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Inhalers-Medical Devices Pipeline Assessment, 2017

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Inhalers-Medical Devices Pipeline Assessment, 2017

Summary

GlobalData's Medical Devices sector report, "Inhalers-Medical Devices Pipeline Assessment, 2017" provides an overview of Inhalers 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 Inhalers 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 Inhalers 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 Inhalers 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 Inhalers 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 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 16

3.5 Inhalers-Pipeline Products by Estimated Approval Date 17

3.6 Inhalers-Ongoing Clinical Trials 18

4 Inhalers-Pipeline Products under Development by Companies 19

4.1 Inhalers Companies-Pipeline Products by Stage of Development 19

4.2 Inhalers-Pipeline Products by Stage of Development 21

5 Inhalers Companies and Product Overview 23

5.1 Acorda Therapeutics Inc Company Overview 23

5.1.1 Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 23

5.2 Adamis Pharmaceuticals Corp Company Overview 28

5.2.1 Adamis Pharmaceuticals Corp Pipeline Products & Ongoing Clinical Trials Overview 28

5.3 Advent Pharmaceuticals Pty Ltd Company Overview 29

5.3.1 Advent Pharmaceuticals Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

5.4 Aespira Ltd. Company Overview 30

5.4.1 Aespira Ltd. Pipeline Products & Ongoing Clinical Trials Overview 30

5.5 AKELA Pharma Inc. (Inactive) Company Overview 31

5.5.1 AKELA Pharma Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 31

5.6 Alexza Pharmaceuticals Inc Company Overview 32

5.6.1 Alexza Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 32

5.7 Aradigm Corp Company Overview 34

5.7.1 Aradigm Corp Pipeline Products & Ongoing Clinical Trials Overview 34

5.8 Bayer HealthCare AG (Inactive) Company Overview 35

5.8.1 Bayer HealthCare AG (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 35

5.9 Bellerophon Therapeutics Inc Company Overview 36

5.9.1 Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 36

5.10 Bespak Europe Ltd Company Overview 37

5.10.1 Bespak Europe Ltd Pipeline Products & Ongoing Clinical Trials Overview 37

5.11 Boehringer Ingelheim GmbH Company Overview 38

5.11.1 Boehringer Ingelheim GmbH Pipeline Products & Ongoing Clinical Trials Overview 38

5.12 Circassia Pharmaceuticals Plc Company Overview 39

5.12.1 Circassia Pharmaceuticals Plc Pipeline Products & Ongoing Clinical Trials Overview 39

5.13 Drexel University Company Overview 40

5.13.1 Drexel University Pipeline Products & Ongoing Clinical Trials Overview 40

5.14 FocusStart LLC Company Overview 41

5.14.1 FocusStart LLC Pipeline Products & Ongoing Clinical Trials Overview 41

5.15 GlaxoSmithKline Plc Company Overview 42

5.15.1 GlaxoSmithKline Plc Pipeline Products & Ongoing Clinical Trials Overview 42

5.16 MannKind Corp Company Overview 46

5.16.1 MannKind Corp Pipeline Products & Ongoing Clinical Trials Overview 46

5.17 Medihale Ltd (Inactive) Company Overview 47

5.17.1 Medihale Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 47

5.18 Monash University Company Overview 48

5.18.1 Monash University Pipeline Products & Ongoing Clinical Trials Overview 48

5.19 Nanotherapeutics Inc Company Overview 49

5.19.1 Nanotherapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 49

5.20 Nektar Therapeutics Company Overview 51

5.20.1 Nektar Therapeutics Pipeline Products & Ongoing Clinical Trials Overview 51

5.21 Nicoventures Trading Ltd Company Overview 52

5.21.1 Nicoventures Trading Ltd Pipeline Products & Ongoing Clinical Trials Overview 52

5.22 North Carolina State University Company Overview 53

5.22.1 North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 53

5.23 Novartis AG Company Overview 54

5.23.1 Novartis AG Pipeline Products & Ongoing Clinical Trials Overview 54

5.24 OPKO Health Inc Company Overview 56

5.24.1 OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 56

5.25 Pharmaxis Ltd Company Overview 57

5.25.1 Pharmaxis Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

5.26 Respira Therapeutics Inc Company Overview 58

5.26.1 Respira Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 58

5.27 Sandoz International GmbH Company Overview 59

5.27.1 Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 59

5.28 Sheffield Hallam University Company Overview 61

5.28.1 Sheffield Hallam University Pipeline Products & Ongoing Clinical Trials Overview 61

5.29 Shin Nippon Biomedical Laboratories Ltd Company Overview 62

5.29.1 Shin Nippon Biomedical Laboratories Ltd Pipeline Products & Ongoing Clinical Trials Overview 62

5.30 Sun Pharma Advanced Research Company Ltd Company Overview 63

5.30.1 Sun Pharma Advanced Research Company Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

5.31 Tetra Bio-Pharma Inc Company Overview 64

5.31.1 Tetra Bio-Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 64

5.32 Teva Pharmaceutical Industries Ltd Company Overview 65

5.32.1 Teva Pharmaceutical Industries Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

5.33 United Therapeutics Corp Company Overview 70

5.33.1 United Therapeutics Corp Pipeline Products & Ongoing Clinical Trials Overview 70

5.34 University of Kansas Company Overview 71

5.34.1 University of Kansas Pipeline Products & Ongoing Clinical Trials Overview 71

5.35 University of Texas Medical Branch at Galveston Company Overview 72

5.35.1 University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 72

5.36 Uscom Ltd. Company Overview 73

5.36.1 Uscom Ltd. Pipeline Products & Ongoing Clinical Trials Overview 73

5.37 Vectura Group Plc Company Overview 74

5.37.1 Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 74

5.38 Verona Pharma Plc Company Overview 76

5.38.1 Verona Pharma Plc Pipeline Products & Ongoing Clinical Trials Overview 76

5.39 Virginia Commonwealth University Company Overview 77

5.39.1 Virginia Commonwealth University Pipeline Products & Ongoing Clinical Trials Overview 77

6 Inhalers-Recent Developments 78

6.1 Jul 26, 2017: GSK delivers further progress in Q2 and sets out new priorities for the Group 78

6.2 Jul 25, 2017: Karenann Terrell appointed Chief Digital & Technology Officer, GSK 84

6.3 Jul 25, 2017: 3M Delivers Second-Quarter Sales of $7.8 Billion and Earnings of $2.58 per Share; Company Updates Its 2017 Outlook 84

6.4 Jul 21, 2017: GSK Submits EU Filing for Extended Use of Relvar Ellipta in Patients with Controlled Asthma on an ICS/LABA Combination 86

6.5 Jul 21, 2017: GSK announces Board and Committee changes 87

6.6 Jul 19, 2017: Orion Group Half-Year Financial Report January-June 2017 87

6.7 Jul 18, 2017: Q2 results confirm full year guidance. Strong pipeline results underpin potential of several highly innovative products 97

6.8 Jul 17, 2017: Steven Binder Joins MannKind as Chief Financial Officer 103

6.9 Jul 13, 2017: Teva Enhances Board of Directors as All Proposals Approved at Annual General Meeting of Shareholders 104

6.10 Jul 12, 2017: Patrick McCauley Joins MannKind as Chief Commercial Officer 105

6.11 Jun 22, 2017: Robert J. Hennessey Appointed Chairman of the Board of Nanotherapeutics 105

6.12 Jun 20, 2017: Peter H. Khoury, Ph.D., MBA Appointed President and Chief Executive Officer of Nanotherapeutics 106

6.13 Jun 19, 2017: GSK confirms start date for Luke Miels 107

6.14 Jun 15, 2017: Consort Medical: Full year results 107

6.15 Jun 14, 2017: SPARC Announces Top-line Results of Pivotal Peak Inspiratory Flow (PIF) study and Low Dose Pharmacokinetic (PK) Study for Salmeterol-Fluticasone Dry Powder Inhaler (SPARC DPI) 108

6.16 Jun 09, 2017: Adherium Appoints New CEO to Drive Global Growth 108

6.17 May 25, 2017: Cipla announces Q4 & FY 17 results Continued strong performance across key markets 109

6.18 May 23, 2017: Novartis' new analyses reinforce the potential of Ultibro Breezhaler for COPD patients historically treated with steroids 110

6.19 May 23, 2017: Spiriva Respimat improves breathing for people with asthma regardless of BMI or allergic status 111

6.20 May 23, 2017: Sunovion Announces Utibron Neohaler (indacaterol/glycopyrrolate) Inhalation Powder Data Showing Lung Function and Health-Related Quality of Life Improvement in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease 111

6.21 May 17, 2017: Teva Announces Presentation on Beclomethasone Dipropionate at the 2017 American Thoracic Society (ATS) International Conference 113

6.22 May 16, 2017: Change in composition of the Board of Directors of Novo Nordisk 114

6.23 May 16, 2017: Change in composition of the Board of Directors of Novo Nordisk 114

6.24 May 15, 2017: Sunovion to Present Data on Utibron Neohaler at the American Thoracic Society 2017 International Conference 114

6.25 May 15, 2017: Bellerophon Reports First Quarter 2017 Financial Results and Provides Business Update 116

6.26 May 11, 2017: Teva Reports First Quarter 2017 Financial Results 117

6.27 May 10, 2017: MannKind Reports 2017 First Quarter Financial Results 122

6.28 May 09, 2017: OPKO Health Reports 2016 Financial and Operating Results 122

6.29 May 09, 2017: Nektar Therapeutics Reports Financial Results for the First Quarter of 2017 124

6.30 May 08, 2017: Dr. Stephen S. Lane joins Alcon as Chief Medical Officer and Global Head Franchise Clinical Strategy 126

6.31 May 05, 2017: Relvar Ellipta Significantly Improved Asthma Control in Salford Lung Study Patients Compared with Their Usual Care 127

6.32 May 03, 2017: Novo Nordisk increased reported operating profit by 10% in the first three months of 2017 129

6.33 Apr 26, 2017: Teva Announces Planned Departure of Eyal Desheh, Group Executive Vice President and Chief Financial Officer 130

6.34 Apr 26, 2017: Orion Group Interim Report January-March 2017 130

6.35 Apr 26, 2017: GSK delivers another quarter of continued progress 131

6.36 Apr 26, 2017: United Therapeutics Reports First Quarter 2017 Financial Results 134

6.37 Apr 25, 2017: Novartis delivered sales growth across all divisions as growth drivers, including Cosentyx and Entresto, more than offset generic erosion; innovation momentum continued 135

6.38 Apr 20, 2017: Teva Launches AirDuo RespiClick and its Authorized Generic, Two Inhalers Containing Fluticasone Propionate and Salmeterol 140

6.39 Apr 05, 2017: Successful financial year 2016 for Boehringer Ingelheim 140

6.40 Apr 04, 2017: GSK responds to Cyclone Debbie 142

6.41 Apr 03, 2017: Sunovion Announces Utibron Neohaler (indacaterol/glycopyrrolate) Inhalation Powder Now Available in the United States 142

6.42 Mar 31, 2017: Verona Pharma Has Developed Its First-In-Class Product Candidate RPL554 As Dry Powder Inhaler 143

6.43 Mar 31, 2017: Verona Pharma appoints commercial director 144

6.44 Mar 31, 2017: Adherium: Change to Registered Address 144

6.45 Mar 21, 2017: Pulmatrix Receives European Patent for its Inhaled Drug Delivery Technology 145

6.46 Mar 21, 2017: Vectura Group: Preliminary Results for the nine-month period ended 31 December 2016 145

6.47 Mar 21, 2017: Vectura Group Announces Preliminary Results for the nine-month period ended 31 December 2016 146

6.48 Mar 16, 2017: MannKind Reports 2016 Fourth Quarter and Full Year Financial Results 148

6.49 Mar 13, 2017: Bellerophon Reports Fourth Quarter 2016 Financial Results and Provides Business Update 149

6.50 Mar 06, 2017: Vectura Group: Board Change 151

6.51 Mar 03, 2017: OPKO Health Appoints Dr. Akhtar Ashfaq as Renal Division Senior Vice President, Clinical Research and Development 151

6.52 Mar 01, 2017: OPKO Health Reports 2016 Financial and Operating Results 152

6.53 Mar 01, 2017: Change in Novo Nordisk Executive Management 153

6.54 Mar 01, 2017: Nektar Therapeutics Reports Fourth Quarter and Year-End 2016 Financial Results 153

6.55 Feb 28, 2017: Novartis shareholders approve all resolutions proposed by Board of Directors at the Annual General Meeting 155

6.56 Feb 22, 2017: United Therapeutics Reports 2016 Fourth Quarter And Annual Financial Results 156

6.57 Feb 22, 2017: Otsuka Pharmaceutical Certified as Excellent Health and Productivity Management Enterprise 157

6.58 Feb 20, 2017: Medical Developments Reports Revenue Of AUD8m In H1 Fiscal 2017 158

6.59 Feb 16, 2017: FDA Expands Approval of SPIRIVA RESPIMAT (tiotropium bromide) Inhalation Spray for Maintenance Treatment of Asthma in Children 158

6.60 Feb 16, 2017: Vectura achieves 9 million royalty cap from GSK Ellipta products 159

6.61 Feb 16, 2017: GSK and EMBL have signed an agreement to enhance understanding of disease and drug mechanisms 159

6.62 Feb 13, 2017: Teva Reports Full Year and Fourth Quarter 2016 Financial Results 160

6.63 Feb 13, 2017: Change in Orion Group Executive Management Board as of 21 February 2017 167

6.64 Feb 08, 2017: Orion Group Financial Statement Release for 2016 168

6.65 Feb 08, 2017: Cipla Updates Appoints Mr. Mital Sanghvi To Senior Business Finance Role 171

6.66 Feb 08, 2017: GlaxoSmithKline: Results announcement for the fourth quarter 2016 171

6.67 Feb 08, 2017: Morepen labs reports yet another growth-filled quarter 190

6.68 Feb 06, 2017: Teva Appoints Dr. Yitzhak Peterburg as Interim Chief Executive Officer, Succeeding Erez Vigodman 191

6.69 Feb 02, 2017: Novo Nordisk increased adjusted operating profit by 6% in local currencies in 2016 193

6.70 Jan 30, 2017: Teva Announces FDA Approval of New AirDuo RespiClick Maintenance Inhalers for the Treatment of Asthma 194

6.71 Jan 30, 2017: Teva Announces FDA Approval of New ArmonAir RespiClick for the Treatment of Asthma 195

6.72 Jan 30, 2017: Adherium: Quarterly cash flow report to 31 December 2016 196

6.73 Jan 27, 2017: Reijo Salonen, Senior Vice President, Pharmaceutical R&D, is CTO of the Year 2017 197

6.74 Jan 26, 2017: Novartis highlights progress towards access and environmental goals in 2016 Corporate Responsibility Performance Report 198

6.75 Jan 26, 2017: Achievement of sales milestone for COPD products 199

6.76 Jan 25, 2017: Seebri / Ultibro Breezhaler 2016 sales reach $512 million triggering $5 million milestone receipt 199

6.77 Jan 25, 2017: Novartis delivered solid 2016 performance, with Growth Products absorbing Gleevec US LOE; innovation momentum continued; announces share buyback 200

6.78 Jan 19, 2017: Abbas Hussain to leave GSK 207

6.79 Jan 19, 2017: Luke Miels appointed President, Global Pharmaceuticals, GSK 208

6.80 Jan 18, 2017: Synchrobreathe-Cipla launches revolutionary respiratory inhaler in SA 208

6.81 Jan 11, 2017: Vectura Group: Pre-close update 209

6.82 Jan 10, 2017: Adherium appoints digital health pioneer to lead European business development 210

6.83 Jan 09, 2017: Cipla appoints Peter Lankau as an Independent Director on its Board 211

6.84 Jan 06, 2017: Teva Provides 2017 Financial Outlook 212

6.85 Jan 04, 2017: MannKind Announces Key Addition to Its Executive Management Ranks 213

6.86 Jan 03, 2017: MannKind Receives $1 Million Milestone From RLS 214

7 Appendix 277

7.1 Methodology 277

7.2 About GlobalData 280

7.3 Contact Us 280

7.4 Disclaimer 280


List Of Figure

1.2 List of Figures

Figure 1: Inhalers-Pipeline Products by Stage of Development 13

Figure 2: Inhalers-Pipeline Products by Segment 14

Figure 3: Inhalers-Pipeline Products by Territory 15

Figure 4: Inhalers-Pipeline Products by Regulatory Path 16

Figure 5: Inhalers-Pipeline Products by Estimated Approval Date 17

Figure 6: Inhalers-Ongoing Clinical Trials 18


List Of Table

1.1 List of Tables

Table 1: Inhalers-Pipeline Products by Stage of Development 13

Table 2: Inhalers-Pipeline Products by Segment 14

Table 3: Inhalers-Pipeline Products by Territory 15

Table 4: Inhalers-Pipeline Products by Regulatory Path 16

Table 5: Inhalers-Pipeline Products by Estimated Approval Date 17

Table 6: Inhalers-Ongoing Clinical Trials 18

Table 7: Inhalers Companies-Pipeline Products by Stage of Development 19

Table 8: Inhalers-Pipeline Products by Stage of Development 21

Table 9: Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 23

Table 10: CVT-427 Drug Delivery Device-Product Status 23

Table 11: CVT-427 Drug Delivery Device-Product Description 23

Table 12: INBRIJA-Product Status 24

Table 13: INBRIJA-Product Description 24

Table 14: PLUMIAZ Nasal Spray Device-Product Status 24

Table 15: PLUMIAZ Nasal Spray Device-Product Description 25

Table 16: Acorda Therapeutics Inc-Ongoing Clinical Trials Overview 26

Table 17: INBRIJA-A 12 Month, Dose-level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients with Motor Response Fluctuations (OFF Phenomena) 27

Table 18: Adamis Pharmaceuticals Corp Pipeline Products & Ongoing Clinical Trials Overview 28

Table 19: Taper DPI-Product Status 28

Table 20: Taper DPI-Product Description 28

Table 21: Advent Pharmaceuticals Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

Table 22: g60 Dry Powder Inhaler-Product Status 29

Table 23: g60 Dry Powder Inhaler-Product Description 29

Table 24: Aespira Ltd. Pipeline Products & Ongoing Clinical Trials Overview 30

Table 25: resQhaler-Product Status 30

Table 26: resQhaler-Product Description 30

Table 27: AKELA Pharma Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 31

Table 28: Fentanyl TAIFUN Inhaler-Product Status 31

Table 29: Fentanyl TAIFUN Inhaler-Product Description 31

Table 30: Alexza Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Table 31: Staccato System-Disposable Single Dose-Product Status 32

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

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

Table 34: Staccato System-Multiple Dose-Product Description 33

Table 35: Aradigm Corp Pipeline Products & Ongoing Clinical Trials Overview 34

Table 36: Aerx Pure Nicotine Inhaler-Product Status 34

Table 37: Aerx Pure Nicotine Inhaler-Product Description 34

Table 38: Bayer HealthCare AG (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 35

Table 39: Ciprofloxacin Dry Powder Inhaler-Product Status 35

Table 40: Ciprofloxacin Dry Powder Inhaler-Product Description 35

Table 41: Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 36

Table 42: Mark2 Device-Product Status 36

Table 43: Mark2 Device-Product Description 36

Table 44: Bespak Europe Ltd Pipeline Products & Ongoing Clinical Trials Overview 37

Table 45: DEV610 DPI-Product Status 37

Table 46: DEV610 DPI-Product Description 37

Table 47: Boehringer Ingelheim GmbH Pipeline Products & Ongoing Clinical Trials Overview 38

Table 48: Next Generation Respimat Inhaler-Product Status 38

Table 49: Next Generation Respimat Inhaler-Product Description 38

Table 50: Circassia Pharmaceuticals Plc Pipeline Products & Ongoing Clinical Trials Overview 39

Table 51: Tiotropium bromide DPI-Product Status 39

Table 52: Tiotropium bromide DPI-Product Description 39

Table 53: Drexel University Pipeline Products & Ongoing Clinical Trials Overview 40

Table 54: BREATHE Inhaler-Product Status 40

Table 55: BREATHE Inhaler-Product Description 40

Table 56: FocusStart LLC Pipeline Products & Ongoing Clinical Trials Overview 41

Table 57: Smart Inhaler-Product Status 41

Table 58: Smart Inhaler-Product Description 41

Table 59: GlaxoSmithKline Plc Pipeline Products & Ongoing Clinical Trials Overview 42

Table 60: ELLIPTA Dry Powder Inhaler-Closed Triple-Product Status 42

Table 61: ELLIPTA Dry Powder Inhaler-Closed Triple-Product Description 42

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

Table 63: Gemini Multi-Dose Combination Inhaler-Product Description 43

Table 64: Relvar Ellipta-Controlled Asthma-Product Status 43

Table 65: Relvar Ellipta-Controlled Asthma-Product Description 43

Table 66: GlaxoSmithKline Plc-Ongoing Clinical Trials Overview 44

Table 67: ELLIPTA Dry Powder Inhaler-Closed Triple-A Phase III, Randomized, Double-blind, Active Controlled, Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI with the Fixed Dose Dual Combination of FF/VI, Administered Once-daily via a Dry Powder Inhaler in Subjects with Inadequately Controlled Asthma 45

Table 68: ELLIPTA Dry Powder Inhaler-Closed Triple-Description of the Ability to Learn How to Handle Inhaler Devices in Asthma-AUDIT 45

Table 69: MannKind Corp Pipeline Products & Ongoing Clinical Trials Overview 46

Table 70: Dreamboat-Product Status 46

Table 71: Dreamboat-Product Description 46

Table 72: Medihale Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 47

Table 73: Toucan Multi-Dose Inhaler-Product Status 47

Table 74: Toucan Multi-Dose Inhaler-Product Description 47

Table 75: Monash University Pipeline Products & Ongoing Clinical Trials Overview 48

Table 76: Aerosol Delivery System-Product Status 48

Table 77: Aerosol Delivery System-Product Description 48

Table 78: Nanotherapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 49

Table 79: GelVac Intranasal Powder Vaccine Delivery System-Product Status 49

Table 80: GelVac Intranasal Powder Vaccine Delivery System-Product Description 49

Table 81: NanoGENT-Product Status 50

Table 82: NanoGENT-Product Description 50

Table 83: Nektar Therapeutics Pipeline Products & Ongoing Clinical Trials Overview 51

Table 84: Nektar Dry Powder Inhaler-Amikacin-Product Status 51

Table 85: Nektar Dry Powder Inhaler-Amikacin-Product Description 51

Table 86: Nicoventures Trading Ltd Pipeline Products & Ongoing Clinical Trials Overview 52

Table 87: Nicadex Electronic Inhaler-Product Status 52

Table 88: Nicadex Electronic Inhaler-Product Description 52

Table 89: North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 53

Table 90: Smart Inhaler System-Product Status 53

Table 91: Smart Inhaler System-Product Description 53

Table 92: Novartis AG Pipeline Products & Ongoing Clinical Trials Overview 54

Table 93: Next Generation Breezhaler Inhaler-Product Status 54

Table 94: Next Generation Breezhaler Inhaler-Product Description 54

Table 95: Seebri Neohaler-Product Status 55

Table 96: Seebri Neohaler-Product Description 55

Table 97: OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 56

Table 98: Inspiromatic-Product Status 56

Table 99: Inspiromatic-Product Description 56

Table 100: Pharmaxis Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

Table 101: Orbital Dry Powder Inhaler-Product Status 57

Table 102: Orbital Dry Powder Inhaler-Product Description 57

Table 103: Respira Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 58

Table 104: RT234 AOS DPI-Product Status 58

Table 105: RT234 AOS DPI-Product Description 58

Table 106: Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 59

Table 107: Solis Multi-Dose Dry Powder Inhaler-Product Status 59

Table 108: Solis Multi-Dose Dry Powder Inhaler-Product Description 59

Table 109: Unit-Dose Dry Powder Inhaler-Product Status 60

Table 110: Unit-Dose Dry Powder Inhaler-Product Description 60

Table 111: Sheffield Hallam University Pipeline Products & Ongoing Clinical Trials Overview 61

Table 112: Dry Powder Inhaler-Product Status 61

Table 113: Dry Powder Inhaler-Product Description 61

Table 114: Shin Nippon Biomedical Laboratories Ltd Pipeline Products & Ongoing Clinical Trials Overview 62

Table 115: co System-Product Status 62

Table 116: co System-Product Description 62

Table 117: Sun Pharma Advanced Research Company Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

Table 118: SPARC DPI-Product Status 63

Table 119: SPARC DPI-Product Description 63

Table 120: Tetra Bio-Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 64

Table 121: PPP001-Kit-Product Status 64

Table 122: PPP001-Kit-Product Description 64

Table 123: Teva Pharmaceutical Industries Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

Table 124: ArmonAir RespiClick-Product Status 65

Table 125: ArmonAir RespiClick-Product Description 65

Table 126: Beclomethasone dipropionate Breath-Actuated Inhaler-Product Status 66

Table 127: Beclomethasone dipropionate Breath-Actuated Inhaler-Product Description 66

Table 128: New Inhaler Device Platform-Product Status 66

Table 129: New Inhaler Device Platform-Product Description 67

Table 130: Tidal Inhaler-Product Status 67

Table 131: Tidal Inhaler-Product Description 67

Table 132: Teva Pharmaceutical Industries Ltd-Ongoing Clinical Trials Overview 68

Table 133: ArmonAir RespiClick-12-Week, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared with Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients Aged 4 Through 11 Years with Persistent Asthma 69

Table 134: United Therapeutics Corp Pipeline Products & Ongoing Clinical Trials Overview 70

Table 135: Tyvaso-ILD-Product Status 70

Table 136: Tyvaso-ILD-Product Description 70

Table 137: University of Kansas Pipeline Products & Ongoing Clinical Trials Overview 71

Table 138: Dry Powder Inhaler-Product Status 71

Table 139: Dry Powder Inhaler-Product Description 71

Table 140: University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 72

Table 141: Dry Powder Drug Delivery System-Product Status 72

Table 142: Dry Powder Drug Delivery System-Product Description 72

Table 143: Uscom Ltd. Pipeline Products & Ongoing Clinical Trials Overview 73

Table 144: Spirosonic SmartSpacer-Product Status 73

Table 145: Spirosonic SmartSpacer-Product Description 73

Table 146: Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 74

Table 147: Flutiform-COPD-Product Status 74

Table 148: Flutiform-COPD-Product Description 74

Table 149: SKP-2075-Product Status 75

Table 150: SKP-2075-Product Description 75

Table 151: Verona Pharma Plc Pipeline Products & Ongoing Clinical Trials Overview 76

Table 152: RPL554-Dry Powder Inhaler-Product Status 76

Table 153: RPL554-Dry Powder Inhaler-Product Description 76

Table 154: Virginia Commonwealth University Pipeline Products & Ongoing Clinical Trials Overview 77

Table 155: Dry Powder Inhaler-Product Status 77

Table 156: Dry Powder Inhaler-Product Description 77

Table 157: Glossary 279

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Products and Companies

Products

Acorda Therapeutics Inc, CVT-427 Drug Delivery Device; Acorda Therapeutics Inc, INBRIJA; Acorda Therapeutics Inc, PLUMIAZ Nasal Spray Device; Adamis Pharmaceuticals Corp, Taper DPI; Advent Pharmaceuticals Pty Ltd, g60 Dry Powder Inhaler; Aespira Ltd., resQhaler; AKELA Pharma Inc. (Inactive), Fentanyl TAIFUN Inhaler; Alexza Pharmaceuticals Inc, Staccato System-Disposable Single Dose; Alexza Pharmaceuticals Inc, Staccato System-Multiple Dose; Aradigm Corp, Aerx Pure Nicotine Inhaler; Bayer HealthCare AG (Inactive), Ciprofloxacin Dry Powder Inhaler; Bellerophon Therapeutics Inc, Mark2 Device; Bespak Europe Ltd, DEV610 DPI; Boehringer Ingelheim GmbH, Next Generation Respimat Inhaler; Circassia Pharmaceuticals Plc, Tiotropium bromide DPI; Drexel University, BREATHE Inhaler; FocusStart LLC, Smart Inhaler; GlaxoSmithKline Plc, ELLIPTA Dry Powder Inhaler-Closed Triple; GlaxoSmithKline Plc, Gemini Multi-Dose Combination Inhaler; GlaxoSmithKline Plc, Relvar Ellipta-Controlled Asthma; MannKind Corp, Dreamboat; Medihale Ltd (Inactive), Toucan Multi-Dose Inhaler; Monash University, Aerosol Delivery System; Nanotherapeutics Inc, GelVac Intranasal Powder Vaccine Delivery System; Nanotherapeutics Inc, NanoGENT; Nektar Therapeutics, Nektar Dry Powder Inhaler-Amikacin; Nicoventures Trading Ltd, Nicadex Electronic Inhaler; North Carolina State University, Smart Inhaler System; Novartis AG, Next Generation Breezhaler Inhaler; Novartis AG, Seebri Neohaler; OPKO Health Inc, Inspiromatic; Pharmaxis Ltd, Orbital Dry Powder Inhaler; Respira Therapeutics Inc, RT234 AOS DPI; Sandoz International GmbH, Solis Multi-Dose Dry Powder Inhaler; Sandoz International GmbH, Unit-Dose Dry Powder Inhaler; Sheffield Hallam University, Dry Powder Inhaler; Shin Nippon Biomedical Laboratories Ltd, co System; Sun Pharma Advanced Research Company Ltd, SPARC DPI; Tetra Bio-Pharma Inc, PPP001-Kit; Teva Pharmaceutical Industries Ltd, ArmonAir RespiClick; Teva Pharmaceutical Industries Ltd, Beclomethasone dipropionate Breath-Actuated Inhaler; Teva Pharmaceutical Industries Ltd, New Inhaler Device Platform; Teva Pharmaceutical Industries Ltd, Tidal Inhaler; United Therapeutics Corp, Tyvaso-ILD; University of Kansas, Dry Powder Inhaler; University of Texas Medical Branch at Galveston, Dry Powder Drug Delivery System; Uscom Ltd., Spirosonic SmartSpacer; Vectura Group Plc, Flutiform-COPD; Vectura Group Plc, SKP-2075; Verona Pharma Plc, RPL554-Dry Powder Inhaler; Virginia Commonwealth University, Dry Powder Inhaler


Companies

Acorda Therapeutics Inc

Adamis Pharmaceuticals Corp

Advent Pharmaceuticals Pty Ltd

Aespira Ltd.

AKELA Pharma Inc.

Alexza Pharmaceuticals Inc

Aradigm Corp

Bayer HealthCare AG

Bellerophon Therapeutics Inc

Bespak Europe Ltd

Boehringer Ingelheim GmbH

Circassia Pharmaceuticals Plc

Drexel University

FocusStart LLC

GlaxoSmithKline Plc

MannKind Corp

Medihale Ltd

Monash University

Nanotherapeutics Inc

Nektar Therapeutics

Nicoventures Trading Ltd

North Carolina State University

Novartis AG

OPKO Health Inc

Pharmaxis Ltd

Respira Therapeutics Inc

Sandoz International GmbH

Sheffield Hallam University

Shin Nippon Biomedical Laboratories Ltd

Sun Pharma Advanced Research Company Ltd

Tetra Bio-Pharma Inc

Teva Pharmaceutical Industries Ltd

United Therapeutics Corp

University of Kansas

University of Texas Medical Branch at Galveston

Uscom Ltd.

Vectura Group Plc

Verona Pharma Plc

Virginia Commonwealth University

Company Profile

Company Profile Title

Inhalers-Medical Devices Pipeline Assessment, 2017

Summary

GlobalData's Medical Devices sector report, "Inhalers-Medical Devices Pipeline Assessment, 2017" provides an overview of Inhalers 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 Inhalers 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 Inhalers 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 Inhalers 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 Inhalers 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 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 16

3.5 Inhalers-Pipeline Products by Estimated Approval Date 17

3.6 Inhalers-Ongoing Clinical Trials 18

4 Inhalers-Pipeline Products under Development by Companies 19

4.1 Inhalers Companies-Pipeline Products by Stage of Development 19

4.2 Inhalers-Pipeline Products by Stage of Development 21

5 Inhalers Companies and Product Overview 23

5.1 Acorda Therapeutics Inc Company Overview 23

5.1.1 Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 23

5.2 Adamis Pharmaceuticals Corp Company Overview 28

5.2.1 Adamis Pharmaceuticals Corp Pipeline Products & Ongoing Clinical Trials Overview 28

5.3 Advent Pharmaceuticals Pty Ltd Company Overview 29

5.3.1 Advent Pharmaceuticals Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

5.4 Aespira Ltd. Company Overview 30

5.4.1 Aespira Ltd. Pipeline Products & Ongoing Clinical Trials Overview 30

5.5 AKELA Pharma Inc. (Inactive) Company Overview 31

5.5.1 AKELA Pharma Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 31

5.6 Alexza Pharmaceuticals Inc Company Overview 32

5.6.1 Alexza Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 32

5.7 Aradigm Corp Company Overview 34

5.7.1 Aradigm Corp Pipeline Products & Ongoing Clinical Trials Overview 34

5.8 Bayer HealthCare AG (Inactive) Company Overview 35

5.8.1 Bayer HealthCare AG (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 35

5.9 Bellerophon Therapeutics Inc Company Overview 36

5.9.1 Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 36

5.10 Bespak Europe Ltd Company Overview 37

5.10.1 Bespak Europe Ltd Pipeline Products & Ongoing Clinical Trials Overview 37

5.11 Boehringer Ingelheim GmbH Company Overview 38

5.11.1 Boehringer Ingelheim GmbH Pipeline Products & Ongoing Clinical Trials Overview 38

5.12 Circassia Pharmaceuticals Plc Company Overview 39

5.12.1 Circassia Pharmaceuticals Plc Pipeline Products & Ongoing Clinical Trials Overview 39

5.13 Drexel University Company Overview 40

5.13.1 Drexel University Pipeline Products & Ongoing Clinical Trials Overview 40

5.14 FocusStart LLC Company Overview 41

5.14.1 FocusStart LLC Pipeline Products & Ongoing Clinical Trials Overview 41

5.15 GlaxoSmithKline Plc Company Overview 42

5.15.1 GlaxoSmithKline Plc Pipeline Products & Ongoing Clinical Trials Overview 42

5.16 MannKind Corp Company Overview 46

5.16.1 MannKind Corp Pipeline Products & Ongoing Clinical Trials Overview 46

5.17 Medihale Ltd (Inactive) Company Overview 47

5.17.1 Medihale Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 47

5.18 Monash University Company Overview 48

5.18.1 Monash University Pipeline Products & Ongoing Clinical Trials Overview 48

5.19 Nanotherapeutics Inc Company Overview 49

5.19.1 Nanotherapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 49

5.20 Nektar Therapeutics Company Overview 51

5.20.1 Nektar Therapeutics Pipeline Products & Ongoing Clinical Trials Overview 51

5.21 Nicoventures Trading Ltd Company Overview 52

5.21.1 Nicoventures Trading Ltd Pipeline Products & Ongoing Clinical Trials Overview 52

5.22 North Carolina State University Company Overview 53

5.22.1 North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 53

5.23 Novartis AG Company Overview 54

5.23.1 Novartis AG Pipeline Products & Ongoing Clinical Trials Overview 54

5.24 OPKO Health Inc Company Overview 56

5.24.1 OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 56

5.25 Pharmaxis Ltd Company Overview 57

5.25.1 Pharmaxis Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

5.26 Respira Therapeutics Inc Company Overview 58

5.26.1 Respira Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 58

5.27 Sandoz International GmbH Company Overview 59

5.27.1 Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 59

5.28 Sheffield Hallam University Company Overview 61

5.28.1 Sheffield Hallam University Pipeline Products & Ongoing Clinical Trials Overview 61

5.29 Shin Nippon Biomedical Laboratories Ltd Company Overview 62

5.29.1 Shin Nippon Biomedical Laboratories Ltd Pipeline Products & Ongoing Clinical Trials Overview 62

5.30 Sun Pharma Advanced Research Company Ltd Company Overview 63

5.30.1 Sun Pharma Advanced Research Company Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

5.31 Tetra Bio-Pharma Inc Company Overview 64

5.31.1 Tetra Bio-Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 64

5.32 Teva Pharmaceutical Industries Ltd Company Overview 65

5.32.1 Teva Pharmaceutical Industries Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

5.33 United Therapeutics Corp Company Overview 70

5.33.1 United Therapeutics Corp Pipeline Products & Ongoing Clinical Trials Overview 70

5.34 University of Kansas Company Overview 71

5.34.1 University of Kansas Pipeline Products & Ongoing Clinical Trials Overview 71

5.35 University of Texas Medical Branch at Galveston Company Overview 72

5.35.1 University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 72

5.36 Uscom Ltd. Company Overview 73

5.36.1 Uscom Ltd. Pipeline Products & Ongoing Clinical Trials Overview 73

5.37 Vectura Group Plc Company Overview 74

5.37.1 Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 74

5.38 Verona Pharma Plc Company Overview 76

5.38.1 Verona Pharma Plc Pipeline Products & Ongoing Clinical Trials Overview 76

5.39 Virginia Commonwealth University Company Overview 77

5.39.1 Virginia Commonwealth University Pipeline Products & Ongoing Clinical Trials Overview 77

6 Inhalers-Recent Developments 78

6.1 Jul 26, 2017: GSK delivers further progress in Q2 and sets out new priorities for the Group 78

6.2 Jul 25, 2017: Karenann Terrell appointed Chief Digital & Technology Officer, GSK 84

6.3 Jul 25, 2017: 3M Delivers Second-Quarter Sales of $7.8 Billion and Earnings of $2.58 per Share; Company Updates Its 2017 Outlook 84

6.4 Jul 21, 2017: GSK Submits EU Filing for Extended Use of Relvar Ellipta in Patients with Controlled Asthma on an ICS/LABA Combination 86

6.5 Jul 21, 2017: GSK announces Board and Committee changes 87

6.6 Jul 19, 2017: Orion Group Half-Year Financial Report January-June 2017 87

6.7 Jul 18, 2017: Q2 results confirm full year guidance. Strong pipeline results underpin potential of several highly innovative products 97

6.8 Jul 17, 2017: Steven Binder Joins MannKind as Chief Financial Officer 103

6.9 Jul 13, 2017: Teva Enhances Board of Directors as All Proposals Approved at Annual General Meeting of Shareholders 104

6.10 Jul 12, 2017: Patrick McCauley Joins MannKind as Chief Commercial Officer 105

6.11 Jun 22, 2017: Robert J. Hennessey Appointed Chairman of the Board of Nanotherapeutics 105

6.12 Jun 20, 2017: Peter H. Khoury, Ph.D., MBA Appointed President and Chief Executive Officer of Nanotherapeutics 106

6.13 Jun 19, 2017: GSK confirms start date for Luke Miels 107

6.14 Jun 15, 2017: Consort Medical: Full year results 107

6.15 Jun 14, 2017: SPARC Announces Top-line Results of Pivotal Peak Inspiratory Flow (PIF) study and Low Dose Pharmacokinetic (PK) Study for Salmeterol-Fluticasone Dry Powder Inhaler (SPARC DPI) 108

6.16 Jun 09, 2017: Adherium Appoints New CEO to Drive Global Growth 108

6.17 May 25, 2017: Cipla announces Q4 & FY 17 results Continued strong performance across key markets 109

6.18 May 23, 2017: Novartis' new analyses reinforce the potential of Ultibro Breezhaler for COPD patients historically treated with steroids 110

6.19 May 23, 2017: Spiriva Respimat improves breathing for people with asthma regardless of BMI or allergic status 111

6.20 May 23, 2017: Sunovion Announces Utibron Neohaler (indacaterol/glycopyrrolate) Inhalation Powder Data Showing Lung Function and Health-Related Quality of Life Improvement in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease 111

6.21 May 17, 2017: Teva Announces Presentation on Beclomethasone Dipropionate at the 2017 American Thoracic Society (ATS) International Conference 113

6.22 May 16, 2017: Change in composition of the Board of Directors of Novo Nordisk 114

6.23 May 16, 2017: Change in composition of the Board of Directors of Novo Nordisk 114

6.24 May 15, 2017: Sunovion to Present Data on Utibron Neohaler at the American Thoracic Society 2017 International Conference 114

6.25 May 15, 2017: Bellerophon Reports First Quarter 2017 Financial Results and Provides Business Update 116

6.26 May 11, 2017: Teva Reports First Quarter 2017 Financial Results 117

6.27 May 10, 2017: MannKind Reports 2017 First Quarter Financial Results 122

6.28 May 09, 2017: OPKO Health Reports 2016 Financial and Operating Results 122

6.29 May 09, 2017: Nektar Therapeutics Reports Financial Results for the First Quarter of 2017 124

6.30 May 08, 2017: Dr. Stephen S. Lane joins Alcon as Chief Medical Officer and Global Head Franchise Clinical Strategy 126

6.31 May 05, 2017: Relvar Ellipta Significantly Improved Asthma Control in Salford Lung Study Patients Compared with Their Usual Care 127

6.32 May 03, 2017: Novo Nordisk increased reported operating profit by 10% in the first three months of 2017 129

6.33 Apr 26, 2017: Teva Announces Planned Departure of Eyal Desheh, Group Executive Vice President and Chief Financial Officer 130

6.34 Apr 26, 2017: Orion Group Interim Report January-March 2017 130

6.35 Apr 26, 2017: GSK delivers another quarter of continued progress 131

6.36 Apr 26, 2017: United Therapeutics Reports First Quarter 2017 Financial Results 134

6.37 Apr 25, 2017: Novartis delivered sales growth across all divisions as growth drivers, including Cosentyx and Entresto, more than offset generic erosion; innovation momentum continued 135

6.38 Apr 20, 2017: Teva Launches AirDuo RespiClick and its Authorized Generic, Two Inhalers Containing Fluticasone Propionate and Salmeterol 140

6.39 Apr 05, 2017: Successful financial year 2016 for Boehringer Ingelheim 140

6.40 Apr 04, 2017: GSK responds to Cyclone Debbie 142

6.41 Apr 03, 2017: Sunovion Announces Utibron Neohaler (indacaterol/glycopyrrolate) Inhalation Powder Now Available in the United States 142

6.42 Mar 31, 2017: Verona Pharma Has Developed Its First-In-Class Product Candidate RPL554 As Dry Powder Inhaler 143

6.43 Mar 31, 2017: Verona Pharma appoints commercial director 144

6.44 Mar 31, 2017: Adherium: Change to Registered Address 144

6.45 Mar 21, 2017: Pulmatrix Receives European Patent for its Inhaled Drug Delivery Technology 145

6.46 Mar 21, 2017: Vectura Group: Preliminary Results for the nine-month period ended 31 December 2016 145

6.47 Mar 21, 2017: Vectura Group Announces Preliminary Results for the nine-month period ended 31 December 2016 146

6.48 Mar 16, 2017: MannKind Reports 2016 Fourth Quarter and Full Year Financial Results 148

6.49 Mar 13, 2017: Bellerophon Reports Fourth Quarter 2016 Financial Results and Provides Business Update 149

6.50 Mar 06, 2017: Vectura Group: Board Change 151

6.51 Mar 03, 2017: OPKO Health Appoints Dr. Akhtar Ashfaq as Renal Division Senior Vice President, Clinical Research and Development 151

6.52 Mar 01, 2017: OPKO Health Reports 2016 Financial and Operating Results 152

6.53 Mar 01, 2017: Change in Novo Nordisk Executive Management 153

6.54 Mar 01, 2017: Nektar Therapeutics Reports Fourth Quarter and Year-End 2016 Financial Results 153

6.55 Feb 28, 2017: Novartis shareholders approve all resolutions proposed by Board of Directors at the Annual General Meeting 155

6.56 Feb 22, 2017: United Therapeutics Reports 2016 Fourth Quarter And Annual Financial Results 156

6.57 Feb 22, 2017: Otsuka Pharmaceutical Certified as Excellent Health and Productivity Management Enterprise 157

6.58 Feb 20, 2017: Medical Developments Reports Revenue Of AUD8m In H1 Fiscal 2017 158

6.59 Feb 16, 2017: FDA Expands Approval of SPIRIVA RESPIMAT (tiotropium bromide) Inhalation Spray for Maintenance Treatment of Asthma in Children 158

6.60 Feb 16, 2017: Vectura achieves 9 million royalty cap from GSK Ellipta products 159

6.61 Feb 16, 2017: GSK and EMBL have signed an agreement to enhance understanding of disease and drug mechanisms 159

6.62 Feb 13, 2017: Teva Reports Full Year and Fourth Quarter 2016 Financial Results 160

6.63 Feb 13, 2017: Change in Orion Group Executive Management Board as of 21 February 2017 167

6.64 Feb 08, 2017: Orion Group Financial Statement Release for 2016 168

6.65 Feb 08, 2017: Cipla Updates Appoints Mr. Mital Sanghvi To Senior Business Finance Role 171

6.66 Feb 08, 2017: GlaxoSmithKline: Results announcement for the fourth quarter 2016 171

6.67 Feb 08, 2017: Morepen labs reports yet another growth-filled quarter 190

6.68 Feb 06, 2017: Teva Appoints Dr. Yitzhak Peterburg as Interim Chief Executive Officer, Succeeding Erez Vigodman 191

6.69 Feb 02, 2017: Novo Nordisk increased adjusted operating profit by 6% in local currencies in 2016 193

6.70 Jan 30, 2017: Teva Announces FDA Approval of New AirDuo RespiClick Maintenance Inhalers for the Treatment of Asthma 194

6.71 Jan 30, 2017: Teva Announces FDA Approval of New ArmonAir RespiClick for the Treatment of Asthma 195

6.72 Jan 30, 2017: Adherium: Quarterly cash flow report to 31 December 2016 196

6.73 Jan 27, 2017: Reijo Salonen, Senior Vice President, Pharmaceutical R&D, is CTO of the Year 2017 197

6.74 Jan 26, 2017: Novartis highlights progress towards access and environmental goals in 2016 Corporate Responsibility Performance Report 198

6.75 Jan 26, 2017: Achievement of sales milestone for COPD products 199

6.76 Jan 25, 2017: Seebri / Ultibro Breezhaler 2016 sales reach $512 million triggering $5 million milestone receipt 199

6.77 Jan 25, 2017: Novartis delivered solid 2016 performance, with Growth Products absorbing Gleevec US LOE; innovation momentum continued; announces share buyback 200

6.78 Jan 19, 2017: Abbas Hussain to leave GSK 207

6.79 Jan 19, 2017: Luke Miels appointed President, Global Pharmaceuticals, GSK 208

6.80 Jan 18, 2017: Synchrobreathe-Cipla launches revolutionary respiratory inhaler in SA 208

6.81 Jan 11, 2017: Vectura Group: Pre-close update 209

6.82 Jan 10, 2017: Adherium appoints digital health pioneer to lead European business development 210

6.83 Jan 09, 2017: Cipla appoints Peter Lankau as an Independent Director on its Board 211

6.84 Jan 06, 2017: Teva Provides 2017 Financial Outlook 212

6.85 Jan 04, 2017: MannKind Announces Key Addition to Its Executive Management Ranks 213

6.86 Jan 03, 2017: MannKind Receives $1 Million Milestone From RLS 214

7 Appendix 277

7.1 Methodology 277

7.2 About GlobalData 280

7.3 Contact Us 280

7.4 Disclaimer 280


List Of Figure

1.2 List of Figures

Figure 1: Inhalers-Pipeline Products by Stage of Development 13

Figure 2: Inhalers-Pipeline Products by Segment 14

Figure 3: Inhalers-Pipeline Products by Territory 15

Figure 4: Inhalers-Pipeline Products by Regulatory Path 16

Figure 5: Inhalers-Pipeline Products by Estimated Approval Date 17

Figure 6: Inhalers-Ongoing Clinical Trials 18


List Of Table

1.1 List of Tables

Table 1: Inhalers-Pipeline Products by Stage of Development 13

Table 2: Inhalers-Pipeline Products by Segment 14

Table 3: Inhalers-Pipeline Products by Territory 15

Table 4: Inhalers-Pipeline Products by Regulatory Path 16

Table 5: Inhalers-Pipeline Products by Estimated Approval Date 17

Table 6: Inhalers-Ongoing Clinical Trials 18

Table 7: Inhalers Companies-Pipeline Products by Stage of Development 19

Table 8: Inhalers-Pipeline Products by Stage of Development 21

Table 9: Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 23

Table 10: CVT-427 Drug Delivery Device-Product Status 23

Table 11: CVT-427 Drug Delivery Device-Product Description 23

Table 12: INBRIJA-Product Status 24

Table 13: INBRIJA-Product Description 24

Table 14: PLUMIAZ Nasal Spray Device-Product Status 24

Table 15: PLUMIAZ Nasal Spray Device-Product Description 25

Table 16: Acorda Therapeutics Inc-Ongoing Clinical Trials Overview 26

Table 17: INBRIJA-A 12 Month, Dose-level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients with Motor Response Fluctuations (OFF Phenomena) 27

Table 18: Adamis Pharmaceuticals Corp Pipeline Products & Ongoing Clinical Trials Overview 28

Table 19: Taper DPI-Product Status 28

Table 20: Taper DPI-Product Description 28

Table 21: Advent Pharmaceuticals Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

Table 22: g60 Dry Powder Inhaler-Product Status 29

Table 23: g60 Dry Powder Inhaler-Product Description 29

Table 24: Aespira Ltd. Pipeline Products & Ongoing Clinical Trials Overview 30

Table 25: resQhaler-Product Status 30

Table 26: resQhaler-Product Description 30

Table 27: AKELA Pharma Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 31

Table 28: Fentanyl TAIFUN Inhaler-Product Status 31

Table 29: Fentanyl TAIFUN Inhaler-Product Description 31

Table 30: Alexza Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Table 31: Staccato System-Disposable Single Dose-Product Status 32

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

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

Table 34: Staccato System-Multiple Dose-Product Description 33

Table 35: Aradigm Corp Pipeline Products & Ongoing Clinical Trials Overview 34

Table 36: Aerx Pure Nicotine Inhaler-Product Status 34

Table 37: Aerx Pure Nicotine Inhaler-Product Description 34

Table 38: Bayer HealthCare AG (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 35

Table 39: Ciprofloxacin Dry Powder Inhaler-Product Status 35

Table 40: Ciprofloxacin Dry Powder Inhaler-Product Description 35

Table 41: Bellerophon Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 36

Table 42: Mark2 Device-Product Status 36

Table 43: Mark2 Device-Product Description 36

Table 44: Bespak Europe Ltd Pipeline Products & Ongoing Clinical Trials Overview 37

Table 45: DEV610 DPI-Product Status 37

Table 46: DEV610 DPI-Product Description 37

Table 47: Boehringer Ingelheim GmbH Pipeline Products & Ongoing Clinical Trials Overview 38

Table 48: Next Generation Respimat Inhaler-Product Status 38

Table 49: Next Generation Respimat Inhaler-Product Description 38

Table 50: Circassia Pharmaceuticals Plc Pipeline Products & Ongoing Clinical Trials Overview 39

Table 51: Tiotropium bromide DPI-Product Status 39

Table 52: Tiotropium bromide DPI-Product Description 39

Table 53: Drexel University Pipeline Products & Ongoing Clinical Trials Overview 40

Table 54: BREATHE Inhaler-Product Status 40

Table 55: BREATHE Inhaler-Product Description 40

Table 56: FocusStart LLC Pipeline Products & Ongoing Clinical Trials Overview 41

Table 57: Smart Inhaler-Product Status 41

Table 58: Smart Inhaler-Product Description 41

Table 59: GlaxoSmithKline Plc Pipeline Products & Ongoing Clinical Trials Overview 42

Table 60: ELLIPTA Dry Powder Inhaler-Closed Triple-Product Status 42

Table 61: ELLIPTA Dry Powder Inhaler-Closed Triple-Product Description 42

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

Table 63: Gemini Multi-Dose Combination Inhaler-Product Description 43

Table 64: Relvar Ellipta-Controlled Asthma-Product Status 43

Table 65: Relvar Ellipta-Controlled Asthma-Product Description 43

Table 66: GlaxoSmithKline Plc-Ongoing Clinical Trials Overview 44

Table 67: ELLIPTA Dry Powder Inhaler-Closed Triple-A Phase III, Randomized, Double-blind, Active Controlled, Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI with the Fixed Dose Dual Combination of FF/VI, Administered Once-daily via a Dry Powder Inhaler in Subjects with Inadequately Controlled Asthma 45

Table 68: ELLIPTA Dry Powder Inhaler-Closed Triple-Description of the Ability to Learn How to Handle Inhaler Devices in Asthma-AUDIT 45

Table 69: MannKind Corp Pipeline Products & Ongoing Clinical Trials Overview 46

Table 70: Dreamboat-Product Status 46

Table 71: Dreamboat-Product Description 46

Table 72: Medihale Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 47

Table 73: Toucan Multi-Dose Inhaler-Product Status 47

Table 74: Toucan Multi-Dose Inhaler-Product Description 47

Table 75: Monash University Pipeline Products & Ongoing Clinical Trials Overview 48

Table 76: Aerosol Delivery System-Product Status 48

Table 77: Aerosol Delivery System-Product Description 48

Table 78: Nanotherapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 49

Table 79: GelVac Intranasal Powder Vaccine Delivery System-Product Status 49

Table 80: GelVac Intranasal Powder Vaccine Delivery System-Product Description 49

Table 81: NanoGENT-Product Status 50

Table 82: NanoGENT-Product Description 50

Table 83: Nektar Therapeutics Pipeline Products & Ongoing Clinical Trials Overview 51

Table 84: Nektar Dry Powder Inhaler-Amikacin-Product Status 51

Table 85: Nektar Dry Powder Inhaler-Amikacin-Product Description 51

Table 86: Nicoventures Trading Ltd Pipeline Products & Ongoing Clinical Trials Overview 52

Table 87: Nicadex Electronic Inhaler-Product Status 52

Table 88: Nicadex Electronic Inhaler-Product Description 52

Table 89: North Carolina State University Pipeline Products & Ongoing Clinical Trials Overview 53

Table 90: Smart Inhaler System-Product Status 53

Table 91: Smart Inhaler System-Product Description 53

Table 92: Novartis AG Pipeline Products & Ongoing Clinical Trials Overview 54

Table 93: Next Generation Breezhaler Inhaler-Product Status 54

Table 94: Next Generation Breezhaler Inhaler-Product Description 54

Table 95: Seebri Neohaler-Product Status 55

Table 96: Seebri Neohaler-Product Description 55

Table 97: OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 56

Table 98: Inspiromatic-Product Status 56

Table 99: Inspiromatic-Product Description 56

Table 100: Pharmaxis Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

Table 101: Orbital Dry Powder Inhaler-Product Status 57

Table 102: Orbital Dry Powder Inhaler-Product Description 57

Table 103: Respira Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 58

Table 104: RT234 AOS DPI-Product Status 58

Table 105: RT234 AOS DPI-Product Description 58

Table 106: Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 59

Table 107: Solis Multi-Dose Dry Powder Inhaler-Product Status 59

Table 108: Solis Multi-Dose Dry Powder Inhaler-Product Description 59

Table 109: Unit-Dose Dry Powder Inhaler-Product Status 60

Table 110: Unit-Dose Dry Powder Inhaler-Product Description 60

Table 111: Sheffield Hallam University Pipeline Products & Ongoing Clinical Trials Overview 61

Table 112: Dry Powder Inhaler-Product Status 61

Table 113: Dry Powder Inhaler-Product Description 61

Table 114: Shin Nippon Biomedical Laboratories Ltd Pipeline Products & Ongoing Clinical Trials Overview 62

Table 115: co System-Product Status 62

Table 116: co System-Product Description 62

Table 117: Sun Pharma Advanced Research Company Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

Table 118: SPARC DPI-Product Status 63

Table 119: SPARC DPI-Product Description 63

Table 120: Tetra Bio-Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 64

Table 121: PPP001-Kit-Product Status 64

Table 122: PPP001-Kit-Product Description 64

Table 123: Teva Pharmaceutical Industries Ltd Pipeline Products & Ongoing Clinical Trials Overview 65

Table 124: ArmonAir RespiClick-Product Status 65

Table 125: ArmonAir RespiClick-Product Description 65

Table 126: Beclomethasone dipropionate Breath-Actuated Inhaler-Product Status 66

Table 127: Beclomethasone dipropionate Breath-Actuated Inhaler-Product Description 66

Table 128: New Inhaler Device Platform-Product Status 66

Table 129: New Inhaler Device Platform-Product Description 67

Table 130: Tidal Inhaler-Product Status 67

Table 131: Tidal Inhaler-Product Description 67

Table 132: Teva Pharmaceutical Industries Ltd-Ongoing Clinical Trials Overview 68

Table 133: ArmonAir RespiClick-12-Week, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared with Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients Aged 4 Through 11 Years with Persistent Asthma 69

Table 134: United Therapeutics Corp Pipeline Products & Ongoing Clinical Trials Overview 70

Table 135: Tyvaso-ILD-Product Status 70

Table 136: Tyvaso-ILD-Product Description 70

Table 137: University of Kansas Pipeline Products & Ongoing Clinical Trials Overview 71

Table 138: Dry Powder Inhaler-Product Status 71

Table 139: Dry Powder Inhaler-Product Description 71

Table 140: University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 72

Table 141: Dry Powder Drug Delivery System-Product Status 72

Table 142: Dry Powder Drug Delivery System-Product Description 72

Table 143: Uscom Ltd. Pipeline Products & Ongoing Clinical Trials Overview 73

Table 144: Spirosonic SmartSpacer-Product Status 73

Table 145: Spirosonic SmartSpacer-Product Description 73

Table 146: Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 74

Table 147: Flutiform-COPD-Product Status 74

Table 148: Flutiform-COPD-Product Description 74

Table 149: SKP-2075-Product Status 75

Table 150: SKP-2075-Product Description 75

Table 151: Verona Pharma Plc Pipeline Products & Ongoing Clinical Trials Overview 76

Table 152: RPL554-Dry Powder Inhaler-Product Status 76

Table 153: RPL554-Dry Powder Inhaler-Product Description 76

Table 154: Virginia Commonwealth University Pipeline Products & Ongoing Clinical Trials Overview 77

Table 155: Dry Powder Inhaler-Product Status 77

Table 156: Dry Powder Inhaler-Product Description 77

Table 157: Glossary 279

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Products

Acorda Therapeutics Inc, CVT-427 Drug Delivery Device; Acorda Therapeutics Inc, INBRIJA; Acorda Therapeutics Inc, PLUMIAZ Nasal Spray Device; Adamis Pharmaceuticals Corp, Taper DPI; Advent Pharmaceuticals Pty Ltd, g60 Dry Powder Inhaler; Aespira Ltd., resQhaler; AKELA Pharma Inc. (Inactive), Fentanyl TAIFUN Inhaler; Alexza Pharmaceuticals Inc, Staccato System-Disposable Single Dose; Alexza Pharmaceuticals Inc, Staccato System-Multiple Dose; Aradigm Corp, Aerx Pure Nicotine Inhaler; Bayer HealthCare AG (Inactive), Ciprofloxacin Dry Powder Inhaler; Bellerophon Therapeutics Inc, Mark2 Device; Bespak Europe Ltd, DEV610 DPI; Boehringer Ingelheim GmbH, Next Generation Respimat Inhaler; Circassia Pharmaceuticals Plc, Tiotropium bromide DPI; Drexel University, BREATHE Inhaler; FocusStart LLC, Smart Inhaler; GlaxoSmithKline Plc, ELLIPTA Dry Powder Inhaler-Closed Triple; GlaxoSmithKline Plc, Gemini Multi-Dose Combination Inhaler; GlaxoSmithKline Plc, Relvar Ellipta-Controlled Asthma; MannKind Corp, Dreamboat; Medihale Ltd (Inactive), Toucan Multi-Dose Inhaler; Monash University, Aerosol Delivery System; Nanotherapeutics Inc, GelVac Intranasal Powder Vaccine Delivery System; Nanotherapeutics Inc, NanoGENT; Nektar Therapeutics, Nektar Dry Powder Inhaler-Amikacin; Nicoventures Trading Ltd, Nicadex Electronic Inhaler; North Carolina State University, Smart Inhaler System; Novartis AG, Next Generation Breezhaler Inhaler; Novartis AG, Seebri Neohaler; OPKO Health Inc, Inspiromatic; Pharmaxis Ltd, Orbital Dry Powder Inhaler; Respira Therapeutics Inc, RT234 AOS DPI; Sandoz International GmbH, Solis Multi-Dose Dry Powder Inhaler; Sandoz International GmbH, Unit-Dose Dry Powder Inhaler; Sheffield Hallam University, Dry Powder Inhaler; Shin Nippon Biomedical Laboratories Ltd, co System; Sun Pharma Advanced Research Company Ltd, SPARC DPI; Tetra Bio-Pharma Inc, PPP001-Kit; Teva Pharmaceutical Industries Ltd, ArmonAir RespiClick; Teva Pharmaceutical Industries Ltd, Beclomethasone dipropionate Breath-Actuated Inhaler; Teva Pharmaceutical Industries Ltd, New Inhaler Device Platform; Teva Pharmaceutical Industries Ltd, Tidal Inhaler; United Therapeutics Corp, Tyvaso-ILD; University of Kansas, Dry Powder Inhaler; University of Texas Medical Branch at Galveston, Dry Powder Drug Delivery System; Uscom Ltd., Spirosonic SmartSpacer; Vectura Group Plc, Flutiform-COPD; Vectura Group Plc, SKP-2075; Verona Pharma Plc, RPL554-Dry Powder Inhaler; Virginia Commonwealth University, Dry Powder Inhaler


Companies

Acorda Therapeutics Inc

Adamis Pharmaceuticals Corp

Advent Pharmaceuticals Pty Ltd

Aespira Ltd.

AKELA Pharma Inc.

Alexza Pharmaceuticals Inc

Aradigm Corp

Bayer HealthCare AG

Bellerophon Therapeutics Inc

Bespak Europe Ltd

Boehringer Ingelheim GmbH

Circassia Pharmaceuticals Plc

Drexel University

FocusStart LLC

GlaxoSmithKline Plc

MannKind Corp

Medihale Ltd

Monash University

Nanotherapeutics Inc

Nektar Therapeutics

Nicoventures Trading Ltd

North Carolina State University

Novartis AG

OPKO Health Inc

Pharmaxis Ltd

Respira Therapeutics Inc

Sandoz International GmbH

Sheffield Hallam University

Shin Nippon Biomedical Laboratories Ltd

Sun Pharma Advanced Research Company Ltd

Tetra Bio-Pharma Inc

Teva Pharmaceutical Industries Ltd

United Therapeutics Corp

University of Kansas

University of Texas Medical Branch at Galveston

Uscom Ltd.

Vectura Group Plc

Verona Pharma Plc

Virginia Commonwealth University