Dry Powder Inhaler Devices - Medical Devices Pipeline Assessment, 2018

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 7

1.2 List of Figures 8

2 Introduction 9

2.1 Dry Powder Inhaler Devices Overview 9

3 Products under Development 10

3.1 Dry Powder Inhaler Devices-Pipeline Products by Stage of Development 10

3.2 Dry Powder Inhaler Devices-Pipeline Products by Territory 11

3.3 Dry Powder Inhaler Devices-Pipeline Products by Regulatory Path 12

3.4 Dry Powder Inhaler Devices-Pipeline Products by Estimated Approval Date 13

3.5 Dry Powder Inhaler Devices-Ongoing Clinical Trials 14

4 Dry Powder Inhaler Devices-Pipeline Products under Development by Companies 15

4.1 Dry Powder Inhaler Devices Companies-Pipeline Products by Stage of Development 15

4.2 Dry Powder Inhaler Devices-Pipeline Products by Stage of Development 16

5 Dry Powder Inhaler Devices Companies and Product Overview 17

5.1 Acorda Therapeutics Inc Company Overview 17

5.2 Adamis Pharmaceuticals Corp Company Overview 19

5.3 Advent Pharmaceuticals Pty Ltd Company Overview 20

5.4 Aespira Ltd. Company Overview 21

5.5 AKELA Pharma Inc. (Inactive) Company Overview 22

5.6 AstraZeneca Plc Company Overview 23

5.7 Bayer AG Company Overview 24

5.8 Bespak Europe Ltd Company Overview 25

5.9 Boehringer Ingelheim GmbH Company Overview 26

5.10 Circassia Pharmaceuticals Plc Company Overview 27

5.11 GlaxoSmithKline Plc Company Overview 28

5.12 MannKind Corp Company Overview 29

5.13 Monash University Company Overview 33

5.14 Nanotherapeutics Inc (Inactive) Company Overview 34

5.15 Nektar Therapeutics Company Overview 36

5.16 OPKO Health Inc Company Overview 37

5.17 Pharmaxis Ltd Company Overview 38

5.18 Respira Therapeutics Inc Company Overview 39

5.19 Sandoz International GmbH Company Overview 40

5.20 Sheffield Hallam University Company Overview 42

5.21 Sun Pharma Advanced Research Company Ltd Company Overview 43

5.22 University of Kansas Company Overview 44

5.23 University of Texas Medical Branch at Galveston Company Overview 45

5.24 Vectura Group Plc Company Overview 46

5.25 Verona Pharma Plc Company Overview 48

5.26 Virginia Commonwealth University Company Overview 49

6 Dry Powder Inhaler Devices- Recent Developments 50

6.1 Jun 07, 2018: MannKind Successfully Completes Phase 1 Trial of Treprostinil Technosphere for Pulmonary Arterial Hypertension Advancing Development to Next Phase 50

6.2 Jun 01, 2018: Vectura Group Appoints Anne Whitaker As Non-Executive Director 50

6.3 May 21, 2018: 3M forms sustainability and product stewardship organization 51

6.4 May 17, 2018: New England Journal of Medicine publishes two trials for Symbicort as an anti-inflammatory reliever therapy as needed in mild asthma 51

6.5 May 16, 2018: Novartis announces changes to the Executive Committee 53

6.6 May 16, 2018: At the Meet Novartis Management investor event, Novartis highlights strategy to focus the company and drive sustainable growth 54

6.7 May 10, 2018: Adamis Pharmaceuticals Announces First Quarter 2018 Financial Results and Business Update 55

6.8 May 10, 2018: Nektar Therapeutics Reports Financial Results for the First Quarter of 2018 56

6.9 May 10, 2018: Novartis India reconstitutes Board appoints Milan Paleja as Vice Chairman Managing Director 60

6.10 May 09, 2018: 3M Announces New Leadership Appointment 60

6.11 May 09, 2018: MannKind Reports 2018 First Quarter Financial Results 60

6.12 May 09, 2018: Simon Dingemans, Chief Financial Officer, to retire from GSK 61

6.13 May 08, 2018: OPKO Health Announces First Quarter 2018 Financial Results 62

6.14 May 03, 2018: Teva Reports First Quarter 2018 Financial Results 63

6.15 May 01, 2018: OPKO Health Appoints Geoff Monk General Manager at BioReference Laboratories 69

6.16 Apr 26, 2018: Consort Medical: Director Declaration 69

6.17 Apr 25, 2018: Novartis launches FocalView app, providing opportunity for patients to participate in ophthalmology clinical trials from home 70

6.18 Apr 24, 2018: Once-daily Trelegy Ellipta gains expanded indication in the US for the treatment of patients with COPD 70

6.19 Apr 20, 2018: Vectura Announces Senior Management Change 72

6.20 Apr 20, 2018: Vectura Group: Directorate Change-Chief Financial Officer 72

6.21 Apr 19, 2018: Boehringer Ingelheim and HealthPrize Expand Successful Digital Patient Support Program 73

6.22 Apr 19, 2018: Novartis delivered a strong first quarter and acted to become a more focused medicines company 74

6.23 Apr 19, 2018: Novartis appoints John Tsai Head of Global Drug Development and Chief Medical Officer 78

6.24 Apr 18, 2018: Landmark IMPACT study published in NEJM shows significant benefits of Trelegy Ellipta for patients with COPD 79

6.25 Apr 18, 2018: GlaxoSmithKline Names Kevin Sin as new Senior Vice President and Head of Worldwide Business Development for Research & Development 80

6.26 Mar 29, 2018: Final results from landmark DYNAGITO trial published in The Lancet Respiratory Medicine 81

6.27 Mar 27, 2018: Construction Launch For New Chiesi Farmaceutici Headquarters 82

6.28 Mar 26, 2018: Acorda Files Marketing Authorization Application for INBRIJA (levodopa inhalation powder) 83

6.29 Mar 21, 2018: Vectura Group: 2017 Preliminary Results 83

6.30 Mar 21, 2018: Vectura Group: 2017 Preliminary Results-Performance in-line with expectations, with strong in-market growth from key inhaled products 84

6.31 Mar 20, 2018: Orion Board of Arrangement 86

6.32 Mar 19, 2018: Orion has Received Positive Conclusions for the Salmeterol-fluticasone Easyhaler Combination Under the EU''''s Decentralized Procedures 87

6.33 Mar 16, 2018: Asthma: Expanded indication for SPIRIVA Respimat for people 6 years and older 87

6.34 Mar 15, 2018: Adamis Pharmaceuticals Discusses 2017 Highlights and Business Update 88

6.35 Mar 13, 2018: MannKind Announces STAT Study Results Accepted for Presentation at American Diabetes Association's 78th Scientific Sessions 89

6.36 Mar 12, 2018: Novartis announces changes to the Executive Committee to support strategic priorities 90

6.37 Mar 08, 2018: GSK announces positive EU approval for labelling update to Relvar Ellipta in patients with asthma 91

6.38 Mar 05, 2018: 3M Announces New Leadership Appointments 92

6.39 Mar 01, 2018: MannKind Opens Enrollment of Phase 1 Trial of Treprostinil Technosphere for Pulmonary Arterial Hypertension 92

6.40 Mar 01, 2018: OPKO Health Reports 2017 Fourth Quarter Business Highlights and Financial Results 93

6.41 Mar 01, 2018: Nektar Therapeutics Announces Fourth Quarter And Year-End 2017 Financial Results 94

6.42 Feb 27, 2018: MannKind Reports 2017 Fourth Quarter and Full Year Financial Results 97

6.43 Feb 23, 2018: GSK, Ministry of Economy, Trade and Industry Superior Health and Good Management Act 2018 (White 500) for 2 consecutive years certified 99

6.44 Feb 22, 2018: Treatment with Novartis Ultibro Breezhaler improved cardiac function in COPD patients with lung hyperinflation 99

6.45 Feb 20, 2018: Acorda Announces FDA Acceptance of New Drug Application for INBRIJA (levodopa inhalation powder) 100

6.46 Feb 20, 2018: Lexington Begins HeartSentry Clinical Trial 101

6.47 Feb 16, 2018: GSK Statement: GSK Voluntary Recall Of Ventolin Diskus Lot 786G In Canada 102

6.48 Feb 14, 2018: GSK submits landmark IMPACT data to European Medicines Agency to support expanded label for Trelegy Ellipta 102

6.49 Feb 13, 2018: BioLife Solutions Executes OEM Agreement with MilliporeSigma 103

6.50 Feb 12, 2018: Pulmatrix Announces First Subject Dosed in Phase 1 Clinical Trial of Pulmazole-an Inhaled Dry-Powder iSPERSE Formulation of Itraconazole 104

6.51 Feb 09, 2018: Novartis layoffs to start in April at closing Broomfield plant 104

6.52 Feb 08, 2018: Teva Reports 2017 Full Year and Fourth Quarter Financial Results 104

6.53 Feb 07, 2018: Orion Group Financial Statement Release for 2017 113

6.54 Feb 07, 2018: GSK delivers improvements in sales, margins and cash flow in 2017 121

6.55 Feb 06, 2018: MannKind Names David Kendall As Chief Medical Officer 122

6.56 Feb 06, 2018: Teva Pharmaceuticals laid off 46 employees in Parsippany 122

6.57 Jan 29, 2018: Novartis India Appoints Jawed Zia As Vice Chairman And Managing Director 123

6.58 Jan 26, 2018: GSK announces CHMP positive opinion for labelling update to Relvar Ellipta in patients with asthma 123

6.59 Jan 26, 2018: OPKO Health Announces Resignation Of Gregory Henderson As President Of BioReference Laboratories 123

6.60 Jan 25, 2018: 3M Reports Fourth-Quarter 2017 Results; Raises 2018 Earnings Outlook 124

6.61 Jan 19, 2018: Teva Layoffs To Affect 65 Employees In Horsham, North Wales 126

6.62 Jan 10, 2018: Boehringer Ingelheim's Respimat Inhaler Awarded Arthritis Foundation's Ease of Use Commendation 126

6.63 Jan 09, 2018: Representative Director and President of GlaxoSmithKline Corporation Personnel notice 127

7 Appendix 235

7.1 Methodology 235

7.2 About GlobalData 238

7.3 Contact Us 238

7.4 Disclaimer 238

List of Figure

1.2 List of Figures

Figure 1: Dry Powder Inhaler Devices-Pipeline Products by Stage of Development 10

Figure 2: Dry Powder Inhaler Devices-Pipeline Products by Territory 11

Figure 3: Dry Powder Inhaler Devices-Pipeline Products by Regulatory Path 12

Figure 4: Dry Powder Inhaler Devices-Pipeline Products by Estimated Approval Date 13

Figure 5: Dry Powder Inhaler Devices-Ongoing Clinical Trials 14

List of Table

1.1 List of Tables

Table 1: Dry Powder Inhaler Devices-Pipeline Products by Stage of Development 10

Table 2: Dry Powder Inhaler Devices-Pipeline Products by Territory 11

Table 3: Dry Powder Inhaler Devices-Pipeline Products by Regulatory Path 12

Table 4: Dry Powder Inhaler Devices-Pipeline Products by Estimated Approval Date 13

Table 5: Dry Powder Inhaler Devices-Ongoing Clinical Trials 14

Table 6: Dry Powder Inhaler Devices Companies-Pipeline Products by Stage of Development 15

Table 7: Dry Powder Inhaler Devices-Pipeline Products by Stage of Development 16

Table 8: Acorda Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 17

Table 9: CVT-427 Drug Delivery Device-Product Status 17

Table 10: CVT-427 Drug Delivery Device-Product Description 17

Table 11: INBRIJA-Product Status 18

Table 12: INBRIJA-Product Description 18

Table 13: Adamis Pharmaceuticals Corp Pipeline Products & Ongoing Clinical Trials Overview 19

Table 14: Taper DPI-Product Status 19

Table 15: Taper DPI-Product Description 19

Table 16: Advent Pharmaceuticals Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 20

Table 17: g60 Dry Powder Inhaler-Product Status 20

Table 18: g60 Dry Powder Inhaler-Product Description 20

Table 19: Aespira Ltd. Pipeline Products & Ongoing Clinical Trials Overview 21

Table 20: resQhaler-Product Status 21

Table 21: resQhaler-Product Description 21

Table 22: AKELA Pharma Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 22

Table 23: Fentanyl TAIFUN Inhaler-Product Status 22

Table 24: Fentanyl TAIFUN Inhaler-Product Description 22

Table 25: AstraZeneca Plc Pipeline Products & Ongoing Clinical Trials Overview 23

Table 26: Duaklir Genuair Metered Dose Inhaler-Product Status 23

Table 27: Duaklir Genuair Metered Dose Inhaler-Product Description 23

Table 28: Bayer AG Pipeline Products & Ongoing Clinical Trials Overview 24

Table 29: Ciprofloxacin Dry Powder Inhaler-Product Status 24

Table 30: Ciprofloxacin Dry Powder Inhaler-Product Description 24

Table 31: Bespak Europe Ltd Pipeline Products & Ongoing Clinical Trials Overview 25

Table 32: DEV610 DPI-Product Status 25

Table 33: DEV610 DPI-Product Description 25

Table 34: Boehringer Ingelheim GmbH Pipeline Products & Ongoing Clinical Trials Overview 26

Table 35: Next Generation Respimat Inhaler-Product Status 26

Table 36: Next Generation Respimat Inhaler-Product Description 26

Table 37: Circassia Pharmaceuticals Plc Pipeline Products & Ongoing Clinical Trials Overview 27

Table 38: Tiotropium bromide DPI-Product Status 27

Table 39: Tiotropium bromide DPI-Product Description 27

Table 40: GlaxoSmithKline Plc Pipeline Products & Ongoing Clinical Trials Overview 28

Table 41: Gemini Multi-Dose Combination Inhaler-Product Status 28

Table 42: Gemini Multi-Dose Combination Inhaler-Product Description 28

Table 43: MannKind Corp Pipeline Products & Ongoing Clinical Trials Overview 29

Table 44: Dreamboat-Product Status 29

Table 45: Dreamboat-Product Description 29

Table 46: Treprostinil Technosphere-Product Status 30

Table 47: Treprostinil Technosphere-Product Description 30

Table 48: MannKind Corp-Ongoing Clinical Trials Overview 31

Table 49: Treprostinil Technosphere-Phase I Clinical Study of Treprostinil Technosphere (TreT) for Pulmonary Arterial Hypertension 32

Table 50: Monash University Pipeline Products & Ongoing Clinical Trials Overview 33

Table 51: Aerosol Delivery System-Product Status 33

Table 52: Aerosol Delivery System-Product Description 33

Table 53: Nanotherapeutics Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 34

Table 54: GelVac Intranasal Powder Vaccine Delivery System-Product Status 34

Table 55: GelVac Intranasal Powder Vaccine Delivery System-Product Description 34

Table 56: NanoGENT-Product Status 35

Table 57: NanoGENT-Product Description 35

Table 58: Nektar Therapeutics Pipeline Products & Ongoing Clinical Trials Overview 36

Table 59: Nektar Dry Powder Inhaler-Amikacin-Product Status 36

Table 60: Nektar Dry Powder Inhaler-Amikacin-Product Description 36

Table 61: OPKO Health Inc Pipeline Products & Ongoing Clinical Trials Overview 37

Table 62: Inspiromatic-Product Status 37

Table 63: Inspiromatic-Product Description 37

Table 64: Pharmaxis Ltd Pipeline Products & Ongoing Clinical Trials Overview 38

Table 65: Orbital Dry Powder Inhaler-Product Status 38

Table 66: Orbital Dry Powder Inhaler-Product Description 38

Table 67: Respira Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 39

Table 68: RT234 AOS DPI-Product Status 39

Table 69: RT234 AOS DPI-Product Description 39

Table 70: Sandoz International GmbH Pipeline Products & Ongoing Clinical Trials Overview 40

Table 71: Solis Multi-Dose Dry Powder Inhaler-Product Status 40

Table 72: Solis Multi-Dose Dry Powder Inhaler-Product Description 40

Table 73: Unit-Dose Dry Powder Inhaler-Product Status 41

Table 74: Unit-Dose Dry Powder Inhaler-Product Description 41

Table 75: Sheffield Hallam University Pipeline Products & Ongoing Clinical Trials Overview 42

Table 76: Dry Powder Inhaler-Product Status 42

Table 77: Dry Powder Inhaler-Product Description 42

Table 78: Sun Pharma Advanced Research Company Ltd Pipeline Products & Ongoing Clinical Trials Overview 43

Table 79: SPARC DPI-Product Status 43

Table 80: SPARC DPI-Product Description 43

Table 81: University of Kansas Pipeline Products & Ongoing Clinical Trials Overview 44

Table 82: Dry Powder Inhaler-Product Status 44

Table 83: Dry Powder Inhaler-Product Description 44

Table 84: University of Texas Medical Branch at Galveston Pipeline Products & Ongoing Clinical Trials Overview 45

Table 85: Dry Powder Drug Delivery System-Product Status 45

Table 86: Dry Powder Drug Delivery System-Product Description 45

Table 87: Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 46

Table 88: Digitally-Connected LOMI Device-Product Status 46

Table 89: Digitally-Connected LOMI Device-Product Description 46

Table 90: SKP-2075-Product Status 47

Table 91: SKP-2075-Product Description 47

Table 92: Verona Pharma Plc Pipeline Products & Ongoing Clinical Trials Overview 48

Table 93: RPL554-Dry Powder Inhaler-Product Status 48

Table 94: RPL554-Dry Powder Inhaler-Product Description 48

Table 95: Virginia Commonwealth University Pipeline Products & Ongoing Clinical Trials Overview 49

Table 96: Dry Powder Inhaler-Product Status 49

Table 97: Dry Powder Inhaler-Product Description 49

Table 98: Glossary 237