Metered Dose Inhaler Devices-Medical Devices Pipeline Assessment, 2017

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 5

2 Introduction 6

2.1 Metered Dose Inhaler Devices Overview 6

3 Products under Development 7

3.1 Metered Dose Inhaler Devices-Pipeline Products by Stage of Development 7

3.2 Metered Dose Inhaler Devices-Pipeline Products by Territory 8

3.3 Metered Dose Inhaler Devices-Pipeline Products by Regulatory Path 9

3.4 Metered Dose Inhaler Devices-Pipeline Products by Estimated Approval Date 10

3.5 Metered Dose Inhaler Devices-Ongoing Clinical Trials 11

4 Metered Dose Inhaler Devices-Pipeline Products under Development by Companies 12

4.1 Metered Dose Inhaler Devices Companies-Pipeline Products by Stage of Development 12

4.2 Metered Dose Inhaler Devices-Pipeline Products by Stage of Development 13

5 Metered Dose Inhaler Devices Companies and Product Overview 14

5.1 Aerophase Inc Company Overview 14

5.1.1 Aerophase Inc Pipeline Products & Ongoing Clinical Trials Overview 14

5.2 Circassia Pharmaceuticals Plc Company Overview 15

5.2.1 Circassia Pharmaceuticals Plc Pipeline Products & Ongoing Clinical Trials Overview 15

5.3 Globe Medical Tech Inc Company Overview 19

5.3.1 Globe Medical Tech Inc Pipeline Products & Ongoing Clinical Trials Overview 19

5.4 Lab Automate Technologies Inc Company Overview 20

5.4.1 Lab Automate Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 20

5.5 Medicom Innovation Partner a/s Company Overview 21

5.5.1 Medicom Innovation Partner a/s Pipeline Products & Ongoing Clinical Trials Overview 21

5.6 Min USA LLC Company Overview 22

5.6.1 Min USA LLC Pipeline Products & Ongoing Clinical Trials Overview 22

5.7 Mylan NV Company Overview 23

5.7.1 Mylan NV Pipeline Products & Ongoing Clinical Trials Overview 23

5.8 Propeller Health Company Overview 24

5.8.1 Propeller Health Pipeline Products & Ongoing Clinical Trials Overview 24

5.9 Rensselaer Polytechnic Institute Company Overview 25

5.9.1 Rensselaer Polytechnic Institute Pipeline Products & Ongoing Clinical Trials Overview 25

5.10 Vectura Group Plc Company Overview 26

5.10.1 Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 26

5.11 Verona Pharma Plc Company Overview 28

5.11.1 Verona Pharma Plc Pipeline Products & Ongoing Clinical Trials Overview 28

6 Metered Dose Inhaler Devices- Recent Developments 29

6.1 May 17, 2017: Teva Showcases Asthma Research at the 2017 American Thoracic Society International Conference 29

6.2 May 10, 2017: Mylan Reports First Quarter 2017 Results 30

6.3 May 08, 2017: Dr. Stephen S. Lane joins Alcon as Chief Medical Officer and Global Head Franchise Clinical Strategy 32

6.4 May 02, 2017: Merck Announces First-Quarter 2017 Financial Results 32

6.5 May 01, 2017: Mylan Nominates Sjoerd Vollebregt for Election to Board of Directors 34

6.6 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 35

6.7 Apr 10, 2017: Dr. John H. Noseworthy Nominated to Stand for Election to Merck Board of Directors 39

6.8 Apr 06, 2017: Merck Receives 2017 ENERGY STAR Sustained Excellence Award from U. S. Environmental Protection Agency 40

6.9 Mar 31, 2017: City Of Austin Announces Merck Economic Development Proposal 40

6.10 Mar 28, 2017: Mylan Names Former SEC Commissioner Daniel Gallagher as Chief Legal Officer 41

6.11 Mar 21, 2017: Vectura Group: Preliminary Results for the nine-month period ended 31 December 2016 42

6.12 Mar 21, 2017: Vectura Group Announces Preliminary Results for the nine-month period ended 31 December 2016 43

6.13 Mar 06, 2017: Vectura Group: Board Change 44

6.14 Mar 01, 2017: Mylan Reports Fourth Quarter and Full Year 2016 Results and Provides 2017 Guidance 45

6.15 Feb 28, 2017: Novartis shareholders approve all resolutions proposed by Board of Directors at the Annual General Meeting 47

6.16 Feb 16, 2017: Vectura achieves GBP9 million royalty cap from GSK Ellipta� products 48

6.17 Feb 02, 2017: Merck Announces Fourth-Quarter and Full-Year 2016 Financial Results 49

6.18 Jan 26, 2017: Symbicort granted paediatric exclusivity in the US 51

6.19 Jan 26, 2017: Novartis highlights progress towards access and environmental goals in 2016 Corporate Responsibility Performance Report 51

6.20 Jan 26, 2017: Achievement of sales milestone for COPD products 52

6.21 Jan 25, 2017: Novartis delivered solid 2016 performance, with Growth Products absorbing Gleevec US LOE; innovation momentum continued; announces share buyback 53

6.22 Jan 25, 2017: Daktari Achieves Milestone in Its Merck HCV Collaboration 60

6.23 Jan 11, 2017: Vectura Group: Pre-close update 60

6.24 Dec 21, 2016: Symbicort Maintenance And Reliever Therapy (SMART) now available for adolescents in the UK offering patient-adjusted asthma treatment 61

6.25 Dec 14, 2016: Consort Medical: Directorate Change 63

6.26 Dec 06, 2016: Consort Medical Reports Interim Results Results For The Six Months Ended 31 October 2016 63

6.27 Dec 01, 2016: Aptar Pharma Nears Completion Of Elastomer Component Capacity In North America 65

6.28 Nov 29, 2016: Novartis Access shares one-year learnings and announces memorandum of understanding with Rwanda 66

6.29 Nov 25, 2016: Consort Medical: CFO Appointment 67

6.30 Nov 09, 2016: Mylan Reports Third Quarter 2016 Results 67

6.31 Oct 25, 2016: Novartis delivered solid third quarter with Growth Products offsetting Gleevec patent expiration; several positive readouts for potential blockbusters 72

6.32 Oct 25, 2016: Merck Announces Third-Quarter 2016 Financial Results 79

6.33 Sep 07, 2016: New Scale-Up and Commercial Supply Agreement 82

6.34 Aug 17, 2016: Consort Medical Announces Directorate Change 82

6.35 Aug 09, 2016: Mylan Reports Strong Second Quarter 2016 Results Including Total Revenues Up 8% 83

6.36 Aug 03, 2016: Boehringer Ingelheim: Growth in all core businesses 86

6.37 Jul 19, 2016: Novartis delivered solid Q2 despite full quarter of US Gleevec generic impact; significant positive innovation news strengthens future growth prospects 88

6.38 Jul 08, 2016: Dr John Brown, Non-Executive Director, confirms date to step down 94

6.39 Jul 04, 2016: Marco Filippini Appointed Vice Coordinator of the Italian Biosimilars Group 94

6.40 Jun 16, 2016: Consort Medical Announces Final results For The Year Ended 30 April 2016 95

6.41 Jun 10, 2016: Vectura Group announces Directorate Changes 104

6.42 Jun 10, 2016: Simone Menne-new Member of the Board of Managing Directors of Boehringer Ingelheim/Responsible for Corporate Board Division Finance 104

6.43 Jun 08, 2016: Merck Expands its Investment Fund Merck Ventures 105

6.44 May 26, 2016: Vectura Group-Preliminary Results for twelve months ending 31 March 2016 105

6.45 May 25, 2016: Novartis highlights its strong foundation for long-term, sustainable growth at the third Meet Novartis Management event 113

6.46 May 24, 2016: COTA Increases Cross-Industry Support With the Addition of Celgene, Foundation Medicine HealthScape Advisors and Novartis as Strategic Investors 114

7 Appendix 116

7.1 Methodology 116

7.2 About GlobalData 119

7.3 Contact Us 119

7.4 Disclaimer 119

List of Figure

1.2 List of Figures

Figure 1: Metered Dose Inhaler Devices-Pipeline Products by Stage of Development 7

Figure 2: Metered Dose Inhaler Devices-Pipeline Products by Territory 8

Figure 3: Metered Dose Inhaler Devices-Pipeline Products by Regulatory Path 9

Figure 4: Metered Dose Inhaler Devices-Pipeline Products by Estimated Approval Date 10

Figure 5: Metered Dose Inhaler Devices-Ongoing Clinical Trials 11

List of Table

1.1 List of Tables

Table 1: Metered Dose Inhaler Devices-Pipeline Products by Stage of Development 7

Table 2: Metered Dose Inhaler Devices-Pipeline Products by Territory 8

Table 3: Metered Dose Inhaler Devices-Pipeline Products by Regulatory Path 9

Table 4: Metered Dose Inhaler Devices-Pipeline Products by Estimated Approval Date 10

Table 5: Metered Dose Inhaler Devices-Ongoing Clinical Trials 11

Table 6: Metered Dose Inhaler Devices Companies-Pipeline Products by Stage of Development 12

Table 7: Metered Dose Inhaler Devices-Pipeline Products by Stage of Development 13

Table 8: Aerophase Inc Pipeline Products & Ongoing Clinical Trials Overview 14

Table 9: Metered Dose Inhaler-Product Status 14

Table 10: Metered Dose Inhaler-Product Description 14

Table 11: Circassia Pharmaceuticals Plc Pipeline Products & Ongoing Clinical Trials Overview 15

Table 12: Fliveo-Product Status 15

Table 13: Fliveo-Product Description 15

Table 14: Fluticasone propionate/Salmeterol xinafoate pMDI-Product Status 16

Table 15: Fluticasone propionate/Salmeterol xinafoate pMDI-Product Description 16

Table 16: Circassia Pharmaceuticals Plc-Ongoing Clinical Trials Overview 17

Table 17: Fluticasone propionate/Salmeterol xinafoate pMDI-A Phase III Registration Study of Seretide Substitute (PSX2005) 18

Table 18: Fluticasone propionate/Salmeterol xinafoate pMDI-An Exploratory, Single-center, Single-dose, Open-label, Randomized, Three-way Crossover Study to Investigate the Pharmacokinetics of Three Orally Inhaled Formulations Containing Fluticasone Propionate and Salmeterol (as Xinafoate) 50/25 mcg Per Actuation Administered From a Pressurized Metered Dose Inhaler, in at Least 24 Healthy Male and Female Subjects 18

Table 19: Globe Medical Tech Inc Pipeline Products & Ongoing Clinical Trials Overview 19

Table 20: Inhaler-Product Status 19

Table 21: Inhaler-Product Description 19

Table 22: Lab Automate Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 20

Table 23: Ultrasonic Metered Dose Inhaler-Product Status 20

Table 24: Ultrasonic Metered Dose Inhaler-Product Description 20

Table 25: Medicom Innovation Partner a/s Pipeline Products & Ongoing Clinical Trials Overview 21

Table 26: Asmair-Product Status 21

Table 27: Asmair-Product Description 21

Table 28: Min USA LLC Pipeline Products & Ongoing Clinical Trials Overview 22

Table 29: Envi-Product Status 22

Table 30: Envi-Product Description 22

Table 31: Mylan NV Pipeline Products & Ongoing Clinical Trials Overview 23

Table 32: Metered Dose Inhaler-Product Status 23

Table 33: Metered Dose Inhaler-Product Description 23

Table 34: Propeller Health Pipeline Products & Ongoing Clinical Trials Overview 24

Table 35: Connected Metered Dose Inhaler-Product Status 24

Table 36: Connected Metered Dose Inhaler-Product Description 24

Table 37: Rensselaer Polytechnic Institute Pipeline Products & Ongoing Clinical Trials Overview 25

Table 38: Bloom Inhaler-Product Status 25

Table 39: Bloom Inhaler-Product Description 25

Table 40: Vectura Group Plc Pipeline Products & Ongoing Clinical Trials Overview 26

Table 41: Flutiform HFA-MDI-Product Status 26

Table 42: Flutiform HFA-MDI-Product Description 26

Table 43: Flutiform K-Haler-Product Status 27

Table 44: Flutiform K-Haler-Product Description 27

Table 45: Verona Pharma Plc Pipeline Products & Ongoing Clinical Trials Overview 28

Table 46: RPL554-Metered Dose Inhaler-Product Status 28

Table 47: RPL554-Metered Dose Inhaler-Product Description 28

Table 48: Glossary 117