table 11: CVT-427 Drug Delivery Device-Product Description 26

Table 12: INBRIJA-Product Status 26

Table 13: INBRIJA-Product Description 26

Table 14: PLUMIAZ Nasal Spray Device-Product Status 27

Table 15: PLUMIAZ Nasal Spray Device-Product Description 27

Table 16: Adamis Pharmaceuticals Corp Pipeline Products & Ongoing Clinical Trials Overview 28

Table 17: Taper DPI-Product Status 28

Table 18: Taper DPI-Product Description 28

Table 19: Advent Pharmaceuticals Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

Table 20: g60 Dry Powder Inhaler-Product Status 29

Table 21: g60 Dry Powder Inhaler-Product Description 29

Table 22: Aespira Ltd. Pipeline Products & Ongoing Clinical Trials Overview 30

Table 23: resQhaler-Product Status 30

Table 24: resQhaler-Product Description 30

Table 25: AKELA Pharma Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 31

Table 26: Fentanyl TAIFUN Inhaler-Product Status 31

Table 27: Fentanyl TAIFUN Inhaler-Product Description 31

Table 28: Alexza Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Table 29: Staccato System-Disposable Single Dose-Product Status 32

Table 30: Staccato System-Disposable Single Dose-Product Description 32

Table 31: Staccato System-Multiple Dose-Product Status 33

Table 32: Staccato System-Multiple Dose-Product Description 33

Table 33: Aradigm Corp Pipeline Products & Ongoing Clinical Trials Overview 34

Table 34: Aerx Pure Nicotine Inhaler-Product Status 34

Table 35: Aerx Pure Nicotine Inhaler-Product Description 34

Table 36: AstraZeneca Plc Pipeline Products & Ongoing Clinical Trials Overview 35

Table 37: Duaklir Genuair Metered Dose Inhaler-Product Status 35

Table 38: Duaklir Genuair Metered Dose Inhaler-Product Description 35

Table 39: Bayer AG Pipeline Products & Ongoing Clinical Trials Overview 36

Table 40: Ciprofloxacin Dry Powder Inhaler-Product Status 36

Table 41: Ciprofloxacin Dry Powder Inhaler-Product Description 36

Table 42: Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 37

Table 43: Mark2 Device-Product Status 37

Table 44: Mark2 Device-Product Description 37

Table 45: Bespak Europe Ltd Pipeline Products & Ongoing Clinical Trials Overview 38

Table 46: DEV610 DPI-Product Status 38

Table 47: DEV610 DPI-Product Description 38

Table 48: Boehringer Ingelheim GmbH Pipeline Products & Ongoing Clinical Trials Overview 39

Table 49: Next Generation Respimat Inhaler-Product Status 39

Table 50: Next Generation Respimat Inhaler-Product Description 39

Table 51: Circassia Pharmaceuticals Plc Pipeline Products & Ongoing Clinical Trials Overview 40

Table 52: Tiotropium bromide DPI-Product Status 40

Table 53: Tiotropium bromide DPI-Product Description 40

Table 54: Drexel University Pipeline Products & Ongoing Clinical Trials Overview 41

Table 55: BREATHE Inhaler-Product Status 41

Table 56: BREATHE Inhaler-Product Description 41

Table 57: FocusStart LLC Pipeline Products & Ongoing Clinical Trials Overview 42

Table 58: Smart Inhaler-Product Status 42

Table 59: Smart Inhaler-Product Description 42

Table 60: GlaxoSmithKline Plc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 61: Gemini Multi-Dose Combination Inhaler-Product Status 43

Table 62: Gemini Multi-Dose Combination Inhaler-Product Description 43

Table 63: MannKind Corp Pipeline Products & Ongoing Clinical Trials Overview 44

Table 64: Dreamboat-Product Status 44

Table 65: Dreamboat-Product Description 44

Table 66: Treprostinil Technosphere-Product Status 45

Table 67: Treprostinil Technosphere-Product Description 45

Table 68: Medihale Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 46

Table 69: Toucan Multi-Dose Inhaler-Product Status 46

Table 70: Toucan Multi-Dose Inhaler-Product Description 46

Table 71: Monash University Pipeline Products & Ongoing Clinical Trials Overview 47

Table 72: Aerosol Delivery System-Product Status 47

Table 73: Aerosol Delivery System-Product Description 47

Table 74: Nanotherapeutics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 48

Table 75: GelVac Intranasal Powder Vaccine Delivery System-Product Status 48

Table 76: GelVac Intranasal Powder Vaccine Delivery System-Product Description 48

Table 77: NanoGENT-Product Status 49

Table 78: NanoGENT-Product Description 49

Table 79: Nektar Therapeutics Pipeline Products & Ongoing Clinical Trials Overview 50

Table 80: Nektar Dry Powder Inhaler-Amikacin-Product Status 50

Table 81: Nektar Dry Powder Inhaler-Amikacin-Product Description 50

Table 82: Nicoventures Trading Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

Table 83: Nicadex Electronic Inhaler-Product Status 51

Table 84: Nicadex Electronic Inhaler-Product Description 51

Table 85: North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 52

Table 86: Smart Inhaler System-Product Status 52

Table 87: Smart Inhaler System-Product Description 52

Table 88: Novartis AG Pipeline Products & Ongoing Clinical Trials Overview 53

Table 89: Next Generation Breezhaler Inhaler-Product Status 53

Table 90: Next Generation Breezhaler Inhaler-Product Description 53

Table 91: OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 54

Table 92: Inspiromatic-Product Status 54

Table 93: Inspiromatic-Product Description 54

Table 94: Perrigo Company Plc Pipeline Products & Ongoing Clinical Trials Overview 55

Table 95: ProAir Inhalation Aerosol-Product Status 55

Table 96: ProAir Inhalation Aerosol-Product Description 55

Table 97: Pharmaxis Ltd Pipeline Products & Ongoing Clinical Trials Overview 56

Table 98: Orbital Dry Powder Inhaler-Product Status 56

Table 99: Orbital Dry Powder Inhaler-Product Description 56

Table 100: Pneuma Respiratory Inc Pipeline Products & Ongoing Clinical Trials Overview 57

Table 101: PNEUMAHALER-Product Status 57

Table 102: PNEUMAHALER-Product Description 57

Table 103: Resolve Digital Health Inc Pipeline Products & Ongoing Clinical Trials Overview 58

Table 104: Breeze Smart Inhaler-Product Status 58

Table 105: Breeze Smart Inhaler-Product Description 58

Table 106: Respira Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 59

Table 107: RT234 AOS DPI-Product Status 59

Table 108: RT234 AOS DPI-Product Description 59

Table 109: Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 60

Table 110: Solis Multi-Dose Dry Powder Inhaler-Product Status 60